Targeted Investigation of Microbiome 2 Treat Atopic Dermatitis (TIME-2)
NCT Number: NCT06504160
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Atopic Dermatitis
Interventions: DRUG: ShA9 Topical Gel|DRUG: Hydrocortisone Ointment|DRUG: Clobetasol Ointment|DRUG: Fluocinonide Ointment|DRUG: Placebo (Vehicle) Topical Gel
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: Atopic Dermatitis Research Network (ADRN)|Rho Federal Systems Division, Inc.|PPD, Thermo Fisher Scientific Inc.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 86
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-15
Completion Date: 2026-04-02
Locations: University of California, San Diego: Dermatology Clinical Trials Unit, San Diego, California, 92093, United States|National Jewish Health: Division of Pediatric Allergy and Clinical Immunology, Denver, Colorado, 80206, United States|Northwestern University Feinberg School of Medicine: Department of Dermatology, Chicago, Illinois, 60611, United States|New York University Langone Health: Department of Pediatric Allergy and Immunology, New York, New York, 10016, United States|Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology, New York, New York, 10029, United States|University of Rochester Medical Center: Department of Dermatology, Rochester, New York, 10029, United States|Cincinnati Children's Hospital Medical Center: Asthma Center, Cincinnati, Ohio, 45229, United States|University of Texas at Austin, Dell Medical School: Department of Pediatric Dermatology, Austin, Texas, 78723, United States|University of Texas Health Science Center at Houston, McGovern Medical School: Division of Pediatric Dermatology, Houston, Texas, 77401, United States|University of Wisconsin School of Medicine and Public Health: Division of Pediatric Allergy, Immunology and Rheumatology, Madison, Wisconsin, 53792, United States

Summary:
This is a Phase 2, randomized, placebo/vehicle-controlled, double-blinded, multi-center trial. It is designed to assess the safety and efficacy of S. hominis A9 (ShA9) topical application as a treatment for atopic dermatitis (AD). The trial will enroll adults and adolescents with atopic dermatitis who are culture positive for S. aureus colonization. The primary objective of this study is to assess the ability of ShA9, compared to placebo (vehicle), to prolong the period of atopic dermatitis control over 12 weeks after conclusion of an initial two-week period of co-treatment with topical corticosteroids (TCS).

Primary Outcome Measures: Time to the first Atopic Dermatitis (AD) flare., Time (in days) to the first Atopic Dermatitis (AD) flare, indicated by having an Investigator Global Assessment (IGA) score that is greater than or equal to 2 and greater than the IGA score determined at Week 2. The IGA score is used to describe the overall appearance of AD lesions on a scale of 0 (clear) to 4 (severe)., Week 2 (exclusive) through Week 14 (inclusive)
Secondary Outcome Measures: Serious and non-serious treatment-emergent adverse events (TEAEs) related or possibly related to study treatment., The number of serious and non-serious treatment-emergent adverse events (TEAEs) related or possibly related to study treatment. If a participant experiences the same TEAE on multiple occasions, the event will be counted once for each occurrence when reporting the number of TEAEs., Baseline through Week 14|Serious and non-serious TEAEs related or possibly related to study treatment., The number of serious and non-serious TEAEs related or possibly related to study treatment. If a participant experiences the same TEAE on multiple occasions, the event will be counted once for each occurrence when reporting the number of TEAEs., Week 14 (exclusive) through Week 18|Duration of topical corticosteroid (TCS) use., The total number of days topical corticosteroid (TCS) was used, adjusted for its formulation and class, within the upper extremities, lower extremities, and trunk per participant., Week 2 (exclusive) through Week 14 (inclusive)|Change in total Eczema Area and Severity Index (EASI) score., The change in total Eczema Area and Severity Index (EASI) score, which measures physical signs of atopic dermatitis, including area of involvement and severity (range: 0-72). Severity components include erythema, papulation, excoriation, and lichenification (0=absent, 1=mild, 2=moderate, 3=severe) for each body region (head/neck, trunk, arms, legs). Area of involvement (%) is assessed for each body region. Area and severity of each body region is weighted based on size of region, and region scores are added for a total EASI score (≤7=mild, \>7 and ≤21.1=moderate, \>21.1=severe). Descriptive note regarding time frame: if a participant was rescued with TCS within 14 days prior to their Week 14 visit, then their total EASI score at this timepoint will not be considered. Instead, the most recent total EASI score before the use of rescue TCS will be carried forward to represent Week 14., Baseline, Week 14|EASI 50, The proportion of participants who achieve 50% or more reduction in their total EASI score. Descriptive note regarding time frame: if a participant was rescued with TCS within 14 days prior to their Week 14 visit, then their total EASI score at this timepoint will not be considered. Instead, the most recent total EASI score before the use of rescue TCS will be carried forward to represent Week 14., Baseline, Week 14|EASI 75, The proportion of participants who achieve 75% or more reduction in their total EASI score. Descriptive note regarding time frame: if a participant was rescued with TCS within 14 days prior to their Week 14 visit, then their total EASI score at this timepoint will not be considered. Instead, the most recent total EASI score before the use of rescue TCS will be carried forward to represent Week 14., Baseline, Week 14|Change in IGA score, The change in IGA score. The IGA score is used to describe the overall appearance of AD lesions on a scale of 0 (clear) to 4 (severe). Descriptive note regarding time frame: if a participant was rescued with TCS within 14 days prior to their Week 14 visit, then their IGA score at this timepoint will not be considered. Instead, the most recent IGA score before the use of rescue TCS will be carried forward to represent Week 14., Baseline, Week 14|Change in Pruritus Numeric Rating Scale (NRS) score., The change in Pruritus Numeric Rating Scale (NRS) score, which measures the average intensity of a pruritus (itch) during a 24-hour recall period on a scale of 0 (none) to 10 (worst imaginable itch). Descriptive note regarding time frame: if a participant was rescued with TCS within 14 days prior to their Week 14 visit, then their NRS score at this timepoint will not be considered. Instead, the most recent NRS score before the use of rescue TCS will be carried forward to represent Week 14., Baseline, Week 14|Change in SCORing Atopic Dermatitis (SCORAD) score., The change in SCORing Atopic Dermatitis (SCORAD) score, which ranges from 0 (no AD) to 103 (severe). SCORAD is a composite index comprising a) the amount/extent of body surface area affected, b) subjective symptom visual analog assessments of itch and sleep loss, each on a scale of 0 (none) to 10 (worst imaginable), and c) 6 disease intensity assessments: dryness, erythema, edema/papulation, excoriation, lichenification and oozing/crusting, each graded from 0 (none) to 3 (severe). Descriptive note regarding time frame: if a participant was rescued with TCS within 14 days prior to their Week 14 visit, then their SCORAD score at this timepoint will not be considered. Instead, the most recent SCORAD score before the use of rescue TCS will be carried forward to represent Week 14., Baseline, Week 14|Time to the first reported use of rescue TCS., Time (in days) to the first reported use of rescue TCS. The decision to begin the rescue TCS regimen due to skin exacerbation is dependent on investigator assessment, self-reported participant need, and standard of care., Week 2 (exclusive) through Week 14 (inclusive)