Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-29 @ 5:21 AM
Study NCT ID:
NCT05003804
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2021-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Allergic Disease Onset Prevention Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blind, placebo-controlled'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 283}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-10-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2021-08-04', 'studyFirstSubmitQcDate': '2021-08-11', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Part B Key Exploratory Endpoint - Mean fecal concentration of 12,13-diHOME', 'timeFrame': 'At day 336', 'description': 'Mean fecal concentration of 12,13-diHOME measured in stool sample in STMC-103H arm as compared to placebo arm'}], 'primaryOutcomes': [{'measure': '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', 'timeFrame': 'Through 56 days of study', 'description': '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)'}, {'measure': '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.', 'timeFrame': 'Through 672 days of study', 'description': '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'}, {'measure': 'Part B: Primary Efficacy Endpoint: Incidence of physician-diagnosed atopic dermatitis at 336 days', 'timeFrame': 'Day 336', 'description': 'Incidence of physician-diagnosed atopic dermatitis at 336 days in STMC-103H-treated subjects compared to placebo'}], 'secondaryOutcomes': [{'measure': 'Part B Secondary Efficacy Endpoint - physician-diagnosed atopic dermatitis', 'timeFrame': 'At days 168 and 672', 'description': 'Incidence of physician-diagnosed atopic dermatitis'}, {'measure': 'Part B - Secondary Efficacy Endpoint - atopic disease assessments', 'timeFrame': 'At days 168, 336 and 672', 'description': 'Proportion of subjects who develop any atopic disease (atopic dermatitis, food allergy, allergic rhinitis/conjunctivitis, asthma)'}, {'measure': 'Part B Secondary Efficacy Endpoint - incidence of sensitization to food and aeroallergen', 'timeFrame': 'At days 168, 336, and 672', 'description': 'Incidence of sensitization to food and aeroallergen as measured by specific serum IgE levels'}, {'measure': 'Part B Secondary Efficacy Endpoint - incidence of food allergy, allergic rhinitis/conjunctivitis, urticaria, and wheezing illness/asthma', 'timeFrame': 'At days 168, 336, and 672', 'description': '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'}, {'measure': 'Part B Secondary Efficacy Endpoint - Time to atopic dermatitis diagnosis', 'timeFrame': 'Through 672 days of study', 'description': 'Time to atopic dermatitis diagnosis by physician assessment'}, {'measure': 'Part B Secondary Efficacy Endpoint - Time to first wheezing episode', 'timeFrame': 'Through 672 days of study', 'description': 'Time to first wheezing episode by physician assessment'}, {'measure': 'Part B Secondary Efficacy Endpoint - severity of atopic dermatitis by Investigator Global Assessment x Body Surface Area (IGAxBSA) assessment', 'timeFrame': 'At days 168, 336 and 672', 'description': 'Severity of atopic dermatitis by IGAxBSA assessment'}, {'measure': 'Part B Secondary Efficacy Endpoint - severity of atopic dermatitis by Severity Scoring Of Atopic Dermatitis (SCORAD) assessment', 'timeFrame': 'At days 168, 336 and 672', 'description': 'Severity of atopic dermatitis by SCORAD assessment'}, {'measure': 'Part B Secondary Efficacy Endpoint - Severity of Wheezing Illness/Asthma', 'timeFrame': 'At days 68, 336, and 672 days', 'description': 'Severity of wheezing illness/asthma by Wheezing Severity Assessment'}, {'measure': 'Part B Secondary Efficacy Endpoint - use of concomitant medications for allergic symptoms or diagnosis', 'timeFrame': 'Through 672 days of study', 'description': 'Concomitant medications prescribed/used for allergic symptoms or diagnosis and use of rescue medications for atopic dermatitis and wheezing/asthma'}, {'measure': 'Part B Secondary Efficacy Endpoint - Total Serum IgE', 'timeFrame': 'At days 168, 336, and 672', 'description': 'Total serum IgE levels'}, {'measure': 'Part B Secondary Efficacy Endpoint - Peripheral Eosinophil Counts', 'timeFrame': 'At day 336', 'description': 'Peripheral eosinophil counts by automated differential'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis', 'Type 1 Hypersensitivity']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Days', 'minimumAge': '0 Days', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All Parts (A1, A2, B)\n\n 1. Subject's parent(s)/legal representative(s) providing consent must be 18 years or older\n 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\n 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\n 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\n\nPart A1 Only\n\nInclusion criteria 1-4 for all parts plus:\n\n5 (A1). Subject is between 1 year and \\< 6 years old at the time of enrollment\n\nPart A2 Only\n\nInclusion criteria 1-4 for all parts plus:\n\n5 (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\n\nPart B Only\n\nInclusion criteria 1-4 for all parts plus:\n\n5 (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.\n\n6 (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.\n\nExclusion Criteria:\n\n* All Parts (A1, A2, B)\n\n 1. Subject's twin (or higher order multiple) is enrolled in STMC-103H-102\n 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).\n 3. Subject is acutely ill or on systemic antibiotics at the time of enrollment\n 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\n 5. Subject has evidence of immune deficiency/immune compromise in the judgment of the investigator\n\nPart B Only\n\nExclusion Criteria 1-5 for all parts plus:\n\n6 (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.)"}, 'identificationModule': {'nctId': 'NCT05003804', 'acronym': 'adored', 'briefTitle': 'Allergic Disease Onset Prevention Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Siolta Therapeutics, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'STMC-103H-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'STMC-103H Part A1', 'description': 'Once daily dosing with one capsule of STMC-103H mixed with milk, formula, or a milk product for 28 days', 'interventionNames': ['Biological: STMC-103H']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Part A1', 'description': 'Once daily dosing with one capsule of placebo mixed with milk, formula, or a milk product for 28 days', 'interventionNames': ['Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'STMC-102H Part A2', 'description': 'Once daily dosing with one capsule of STMC-103H mixed with milk, formula, or a milk product for 28 days', 'interventionNames': ['Biological: STMC-103H']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Part A2', 'description': 'Once daily dosing with one capsule of placebo mixed with milk, formula or a milk product for 28 days', 'interventionNames': ['Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'STMC-103H Part B', 'description': 'Once daily dosing with one capsule of STMC-103H mixed with breastmilk, formula or a milk product for 336 days', 'interventionNames': ['Biological: STMC-103H']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Part B', 'description': 'Once daily dosing with one capsule of placebo mixed with breastmilk, formula or a milk product for 336 days', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'STMC-103H', 'type': 'BIOLOGICAL', 'description': 'STMC-103H is a live biotherapeutic product (LBP) containing a consortium of intestinal bacteria', 'armGroupLabels': ['STMC-102H Part A2', 'STMC-103H Part A1', 'STMC-103H Part B']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Powder containing excipients found in STMC-103H: magnesium stearate, mannitol and silicon dioxide.', 'armGroupLabels': ['Placebo Part A1', 'Placebo Part A2', 'Placebo Part B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona Health Sciences', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Research Institute", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Health', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Rady Children's Hospital - San Diego", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': "UCSF Benioff Children's Hospital", 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Lurie Children's Hospital", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': "Riley Children's Health at University of Indiana", 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21205', 'city': 'Baltimore, MD', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48104', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Health', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '11021', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Healthcare', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "NYU Langone Fink Children's", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mt. Sinai Jaffe Allergy Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '29607', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Tribe Clinical Research', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29486', 'city': 'Summerville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Coastal Pediatrics Research', 'geoPoint': {'lat': 33.0185, 'lon': -80.17565}}, {'zip': '78723', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Dell Medical School at UT Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': "UT Southwestern/Children's Health", 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '98115', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle Allergy and Asthma Research Institute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Univ. of Wisconsin-Madison/Jackson Research Group', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': "The Children's Hospital at Westmead", 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '4101', 'city': 'South Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': "Queensland Children's Hospital", 'geoPoint': {'lat': -27.48034, 'lon': 153.02049}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': "The Women's and Children's Hospital", 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'country': 'Australia', 'facility': "Monash Children's Hospital", 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'zip': '3052', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': "Murdoch Children's Research Institute", 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': '6150', 'city': 'Murdoch', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Fiona Stanley Hospital', 'geoPoint': {'lat': -32.06987, 'lon': 115.83757}}, {'zip': '00725', 'city': 'Caguas', 'state': 'Puerto Rico', 'country': 'Puerto Rico', 'facility': 'Centro de Neumologia Pediatrica', 'geoPoint': {'lat': 18.23412, 'lon': -66.0485}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Siolta Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}