Allergic Disease Onset Prevention Study

Atopic Dermatitis Clinical Trial

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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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05003804
• Other study ID #: STMC-103H-102
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: September 1, 2021
• Est. completion date: October 2025

Study information

• Verified date: January 2024
• Source: Siolta Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 264
• Est. completion date: October 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Days to 14 Days

Eligibility

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.)

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Hypersensitivity
• Hypersensitivity, Immediate

Intervention

Biological:
• STMC-103H
STMC-103H is a live biotherapeutic product (LBP) containing a consortium of intestinal bacteria
• Placebo
Powder containing excipients found in STMC-103H: magnesium stearate, mannitol and silicon dioxide.

Locations

Country	Name	City	State
Australia	The Women's and Children's Hospital	Adelaide	South Australia
Australia	Monash Children's Hospital	Clayton	Victoria
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	Murdoch Children's Research Institute	Parkville	Victoria
Australia	Queensland Children's Hospital	South Brisbane	Queensland
Australia	The Children's Hospital at Westmead	Westmead	New South Wales
Puerto Rico	Centro de Neumologia Pediatrica	Caguas
United States	University of Michigan Health	Ann Arbor	Michigan
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Dell Medical School at UT Austin	Austin	Texas
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Lurie Children's Hospital	Chicago	Illinois
United States	University of Chicago Medicine	Chicago	Illinois
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	UT Southwestern/Children's Health	Dallas	Texas
United States	Northwell Healthcare	Great Neck	New York
United States	Tribe Clinical Research	Greenville	South Carolina
United States	Riley Children's Health at University of Indiana	Indianapolis	Indiana
United States	Arkansas Children's Research Institute	Little Rock	Arkansas
United States	UCLA Health	Los Angeles	California
United States	Univ. of Wisconsin-Madison/Jackson Research Group	Madison	Wisconsin
United States	Mt. Sinai Jaffe Allergy Institute	New York	New York
United States	NYU Langone Fink Children's	New York	New York
United States	University of Rochester Medical Center	Rochester	New York
United States	Rady Children's Hospital - San Diego	San Diego	California
United States	UCSF Benioff Children's Hospital	San Francisco	California
United States	Seattle Allergy and Asthma Research Institute	Seattle	Washington
United States	Coastal Pediatrics Research	Summerville	South Carolina
United States	University of Arizona Health Sciences	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Siolta Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Part B Key Exploratory Endpoint - Mean fecal concentration of 12,13-diHOME	Mean fecal concentration of 12,13-diHOME measured in stool sample in STMC-103H arm as compared to placebo arm	At day 336
Primary	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
Primary	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
Primary	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	Part B Secondary Efficacy Endpoint - physician-diagnosed atopic dermatitis	Incidence of physician-diagnosed atopic dermatitis	At days 168 and 672
Secondary	Part B - Secondary Efficacy Endpoint - atopic disease assessments	Proportion of subjects who develop any atopic disease (atopic dermatitis, food allergy, allergic rhinitis/conjunctivitis, asthma)	At days 168, 336 and 672
Secondary	Part B Secondary Efficacy Endpoint - incidence of sensitization to food and aeroallergen	Incidence of sensitization to food and aeroallergen as measured by specific serum IgE levels	At days 168, 336, and 672
Secondary	Part B Secondary Efficacy Endpoint - incidence of food allergy, allergic rhinitis/conjunctivitis, urticaria, and wheezing illness/asthma	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	At days 168, 336, and 672
Secondary	Part B Secondary Efficacy Endpoint - Time to atopic dermatitis diagnosis	Time to atopic dermatitis diagnosis by physician assessment	Through 672 days of study
Secondary	Part B Secondary Efficacy Endpoint - Time to first wheezing episode	Time to first wheezing episode by physician assessment	Through 672 days of study
Secondary	Part B Secondary Efficacy Endpoint - severity of atopic dermatitis by Investigator Global Assessment x Body Surface Area (IGAxBSA) assessment	Severity of atopic dermatitis by IGAxBSA assessment	At days 168, 336 and 672
Secondary	Part B Secondary Efficacy Endpoint - severity of atopic dermatitis by Severity Scoring Of Atopic Dermatitis (SCORAD) assessment	Severity of atopic dermatitis by SCORAD assessment	At days 168, 336 and 672
Secondary	Part B Secondary Efficacy Endpoint - Severity of Wheezing Illness/Asthma	Severity of wheezing illness/asthma by Wheezing Severity Assessment	At days 68, 336, and 672 days
Secondary	Part B Secondary Efficacy Endpoint - use of concomitant medications for allergic symptoms or diagnosis	Concomitant medications prescribed/used for allergic symptoms or diagnosis and use of rescue medications for atopic dermatitis and wheezing/asthma	Through 672 days of study
Secondary	Part B Secondary Efficacy Endpoint - Total Serum IgE	Total serum IgE levels	At days 168, 336, and 672
Secondary	Part B Secondary Efficacy Endpoint - Peripheral Eosinophil Counts	Peripheral eosinophil counts by automated differential	At day 336