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within category "Infections, Immune System & Allergies"
Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
Childhood Allergy and the Neonatal Environment (CANOE)
The purpose of this research study is to study the relationship between childhood asthma,
allergies, and early-life environmental factors that may cause childhood asthma and
allergies. Previous birth cohort studies have found early-life environmental factors such as
allergies, pollutants, viruses and bacteria have all contributed to the development of asthma
and allergies. Investigators are doing this research because there continues to be a strong
need to understand the root causes of asthma and allergies. The CANOE study is an
observational cohort study, which means investigators are not asking participants or
participant's child to change their medications and investigators will not be giving
participants or participant's child a study drug.
Anne Singh
All
Not specified
NA
This study is NOT accepting healthy volunteers
NCT04215783
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Inclusion Criteria:
1. History of or concurrent asthma or allergic rhinitis (hay fever) in either biologic
parent or sibling (at least one shared biological parent) by parental report. The
presence of paternal or sibling allergy or asthma will be ascertained by maternal
report.
2. Maternal age greater than or equal to 18 years at the time of study enrollment.
Exclusion Criteria:
1. Maternal HIV infection at time of delivery.
2. Plans for the family to move out of the geographic area during the period of the
study.
3. Does not speak English.
4. Current maternal use of progesterone during pregnancy to prevent preterm birth.
• Progesterone use is only an exclusion if currently being taken at time of
enrollment for preterm birth. Previous use to prevent preterm birth or use at any
time for other indications is allowed.
5. Pregnancy is a result of an embryo donor (egg and sperm donor pregnancies are
permitted).
6. Past or current medical problems or findings from physical examination or laboratory
testing which, in the opinion of the investigator or designee, may pose additional
risks from participation in the study, may interfere with the participant's ability to
comply with study requirements or that may impact the quality or interpretation of the
data obtained from the study.
Asthma in Children, Allergy, Allergic rhinitis due to animal (cat) (dog) hair and dander, Allergic rhinitis due to food, Allergic rhinitis due to pollen, Asthma, Other, Infections, Immune System & Allergies
Comparison of Two- Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease (MAC2v3)
NTM therapy consists of a multi-drug macrolide based regimen for 18-24 months. Treated
patients frequently experience debilitating side effects, and many patients delay the start
of antibiotic treatment due to these risks. Common side effects include nausea, diarrhea, and
fatigue, and rare but serious toxicities include ocular toxicity, hearing loss, and
hematologic toxicity. To date, most of the evidence underlying the current treatment
recommendations has come from observational studies in which either a macrolide has been
combined with rifampin and ethambutol, or in some cases combined with ethambutol alone. The
proposed study will answer whether a third drug is necessary or whether taking two drugs can
increase tolerability without a substantial loss of efficacy.
Christopher Saddler
All
18 Years and over
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT03672630
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Inclusion Criteria:
• Culture positive pulmonary MAC meeting ATS/IDSA disease criteria
• Age over 18 years
• Ability to provide informed consent
Exclusion Criteria:
• Fibrocavitary disease
• Planned surgery for MAC disease
• Patients who have cumulatively taken 6 weeks or more of multi-drug antimicrobial
treatment for MAC
• Patients who are currently taking or have taken multi-drug antimicrobial treatment for
NTM within the prior 30 days
• Diagnosis of Cystic fibrosis
• Diagnosis of HIV
• History of solid organ or hematologic transplant
• Significant drug-drug interaction not clinically manageable in the opinion of the
investigator
• Contraindication to any component of the study treatment regimen
Mycobacterium Avium Complex, Nontuberculous Mycobacterium Infection, Infection due to other mycobacteria, Other, Infections, Immune System & Allergies
The goal of this study is to establish a birth cohort that collects prenatal and early life
biosamples and environmental samples and rigorously phenotypes young children for food
allergy and Atopic Dermatitis (AD) to identify prenatal and early life markers of high risk
for food allergy and AD, as well as biological pathways (endotypes) that result in these
conditions.
Primary Objectives:
- To study the role and interrelationships of established and novel clinical,
environmental, biological, and genetic prenatal and early-life factors in the
development of allergic diseases through age 3 years, with an emphasis on atopic
dermatitis and food allergy
- To apply systems biology to identify mechanisms and biomarkers underlying the
development of food allergy, atopic dermatitis, and their endotypes
- To collect, process, and assay or store environmental and biological samples for current
and future use in the study of allergic disease development
James Gern
All
0 Years and over
NA
This study is also accepting healthy volunteers
NCT04798079
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Inclusion Criteria:
Pregnant Women-
Pregnant women who meet all of the following criteria are eligible for enrollment as study
participants:
1. Age 18 years or older
2. Able to understand the oral and written instructions associated with study visits and
procedures and provide informed consent
3. Pregnant at any stage
4. Planning to give birth at a study-site designated center
5. Agrees to enroll offspring into the study at birth
6. In the case of multiple gestation, agrees to enroll only one child who will be
selected by randomized birth order
Biological Fathers-
Biological fathers who meet all of the following criteria are eligible for enrollment as
study participants:
1. Age 18 years or older
2. Able to understand the oral and written instructions associated with study visits and
procedures and provide informed consent
Exclusion Criteria:
Pregnant Women-
Pregnant women who meet any of these criteria are not eligible for enrollment:
1. Inability or unwillingness to comply with study protocol
2. Serious pregnancy complication (in the judgement of the investigator) prior to
enrollment
3. Fetus has a major chromosomal anomaly
4. Plans to move and would not be available for in-person visits at a study site
5. Plans to give up her child for adoption at birth
6. Pregnancy is the result of an egg donation
Infants-
Infants who meet any of these criteria are not eligible for enrollment:
1. Delivered earlier than 34 weeks of gestation
2. Sibling already enrolled
3. Born with a significant birth defect or medical condition, and in the judgment of the
investigators, participation is not in the infant's best interest
Biological Father-
1. Biological fathers who are unable or unwilling to comply with the study protocol as it
pertains to the biological father's participation are not eligible for enrollment
----Note Regarding Legal Guardians who are not the Biological Parents:
1. At screening for enrollment of either the mother or the child, if the biological
mother intends to give the infant up for adoption, neither the mother nor the child
are eligible for enrollment
2. If the biological mother gives up legal guardianship of the child during the child's
follow-up period, the child may remain enrolled as long as the new legal guardian:
• Agrees to meet the child's study requirements, and
• Provides written informed consent for the child's continued participation.
3. Throughout the protocol where it refers to the mother, father, or parent answering
questionnaires about the child or collecting samples from the child and the child's
primary home, the legal guardian who provides consent for the child's participation
may complete those procedures
Prospective Study of Pregnancy in Women With Cystic Fibrosis (MAYFLOWERS)
In this study, the investigators aim to evaluate changes in lung function in women with
cystic fibrosis (CF) during pregnancy and for 2 years after pregnancy based on exposure to
highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators.
Erin Lowery
Female
16 Years and over
NA
This study is NOT accepting healthy volunteers
NCT04828382
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Inclusion Criteria:
• Pregnant, intending to continue pregnancy, enrolled in the Cystic Fibrosis Foundation
Patient Registry (CFFPR)
Exclusion Criteria:
• None
Pregnancy Related, Cystic Fibrosis, Cystic fibrosis, Other
This study measures the safety, feasibility, and efficacy of viral-specific T cells (VST)
against BK Virus (BKV) in adult kidney transplant recipients. Participants are expected to be
on study for 52 weeks.
Sandesh Parajuli
All
18 Years to 75 Years old
Phase 1
This study is also accepting healthy volunteers
NCT05042076
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Inclusion Criteria:
• Age18 ≤ 75 years
• Have BKV infection/viremia following kidney transplantation, where BKV viremia is
defined as positive BKV qPCR (≥ 250 copies)
• Have evidence of invasive BKV infection (BK Nephropathy)
• Experience one of the following:
• New, persistent and/or worsening BKV-related symptoms, signs and/or markers of
end organ compromise despite being on lower immunosuppressive medication
• Adverse effects of lower immunosuppressive medications (e.g., dnDSA, biopsy
proven rejection)
• Eligible Donor
• Provide Written informed consent
Exclusion Criteria:
• Non-kidney organ transplant recipient
• Patient with acute rejection of the kidney allograft at time of T-cell transfer
• Patient receiving steroids (>0.5 mg/kg body weight (BW) prednisone equivalent) at the
time of T-cell transfer
• Patient treated with Thymoglobulin (ATG), Alemtuzumab or T-cell immunosuppressive
monoclonal antibodies within 28 days prior to T-cell transfer
• Extra renal tissue invasive BK infection
• Concomitant enrollment in another clinical trial interfering with endpoints of this
study
• Any medical condition which could compromise participation in the study according to
the investigator's assessment
• Known HIV infection
• Female patient who is pregnant or breast-feeding, or adult of reproductive potential
not willing to use an effective method of birth control during study treatment Note:
Women of childbearing potential must have a negative urine pregnancy test at study
entry.
• Patients unwilling or unable to comply with the protocol or unable to give informed
consent
Donor Eligibility
• ≥ 18 years old
• Available and capable of undergoing a single standard 2 blood volume leukapheresis
• HLA Compatible (see Donor selection priority below):
• Original kidney transplant donor
• Fully HLA matched family member (6/6 HLA match considering HLA-A, HLA-B and
HLA-DRB1 genes)
• Partially matched family member (≥ 2/6 HLA match, considering HLA-A, HLA-B and
HLA-DRB1 genes)
• BK IgG seropositive
• Meets the criteria for donor eligibility defined in the UW Program for Advanced Cell
Therapy Standard Operating Policies and Procedures for Donor Evaluation and
Eligibility Determination for the Donation of Viral Specific T Cells, which is in
compliance with FACT standards for Immune Effector Cells, and 21 CFR 1271, subpart C.
• Provide written informed consent
Donor selection priority: The original kidney donor will be the first choice of donor
peripheral mononuclear cells. If the original donor is not available or does not meet all
donor eligibility criteria, alternative related donors will be selected, with preference
for fully matched related donors (6/6 HLA match, considering HLA-A, -B, and -DRB1 genes)
over related donors with partial HLA match (≥ 2/6 HLA match, considering HLA-A, -B, and
-DRB1 genes).
Note that if the selected donor is related, but not a biological parent or child of the
recipient (i.e., at least haploidentical), then high resolution testing of HLA-A and HLA-B
will be performed on donor and recipient (if high resolution HLA genotyping not already
available in the medical record). If the degree of matching at high resolution reveals a
less favorable match than an alternative donor, then prioritization of the alternative
donor will occur.
Kidney replaced by transplant, Other, Kidney Transplant Infection, BK Virus Infection, Infections, Immune System & Allergies, Kidney Disease & Urinary
A Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive (TCR) CFTR Mutation and No F508del Mutation
The purpose of this study is to evaluate the efficacy and safety of
VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who are homozygous for
F508del, heterozygous for F508del and a gating (F/G) or residual function (F/RF) mutation, or
have at least 1 other TCR CF transmembrane conductance regulator (CFTR) gene mutation and no
F508del mutation.
Andrew Braun
All
12 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05076149
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Key
Inclusion Criteria:
• Participant has one of the following genotypes:
• Homozygous for F508del;
• Heterozygous for F508del and a gating (F/G) mutation;
• Heterozygous for F508del and a residual function (F/RF) mutation;
• At least 1 other TCR CFTR gene mutation identified as responsive to ELX/TEZ/IVA
and no F508del mutation
• Forced expiratory volume in 1 second (FEV1) value >=40% and <=90% of predicted mean
for age, sex, and height for participants currently receiving CFTR protein modulator
therapy; FEV1 >=40% and <=80% for participants not currently receiving CFTR protein
modulator therapy
Key
Exclusion Criteria:
• History of solid organ or hematological transplantation
• Hepatic cirrhosis with portal hypertension, moderate hepatic impairment (Child Pugh
Score 7 to 9), or severe hepatic impairment (Child Pugh Score 10 to 15)
• Lung infection with organisms associated with a more rapid decline in pulmonary status
• Pregnant or breast-feeding females
Other protocol defined Inclusion/Exclusion criteria may apply
Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc)
The purpose of this study is to evaluate the efficacy, safety and tolerability of oral
omadacycline as compared to placebo in the treatment of adults with Nontuberculous
Mycobacterial (NTM) pulmonary disease caused by Mycobacterium abscessus complex (MABc)
Elizabeth Misch, MD
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT04922554
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Key
Inclusion Criteria:
• Has a diagnosis of Nontuberculous Mycobacterial pulmonary disease caused by MABc
• Has at least 2 of the following NTM-infection symptoms present at Screening and
Baseline: chronic cough, coughing up blood (hemoptysis), wheezing, chest pain,
frequent throat clearing, phlegm or sputum production, shortness of breath, fatigue,
fever, night sweats, poor appetite, and/or weight loss.
• At least 1 positive pulmonary (sputum) culture for MABc in the 6 months prior to
Screening and 1 positive culture at Screening
• Radiographic evidence of MABc infection via computed tomography (CT) scan of the chest
within 3 months prior to Screening
• In the opinion of the investigator, guideline-directed antibiotic therapy for
treatment of MABc will not be required within the next 3 months, and a delay, in order
for the subject to participate in a placebo-controlled clinical trial, is considered
reasonable and clinically acceptable
• Additional inclusion criteria as per protocol
Key
Exclusion Criteria:
• Has received antibiotic treatment within 6 months prior to Screening for MABc or MAC
• Has received systemic or inhaled antibiotic therapy (other than chronic macrolide
therapy) within 4 weeks prior to Screening
• Has any of the following medical conditions:
• Active pulmonary malignancy, or any type of malignancy requiring chemotherapy or
radiation within 1 year prior to Screening
• Active allergic bronchopulmonary mycosis, or any other condition requiring chronic
treatment with systemic corticosteroids within 90 days prior to Screening
• Radiologic evidence of cavitary disease
• Known active pulmonary tuberculosis
• Cystic fibrosis
• History of lung transplantation
• Another advanced lung disease with a known percent predicted forced expiratory volume
in 1 second < 30%.
• Disseminated or extra-pulmonary NTM disease
• Has been previously treated with omadacycline
• Has a history of hypersensitivity or allergic reaction to tetracyclines
• Additional exclusion criteria as per protocol
This is a Phase 1b/2, randomized, double-blind, multi-center study to evaluate the safety,
tolerability, and preliminary clinical efficacy of STMC-103H in neonates and infants at risk
for developing allergic disease (Type 1 hypersensitivity). Subjects will be enrolled in a
three-part sequential approach. Participants in the safety-run portion of the study (Part A1:
1 year to <6 years of age and A2: 1 month to <12 months of age) will receive 28 days of
treatment with STMC-103H or placebo, followed by 28 days of follow-up. A Data and Safety
Monitoring Committee (DSMC) will review safety data after all patients in each part complete
28 days of therapy prior to enrolling the next part. After A2, Part B will enroll 224
patients for 336 days of treatment with STMC-103H or placebo, followed by 336 days of
follow-up. Stool, blood, and optional samples will be collected in Parts A2 and part B.
Primary safety endpoints are frequency, type and severity of Adverse Events (AEs) and Serious
Adverse Events (SAEs), as well as findings on physical exams, vitals, and safety
laboratories. The primary efficacy endpoint is incidence of physician-diagnosed atopic
dermatitis at day 336.
Daniel Jackson
All
0 Days to 14 Days old
Phase 1/Phase 2
This study is also accepting healthy volunteers
NCT05003804
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Inclusion Criteria:
• All Parts (A1, A2, B)
1. Subject's parent(s)/legal representative(s) providing consent must be 18 years or
older
2. Biological mother and/or biological father and/or full sibling(s), have a history
of asthma, atopic dermatitis, food allergy, or allergic rhinitis as determined by
the screening questionnaire
3. Subject's parent(s)/legal representative(s) (if appropriate according to local
laws) is/are willing and able to give informed consent for participation in the
study
4. Subject's parent(s)/legal representative(s) (if appropriate according to local
laws) is/are willing and able, in the PI's opinion, to comply with all study
requirements
Part A1 Only
Inclusion criteria 1-4 for all parts plus:
5 (A1). Subject is between 1 year and < 6 years old at the time of enrollment
Part A2 Only
Inclusion criteria 1-4 for all parts plus:
5 (A2). Subject is between 28 days and < 12 months of life at the time of enrollment 6
(A2). Subject's parent(s)/legal representative(s) do not plan to give probiotics (including
infant formula that contain probiotics) to the subject during the trial
Part B Only
Inclusion criteria 1-4 for all parts plus:
5 (B). Subject is ≤ 14 days of life at the time of enrollment. Sites should make every
effort to enroll newborns as soon as possible after birth.
6 (B). Subject has a birthweight ≥ 2.5 kg and ≤ 4.5 kg 7 (B). Subject's parent(s)/legal
representative(s) do not plan to give probiotics (including infant formula that contain
probiotics) to the subject from the time of birth to the end of the trial.
Exclusion Criteria:
• All Parts (A1, A2, B)
1. Subject's twin (or higher order multiple) is enrolled in STMC-103H-102
2. Subject has any congenital abnormalities or condition, significant disease,
illness, physical exam finding, or disorder that, in the opinion of the PI, may
put the subject at safety risk or is likely to hinder feeding or affect
metabolism that may influence the results of the study. (Neonatal
hyperbilirubinemia (jaundice), including jaundice that requires phototherapy,
should not be considered exclusionary).
3. Subject is acutely ill or on systemic antibiotics at the time of enrollment
4. Subject is participating in another interventional clinical study involving
investigational medication, formula, probiotic, or prebiotic use within 30 days
(or five half-lives, whichever is longer) of this study
5. Subject has evidence of immune deficiency/immune compromise in the judgment of
the investigator
Part B Only
Exclusion Criteria 1-5 for all parts plus:
6 (B). Subject was born at < 35 weeks' gestation 7 (B). Biological maternal medical
condition during the pregnancy that, in the opinion of the PI, may put the subject at risk
because of participation in the study. (Maternal antibiotics during the time of delivery
should not be considered exclusionary.)
Atopic Dermatitis, Type 1 Hypersensitivity, Healthy Volunteers, Other, Infections, Immune System & Allergies, Children's & Adolescent Health
Phase I Trial to Evaluate VLP Peanut in Healthy and Peanut Allergic Subjects (PROTECT)
This phase I clinical trial is designed to evaluate the safety and tolerability of VLP Peanut
in healthy subjects and in subjects with peanut allergy (PA). This clinical trial will
evaluate the immunotoxicity profile of VLP Peanut in healthy subjects and assess the
immunotoxicity profile and the degree of reactogenicity (allergenicity) in subjects with PA.
This clinical trial will also explore preliminary proof of efficacy of VLP Peanut in subjects
with PA.
Mark Moss
All
18 Years to 50 Years old
Phase 1
This study is also accepting healthy volunteers
NCT05476497
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Part A Main
Inclusion Criteria:
1. Capable of giving signed informed consent.
2. Subject who has a signed and dated Informed Consent Form (ICF).
3. Subject must be 18 to 50 years inclusive, at the time of signing the ICF.
4. Male or female.
5. Female subjects who are not of childbearing potential (or females of childbearing
potential who agree to comply with the contraceptive requirements of the clinical
trial protocol).
6. Good general health, as determined by the Investigator.
7. A positive SPT to histamine.
The following additional inclusion criteria are only applicable to the healthy
subjects in Group A1:
8. Healthy subjects (non-atopic) with no clinically significant co-morbidity (including
broncho-reactive airway disease like asthma, current allergic rhinitis, etc.).
9. Subjects with no history of allergy or intolerance to peanut or any other food and who
consume peanuts with no effect.
10. Subjects with lack of sensitivity to peanut allergen confirmed by SPT using whole
peanut extract.
11. Peanut specific immunoglobulin E (IgE) <0.1 kU/L.
12. Ara h 2 specific IgE <0.1 kU/L.
13. Subjects with negative basophil activation test (BAT).
The following additional inclusion criteria are only applicable to the subjects with
PA in Group A2:
14. Clinical history of physician diagnosed PA.
15. Peanut allergen sensitivity confirmed by SPT and IgE.
16. Subjects who currently adhere to a strict peanut-free diet and who agree to continue
this for the duration of the clinical trial.
17. Subjects who are able to handle and correctly use an adrenaline auto-injector.
Part B Main
Inclusion Criteria:
1. Capable of giving signed informed consent.
2. Subject who has a signed and dated ICF.
3. Subjects aged 18 to 50 years of age inclusive, at the time of signing the ICF.
4. Male or female.
5. Female subjects who are not of childbearing potential (or females of childbearing
potential who agree to comply with the contraceptive requirements of the clinical
trial protocol).
6. Clinical history of physician diagnosed PA.
7. Peanut allergen sensitivity confirmed by SPT and IgE.
8. Subjects with positive BAT.
9. Subjects who currently adhere to a strict peanut-free diet and who agree to continue
this for the duration of the clinical trial.
10. Good general health, as determined by the Investigator.
11. Subjects who are able to handle and correctly use an adrenaline auto-injector.
Main Exclusion Criteria Part A and B:
1. Pregnant or lactating subject.
2. Presence of any medical condition that may reduce the ability to survive a serious
allergic reaction.
3. Subjects with atopic dermatitis with >25% skin surface involvement.
4. For subjects with PA, presence of severe, poorly controlled or uncontrolled asthma.
5. History of severe or life-threatening anaphylactic reactions to peanut resulting in
neurological compromise or requiring mechanical ventilation.
6. Clinical history of severe systemic or life-threatening anaphylactic reactions to
other foods (apart from peanut), insect venom, exercise, drugs, etc. or idiopathic
anaphylaxis.
7. Unable to receive epinephrine therapy.
8. Clinical history of drug or alcohol abuse, which, in the Investigator's opinion, could
interfere with the subject's ability to participate in the clinical trial.
9. Participation in a clinical research trial with any investigational drug/placebo
within 3 months of screening (Visit 1) or concomitantly with this clinical trial.
10. Personal, financial or other dependent relationship (e.g., employee or immediate
relative) with the clinical trial site, Sponsor, Sponsor's representative, or another
individual who has access to the clinical trial protocol.
11. Vulnerable subjects or those in judicial or governmental detention, detainment or
imprisonment in a public institution.
Allergic rhinitis due to food, Other, Infections, Immune System & Allergies, Peanut Allergy
A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of
VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with cystic fibrosis.
Andrew Braun
All
12 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05444257
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Inclusion Criteria:
• Completed study drug treatment in a parent study VX20-121-102 (NCT05033080) and
VX20-121-103 (NCT05076149); or had study drug interruption(s) in a parent study but
did not permanently discontinue study drug, and completed study visits up to the last
scheduled visit of the Treatment Period in the parent study
Key
Exclusion Criteria:
• History of drug intolerance in a parent study
• Pregnant or breast-feeding females
Other protocol defined Inclusion/Exclusion criteria may apply.
Efficacy and Safety of PQ Grass in Subjects With Seasonal Allergic Rhinitis and/or Rhinoconjunctivitis Induced by Grass Pollen
The PQGrass306 (G306) clinical trial is the pivotal Phase III efficacy clinical trial of PQ
Grass.
The aim of the G306 pivotal clinical trial is to confirm the efficacy and safety of the
optimal effective dose of PQ Grass 27600 SU. This will be determined through the measurements
of the effect of PQ Grass on the symptoms of seasonal allergic rhinitis
(SAR)/rhinoconjunctivitis and the use of relief medications to control these symptoms during
the peak grass pollen season (GPS).
Mark Moss
All
18 Years to 65 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT05540717
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Inclusion Criteria:
1. Capable of giving signed informed consent as described in Appendix 1 which includes
compliance with the requirements and restrictions listed in the ICF (informed consent
form) and in this clinical trial protocol and to attend required clinical trial
visits.
2. Subject who has a signed and dated ICF.
3. Subject must be 18 to 65 years of age inclusive, at the time of signing the ICF.
4. Male or female.
5. Female subjects who are not of childbearing potential (defined as at least 12 months
natural spontaneous amenorrhoea, or at least 6 weeks following surgical
menopause/permanent sterilisation [hysterectomy, bilateral oophorectomy and bilateral
salpingectomy]) or females of childbearing potential who agree to comply with the
contraceptive requirements of the clinical trial protocol.
6. Good general health, as determined by the Investigator, based on a medical evaluation,
including medical history, physical examination, mental status assessment and
laboratory tests. A subject with a clinical abnormality or laboratory parameters
outside the reference range for the population being studied may be included only if
the Investigator agrees that the finding is unlikely to introduce additional risk
factors and will not interfere with the clinical trial procedures.
7. Positive history of moderate to severe symptoms of SAR/rhinoconjunctivitis ascribed to
grass (Pooideae) pollen exposure of at least 2 seasons duration, despite having
received allergy pharmacotherapy (e.g., antihistamines, nasal corticosteroids,
leukotriene modifiers, etc.) during the last 2 consecutive grass pollen seasons prior
to the clinical trial, confirmed by subject records.
Please note: Subjects with asthma may be included, but the asthma must be well
controlled (according to current Global Initiative for Asthma [GINA] guidelines [GINA
2022]).
8. A positive SPT (skin prick test) to histamine (wheals [longest diameter] ≥3 mm) and a
negative SPT to the negative control (wheal diameter = 0 mm) at screening.
9. A positive SPT for grass pollen (wheals [longest diameter] ≥3 mm).
10. Grass specific IgE (immunoglobulin E) class ≥2 as documented by an ImmunoCAP test at
screening.
11. Forced expiratory volume in one second (FEV1) ≥70% of predicted, with a FEV1/forced
vital capacity (FVC) ratio >75% and PEFR (peak expiratory flow rate) ≥70% of predicted
at screening.
Exclusion Criteria:
1. Pregnant or lactating subject.
2. Presence of any medical history of moderate to severe allergy symptoms (verified by a
positive SPT at screening or positive specific IgE [≥2] at screening) to any other
seasonal allergen (other than grass) or perennial allergens.
Exception: Period 1, Period 2 and Period 3 of the entire clinical trial will be
conducted outside of the pollen season(s) of concern or perennial allergies are
irrelevant due to avoidance measures (e.g., cats and dog allergy). Subjects with mild
allergy symptoms (only) to any other allergen apart from grass may be included at the
discretion of the Investigator.
3. Subjects at US clinical trial sites in regions where southern grasses (Bahia grass,
Bermuda grass or Johnson grass) are the dominant grasses and the main cause of grass
allergy symptoms with a positive SPT to any of the 3 grasses (irrespective of the
severity of symptoms).
4. Moderate to severe symptoms during the 3 years prior to Visit 1 to any other seasonal
or perennial allergen not tested in the SPT done at screening that cannot be avoided
during the Period 1 to Period 3 of the clinical trial and the symptoms of which may
interfere with administration of treatment and/or impact the data collected.
5. Presence of any medical condition that may reduce the ability to survive a serious
allergic reaction.
6. Presence of active systemic autoimmune disorder, systemic autoimmune disorders in
remission or active organ specific autoimmune disorder.
7. Presence of active malignant neoplasia, severe cardiovascular disease (e.g., coronary
artery disease, cardiac insufficiency, etc.), pulmonary insufficiency, severe
psychiatric disorders or primary and secondary immunodeficiencies.
8. History of any other immunological disorder or other diseases (including, but not
limited cardiovascular [including uncontrolled or inadequately controlled
hypertension], gastro-intestinal, hepatic, renal, haematological, neurological,
endocrine or pulmonary disease) that in the opinion of the Investigator may pose a
safety risk or compromise the interpretation of efficacy of the clinical trial
treatment.
9. Presence of severe or poorly controlled or uncontrolled asthma as defined by at least
1 of the following criteria:
1. Severe asthma (as per the current GINA guidelines [GINA, 2022]).
2. Uncontrolled or poorly controlled asthma as per the current GINA guidelines
(GINA, 2022).
3. Asthma that requires more than a daily dose above 800 μg of inhaled budesonide
(or clinically comparable inhaled corticosteroid) as per the current GINA
guidelines (GINA, 2022).
4. History of 2 or more systemic corticosteroid courses within 6 months of screening
or Visit 2 or 1 course of systemic corticosteroids within 3 months of screening
or Visit 2 to treat asthma.
5. Prior intubation/mechanical ventilation for asthma.
6. Emergency room visit or hospitalisation for asthma in the 12 months prior to
screening or Visit 2.
7. Any history of a life-threatening asthma attack.
8. FEV1 <70% of predicted or FEV1/FVC ≤75% or PEFR <70% of predicted with or without
controller medications at screening or Visit 2.
10. Presence non-atopic rhinitis and/or rhino-sinusitis (with or without polyps).
11. Presence of nasal polyps and/or chronic sinusitis.
12. Presence of any acute or chronic ocular disorder, other than allergic conjunctivitis.
13. Eye surgery within the past 6 months.
14. Presence of any skin conditions (e.g., skin abnormalities, tattoos etc.), which might
interfere with the interpretation of the SPT results.
15. Clinical history of Type I diabetes or poorly controlled Type II diabetes.
16. Moderate to severe upper or lower respiratory infections requiring medication within
14 days before screening (Visit 1) or Visit 2.
17. Presence of acute or chronic infection, fever or inflammation at screening or Visit 2.
18. Clinical history of severe systemic reaction or serious systemic reaction in response
to AIT (allergen immunotherapy) in the past.
19. Clinical history of severe or life-threatening anaphylactic reactions to foods, insect
venom, exercise, drugs or idiopathic anaphylaxis.
20. Clinical history of allergy, hypersensitivity or intolerance to the excipients of the
investigational drug/placebo.
21. Clinical history of allergy, hypersensitivity or intolerance to the relief medications
(for relief of allergy symptoms during Period 3) provided for use in this clinical
trial.
22. Clinical history of hereditary angioedema.
23. Unable to receive epinephrine therapy (i.e., use of epinephrine is contraindicated
such as in subjects with hyperthyroidism, uncontrolled hypertension, cardiac
arrhythmias, closed angle glaucoma or subjects taking other sympathomimetics).
24. Tyrosine metabolism disorders, especially tyrosinemia and alkaptonuria.
25. Clinical history of drug or alcohol abuse, which, in the Investigator's opinion, could
interfere with the subject's ability to participate in the clinical trial.
26. Subjects who have suspicion or symptoms of severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) infection (as assessed by the Investigator) or who have had
unprotected contact with a confirmed case of COVID-19 (coronavirus disease 2019) in
the 2 weeks prior to screening or Visit 2 (based on the Investigator's discretion).
27. Subjects who were hospitalised for COVID-19 within 6 months prior to screening or
Visit 2.
28. Any history of AIT for grass pollen allergy in the past or history of AIT for any
other type of allergy (excluding food allergy) in the past 5 years.
29. Inability to adhere to the washout periods listed in the protocol, with respect to
screening and to refrain from using the medications indicated until after Visit 11.
30. Treatment with a preparation containing MPL (monophosphoryl lipid-A) (e.g., Cervarix,
Shingrix, Fendrix) within 2 years prior to Visit 1 and until after completion of Visit
11 (with the exception of the investigational drug).
31. Previous history of epinephrine auto-injector use.
32. β-blocker medication (local or systemic, including eye drops) for any indication.
33. Monoamine oxidase inhibitors and tricyclic antidepressants. Please note: Tricyclic
antidepressants should be avoided at least 2 weeks prior to screening.
34. Any previous therapy (within the previous 5 years) or current therapy with anti IgE
(e.g., omalizumab [Xolair]) or anti-interleukins (e.g., mepolizumab).
35. Current or past therapy (within the previous 5 years) with any other immunomodulary
biologics.
36. Unable to refrain from any vaccination (including influenza vaccine and COVID-19
vaccine) during the clinical trial (unless administered >30 days prior to
randomisation).
Please note: Emergency vaccinations (e.g., tetanus due to injury) can be administered
at any time. Booster vaccinations (only) for COVID-19 can be administered during the
clinical trial apart from during the treatment period. There should be at least 14
days interval from the last administration of the investigational drug/placebo prior
to administration of a COVID-19 booster injection.
37. Participation in a clinical research trial with any investigational drug within 4
weeks of Visit 1 or concomitantly with this clinical trial.
Please note: The period of exclusion begins at the time of the last visit of the prior
clinical research trial. Subjects consented and screened, but not dosed in the prior
clinical research trial are not excluded.
38. Personal, financial or other dependent relationship (e.g., employee or immediate
relative) with the clinical trial site, Sponsor, Sponsor's representative, or another
individual who has access to the clinical trial protocol.
39. Vulnerable subjects or those in judicial or governmental detention, detainment or
imprisonment in a public institution.
40. Subjects likely to have prolonged periods of absence (e.g., business or personal
travel) during the GPS defined as:
• Absence of a total of 22 days or more in similar geographical regions (as
determined by the Investigator), with no single trip in a similar geographical
region exceeding 14 days.
• Absence of a total of 15 days or more in non-similar geographic regions (as
determined by the Investigator), with no single trip in a non-similar
geographical region exceeding 7 days.
41. Have changed residence to a different geographical region(s) since the last GPS.
Exception: The old and new residences are in the same or similar geographical region as
determined by the Investigator.
Seasonal Allergic Rhinitis, Rhinoconjunctivitis, Other, Infections, Immune System & Allergies
REC 0/0559 Eye Drops for Treatment of Moderate and Severe Neurotrophic Keratitis in Adult Patients
A phase 2 study, aiming to evaluate the efficacy, safety and pharmacokinetics of REC 0/0559
in treatment of Neurotrophic Keratitis in Adult Patient in Europe and United States of
America.
Evan Warner
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT04276558
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Inclusion Criteria:
1. Have read, understood, and signed the informed consent form (ICF).
2. Be a male or female aged ≥18 years at the time of ICF signature.
3. Have stage 2 moderate (PED) or stage 3 severe (corneal ulcer) NK involving only 1 eye
(study eye) and of at least 2 weeks duration. Patients with Stage 1 NK in the fellow
eye can be enrolled.
for the study eye
4. Have no objective clinical evidence of improvement in the PED or corneal ulceration
within the 2 weeks before the screening visit despite use of conventional non-surgical
treatment (eg, nonpreserved ocular lubricants, nonpreserved topical antibiotics, oral
doxycycline, patching, serum tears, and/or therapeutic contact lenses) as determined
by the investigator's or referring physician's medical record.
5. Have decreased corneal sensitivity (≤ 4 cm using the Cochet-Bonnet aesthesiometer)
within the area of the PED or corneal ulcer and outside of the area of the defect in
at least one corneal quadrant.
6. Have a BCDVA score ≤ 75 ETDRS letters in the study eye, due to NK.
Exclusion Criteria:
1. Have participated in any clinical trial with an investigational drug/device within 2
months before the Screening Visit and throughout the study duration.
2. Have a known hypersensitivity to one of the components of the study drug or procedural
medications (eg, fluorescein), including to a compound chemically related to MT8
3. Have a presence or history of any ocular or systemic disorder or condition that might
hinder the efficacy of the study treatment or its evaluation, could possibly interfere
with the interpretation of study results, or could be judged by the investigator to be
incompatible with the study visit schedule or conduct (eg, progressive or degenerative
corneal or retinal conditions, lagophthalmos, uveitis, optic neuritis, poorly
controlled diabetes, autoimmune disease, systemic infection, neoplastic diseases), or
that may compromise the safety of the patient.
4. Have a significant history of alcohol abuse or drug/solvent abuse
5. Be unwilling to comply with any study assessments or procedures.
6. Be a woman who is pregnant, nursing or planning a pregnancy.
7. Be a woman of childbearing potential not using a highly effective method of birth
control.
8. Be a male patient who is not permanently sterile and who is not willing to use condoms
during the study and for 4 weeks after the end of study treatment.
For the study eye:
9. Have any active ocular infection (bacterial, viral, fungal or protozoal) or active
inflammation not related to NK in the study eye.
10. Have any other ocular disease requiring topical ocular treatment in the study eye
during the course of the study treatment period, except for glaucoma if treated by
preservative-free eye drop (single-agent treatment, once daily, stable regimen 4 weeks
before screening and during the study),
11. Receive topical ophthalmological treatments other than the study drug provided by the
study Sponsor and the treatments allowed by the study protocol (eg, preservative-free
artificial tears; preservative-free eye drop (single-agent treatment, once daily,
stable regimen 4 weeks before screening and during the study) for glaucoma; topical
antibiotics; other than tetracycline).
12. Have severe blepharitis and/or severe meibomian gland disease in the study eye.
13. Have severe vision loss in the study eye with no potential for visual improvement in
the opinion of the investigator as a result of the study treatment.
14. Have evidence of corneal ulceration/melting involving the posterior third of the
corneal stroma, or perforation in the study eye.
15. Have a history of any ocular surgery (including laser or refractive surgical
procedures) within 3 months before the Screening Visit in the study eye. An exception
to the preceding statement will be allowed if the ocular surgery is considered to be
the cause of the Stage 2 or 3 NK.
16. Have a history of corneal transplantation in the study eye, except if performed to
treat NK and at least 6 months prior screening.
17. Have had prior surgical procedures for the treatment of NK (eg, tarsorrhaphy,
conjunctival flap, etc.) except AMT, if at least 2 wks after the membrane has
disappeared within the area of the PED or corneal ulcer (and at least 6 weeks after
the procedure) in the study eye.
18. Use therapeutic contact lenses or wear contact lenses for refractive correction during
the study treatment periods in the eye(s) with NK.
19. Have an anticipated need for punctal occlusion during the study treatment period.
Patients with punctal occlusion or punctal plugs inserted before the study are
eligible for enrolment provided that the punctal occlusion is maintained during the
study.
20. Have an uncontrolled glaucoma at the Screening Visit. (Patients suffering from
glaucoma requiring ophthalmic drops for topical treatment at the Screening Visit or
during the study are not eligible, except if the ophthalmic drops is a
preservative-free treatment administered maximum once daily as a single-agent
treatment and at a stable regimen 4 weeks before screening and at the same dose during
the study. Patients treated with oral intraocular pressure-lowering drugs at the
Screening Visit and during the study may be enrolled if their glaucoma status is
assessed as stable and controlled.
For the fellow eye
21. Have Stage 2 or 3 NK or perforation.
For any eye:
22. Have a history of ocular cancer.
23. Have had prior treatment with Oxervate™
Vamikibart in Participants With Uveitic Macular Edema (Sandcat)
This study will assess the efficacy and safety of vamikibart in participants with uveitic
macular edema.
Laura Kopplin
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05642325
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Inclusion Criteria:
• Female participants: Agreement to remain abstinent (refrain from heterosexual
intercourse) or use contraception as defined by the protocol
• Diagnosis of macular edema associated with non-infectious uveitis (NIU)
• Diagnosis of active or inactive, acute, or chronic NIU of any etiology and of any
anatomical type (anterior, intermediate, posterior, panuveitis)
• BCVA letter score of 73 to 19 letters (inclusive) on Early Treatment Diabetic
Retinopathy Study (EDTRS)-like charts
Exclusion Criteria:
• Evidence of active or latent syphilis infection
• Evidence of active or latent tuberculosis infection and/or positive tuberculosis
assay, or previous or current HIV diagnosis
• Serious acute or chronic medical or psychiatric illness
• History of major ocular and non-ocular surgical procedures
• Uncontrolled IOP or glaucoma or chronic hypotony
• Any anatomical changes or media opacity in the study eye preventing evaluation of
retina, vitreous, and capture of study images
• Prior use of IVT biologics including anti-VEGFs less than 2-4 months prior to Day 1;
received IVT Methotrexate within 4 months prior to Day 1
• Prior macular laser therapy, cataract surgery within 6 months and laser capsulotomy
within 3 months of Day 1
• Topical corticosteroids and/or topical NSAID > 3 drops per day in the 14 days prior to
Day 1 (D1); intraocular or periocular corticosteroid injections in the 2 months prior
to D1; subconjunctival corticosteroid injection within 1 month prior to Day 1; an
OZURDEX implant in the 4 months prior to D1; YUTIQ, RETISERT or ILUVIEN implant in the
3 years prior to D1
• Diagnosis of macular edema due to any cause other than NIU
• Any major ocular conditions that may require medical or surgical intervention during
the study period to prevent vision loss
A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection (CDI-SCOPE)
This trial will be initiated to explore whether RBX2660 (REBYOTA®) could be suitable for
administration by the practice of colonoscopy. More specifically, the purpose of this trial
is to explore the safety and clinical effectiveness of RBX2660 when delivered by colonoscopy
to adults with rCDI. The experience of physicians will be documented through a
physician-experience questionnaire to explore the usability of RBX2660 in clinical practice
for colonoscopic administration. Furthermore, to explore the patient-experience of RBX2660
treatment, each trial participant will be offered to undergo a structured interview.
Nasia Safdar, MD
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05831189
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Inclusion Criteria:
• have documented evidence of rCDI (≥1 recurrence after a primary CDI episode)
• be undergoing antibiotic treatment for the qualifying rCDI episode that was diagnosed
by a stool test for the presence of toxigenic C. difficile or C. difficile toxin
• be eligible for FMT as judged by the investigator or current treatment guidelines for
rCDI in the US
• be a candidate for colonoscopy as judged by the investigator
Exclusion Criteria:
• Use or planned use of systemic antibiotics for an indication other than the qualifying
rCDI episode.
• Current uncontrolled chronic diarrhea not related to CDI.
• Receipt of CDI vaccine or treatment with CDI monoclonal antibodies within the past 12
months before screening.
• Evidence of active, severe, or fulminant colitis, diagnosis of toxic megacolon or have
a current colostomy or ileostomy
Clostridium Difficile Infection Recurrence, Enterocolitis due to Clostridium difficile, Other, Infections, Immune System & Allergies, Digestive Health & Liver Disease
A Phase 1 Study of VX-522 in Participants With Cystic Fibrosis (CF)
The purpose of this study is to evaluate the safety and tolerability of VX-522 in
participants 18 years of age and older with cystic fibrosis and a cystic fibrosis
transmembrane conductance regulator (CFTR) genotype not responsive to CFTR modulator therapy.
Andrew Braun
All
18 Years to 65 Years old
Phase 1
This study is NOT accepting healthy volunteers
NCT05668741
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Key
Inclusion Criteria:
• Body mass index is less than (<) 30.0 kilograms per meter square (kg/m^2)
• A total body weight greater than (>) 50 kg
• Stable CF disease
• CFTR gene mutations on both alleles that are not responsive to CFTR modulator therapy
o Example mutations include but are not limited to, mutations that do not produce CFTR
protein (i.e., Class I): nonsense mutations (e.g., G542X, W1282X) and canonical splice
mutations (e.g., 621+1G->T)
• Forced expiratory volume in 1 second (FEV1) value, percent of predicted mean for age,
sex, and height (equations of the Global Lung Function Initiative [GLI])18 ≥40%
Key
Exclusion Criteria:
• History of uncontrolled asthma within a year prior to screening
• History of solid organ or hematological transplantation
• Hepatic cirrhosis with portal hypertension, moderate hepatic impairment (Child Pugh
Score 7 to 9), or severe hepatic impairment (Child Pugh Score 10 to 15)
• Arterial oxygen saturation on room air less than (<) 94% at screening
Other protocol defined Inclusion/Exclusion criteria may apply.
This study is called the Microbes and Respiratory Illnesses (MARI) Study. Children growing up
on farms are exposed to many types of microbes that could be beneficial. It is thought that
increased exposure to certain types of microbes early in life helps to develop a healthy
immune system and reduce the risk for severe common cold illnesses, breathing problems, and
allergies.
James Gern
All
4 Years to 12 Years old
N/A
This study is also accepting healthy volunteers
NCT06059027
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Inclusion Criteria:
1. Participant and/or parent guardian must be able to understand and provide informed
consent
2. Children ages 4-12 years of age
3. Cohort 1: Family is self-identified as Plain community member
4. Cohort 2: Madison-area children with parental report of doctor-diagnosed asthma
5. Cohort 3: Madison-area children with no history of asthma by parental report
Exclusion Criteria:
1. Inability or unwillingness of a participant to give written informed consent or comply
with study protocol
2. Chronic sinusitis (frequent sinus infections)
3. Plans to move out of the area before completing the study
4. Past or current medical problems or findings from physical examination or laboratory
testing that are not listed above, which, in the opinion of the investigator, may pose
additional risks from participation in the study, may interfere with the participant's
ability to comply with study requirements or that may impact the quality or
interpretation of the data obtained from the study
5. Enrolled family member
Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of
vanzacaftor/tezacaftor/deutivacaftor (VNZ/TEZ/D-IVA) in participants with cystic fibrosis
(CF).
Hara Levy, MD
All
1 Year and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05844449
Show full eligibility criteria
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Key
Inclusion Criteria:
• Participants who have completed study drug treatment in the parent study
(VX21-121-105; NCT Number: NCT05422222)
Key
Exclusion Criteria:
• Hepatic cirrhosis with portal hypertension, moderate hepatic impairment, or severe
hepatic impairment that might pose an additional risk in administering study drug
• History of solid organ, hematological transplantation, or cancer
• History of drug intolerance in the parent study
Other protocol defined Inclusion/Exclusion criteria may apply.
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