This Study Will Evaluate the Safety, Tolerability, and Efficacy of ANB032 in Subjects With Moderate to Severe Atopic Dermatitis (AD).
- Conditions
- Atopic Dermatitis Eczema
- Registration Number
- NCT05935085
- Lead Sponsor
- AnaptysBio, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 160
Key Inclusion Criteria:<br><br> - Male or female aged 18 to 65 years and in good general health<br><br> - Moderate to severe AD for at least 6 months prior to Randomization<br><br> - History of inadequate response to treatment for AD with topical medications or for<br> whom topical treatments are otherwise medically inadvisable<br><br> - EASI score = 16 at Screening and at Randomization<br><br> - vIGA AD score = 3 at Screening and at Randomization<br><br> - AD involved BSA = 10% at Screening and at Randomization<br><br>Key Exclusion Criteria:<br><br> - Any factors that in the Investigator's opinion would predispose the subject to<br> develop an infection<br><br> - Known or suspected congenital or acquired immunodeficiency state, or condition that<br> would compromise the subject's immune status<br><br> - Not able to tolerate SC drug administration<br><br> - Tanning booth use or extended sun exposure that could affect disease severity or<br> interfere with disease assessments within 4 weeks before Randomization
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects who achieve =75% reduction (improvement) from Baseline in EASI-75 as Week 14
- Secondary Outcome Measures
Name Time Method Mean percent change from Baseline in EASI at Week 14;Mean change from Baseline in EASI at Week 14;Proportion of subjects who achieve a vIGA-AD score of 0 or 1 and = 2-point reduction (improvement) from Baseline in vIGA-AD score at Week 14