Phase 2b Study of EVO756 in Adults With Atopic Dermatitis
- Registration Number
- NCT07150845
- Lead Sponsor
- Evommune, Inc.
- Brief Summary
This study will evaluate the efficacy and safety of different doses of EVO756 in adults with moderate to severe atopic dermatitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- Chronic AD that has been present for ≥6 months
- Validated-Investigator's Global Assessment score of ≥3
- EASI of ≥16
- BSA of AD involvement of ≥10%
- Any clinically significant abnormality in laboratory evaluations, physical examinations, vital signs, or ECG at Screening
- Use of certain medications
- Presence of skin comorbidities or other condition(s) that may interfere with study assessments
- Significant AD flare, in the opinion of the Investigator, within 4 weeks prior to study entry
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dose 1 EVO756 Orally administered EVO756, Dose 1 Dose 2 EVO756 Orally administered EVO756, Dose 2 Dose 3 EVO756 Orally administered EVO756, Dose 3 Placebo Placebo control Placebo control
- Primary Outcome Measures
Name Time Method Percentage change in Eczema Area and Severity Index (EASI) from Baseline Week 12
- Secondary Outcome Measures
Name Time Method Mean and absolute changes in validated Investigator Global Assessment (vIGA) score from Baseline Weeks 2, 4, 8, and 12 Percentage change in EASI from Baseline Weeks 2, 4, and 8 Mean changes in EASI from Baseline Week 2, 4, 8, and 12 Proportion of subjects with EASI-50, EASI-75, and EASI-90 from Baseline Weeks 2, 4, 8, and 12 Proportion of subjects achieving a vIGA score of 0,1 with at least a 2-point reduction from Baseline Weeks 2, 4, 8, and 12 Mean and percentage change from Baseline in the pruritus-NRS score Weeks 2, 4, 8, and 12 Proportion of subjects achieving a 4-pt reduction in the pruritus-NRS score from Baseline Week 2, 4, 8, and 12 Mean and percentage changes from Baseline in Body Surface Area (BSA) of affected area Weeks 2, 4, 8, and 12 Occurrence of treatment emergent adverse events (TEAE) and serious adverse events (SAE) through Week 14
Trial Locations
- Locations (11)
Equity Medical
🇺🇸New York, New York, United States
International Clinical Research - Murfreesboro
🇺🇸Murfreesboro, Tennessee, United States
Center for Dermatology Clinical Research
🇺🇸Fremont, California, United States
Metropolis Dermatology - Downtown Los Angeles
🇺🇸Los Angeles, California, United States
Skin and Beauty Center
🇺🇸Pasadena, California, United States
Skin Care Research, LLC
🇺🇸Boca Raton, Florida, United States
Driven Research, LLC
🇺🇸Coral Gables, Florida, United States
Skin Care Research - Hollywood Dermatology
🇺🇸Hollywood, Florida, United States
Empire Dermatology
🇺🇸East Syracuse, New York, United States
Skin Search of Rochester, Inc.
🇺🇸Rochester, New York, United States
Scroll for more (1 remaining)Equity Medical🇺🇸New York, New York, United StatesJennie MataContact914-297-8913jmata@equity-med.com