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

February 20, 2024 updated by: Opsidio, LLC

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Oshawa, Ontario, Canada, L1H 1B9
        • Recruiting
        • Oshawa Clinic Dermatology Trials
        • Contact:
      • Toronto, Ontario, Canada, M4W 2N2
        • Recruiting
        • Research Toronto
        • Contact:
          • Sameh Hanna, MD
          • Phone Number: 416-962-0123
    • Quebec
      • Montréal, Quebec, Canada, H2X 2V1
        • Recruiting
        • Innovaderm Research Inc
        • Contact:
      • Québec City, Quebec, Canada, G1W 4R4
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 33607
        • Recruiting
        • Cahaba Dermatology & Skin Health Center
        • Contact:
    • California
      • Fountain Valley, California, United States, 92708
      • Inglewood, California, United States, 90301
      • San Diego, California, United States, 92123
        • Recruiting
        • University Clinical Trials
        • Contact:
          • Carlos Vega, CRC
          • Phone Number: 311 858-278-8470
      • Sherman Oaks, California, United States, 91403
    • Florida
      • Boca Raton, Florida, United States, 33456
      • Miami, Florida, United States, 33173
      • Miami Lakes, Florida, United States, 33014
      • Tampa, Florida, United States, 33607
        • Recruiting
        • Advanced Clinical Research Institute
        • Contact:
    • Illinois
      • Rolling Meadows, Illinois, United States, 60008
        • Recruiting
        • Arlington Dermatology
        • Contact:
          • Ursula Cholewa, MA MBA
          • Phone Number: 313 847-392-5440
    • Indiana
      • West Lafayette, Indiana, United States, 47906
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Recruiting
        • DS Research of Kentucky
        • Contact:
    • Michigan
      • Auburn Hills, Michigan, United States, 48326
      • Bay City, Michigan, United States, 48706
        • Recruiting
        • Saginaw Bay Dermatology
        • Contact:
    • Nevada
      • Reno, Nevada, United States, 89509
        • Recruiting
        • Skin Cancer and Dermatology Institute
        • Contact:
          • Jennifer Diaz, MA
          • Phone Number: 775-336-3665
    • New York
      • Kew Gardens, New York, United States, 11415
        • Recruiting
        • Forest Hills Dermatology Group
        • Contact:
          • Tazrin Tripti
          • Phone Number: 718-459-0900
    • Texas
      • Frisco, Texas, United States, 75034
        • Recruiting
        • Rodgers Dermatology
        • Contact:
          • Keisha Neal, CRC
          • Phone Number: 214-618-0220
    • Washington
      • Bellevue, Washington, United States, 98004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 16 weeks
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
Time Frame: Through study completion, approximately 1 year including the open label extension phase
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
Time Frame: 16 weeks
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)
Time Frame: 16 weeks
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
Time Frame: 16 weeks
Blood tests
16 weeks
Change from baseline in skin biomarkers collected using skin biopsies at Weeks 4 and 16 (optional for consenting subjects)
Time Frame: 16 weeks
Histopathological examination
16 weeks
Change from baseline in skin biomarkers collected using tape strips at Weeks 4 and 16 (optional for consenting subjects)
Time Frame: 16 weeks
Analysis of proteomics and mRNA levels
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Opsidio, LLC

Collaborators

Innovaderm Research Inc.

Investigators

  • Study Director: Martin Phillips, Opsidio, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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