Phase 2a Study of Efficacy and Safety of OpSCF in Moderate to Severe Atopic Dermatitis
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
1 other identifier
interventional
48
2 countries
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2023
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2023
CompletedStudy Start
First participant enrolled
October 25, 2023
CompletedFirst Posted
Study publicly available on registry
October 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedMay 7, 2024
September 1, 2023
11 months
October 19, 2023
May 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent change in Eczema Area and Severity Index (EASI) score from baseline at Week 16
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.
16 weeks
Secondary Outcomes (3)
Incidence of AEs and SAEs
Through study completion, approximately 1 year including the open label extension phase
Proportion of subjects achieving at least a 2-grade reduction from baseline to clear (0) or almost clear (1) in vIGA-AD
16 weeks
Change and percent change from baseline in weekly average of the daily Peak Pruritus Numerical Rating Scale (PP-NRS)
16 weeks
Other Outcomes (3)
Change from baseline in blood biomarkers and IgE at Weeks 4, 8, 12, and 16
16 weeks
Change from baseline in skin biomarkers collected using skin biopsies at Weeks 4 and 16 (optional for consenting subjects)
16 weeks
Change from baseline in skin biomarkers collected using tape strips at Weeks 4 and 16 (optional for consenting subjects)
16 weeks
Study Arms (3)
OpSCF
ACTIVE COMPARATOROpSCF, 600 mg, subcutaneously, every two weeks x 14 weeks
Placebo
PLACEBO COMPARATORMatched placebo, subcutaneously, every two weeks x 14 weeks
Open Label Extension
ACTIVE COMPARATORSubjects 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.
Interventions
Subjects may continue on an Open Label Extension after completing the 16-week randomized portion of the study
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Opsidio, LLClead
- Innovaderm Research Inc.collaborator
Study Sites (22)
Cahaba Dermatology & Skin Health Center
Birmingham, Alabama, 33607, United States
First OC Dermatology Research
Fountain Valley, California, 92708, United States
Axon Clinical Research
Inglewood, California, 90301, United States
University Clinical Trials
San Diego, California, 92123, United States
Unison Clinical Trials
Sherman Oaks, California, 91403, United States
Skin Care Research
Boca Raton, Florida, 33456, United States
Skin Research of South Florida
Miami, Florida, 33173, United States
RM Medical Research
Miami Lakes, Florida, 33014, United States
Advanced Clinical Research Institute
Tampa, Florida, 33607, United States
Arlington Dermatology
Rolling Meadows, Illinois, 60008, United States
Options Research Group
West Lafayette, Indiana, 47906, United States
DS Research of Kentucky
Louisville, Kentucky, 40241, United States
Oakland Hills Dermatology P.C
Auburn Hills, Michigan, 48326, United States
Saginaw Bay Dermatology
Bay City, Michigan, 48706, United States
Skin Cancer and Dermatology Institute
Reno, Nevada, 89509, United States
Forest Hills Dermatology Group
Kew Gardens, New York, 11415, United States
Rodgers Dermatology
Frisco, Texas, 75034, United States
Dermatology Of Seattle
Bellevue, Washington, 98004, United States
Oshawa Clinic Dermatology Trials
Oshawa, Ontario, L1H 1B9, Canada
Research Toronto
Toronto, Ontario, M4W 2N2, Canada
Innovaderm Research Inc
Montreal, Quebec, H2X 2V1, Canada
Centre de Recherche Saint-Louis
Québec, Quebec, G1W 4R4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Martin Phillips
Opsidio, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2023
First Posted
October 26, 2023
Study Start
October 25, 2023
Primary Completion
October 1, 2024
Study Completion
June 1, 2025
Last Updated
May 7, 2024
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share