This is a phase IIa, randomized, double-blind, placebo-controlled, multi-center proof-of-concept (POC) study in subjects with moderate to severe Atopic Dermatitis.
This is a two-part phase IIa, randomized, double-blind, placebo-controlled, multi-center proof-of-concept (POC) study in adult subjects with persistent moderate to severe Atopic Dermatitis (AD). ADX-914 or matching placebo for administered subcutaneously in the clinic setting every 2 weeks for 12 weeks, and follow-up for 12 weeks. ADX-914 or matching placebo will be in the clinic setting post-randomization. In Part A, up to 3 cohorts of subjects will be randomized 2:1 drug vs placebo. In Part B subjects will be randomized 1:1 to drug vs placebo at a doses selected in Part A.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
102
Cahaba Dermatology Skin Health Center
Birmingham, Alabama, United States
Part A only: Safety parameters including incidence of serious adverse events and adverse events of special interest
Time frame: 14 Weeks
Part A and B: Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score at Week 14 for ADX-914 vs placebo
Severity score is based on evaluation of severity of atopic dermatitis in 4 body regions (head and neck, trunk, upper limbs, and lower limbs). The minimum score is 0 (less severe) and maximum score is 72 (most severe).
Time frame: 14 Weeks
Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score
Severity score is based on evaluation of severity of atopic dermatitis in 4 body regions (head and neck, trunk, upper limbs, and lower limbs). The minimum score is 0 (least severe) and maximum score is 72 (most severe)
Time frame: 24 Weeks
Mean percentage change from baseline in Scoring Atopic Dermatitis (SCORAD) score
Score is based on evaluation of 6 body regions (Head and neck, upper limbs, lower limbs, anterior trunk, back, and genitals). The minimum score is 0% (least severe) and the maximum score is 100% (most severe)
Time frame: 24 Weeks
Proportion of subjects achieving Eczema Area and Severity Index (EASI) reduction of 50%, 75% and 90%
Severity score is based on evaluation of severity of atopic dermatitis in 4 body regions (head and neck, trunk, upper limbs, and lower limbs). The minimum score is 0 (least severe) and maximum score is 72 (most severe)
Time frame: 24 Weeks
Proportion of subjects achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1 with at least 2 grades of reduction from Baseline
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First OC Dermatology
Fountain Valley, California, United States
California Allergy and Asthma Medical Group- Los Angeles
Los Angeles, California, United States
Integrative Skin Science and Research
Sacramento, California, United States
Dermatology Institute and Skin Care Center
Santa Monica, California, United States
Torrance Clinical Research Institute Inc.
Torrance, California, United States
Integrated Research of Inland, Inc.
Upland, California, United States
RM Medical Research Inc.
Homestead, Florida, United States
Medical Research Center of Miami
Miami, Florida, United States
Well Pharma Medical Research Corporation
Miami, Florida, United States
...and 14 more locations
Score is based on Investigator's impresion of the severity of Atopic Dermatitis with 0 being the least severe and 4 being the most severe
Time frame: 24 Weeks
Incidence of adverse events
As evaluated by vital signs, physical examinations, laboratory evaluations, and 12-lead electrocardiograms
Time frame: 24 Weeks