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Phase 2a Study of Efficacy and Safety of OpSCF in Moderate to Severe AD (Atopic Dermatitis)
Sponsor: Insmed Incorporated
Summary
The purpose of this study is to determine the efficacy and safety of a monoclonal antibody, OpSCF, in the treatment of adults with moderate to severe Atopic Dermatitis (Eczema). OpSCF will be compared to a placebo. OpSCF or placebo will be administered every 2 weeks for 14 weeks, and the efficacy will be assessed two weeks later. After that, subjects may choose to enter an Open Label Extension phase in which all subjects will receive OpSCF every 4 weeks for 40 additional weeks.
Official title: A Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of OpSCF in the Treatment of Adult Subjects With Moderate to Severe Atopic Dermatitis
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2023-11-21
Completion Date
2025-08-18
Last Updated
2026-09-11
Healthy Volunteers
No
Conditions
Interventions
OpSCF
Administered SC.
Placebo
Administered SC.
Locations (22)
Cahaba Dermatology & Skin Health Center
Birmingham, Alabama, United States
First OC Dermatology Research
Fountain Valley, California, United States
Axon Clinical Research
Inglewood, California, United States
University Clinical Trials
San Diego, California, United States
Unison Clinical Trials
Sherman Oaks, California, United States
Skin Care Research
Boca Raton, Florida, United States
Skin Research of South Florida
Miami, Florida, United States
RM Medical Research
Miami Lakes, Florida, United States
Advanced Clinical Research Institute
Tampa, Florida, United States
Arlington Dermatology
Rolling Meadows, Illinois, United States
Options Research Group
West Lafayette, Indiana, United States
DS Research of Kentucky
Louisville, Kentucky, United States
Oakland Hills Dermatology P.C
Auburn Hills, Michigan, United States
Saginaw Bay Dermatology
Bay City, Michigan, United States
Skin Cancer and Dermatology Institute
Reno, Nevada, United States
Forest Hills Dermatology Group
Kew Gardens, New York, United States
Rodgers Dermatology
Frisco, Texas, United States
Dermatology Of Seattle
Bellevue, Washington, United States
Oshawa Clinic Dermatology Trials
Oshawa, Ontario, Canada
Research Toronto
Toronto, Ontario, Canada
Innovaderm Research Inc
Montreal, Quebec, Canada
Centre de Recherche Saint-Louis
Québec, Quebec, Canada