Alopecia Areata
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Alopecia Areata
DRI18180 Enrolling

Adult Severe Alopecia Areata Research Trial (56 Weeks)


Treatment: Injection Age: 18 Years


Who Can Participate?

Adults at least 18 years old inclusive with alopecia areata (AA), may be eligible to participate.

 

Eligibility Criteria:

      • have a definitive diagnosis of AA of more than 6 months
      • have a diagnosis of severe AA, as determined by all of the following:
        1. hair loss affecting ≥ 50% of the scalp
        2. current episode of hair loss of less than 8 years
        3. no evidence of terminal hair regrowth within 6 months
      • have a willingness in maintaining a consistent hair style and hair care, including hair products, and refrain from shaving of scalp hair for 2 weeks prior to each study visit

 

Participant Info:

      • No cost to participate or receive treatment
      • Regular visits with study doctors who specialize in treating alopecia areata (AA)
      • 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?

      • 56 weeks

Participating Locations

COUNTRY
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Canada

Participating Experts

Dr. Charles Lynde

Dermatologist

Dr. Marni Wiseman

Dermatologist

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The following information is from ClinicalTrials.gov

Last Update Posted: July 09, 2024

Official Title

A Phase 2, Randomized, Double-blind, Placebo--controlled, Parallel Group, 3-arm, Multinational, Multicenter, Proof-of-concept Study to Evaluate the Efficacy and Safety of Amlitelimab Monotherapy by Subcutaneous Injection in Adult Participants With Severe Alopecia Areata

ClinicalTrials.gov ID

NCT06444451

Sponsor

Sanofi

Study Description

  • Brief Summary:

    This is a parallel, Phase 2 multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study to investigate the efficacy and safety of subcutaneous (SC) injections of amlitelimab treatment as monotherapy in participants aged 18 years and older with severe alopecia areata (AA). At the end of the treatment period, all participants will have the option to enter a separate study, the open-label extension (OLE) study, once eligibility is confirmed. The study duration will be up to 56 weeks for participants not entering the OLE including a 2-to-4-week screening, a 36-week randomized double-blind period, and a 16-week safety follow-up. For participants entering the OLE, the DRI18180 study duration will be up to 40 weeks, including a 2-to-4-week screening, a 36-week randomized double-blind period The total number of visits will be up to 12 visits (or 11 visits for those entering the OLE study).

  • Condition or Disease:

    Alopecia Areata

  • Intervention/Treatment:

    Drug: Amlitelimab Drug: Amlitelimab Drug: Placebo
  • Phase:

    PHASE 2

  • Ages Eligible for Study:

    18 Years and older (ADULT,OLDER_ADULT)

  • Sexes Eligible for Study:

    ALL


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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