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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
131
Subcutaneous Administration
Subcutaneous Administration
Percent change from Baseline in the weekly average of the daily Peak Pruritus Numerical Rating Scale (PP-NRS) score at Week 16
Evaluate the clinical efficacy of 2 dose levels (150 mg and 300 mg) of barzolvolimab, compared to placebo, in adult participants with moderate to severe atopic dermatitis (AD) using the PP-NRS. The PP-NRS ranges from 0 = "no itch" to 10 ="worst imaginable itch" for the worst intensity itch in the preceding 24-hr period.
Time frame: From Day 1 (first dose) to Day 113 (week 16)
Percent change from Baseline in Eczema Area Severity Index (EASI) score at Week 16.
A total EASI score range from 0 to 72 points will be recorded for each assessment, with higher scores reflecting worse severity of AD. * 0 = clear * 0.1-1.0 = almost clear * 1.1-7.0 = mild * 7.1-21.0 = moderate * 21.1-50.0 = severe * 50.1-72.0 = very severe
Time frame: From Day 1 (first dose) to Day 113 (week 16)
Proportion of participants achieving an Investigator Global Assessment (IGA) score of "0" or "1" at Week 16.
The IGA determines severity of AD and clinical response to treatment on a static 5-point scale based on erythema and papulation/infiltration * 0 = Clear * 1 = Almost clear * 2 = Mild * 3 = Moderate * 4 = Severe
Time frame: From Day 1 (first dose) to Day 113 (week 16)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
FOMAT Medical Research - Allergy, Asthma, & Immunology Medical Group
Ventura, California, United States
...and 23 more locations