This study will assess the efficacy and safety of MSTT1041A (astegolimab) in participants with moderate to severe atopic dermatitis (AD). The study consists of a screening period, a 16-week treatment period, and an 8-week follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
65
Alabama Allergy & Asthma
Birmingham, Alabama, United States
Percent Change of Total Eczema Area and Severity Index (EASI) Score
The Eczema Area and Severity Index (EASI) is a standardized instrument to evaluate the extent and severity of atopic dermatitis. An area score comprised of the percentage of skin affected by eczema for each of 4 body regions (head/neck, trunk, upper extremities, and lower extremities) is calculated with 0 = none, 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89%, and 6 = 90-100%. Severity is scored for each of the 4 body regions by the summation of the intensity scores for 4 signs (redness, thickness, scratching, and lichenification), with 0 = none/absent, 1 = mild, 2 = moderate, and 3 = severe. The minimum final EASI score is 0 and the maximum score is 72.
Time frame: Baseline, Week 16
Proportion of Participants Who Achieve Investigator's Global Assessment (IGA) Response of 0 or 1
Time frame: Baseline, Week 16
Proportion of Participants Who Achieve >/=75% Reduction From Baseline in Eczema Area and Severity Index (EASI-75) Score
Time frame: Baseline, Week 16
Percent Change in Pruritus as Assessed by a Numeric Rating Scale (NRS)
The Peak Pruritis Numerical Rating Scale (NRS) is a single-item patient-reported outcome (PRO) of itch severity rated on a scale of 0-10, with 0 = no itch and 10 = worst itch imaginable for the prior 24-hour period.
Time frame: Baseline, Week 16
Percent Change in Body Surface Area (BSA) With Atopic Dermatitis (AD) Involvement
Time frame: Baseline, Week 16
Percent Change in Disease Severity as Assessed by SCORing Atopic Dermatitis (SCORAD)
SCORAD is a tool used to assess the extent and severity of eczema based on three aspects of disease severity: extent, intensity, and a subjective (PRO) symptoms. A total score (0-103) is calculated, with higher scores indicating a higher extent and severity of symptoms.
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California Allergy and Asthma Medical Group - CRN
Los Angeles, California, United States
Jonathan Corren MD, Inc.
Los Angeles, California, United States
Asthma & Allergy; Associates, P.C.
Colorado Springs, Colorado, United States
South Coast Research Center, Inc.
Miami, Florida, United States
Harmony Clinical Research, Inc
North Miami Beach, Florida, United States
GCP Global Clinical Professionals
St. Petersburg, Florida, United States
Forward Clinical Trials
Tampa, Florida, United States
Florida Pulmonary Research Institute, LLC
Winter Park, Florida, United States
Midwest Sinus Allergy and Asthma - CRN
Normal, Illinois, United States
...and 11 more locations
Time frame: Baseline, Week 16
Percentage of Participants With Adverse Events (AE)
Time frame: Up to Week 24
Serum Concentrations of MSTT1041A
Time frame: At pre-defined intervals from baseline up to Week 24
Incidence of Treatment-Emergent Anti-Drug Antibodies (ADAs)
Time frame: Up to Week 24