Allergic Disease Onset Prevention Study

NCT05003804 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: STMC-103H-102
• Study Type: interventional
• Target: 283
• Locations: 3 countries
• Sites: 31

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.

Conditions

Atopic Dermatitis; Type 1 Hypersensitivity

Outcome Measures

Primary Outcomes (3)

• 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

  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)

  Through 56 days of study

• 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.

  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

  Through 672 days of study

• Part B: Primary Efficacy Endpoint: Incidence of physician-diagnosed atopic dermatitis at 336 days

  Incidence of physician-diagnosed atopic dermatitis at 336 days in STMC-103H-treated subjects compared to placebo

  Day 336

Secondary Outcomes (12)

• Part B Secondary Efficacy Endpoint - physician-diagnosed atopic dermatitis

  At days 168 and 672

• Part B - Secondary Efficacy Endpoint - atopic disease assessments

  At days 168, 336 and 672

• Part B Secondary Efficacy Endpoint - incidence of sensitization to food and aeroallergen

  At days 168, 336, and 672

• Part B Secondary Efficacy Endpoint - incidence of food allergy, allergic rhinitis/conjunctivitis, urticaria, and wheezing illness/asthma

  At days 168, 336, and 672

• Part B Secondary Efficacy Endpoint - Time to atopic dermatitis diagnosis

  Through 672 days of study

Other Outcomes (1)

• Part B Key Exploratory Endpoint - Mean fecal concentration of 12,13-diHOME

  At day 336

Study Arms (6)

STMC-103H Part A1

EXPERIMENTAL

Once daily dosing with one capsule of STMC-103H mixed with milk, formula, or a milk product for 28 days

Biological: STMC-103H

Placebo Part A1

PLACEBO COMPARATOR

Once daily dosing with one capsule of placebo mixed with milk, formula, or a milk product for 28 days

Biological: Placebo

STMC-102H Part A2

EXPERIMENTAL

Once daily dosing with one capsule of STMC-103H mixed with milk, formula, or a milk product for 28 days

Biological: STMC-103H

Placebo Part A2

PLACEBO COMPARATOR

Once daily dosing with one capsule of placebo mixed with milk, formula or a milk product for 28 days

Biological: Placebo

STMC-103H Part B

EXPERIMENTAL

Once daily dosing with one capsule of STMC-103H mixed with breastmilk, formula or a milk product for 336 days

Biological: STMC-103H

Placebo Part B

PLACEBO COMPARATOR

Once daily dosing with one capsule of placebo mixed with breastmilk, formula or a milk product for 336 days

Biological: Placebo

Interventions

STMC-103H BIOLOGICAL

STMC-103H is a live biotherapeutic product (LBP) containing a consortium of intestinal bacteria

STMC-102H Part A2; STMC-103H Part A1; STMC-103H Part B

Placebo BIOLOGICAL

Powder containing excipients found in STMC-103H: magnesium stearate, mannitol and silicon dioxide.

Placebo Part A1; Placebo Part A2; Placebo Part B

Eligibility Criteria

• Age: 0 Days - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• (A1). Subject is between 1 year and \< 6 years old at the time of enrollment
• Part A2 Only
• (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
• (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.
• (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.

You may not qualify if:

• All Parts (A1, A2, B)
• Subject's twin (or higher order multiple) is enrolled in STMC-103H-102
• 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

Sponsors & Collaborators

• Siolta Therapeutics, Inc.: lead

Study Sites (31)

University of Arizona Health Sciences

Tucson, Arizona, 85724, United States

Location

Arkansas Children's Research Institute

Little Rock, Arkansas, 72202, United States

Location

UCLA Health

Los Angeles, California, 90095, United States

Location

Rady Children's Hospital - San Diego

San Diego, California, 92123, United States

Location

UCSF Benioff Children's Hospital

San Francisco, California, 94158, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30329, United States

Location

Lurie Children's Hospital

Chicago, Illinois, 60611, United States

Location

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Riley Children's Health at University of Indiana

Indianapolis, Indiana, 46202, United States

Location

Johns Hopkins University School of Medicine

Baltimore, MD, Maryland, 21205, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02215, United States

Location

University of Michigan Health

Ann Arbor, Michigan, 48104, United States

Location

Northwell Healthcare

Great Neck, New York, 11021, United States

Location

NYU Langone Fink Children's

New York, New York, 10016, United States

Location

Mt. Sinai Jaffe Allergy Institute

New York, New York, 10029, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

Tribe Clinical Research

Greenville, South Carolina, 29607, United States

Location

Coastal Pediatrics Research

Summerville, South Carolina, 29486, United States

Location

Dell Medical School at UT Austin

Austin, Texas, 78723, United States

Location

UT Southwestern/Children's Health

Dallas, Texas, 75235, United States

Location

Seattle Allergy and Asthma Research Institute

Seattle, Washington, 98115, United States

Location

Univ. of Wisconsin-Madison/Jackson Research Group

Madison, Wisconsin, 53792, United States

Location

The Children's Hospital at Westmead

Westmead, New South Wales, 2145, Australia

Location

Queensland Children's Hospital

South Brisbane, Queensland, 4101, Australia

Location

The Women's and Children's Hospital

Adelaide, South Australia, 5000, Australia

Location

Monash Children's Hospital

Clayton, Victoria, 3168, Australia

Location

Murdoch Children's Research Institute

Parkville, Victoria, 3052, Australia

Location

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

Location

Centro de Neumologia Pediatrica

Caguas, Puerto Rico, 00725, Puerto Rico

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Hypersensitivity, Immediate

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind, placebo-controlled
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be enrolled in a three-part sequential approach (Parts A1, A2, and B). Part A will enroll at risk participants of 1 year to less than 6 years of age; after safety review, Part A2 will enroll at risk participants of 1 month to less than 12 months of age; and after safety review, Part B will enroll at -risk participants between 0 and 14 days of life.

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 12, 2021
• Study Start: September 1, 2021
• Primary Completion: November 26, 2024
• Study Completion: October 21, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (24); AU (6); PR (1)