Allergic Disease Onset Prevention Study
- Conditions
- Atopic DermatitisType 1 Hypersensitivity
- Registration Number
- NCT05003804
- Lead Sponsor
- Siolta Therapeutics, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 264
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All Parts (A1, A2, B)
- Subject's parent(s)/legal representative(s) providing consent must be 18 years or older
- 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
- 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
- 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.
-
All Parts (A1, A2, B)
- Subject's twin (or higher order multiple) is enrolled in STMC-103H-102
- 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).
- Subject is acutely ill or on systemic antibiotics at the time of enrollment
- 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
- 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.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Part A1 and A2: Assess safety and tolerability of STMC-103H in children and infants at risk for development of allergic disease by assessing adverse events (AE), serious adverse events (SAE), and AEs of special interest Through 56 days of study Frequency, type, and severity of AEs and SAEs, including AEs of special interest (AESI) as in Appendix 9 (Adverse Events of Special Interest) and Appendix 10 (Adverse Event Grading Scale)
Part B: Assess the safety, tolerability of STMC-103H in neonate and infants subjects at risk for development of atopic disease by monitoring AEs, SAEs, AESI, physical exam findings, and clinical safety laboratories. Through 672 days of study Frequency, type and severity of AEs, SAEs, and AESIs as in Appendix 9 (Adverse Events of Special Interest) and Appendix 10 (Adverse Event Grading Scale), as well as clinically significant findings on physical examinations including growth (length, weight, height and head circumference) and vital signs (RR, HR, and temperature); clinical safety laboratories including complete blood count with manual differential and blood chemistry
Part B: Primary Efficacy Endpoint: Incidence of physician-diagnosed atopic dermatitis at 336 days Day 336 Incidence of physician-diagnosed atopic dermatitis at 336 days in STMC-103H-treated subjects compared to placebo
- Secondary Outcome Measures
Name Time Method Part B Secondary Efficacy Endpoint - Time to first wheezing episode Through 672 days of study Time to first wheezing episode by physician assessment
Part B Secondary Efficacy Endpoint - physician-diagnosed atopic dermatitis At days 168 and 672 Incidence of physician-diagnosed atopic dermatitis
Part B Secondary Efficacy Endpoint - incidence of food allergy, allergic rhinitis/conjunctivitis, urticaria, and wheezing illness/asthma At days 168, 336, and 672 Incidence of physician-diagnosed food allergy, allergic rhinitis/conjunctivitis, urticaria and wheezing illnesses/asthma using physician assessment, Allergic Disease Assessment and Diagnosis questionnaire, and Allergic Disease Diagnostic Criteria \& Severity Evaluation
Part B Secondary Efficacy Endpoint - severity of atopic dermatitis by Severity Scoring Of Atopic Dermatitis (SCORAD) assessment At days 168, 336 and 672 Severity of atopic dermatitis by SCORAD assessment
Part B Secondary Efficacy Endpoint - incidence of sensitization to food and aeroallergen At days 168, 336, and 672 Incidence of sensitization to food and aeroallergen as measured by specific serum IgE levels
Part B Secondary Efficacy Endpoint - Time to atopic dermatitis diagnosis Through 672 days of study Time to atopic dermatitis diagnosis by physician assessment
Part B Secondary Efficacy Endpoint - severity of atopic dermatitis by Investigator Global Assessment x Body Surface Area (IGAxBSA) assessment At days 168, 336 and 672 Severity of atopic dermatitis by IGAxBSA assessment
Part B Secondary Efficacy Endpoint - Severity of Wheezing Illness/Asthma At days 68, 336, and 672 days Severity of wheezing illness/asthma by Wheezing Severity Assessment
Part B - Secondary Efficacy Endpoint - atopic disease assessments At days 168, 336 and 672 Proportion of subjects who develop any atopic disease (atopic dermatitis, food allergy, allergic rhinitis/conjunctivitis, asthma)
Part B Secondary Efficacy Endpoint - use of concomitant medications for allergic symptoms or diagnosis Through 672 days of study Concomitant medications prescribed/used for allergic symptoms or diagnosis and use of rescue medications for atopic dermatitis and wheezing/asthma
Part B Secondary Efficacy Endpoint - Peripheral Eosinophil Counts At day 336 Peripheral eosinophil counts by automated differential
Part B Secondary Efficacy Endpoint - Total Serum IgE At days 168, 336, and 672 Total serum IgE levels
Trial Locations
- Locations (31)
University of Arizona Health Sciences
🇺🇸Tucson, Arizona, United States
Arkansas Children's Research Institute
🇺🇸Little Rock, Arkansas, United States
UCLA Health
🇺🇸Los Angeles, California, United States
Rady Children's Hospital - San Diego
🇺🇸San Diego, California, United States
UCSF Benioff Children's Hospital
🇺🇸San Francisco, California, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Lurie Children's Hospital
🇺🇸Chicago, Illinois, United States
University of Chicago Medicine
🇺🇸Chicago, Illinois, United States
Riley Children's Health at University of Indiana
🇺🇸Indianapolis, Indiana, United States
Scroll for more (21 remaining)University of Arizona Health Sciences🇺🇸Tucson, Arizona, United States