Actively Recruiting
Phase 2b Study of IMG-007 for Adults with Moderate-to-Severe Atopic Dermatitis Evaluating Different Dose Regimens and Safety
Led by Inmagene LLC · Updated on 2026-08-12
405
Participants Needed
30
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of different doses of IMG-007 compared to placebo in adults with moderate-to-severe active atopic dermatitis. This Phase 2b, multicenter, randomized, double-blind, placebo-controlled study aims to understand how well IMG-007 works and its safety profile over a period of up to 48 weeks. Participants will receive subcutaneous injections of IMG-007 or placebo according to the study protocol. The study includes multiple dose regimens of IMG-007 and placebo groups, with some placebo participants crossing over to receive IMG-007 later. Treatments follow a parallel group design where different groups receive different doses or placebo. During the study, participants will undergo assessments including Eczema Area and Severity Index EASI scoring and Investigator Global Assessment for Atopic Dermatitis vIGA-AD at baseline and Week 24. Researchers will monitor treatment-emergent adverse events throughout the study. Participants will be followed for up to 48 weeks to evaluate changes in skin condition and safety outcomes during and after treatment.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 74 years
- Moderate-to-severe atopic dermatitis
- Documented history of inadequate response or intolerance to stable topical treatments before screening, or topical treatments are inadvisable
- Female participants must not be pregnant or breastfeeding and either not of childbearing potential or agree to use highly effective contraception
- Male participants must agree to use highly effective contraception
- Eczema Area and Severity Index (EASI) score of 16 or higher
- Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 3 or higher
- At least 10% body surface area affected by atopic dermatitis
- Mean peak itch score of 4 or higher on a numerical rating scale during the 7 days before randomization
You will not qualify if you...
- Positive test for hepatitis B, hepatitis C, or HIV infection
- Evidence or history of active or latent tuberculosis (TB) not adequately treated
- Active infection requiring systemic antibiotic, antiviral, antifungal, antiparasitic, or antiprotozoal treatment
- Unstable pruritic skin conditions other than atopic dermatitis that interfere with assessment
- Other medical conditions or lab abnormalities increasing risk or interfering with study participation
- Receipt of prohibited therapies within specified timeframes before baseline visit
Research Team
A
ADAPTIVE Study Lead
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