Phase 2a Study of Efficacy and Safety of OpSCF in Moderate to Severe Atopic Dermatitis
NCT ID: NCT06101823
Last Updated: 2024-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
48 participants
INTERVENTIONAL
2023-10-25
2025-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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OpSCF
OpSCF, 600 mg, subcutaneously, every two weeks x 14 weeks
OpSCF
Monoclonal Antibody
Placebo
Matched placebo, subcutaneously, every two weeks x 14 weeks
Placebo
Formulation buffer without active agent
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.
OpSCF
Monoclonal Antibody
OpSCF (Open Label Extension)
Subjects may continue on an Open Label Extension after completing the 16-week randomized portion of the study
Interventions
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OpSCF
Monoclonal Antibody
Placebo
Formulation buffer without active agent
OpSCF (Open Label Extension)
Subjects may continue on an Open Label Extension after completing the 16-week randomized portion of the study
Eligibility Criteria
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Inclusion Criteria
* Subject has at least a 6-month history of AD
* Subject is willing to use effective birth control
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Innovaderm Research Inc.
OTHER
Opsidio, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Martin Phillips
Role: STUDY_DIRECTOR
Opsidio, LLC
Locations
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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
Countries
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Other Identifiers
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OpSCF-201
Identifier Type: -
Identifier Source: org_study_id
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