A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Moderate to Severe Atopic Dermatitis
- Registration Number
- NCT03747575
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment MSTT1041A Participants will receive MSTT1041A Placebo Placebo Participants will receive placebo matched to MSTT1041A
- Primary Outcome Measures
Name Time Method Percent Change of Total Eczema Area and Severity Index (EASI) Score Baseline, Week 16 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.
- Secondary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Anti-Drug Antibodies (ADAs) Up to Week 24 Proportion of Participants Who Achieve >/=75% Reduction From Baseline in Eczema Area and Severity Index (EASI-75) Score Baseline, Week 16 Percent Change in Body Surface Area (BSA) With Atopic Dermatitis (AD) Involvement Baseline, Week 16 Percent Change in Disease Severity as Assessed by SCORing Atopic Dermatitis (SCORAD) Baseline, Week 16 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.
Percentage of Participants With Adverse Events (AE) Up to Week 24 Serum Concentrations of MSTT1041A At pre-defined intervals from baseline up to Week 24 Proportion of Participants Who Achieve Investigator's Global Assessment (IGA) Response of 0 or 1 Baseline, Week 16 Percent Change in Pruritus as Assessed by a Numeric Rating Scale (NRS) Baseline, Week 16 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.
Trial Locations
- Locations (21)
Florida Pulmonary Research Institute, LLC
🇺🇸Winter Park, Florida, United States
Skin Laser and Surgery Specialists of New York and New Jersey LLC - Interspond - PPDS
🇺🇸Hackensack, New Jersey, United States
Harmony Clinical Research, Inc
🇺🇸North Miami Beach, Florida, United States
GCP Global Clinical Professionals
🇺🇸Saint Petersburg, Florida, United States
Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina; Klinika Dermatologii
🇵🇱Rzeszow, Poland
Wro Medica
🇵🇱Wroc?aw, Poland
California Allergy and Asthma Medical Group - CRN
🇺🇸Los Angeles, California, United States
Alabama Allergy & Asthma
🇺🇸Birmingham, Alabama, United States
Asthma & Allergy; Associates, P.C.
🇺🇸Colorado Springs, Colorado, United States
Jonathan Corren MD, Inc.
🇺🇸Los Angeles, California, United States
South Coast Research Center, Inc.
🇺🇸Miami, Florida, United States
Midwest Sinus Allergy and Asthma - CRN
🇺🇸Normal, Illinois, United States
Dermatology Specialists Research, LLC
🇺🇸Louisville, Kentucky, United States
Clinical Research Consortium Nevada
🇺🇸Las Vegas, Nevada, United States
Center for Clinical Studies
🇺🇸Houston, Texas, United States
Centrum Medyczne ALL-MED
🇵🇱Krakow, Poland
Universitatsklinikum Munster
🇩🇪Münster, Germany
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
🇵🇱Lodz, Poland
Laser Clinic
🇵🇱Szczecin, Poland
Vital Prospects Clinical Research Institute PC - CRN
🇺🇸Tulsa, Oklahoma, United States
Forward Clinical Trials
🇺🇸Tampa, Florida, United States