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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06101823
Other study ID # OpSCF-201
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date October 25, 2023
Est. completion date June 2025

Study information

Verified date September 2023
Source Opsidio, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 48
Est. completion date June 2025
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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


Related Conditions & MeSH terms


Intervention

Biological:
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

Locations

Country Name City State
Canada Innovaderm Research Inc Montréal Quebec
Canada Oshawa Clinic Dermatology Trials Oshawa Ontario
Canada Centre de Recherche Saint-Louis Québec City Quebec
Canada Research Toronto Toronto Ontario
United States Oakland Hills Dermatology P.C Auburn Hills Michigan
United States Saginaw Bay Dermatology Bay City Michigan
United States Dermatology Of Seattle Bellevue Washington
United States Cahaba Dermatology & Skin Health Center Birmingham Alabama
United States Skin Care Research Boca Raton Florida
United States First OC Dermatology Research Fountain Valley California
United States Rodgers Dermatology Frisco Texas
United States Axon Clinical Research Inglewood California
United States Forest Hills Dermatology Group Kew Gardens New York
United States DS Research of Kentucky Louisville Kentucky
United States Skin Research of South Florida Miami Florida
United States RM Medical Research Miami Lakes Florida
United States Skin Cancer and Dermatology Institute Reno Nevada
United States Arlington Dermatology Rolling Meadows Illinois
United States University Clinical Trials San Diego California
United States Unison Clinical Trials Sherman Oaks California
United States Advanced Clinical Research Institute Tampa Florida
United States Options Research Group West Lafayette Indiana

Sponsors (2)

Lead Sponsor Collaborator
Opsidio, LLC Innovaderm Research Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Change from baseline in blood biomarkers and IgE at Weeks 4, 8, 12, and 16 Blood tests 16 weeks
Other Change from baseline in skin biomarkers collected using skin biopsies at Weeks 4 and 16 (optional for consenting subjects) Histopathological examination 16 weeks
Other Change from baseline in skin biomarkers collected using tape strips at Weeks 4 and 16 (optional for consenting subjects) Analysis of proteomics and mRNA levels 16 weeks
Primary 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 Incidence of AEs and SAEs Safety Through study completion, approximately 1 year including the open label extension phase
Secondary Proportion of subjects achieving at least a 2-grade reduction from baseline to clear (0) or almost clear (1) in vIGA-AD Validated Investigator scoring of AD activity 16 weeks
Secondary Change and percent change from baseline in weekly average of the daily Peak Pruritus Numerical Rating Scale (PP-NRS) 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". 16 weeks
See also
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