Allergic Disease Onset Prevention Study
Public ClinicalTrials.gov record NCT05003804. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1b/2, Randomized, Double-blind, Placebo-controlled, Multi-center Study of STMC-103H in Neonates and Infants at Risk for Developing Allergic Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05003804
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 283 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 0 Days to 14 Days
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 1, 2021 (Actual)
- Primary completion
- Nov 26, 2024 (Actual)
- Completion
- Oct 21, 2025 (Actual)
- Last update posted
- Nov 20, 2025
2021 – 2025
United States locations
- U.S. sites
- 24
- U.S. states
- 16
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arizona Health Sciences | Tucson | Arizona | 85724 | — |
| Arkansas Children's Research Institute | Little Rock | Arkansas | 72202 | — |
| UCLA Health | Los Angeles | California | 90095 | — |
| Rady Children's Hospital - San Diego | San Diego | California | 92123 | — |
| UCSF Benioff Children's Hospital | San Francisco | California | 94158 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30329 | — |
| Lurie Children's Hospital | Chicago | Illinois | 60611 | — |
| University of Chicago Medicine | Chicago | Illinois | 60637 | — |
| Riley Children's Health at University of Indiana | Indianapolis | Indiana | 46202 | — |
| Johns Hopkins University School of Medicine | Baltimore, MD | Maryland | 21205 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02215 | — |
| University of Michigan Health | Ann Arbor | Michigan | 48104 | — |
| Northwell Healthcare | Great Neck | New York | 11021 | — |
| NYU Langone Fink Children's | New York | New York | 10016 | — |
| Mt. Sinai Jaffe Allergy Institute | New York | New York | 10029 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | — |
| Tribe Clinical Research | Greenville | South Carolina | 29607 | — |
| Coastal Pediatrics Research | Summerville | South Carolina | 29486 | — |
| Dell Medical School at UT Austin | Austin | Texas | 78723 | — |
| UT Southwestern/Children's Health | Dallas | Texas | 75235 | — |
| Seattle Allergy and Asthma Research Institute | Seattle | Washington | 98115 | — |
| Univ. of Wisconsin-Madison/Jackson Research Group | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05003804, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 20, 2025 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05003804 live on ClinicalTrials.gov.