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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients With Moderate to Severe Atopic Dermatitis
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with Atopic Dermatitis
This is a multicenter, randomized, double-blind, parallel group, placebo controlled phase 2 study to assess the efficacy and safety of barzolvolimab (CDX-0159) in adult participants with Atopic Dermatitis. There is a screening period of up to 28 days, a 16-week double-blind, placebo-controlled treatment period, a 16-week double-blind, active treatment period, and a 16-week follow-up period. On Day 1, participants will be randomly assigned on a 1:1:1 ratio to receive barzolvolimab (CDX-0159) by subcutaneous injections of 150 mg every 4 weeks (Q4W) after an initial loading dose of 450 mg \[Arm 1\], 300 mg Q4W after an initial loading dose of 450 mg \[Arm 2\], or placebo Q4W \[Arm 3\]. At Week 16, participants on placebo will be re-randomized on a 1:1 ratio to receive barzolvolimab by subcutaneous injections of 150 mg every 4 weeks (Q4W) after an initial loading dose of 450 mg, 300 mg Q4W after an initial loading dose of 450 mg. Participants on Arms 1 and 2 will undergo a mock re-randomization at Week 16 to maintain the blind.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
AllerVie Clinical Research
Birmingham, Alabama, United States
Cahaba Dermatology & Skin Health Center, LLC
Birmingham, Alabama, United States
Ohara Aivaz MD Dermatology
Beverly Hills, California, United States
Advanced Dermatology Center - Burbank
Burbank, California, United States
310 Clinical Research
Inglewood, California, United States
Avance Trials
Laguna Niguel, California, United States
LA Universal Research Center, Inc.
Los Angeles, California, United States
UCLA Division of Dermatology
Los Angeles, California, United States
Dynasty Dermatology
Pasadena, California, United States
Acclaim Clinical Research
San Diego, California, United States
Start Date
December 18, 2024
Primary Completion Date
October 1, 2026
Completion Date
May 1, 2027
Last Updated
February 10, 2026
131
ACTUAL participants
Barzolvolimab
BIOLOGICAL
Matching placebo
DRUG
Lead Sponsor
Celldex Therapeutics
NCT07262983
NCT06389136
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06342713