The purpose of this study is to assess the efficacy and safety of Afimkibart (also known as RO7790121) in participants with moderate to severe atopic dermatitis (AD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
162
Afimkibart will be administered as SC injection.
Placebo will be administered as SC injection.
Percentage of Participants who Achieve Eczema Area and Severity Index-75 (EASI-75) Response (>= 75% Improvement from Baseline) at Week 16
Time frame: Baseline and Week 16
Percentage of Participants who Achieve Investigator Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) with >= 2-Grade Improvement at Week 16 and Week 32
Time frame: At Week 16 and Week 32
Percentage of Participants who Achieve EASI-75 Response at Week 32
Time frame: At Week 32
Percentage of Participants who Achieve EASI-90 Response at Week 16 and Week 32
Time frame: At Week 16 and Week 32
Percent Change from Baseline in EASI by Visit
Time frame: Baseline up to end of study (approximately 1 year)
Percent Change from Baseline in Peak Pruritus Numerical Rating Scale (NRS) Score by Visit
Time frame: Baseline up to end of study (approximately 1 year)
Change from Baseline in Dermatology Quality of Life Index at Week 16, Week 32 and by Visit
Time frame: Baseline, weeks 4, 10, 16, 22 and 32
Percentage of EASI-75 Responders at Week 16
Time frame: At Week 16
Percentage of Participants with Adverse Events
Time frame: Baseline up to end of study (approximately 1 year)
Serum Concentration of Afimkibart at Specified Timepoints
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The Center for Dermatology Clinical Research
Fremont, California, United States
UCLA Division of Dermatology
Los Angeles, California, United States
Dermatology Research Associate
Los Angeles, California, United States
AMR Fort Myers
Fort Myers, Florida, United States
Olympian Clinical Research
Tampa, Florida, United States
Hamilton Research, LLC
Alpharetta, Georgia, United States
Dermatology Affiliates Research Institute, LLC
Atlanta, Georgia, United States
Dawes Fretzin Clinical Res LLC
Indianapolis, Indiana, United States
Southern Indiana Clinical Trials
New Albany, Indiana, United States
Revival Research Institute, LLC
Troy, Michigan, United States
...and 50 more locations
Time frame: Weeks 0, 2, 4, 6, 10, 14, 16, 18, 22, 26, 30, 32 and monthly at weeks 4, 8 and 12 after treatment discontinuation.