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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, Other, Allergic rhinitis due to pollen, Allergic rhinitis due to food, Allergic rhinitis due to animal (cat) (dog) hair and dander, Asthma, 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, Infections, Immune System & Allergies, Other
Accelerating COVID-19 Therapeutic Interventions and Vaccines 4 ACUTE (ACTIV-4A)
This is a randomized, open label, adaptive platform trial to compare the effectiveness of
antithrombotic and additional strategies for prevention of adverse outcomes in COVID-19
positive inpatients
John Sheehan
All
18 Years and over
Phase 4
This study is NOT accepting healthy volunteers
NCT04505774
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Inclusion Criteria:
• ≥ 18 years of age
• Hospitalized for COVID-19
• Enrolled within 72 hours of hospital admittance or 72 hours of positive COVID test
• Expected to require hospitalization for > 72 hours
Exclusion Criteria:
• Imminent death
• Requirement for chronic mechanical ventilation via tracheostomy prior to
hospitalization
• Pregnancy
Inclusion Criteria for Arm E
Inclusion criteria contained in the master protocol in addition to the following:
Moderate illness severity •defined as non-ICU level of care at the time of randomization
(not receiving high flow nasal oxygen (HFNO), non-invasive ventilation (NIV), invasive
ventilation (IV), vasopressors or inotropes, or extracorporeal membrane oxygenation (ECMO)
OR Severe illness severity •defined as ICU level of care at the time of randomization
(receiving HFNO, NIV, IV, vasopressors or inotropes, or ECMO)
For moderate illness severity, participants are required to meet one or more of the
following risk criteria:
1. Age ≥ 65 years or
2. ≥2 of the following -
• O2 supplementation > 2 liters per minute
• BMI ≥ 35
• GFR ≤ 60
• History of Type 2 diabetes
• History of heart failure (regardless of ejection fraction)
• D dimer ≥ 2x the site's upper limit of normal (ULN)
• Troponin ≥ 2x the site's ULN
• BNP≥100 pg/mL or NT-proBNP≥300 pg/mL
• CRP ≥50 mg/L
Exclusion Criteria for Arm E
• Exclusion criteria contained in the master protocol, and
• Any condition that, in the opinion of the investigator, precludes the use of
crizanlizumab such as uncontrolled bleeding or severe anemia (hemoglobin<4 g/dL)
• Open label treatment with crizanlizumab within the past three months
Inclusion Criteria for Arm F
Inclusion criteria contained in the master protocol in addition to the following:
Moderate illness severity •defined as non-ICU level of care at the time of randomization
(not receiving high flow nasal oxygen (HFNO), non-invasive ventilation (NIV), invasive
ventilation (IV), vasopressors or inotropes, or extracorporeal membrane oxygenation (ECMO))
OR Severe illness severity •defined as ICU level of care at the time of randomization
(receiving HFNO, NIV, IV, vasopressors or inotropes, or ECMO)
For moderate illness severity, participants are required to meet one or more of the
following risk criteria:
1. Age ≥ 65 years or
2. ≥2 of the following-
• O2 supplementation > 2 liters per minute
• BMI ≥ 35
• GFR ≤ 60
• History of Type 2 diabetes
• History of heart failure (regardless of ejection fraction)
• D dimer ≥ 2x the site's upper limit of normal (ULN)
• Troponin ≥ 2x the site's ULN
• BNP≥100 pg/mL or NT-proBNP≥300 pg/mL
• CRP ≥50 mg/L
Exclusion Criteria for Arm F
In addition to the exclusion criteria noted in the master protocol, arm-specific exclusion
criteria are as follows:
• Known hypersensitivity to any SGLT2 inhibitors
• Type 1 diabetes
• History of diabetic ketoacidosis
• eGFR <20 and/or requirement for renal replacement therapy
• Open label treatment with any SGLT2 inhibitor
• Based on a recommendation from the ACTIV4 DSMB on December 19, 2020, enrollment
of patients requiring ICU level of care into the therapeutic anti-coagulation arm
was stopped due to meeting a futility threshold and a potential for harm for this
sub-group could not be excluded. Enrollment continues for moderately ill
hospitalized COVID-19 patients.
• Based on a recommendation from the ACTIV4 DSMB on June 18, 2021, enrollment of
patients not requiring ICU level of care and randomized to P2Y12 or standard care
was stopped due to meeting a futility threshold. Enrollment continues for
severely ill (ICU level of care) hospitalized COVID-19 patients.
Covid19, Coronavirus infection, Infections, Immune System & Allergies, Other
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
CARDIO-TTRansform: A Study to Evaluate the Efficacy and Safety of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Participants With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
To evaluate the efficacy of eplontersen compared to placebo in participants with ATTR-CM
receiving available standard of care (SoC). For more information, please visit
https://www.cardio-ttransform.com.
David Pham
All
18 Years to 90 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT04136171
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Inclusion Criteria:
• Females must be non-pregnant and non-lactating, and either surgically sterile or
post-menopausal or abstinent. If engaged in sexual relations of child-bearing
potential, agree to use 1 highly effective contraceptive method
• Males must be surgically sterile or, abstinent or, if engaged in sexual relations with
a woman of child-bearing potential, the participant or the participant's non-pregnant
female partner must be using a highly effective contraceptive method
• Amyloid deposits in cardiac or non-cardiac tissue confirmed by Congo Red (or
equivalent) staining OR technetium scintigraphy (99mTc -3,3-diphosphono-1,2-
propanodicarboxylic acid [DPD-Tc], 99m Tc-pyrophosphate [PYP-Tc], or 99m
Tc-hydroxymethylene-diphosphonate [HMDP-Tc]) with Grade 2 or 3 cardiac uptake in the
absence of abnormal light chains ratio, centrally confirmed
• End-diastolic interventricular septum thickness of > 12 millimeters (mm) on Screening
echocardiogram
• New York Heart Association (NYHA) class I-III
Exclusion Criteria:
• Acute coronary syndrome, unstable angina, stroke, transient ischemic attack (TIA),
coronary revascularization, cardiac device implantation, cardiac valve repair, or
major surgery within 3 months of Screening
• Cardiomyopathy not primarily caused by ATTR-CM, for example, cardiomyopathy due to
hypertension, valvular heart disease, or ischemic heart disease
• Monoclonal gammopathy of undetermined significance (MGUS) and/or alterations in
immunoglobulin free light chain (FLC) ratio unless fat, bone marrow, or heart biopsy
confirming the absence of light chain and the presence of TTR protein by mass
spectrometry or immunoelectron microscopy. For participants with chronic kidney
disease (CKD) and without presence of monoclonal protein in blood and urine, the
acceptable FLC ratio is 0.26-2.25. Results different from that may be discussed with
local hematologist, Investigator and Medical Monitor if the risks associated with the
biopsy outweigh the benefits
• Prior liver or heart transplant, and/or Left Ventricular Assist Device (LVAD) or
anticipated liver transplant or LVAD within 1 year after randomization
• Current or previous treatment with Tegsedi™ (inotersen) or Onpattro™ (patisiran) or
other oligonucleotide or ribonucleic acid (RNA) therapeutic (including small
interfering ribonucleic acid [siRNA]; does not apply to COVID-19 mitochondrial [mRNA]
vaccinations)
• Current treatment with diflunisal, doxycycline, with or without ursodeoxycholic acid,
and/or non-dihydropyridine calcium-channel blocker (e.g., verapamil, diltiazem).
Participants receiving any of these agents must respect a wash-out period of 14 days
before randomization.
Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM), Heart & Vascular, Infections, Immune System & Allergies, 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 Transplant Infection, BK Virus Infection, Kidney replaced by transplant, Infections, Immune System & Allergies, Kidney Disease & Urinary, Other
A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/MF)
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 heterozygous
for F508del and a minimal function mutation (F/MF participants).
Andrew Braun
All
12 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05033080
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Key
Inclusion Criteria:
• Heterozygous for F508del and a minimal function mutation (F/MF genotype)
• Forced expiratory volume in 1 second (FEV1) value >=40% and <=90% of predicted mean
for age, sex, and height for participants currently receiving ELX/TEZ/IVA therapy;
FEV1 >=40% and <=80% for participants not currently receiving ELX/TEZ/IVA
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
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
Mycobacterium Infections, Nontuberculous, Mycobacterium Abscessus Infection, Nontuberculous Mycobacterial Lung Disease, Nontuberculous Mycobacterial Pulmonary Infection, Infections, Immune System & Allergies, Other
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.)
Healthy Volunteers, Other, Infections, Immune System & Allergies, Children's & Adolescent Health, Atopic Dermatitis, Type 1 Hypersensitivity
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