A Phase 2b, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
Inmagene LLC
Summary
The purpose of this study is to evaluate the efficacy and safety of different dose regimens of IMG-007, compared to placebo.
Description
A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety profile of various dose regimens of IMG-007 in adult participants with moderate-to-severe active atopic dermatitis (AD) up to 52 weeks.
Eligibility
- Age range
- 18–74 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Moderate-to-severe AD * Documented history of inadequate response or lack of tolerability to a stable regimen of one or more topical treatment before the Screening visit, or for whom topical treatments are otherwise inadvisable * Female participants who are not pregnant or breastfeeding and meet at least one of the following conditions: not of childbearing potential or of childbearing potential and agrees to use a highly effective method of contraception * Male participants must agree to use a highly effective method of contraception * EASI score ≥16 * vIGA-AD score…
Interventions
- DrugIMG-007
Participants will receive IMG-007 subcutaneously.
- DrugPlacebo
Participants will receive a placebo subcutaneously.
Locations (23)
- Antelope Valley Clinical TrialsLancaster, California
- UCLA Division of DermatologyLos Angeles, California
- Renstar Medical ResearchOcala, Florida
- Palm Harbor Dermatology PA d/b/a TrueBlue Clinical ResearchTampa, Florida
- Arlington DermatologyRolling Meadows, Illinois
- Forest Hills Dermatology GroupKew Gardens, New York