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Allergic Disease Onset Prevention Study (adored)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05003804
Recruitment Status : Recruiting
First Posted : August 12, 2021
Last Update Posted : September 6, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Type 1 Hypersensitivity Biological: STMC-103H Biological: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 7 days of life.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind, placebo-controlled
Primary Purpose: Prevention
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
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Biological: STMC-103H
STMC-103H is a live biotherapeutic product (LBP) containing a consortium of intestinal bacteria

Placebo Comparator: Placebo Part A1
Once daily dosing with one capsule of placebo mixed with milk, formula, or a milk product for 28 days
Biological: Placebo
Powder containing excipients found in STMC-103H: magnesium stearate, mannitol and silicon dioxide.

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

Placebo Comparator: Placebo Part A2
Once daily dosing with one capsule of placebo mixed with milk, formula or a milk product for 28 days
Biological: Placebo
Powder containing excipients found in STMC-103H: magnesium stearate, mannitol and silicon dioxide.

Experimental: STMC-103H Part B
Once daily dosing with one capsule of STMC-103H mixed with breastmilk, formula or a milk product for 28 days
Biological: STMC-103H
STMC-103H is a live biotherapeutic product (LBP) containing a consortium of intestinal bacteria

Placebo Comparator: Placebo Part B
Once daily dosing with one capsule of placebo mixed with breastmilk, formula or a milk product for 28 days
Biological: Placebo
Powder containing excipients found in STMC-103H: magnesium stearate, mannitol and silicon dioxide.




Primary Outcome Measures :
  1. 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 [ Time Frame: 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)

  2. 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. [ Time Frame: 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

  3. Part B: Primary Efficacy Endpoint: Incidence of physician-diagnosed atopic dermatitis at 336 days [ Time Frame: Day 336 ]
    Incidence of physician-diagnosed atopic dermatitis at 336 days in STMC-103H-treated subjects compared to placebo


Secondary Outcome Measures :
  1. Part B Secondary Efficacy Endpoint - physician-diagnosed atopic dermatitis [ Time Frame: At days 168 and 672 ]
    Incidence of physician-diagnosed atopic dermatitis

  2. Part B - Secondary Efficacy Endpoint - atopic disease assessments [ Time Frame: At days 168, 336 and 672 ]
    Proportion of subjects who develop any atopic disease (atopic dermatitis, food allergy, allergic rhinitis/conjunctivitis, asthma)

  3. Part B Secondary Efficacy Endpoint - incidence of sensitization to food and aeroallergen [ Time Frame: At days 168, 336, and 672 ]
    Incidence of sensitization to food and aeroallergen as measured by specific serum IgE levels

  4. Part B Secondary Efficacy Endpoint - incidence of food allergy, allergic rhinitis/conjunctivitis, urticaria, and wheezing illness/asthma [ Time Frame: 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

  5. Part B Secondary Efficacy Endpoint - Time to atopic dermatitis diagnosis [ Time Frame: Through 672 days of study ]
    Time to atopic dermatitis diagnosis by physician assessment

  6. Part B Secondary Efficacy Endpoint - Time to first wheezing episode [ Time Frame: Through 672 days of study ]
    Time to first wheezing episode by physician assessment

  7. Part B Secondary Efficacy Endpoint - severity of atopic dermatitis by Investigator Global Assessment x Body Surface Area (IGAxBSA) assessment [ Time Frame: At days 168, 336 and 672 ]
    Severity of atopic dermatitis by IGAxBSA assessment

  8. Part B Secondary Efficacy Endpoint - severity of atopic dermatitis by Severity Scoring Of Atopic Dermatitis (SCORAD) assessment [ Time Frame: At days 168, 336 and 672 ]
    Severity of atopic dermatitis by SCORAD assessment

  9. Part B Secondary Efficacy Endpoint - Severity of Wheezing Illness/Asthma [ Time Frame: At days 68, 336, and 672 days ]
    Severity of wheezing illness/asthma by Wheezing Severity Assessment

  10. Part B Secondary Efficacy Endpoint - use of concomitant medications for allergic symptoms or diagnosis [ Time Frame: 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

  11. Part B Secondary Efficacy Endpoint - Total Serum IgE [ Time Frame: At days 168, 336, and 672 ]
    Total serum IgE levels

  12. Part B Secondary Efficacy Endpoint - Peripheral Eosinophil Counts [ Time Frame: At day 336 ]
    Peripheral eosinophil counts by automated differential


Other Outcome Measures:
  1. Part B Key Exploratory Endpoint - Mean fecal concentration of 12,13-diHOME [ Time Frame: At day 336 ]
    Mean fecal concentration of 12,13-diHOME measured in stool sample in STMC-103H arm as compared to placebo arm



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   0 Days to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 ≤ 7 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.)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05003804


Contacts
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Contact: Elizabeth C Chesnut 4048030358 echesnut@sioltatherapeutics.com
Contact: Richard Shames, MD 6505750798 rshames@sioltatherapeutics.com

Locations
Show Show 26 study locations
Sponsors and Collaborators
Siolta Therapeutics, Inc.
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Responsible Party: Siolta Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05003804    
Other Study ID Numbers: STMC-103H-102
First Posted: August 12, 2021    Key Record Dates
Last Update Posted: September 6, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Hypersensitivity
Hypersensitivity, Immediate
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Immune System Diseases