At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 34 enrolled
Drug / intervention
GSK1070806 +1 moredrug
Likely dose
Not stated in record
Key inclusion· 5
- ✓Moderate to severe atopic dermatitis confirmed by dermatologist per Hannifin and Rajka or Eichenfield revised criteria
- ✓Eczema Activity Severity Index ≥16 and Investigator Global Assessment score ≥3
- ✓Atopic dermatitis onset ≥6 months prior to screening with stable disease ≥1 month before screening
- ✓Group 1 (Biologic-naïve): documented inadequate response to topical corticosteroid, topical calcineurin inhibitor, topical inhibitor, or PDE4 inhibitor within 6 months of screening, or topical treatments contraindicated
Key exclusion· 2
- ✕Other significant skin morbidity that would impair disease assessment (e.g., psoriasis, cutaneous T-cell lymphoma, autoimmune bullous disease, fixed drug reaction, Stevens-Johnson syndrome)
- ✕Uncontrolled medical conditions other than atopic dermatitis that put participant at unacceptable risk or interfere with study assessments
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase Ib, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study of the Clinical Effect, Safety and Tolerability of a Single Intravenous Infusion of GSK1070806 in Moderate to Severe Atopic Dermatitis Patients
In Brief
A Phase 1 clinical trial evaluating GSK1070806 and Placebo for Dermatitis, Atopic. Completed, enrolled 34 participants across 11 sites in 2 countries.
Detailed Summary
This study will evaluate efficacy and safety of GSK1070806 in moderate to severe atopic dermatitis (AtD) participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDermatitis, Atopic
CountriesCanada, United States
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
First PostedJul 2021
Enrollment StartNov 2021
Primary CompletionDec 2022
Study CompletionMar 2023
TodayJul 2026
First PostedJul 23, 2021
Enrollment StartNov 18, 2021
Primary CompletionDec 19, 2022
Study CompletionMar 13, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.9 years ago
Interventions
GSK1070806drug
GSK1070806 will be administered
Placebodrug
Placebo will be administered