Phase 2a Study of Efficacy and Safety of OpSCF in Moderate to Severe Atopic Dermatitis

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06101823
• Other study ID #: OpSCF-201
• Status: Active, not recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

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