This Study Will Evaluate the Safety, Tolerability, and Efficacy of ANB032 in Subjects with Moderate to Severe Atopic Dermatitis (AD).
- Registration Number
- NCT05935085
- Lead Sponsor
- AnaptysBio, Inc.
- Brief Summary
This study will evaluate the safety, tolerability, and efficacy of ANB032 in subjects with moderate to severe atopic dermatitis (AD).
- Detailed Description
This is a Phase 2, randomized, double blind, placebo controlled, parallel group, multicenter study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of ANB032 in subjects with moderate to severe atopic dermatitis (AD).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 201
- Male or female aged 18 to 65 years and in good general health
- Moderate to severe AD for at least 6 months prior to Randomization
- History of inadequate response to treatment for AD with topical medications or for whom topical treatments are otherwise medically inadvisable
- EASI score ≥ 16 at Screening and at Randomization
- vIGA AD score ≥ 3 at Screening and at Randomization
- AD involved BSA ≥ 10% at Screening and at Randomization
Key
- Any factors that in the Investigator's opinion would predispose the subject to develop an infection
- Known or suspected congenital or acquired immunodeficiency state, or condition that would compromise the subject's immune status
- Not able to tolerate SC drug administration
- Tanning booth use or extended sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks before Randomization
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ANB032 SC Dose 3 ANB032 This arm will receive treatment SC Placebo Placebo This arm will receive Placebo SC ANB032 SC Dose 1 ANB032 This arm will receive treatment SC ANB032 SC Dose 2 ANB032 This arm will receive treatment SC
- Primary Outcome Measures
Name Time Method Proportion of subjects who achieve ≥75% reduction (improvement) from Baseline in EASI-75 as Week 14 Baseline to Week 14 The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72.
- Secondary Outcome Measures
Name Time Method 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 Baseline to Week 14 Mean change from Baseline in EASI at Week 14 Baseline to Week 14 Mean percent change from Baseline in EASI at Week 14 Baseline to Week 14 The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72.
Trial Locations
- Locations (78)
AnaptysBio Investigative Site 10-140
🇺🇸Anaheim, California, United States
AnaptysBio Investigative Site 10-141
🇺🇸Cerritos, California, United States
AnaptysBio Investigative Site 10-121
🇺🇸Fountain Valley, California, United States
AnaptysBio Investigative Site 10-107
🇺🇸Fremont, California, United States
AnaptysBio Investigative Site 10-120
🇺🇸Lancaster, California, United States
AnaptysBio Investigative 10-125
🇺🇸Lomita, California, United States
AnaptysBio Investigative Site 10-146
🇺🇸Oxnard, California, United States
AnaptysBio Investigative Site 10-147
🇺🇸Pasadena, California, United States
AnaptysBio Investigative Site 10-112
🇺🇸Santa Monica, California, United States
AnaptysBio Investigative Site 10-136
🇺🇸Doral, Florida, United States
Scroll for more (68 remaining)AnaptysBio Investigative Site 10-140🇺🇸Anaheim, California, United States