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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Biological: OpSCF; Biological: Placebo; Biological: OpSCF (Open Label Extension)

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Oshawa, Ontario, Canada, L1H 1B9
      • Oshawa Clinic Dermatology Trials
    • Toronto, Ontario, Canada, M4W 2N2
      • Research Toronto
  • Quebec
    • Montréal, Quebec, Canada, H2X 2V1
      • Innovaderm Research Inc
    • Québec City, Quebec, Canada, G1W 4R4
      • Centre de Recherche Saint-Louis
• United States
  • Alabama
    • Birmingham, Alabama, United States, 33607
      • Cahaba Dermatology & Skin Health Center
  • California
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology Research
    • Inglewood, California, United States, 90301
      • Axon Clinical Research
    • San Diego, California, United States, 92123
      • University Clinical Trials
    • Sherman Oaks, California, United States, 91403
      • Unison Clinical Trials
  • Florida
    • Boca Raton, Florida, United States, 33456
      • Skin Care Research
    • Miami, Florida, United States, 33173
      • Skin Research of South Florida
    • Miami Lakes, Florida, United States, 33014
      • RM Medical Research
    • Tampa, Florida, United States, 33607
      • Advanced Clinical Research Institute
  • Illinois
    • Rolling Meadows, Illinois, United States, 60008
      • Arlington Dermatology
  • Indiana
    • West Lafayette, Indiana, United States, 47906
      • Options Research Group
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • DS Research of Kentucky
  • Michigan
    • Auburn Hills, Michigan, United States, 48326
      • Oakland Hills Dermatology P.C
    • Bay City, Michigan, United States, 48706
      • Saginaw Bay Dermatology
  • Nevada
    • Reno, Nevada, United States, 89509
      • Skin Cancer and Dermatology Institute
  • New York
    • Kew Gardens, New York, United States, 11415
      • Forest Hills Dermatology Group
  • Texas
    • Frisco, Texas, United States, 75034
      • Rodgers Dermatology
  • Washington
    • Bellevue, Washington, United States, 98004
      • Dermatology of Seattle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: OpSCF; OpSCF, 600 mg, subcutaneously, every two weeks x 14 weeks	Biological: OpSCF; Monoclonal Antibody
Placebo Comparator: Placebo; Matched placebo, subcutaneously, every two weeks x 14 weeks	Biological: Placebo; Formulation buffer without active agent
Active Comparator: 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.	Biological: OpSCF; Monoclonal Antibody; Biological: OpSCF (Open Label Extension); Subjects may continue on an Open Label Extension after completing the 16-week randomized portion of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of AEs and SAEs	Safety	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	Validated Investigator scoring of AD activity	16 weeks
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in blood biomarkers and IgE at Weeks 4, 8, 12, and 16	Blood tests	16 weeks
Change from baseline in skin biomarkers collected using skin biopsies at Weeks 4 and 16 (optional for consenting subjects)	Histopathological examination	16 weeks
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

Collaborators and Investigators

• Sponsor: Opsidio, LLC
• Collaborators: Innovaderm Research Inc.
• Investigators: Study Director: Martin Phillips, Opsidio, LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Monoclonal Antibody; Eczema
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: OpSCF-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No