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

Last updated: May 3, 2024
Sponsor: Opsidio, LLC
Overall Status: Active - Not Recruiting

Phase

2

Condition

Atopic Dermatitis

Allergies & Asthma

Skin Infections/disorders

Treatment

OpSCF (Open Label Extension)

Placebo

OpSCF

Clinical Study ID

NCT06101823
OpSCF-201
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Subject is a female who is breastfeeding, pregnant, or who is planning to becomepregnant during the study.
  • Subject has any clinically significant medical condition that would put the subject atundue 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

Total Participants: 48
Treatment Group(s): 3
Primary Treatment: OpSCF (Open Label Extension)
Phase: 2
Study Start date:
October 25, 2023
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • DermEdge Research Inc

    Mississauga, Ontario L4Y 4C5
    Canada

    Site Not Available

  • Oshawa Clinic Dermatology Trials

    Oshawa, Ontario L1H 1B9
    Canada

    Site Not Available

  • Research Toronto

    Toronto, Ontario M4W 2N2
    Canada

    Site Not Available

  • Innovaderm Research Inc

    Montréal, Quebec H2X 2V1
    Canada

    Site Not Available

  • Centre de Recherche Saint-Louis

    Québec City, Quebec G1W 4R4
    Canada

    Site Not Available

  • Cahaba Dermatology & Skin Health Center

    Birmingham, Alabama 33607
    United States

    Site Not Available

  • First OC Dermatology Research

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Axon Clinical Research

    Inglewood, California 90301
    United States

    Site Not Available

  • University Clinical Trials

    San Diego, California 92123
    United States

    Site Not Available

  • Unison Clinical Trials

    Sherman Oaks, California 91403
    United States

    Site Not Available

  • Skin Care Research

    Boca Raton, Florida 33456
    United States

    Site Not Available

  • Skin Research of South Florida

    Miami, Florida 33173
    United States

    Site Not Available

  • RM Medical Research

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Advanced Clinical Research Institute

    Tampa, Florida 33607
    United States

    Site Not Available

  • Arlington Dermatology

    Rolling Meadows, Illinois 60008
    United States

    Site Not Available

  • Options Research Group

    West Lafayette, Indiana 47906
    United States

    Site Not Available

  • DS Research of Kentucky

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Oakland Hills Dermatology P.C

    Auburn Hills, Michigan 48326
    United States

    Site Not Available

  • Saginaw Bay Dermatology

    Bay City, Michigan 48706
    United States

    Site Not Available

  • Skin Cancer and Dermatology Institute

    Reno, Nevada 89509
    United States

    Site Not Available

  • Forest Hills Dermatology Group

    Kew Gardens, New York 11415
    United States

    Site Not Available

  • Rodgers Dermatology

    Frisco, Texas 75034
    United States

    Site Not Available

  • Dermatology Of Seattle

    Bellevue, Washington 98004
    United States

    Site Not Available

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