Eczema (Atopic Dermatitis)
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Eczema (Atopic Dermatitis)
OpSCF-201 Enrolling

Atopic Dermatitis Research Trial (71 Weeks)


Treatment: Injection Age: 18 Years


Who Can Participate?

Adults (aged 18 to 75 years) with atopic dermatitis (AD), may be eligible to participate.

 

Inclusion Criteria:

      • Clinically confirmed diagnosis of active AD
      • At least a 6-month history of AD before screening
      • Moderate to severe AD
      • AD covering ≥ 10% of the total body surface area (BSA)
      • Using an emollient (except those containing urea) daily for at least 1 week, and agree to continue using that same emollient daily at the same frequency throughout the study

 

What Are The Benefits?

      • No cost to participate or receive treatment
      • Regular visits with study doctors who specialize in treating atopic dermatitis (20 clinic visits, plus 1 follow-up phone visit)
      • Will receive either an investigational injected treatment (active study drug) or placebo
      • Reimbursement for study-related expenses may be provided

 

How Long Will The Study Last?

71 weeks


Participating Locations

COUNTRY
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Canada

Participating Experts

Dr. Sameh Hanna

Dermatologist

Dr. G. Daniel Schachter

Dermatologist

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The following information is from ClinicalTrials.gov

Last Update Posted: February 25, 2024

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

ClinicalTrials.gov ID

NCT06101823

Sponsor

Opsidio, LLC

Study Description

  • Brief 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.

  • Condition or Disease:

    Atopic Dermatitis

  • Intervention/Treatment:

    Biological: OpSCF
    Biological: Placebo
    Biological: OpSCF
  • Phase:

    Phase 2

  • Ages Eligible for Study:

    18 Years and 75 Years (Adult)

  • Sexes Eligible for Study:

    All

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


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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Eczema (Atopic Dermatitis)

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