Phase 2a Study of Efficacy and Safety of OpSCF in Moderate to Severe Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Biological: OpSCFBiological: PlaceboBiological: OpSCF (Open Label Extension)
- Registration Number
- NCT06101823
- Lead Sponsor
- Opsidio, LLC
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 48
- Subject has clinically confirmed diagnosis of active AD
- Subject has at least a 6-month history of AD
- Subject is willing to use effective birth control
- Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
- Subject has any clinically significant medical condition that would put the subject at undue risk or interfere with interpretation of study results.
- Subject has used dupilumab within 26 weeks prior to Day 1
- Subject has used tralokinumab within 12 weeks prior to Day 1
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OpSCF OpSCF OpSCF, 600 mg, subcutaneously, every two weeks x 14 weeks Placebo Placebo Matched placebo, subcutaneously, every two weeks x 14 weeks Open Label Extension OpSCF Subjects may choose to continue in an Open Label Extension (OLE) phase if they complete the randomized phase. All subjects regardless of treatment assignment in the randomized phase will receive OpSCF, 600 mg every 4 weeks for up to 36 weeks. Open Label Extension OpSCF (Open Label Extension) Subjects may choose to continue in an Open Label Extension (OLE) phase if they complete the randomized phase. All subjects regardless of treatment assignment in the randomized phase will receive OpSCF, 600 mg every 4 weeks for up to 36 weeks.
- Primary Outcome Measures
Name Time Method Percent change in Eczema Area and Severity Index (EASI) score from baseline at Week 16 16 weeks Validated measure of activity of atopic dermatitis. A score of 0 indicates clear or no eczema, 0.1 to 1.0 indicates almost clear, 1.1 to 7 indicates mild disease, 7.1 to 21 indicates moderate disease, 21.1 to 50 indicates severe disease, and greater than 51 indicates very severe disease.
- Secondary Outcome Measures
Name Time Method Change and percent change from baseline in weekly average of the daily Peak Pruritus Numerical Rating Scale (PP-NRS) 16 weeks Validated scale of subject-reported itch. The Peak Pruritus Numerical Rating Scale is a single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours based on the following question: 'On a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".
Incidence of AEs and SAEs Through study completion, approximately 1 year including the open label extension phase Safety
Proportion of subjects achieving at least a 2-grade reduction from baseline to clear (0) or almost clear (1) in vIGA-AD 16 weeks Validated Investigator scoring of AD activity
Trial Locations
- Locations (22)
Axon Clinical Research
🇺🇸Inglewood, California, United States
Unison Clinical Trials
🇺🇸Sherman Oaks, California, United States
Options Research Group
🇺🇸West Lafayette, Indiana, United States
Arlington Dermatology
🇺🇸Rolling Meadows, Illinois, United States
DS Research of Kentucky
🇺🇸Louisville, Kentucky, 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
Oakland Hills Dermatology P.C
🇺🇸Auburn Hills, Michigan, United States
Centre de Recherche Saint-Louis
🇨🇦Québec City, Quebec, Canada
Innovaderm Research Inc
🇨🇦Montréal, Quebec, Canada
Saginaw Bay Dermatology
🇺🇸Bay City, Michigan, United States
Cahaba Dermatology & Skin Health Center
🇺🇸Birmingham, Alabama, United States
First OC Dermatology Research
🇺🇸Fountain Valley, California, United States
University Clinical Trials
🇺🇸San Diego, California, United States
Skin Care Research
🇺🇸Boca Raton, Florida, United States
RM Medical Research
🇺🇸Miami Lakes, Florida, United States
Skin Research of South Florida
🇺🇸Miami, Florida, United States
Advanced Clinical Research Institute
🇺🇸Tampa, Florida, United States
Skin Cancer and Dermatology Institute
🇺🇸Reno, Nevada, United States
Oshawa Clinic Dermatology Trials
🇨🇦Oshawa, Ontario, Canada
Research Toronto
🇨🇦Toronto, Ontario, Canada