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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05003804




Registration number
NCT05003804
Ethics application status
Date submitted
4/08/2021
Date registered
12/08/2021
Date last updated
3/01/2024

Titles & IDs
Public title
Allergic Disease Onset Prevention Study
Scientific 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
Secondary ID [1] 0 0
STMC-103H-102
Universal Trial Number (UTN)
Trial acronym
adored
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Type 1 Hypersensitivity 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - STMC-103H
Treatment: Other - Placebo

Experimental: STMC-103H Part A1 - Once daily dosing with one capsule of STMC-103H mixed with milk, formula, or a milk product for 28 days

Placebo comparator: Placebo Part A1 - Once daily dosing with one capsule of placebo mixed with milk, formula, or a milk product for 28 days

Experimental: STMC-102H Part A2 - Once daily dosing with one capsule of STMC-103H mixed with milk, formula, or a milk product for 28 days

Placebo comparator: Placebo Part A2 - Once daily dosing with one capsule of placebo mixed with milk, formula or a milk product for 28 days

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

Placebo comparator: Placebo Part B - Once daily dosing with one capsule of placebo mixed with breastmilk, formula or a milk product for 336 days


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

Treatment: Other: Placebo
Powder containing excipients found in STMC-103H: magnesium stearate, mannitol and silicon dioxide.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Through 56 days of study
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Through 672 days of study
Primary outcome [3] 0 0
Part B: Primary Efficacy Endpoint: Incidence of physician-diagnosed atopic dermatitis at 336 days
Timepoint [3] 0 0
Day 336
Secondary outcome [1] 0 0
Part B Secondary Efficacy Endpoint - physician-diagnosed atopic dermatitis
Timepoint [1] 0 0
At days 168 and 672
Secondary outcome [2] 0 0
Part B - Secondary Efficacy Endpoint - atopic disease assessments
Timepoint [2] 0 0
At days 168, 336 and 672
Secondary outcome [3] 0 0
Part B Secondary Efficacy Endpoint - incidence of sensitization to food and aeroallergen
Timepoint [3] 0 0
At days 168, 336, and 672
Secondary outcome [4] 0 0
Part B Secondary Efficacy Endpoint - incidence of food allergy, allergic rhinitis/conjunctivitis, urticaria, and wheezing illness/asthma
Timepoint [4] 0 0
At days 168, 336, and 672
Secondary outcome [5] 0 0
Part B Secondary Efficacy Endpoint - Time to atopic dermatitis diagnosis
Timepoint [5] 0 0
Through 672 days of study
Secondary outcome [6] 0 0
Part B Secondary Efficacy Endpoint - Time to first wheezing episode
Timepoint [6] 0 0
Through 672 days of study
Secondary outcome [7] 0 0
Part B Secondary Efficacy Endpoint - severity of atopic dermatitis by Investigator Global Assessment x Body Surface Area (IGAxBSA) assessment
Timepoint [7] 0 0
At days 168, 336 and 672
Secondary outcome [8] 0 0
Part B Secondary Efficacy Endpoint - severity of atopic dermatitis by Severity Scoring Of Atopic Dermatitis (SCORAD) assessment
Timepoint [8] 0 0
At days 168, 336 and 672
Secondary outcome [9] 0 0
Part B Secondary Efficacy Endpoint - Severity of Wheezing Illness/Asthma
Timepoint [9] 0 0
At days 68, 336, and 672 days
Secondary outcome [10] 0 0
Part B Secondary Efficacy Endpoint - use of concomitant medications for allergic symptoms or diagnosis
Timepoint [10] 0 0
Through 672 days of study
Secondary outcome [11] 0 0
Part B Secondary Efficacy Endpoint - Total Serum IgE
Timepoint [11] 0 0
At days 168, 336, and 672
Secondary outcome [12] 0 0
Part B Secondary Efficacy Endpoint - Peripheral Eosinophil Counts
Timepoint [12] 0 0
At day 336

Eligibility
Key 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.
Minimum age
0 Days
Maximum age
14 Days
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
264
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 0 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [3] 0 0
The Women's and Children's Hospital - Adelaide
Recruitment hospital [4] 0 0
Monash Children's Hospital - Clayton
Recruitment hospital [5] 0 0
Murdoch Children's Research Institute - Parkville
Recruitment hospital [6] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3052 - Parkville
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
South Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
United States of America
State/province [16] 0 0
Wisconsin
Country [17] 0 0
Puerto Rico
State/province [17] 0 0
Caguas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Siolta Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05003804
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05003804