DR-01-AIM-001 Enrolling

Research Trial for Alopecia Areata and Vitiligo (52 Weeks)


Treatment: IV Age: 18 Years


Who Can Participate?

Adults aged ≥ 18 with alopecia areata (AA) or vitiligo, may be eligible to participate.

 

Inclusion Criteria:

      • Have the following regarding alopecia areata (AA):
          • diagnosed with moderate to severe AA with > 20% scalp hair loss
          • current episode of AA lasting from > 6 months to < 10 years
          • no spontaneous improvement in the 6 months prior to screening or between screening and baseline; OR
      • Have active or stable non-segmental vitiligo defined as follows:
          • clinical diagnosis of non-segmental vitiligo for at least 3 months
          • body surface area (BSA) involvement of 4% to 60% excluding palms of hands and soles of feet
          • BSA ≥ 0.25% involvement on the face excluding the lips
          • subjects with active vitiligo should have at least 1 active lesion

 

Participant Info:

      • No cost to participate or receive treatment
      • Regular visits with study doctors who specialize in treating alopecia areata and vitiligo
      • Will receive investigational medication (active study drug) administered via IV infusion
      • Reimbursement for time and travel expenses will be provided

 

How Long Will The Study Last?

      • About 52 weeks and involve about 16 visits to the study research site

Participating Locations

COUNTRY
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Australia

Participating Experts

No Doctors Found

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The following information is from ClinicalTrials.gov

Last Update Posted: February 07, 2025

Official Title

A Pilot, Safety and Clinical Activity, Phase 1b Study of DR-01 in Adults With Alopecia Areata or Vitiligo

ClinicalTrials.gov ID

NCT06602232

Sponsor

Dren Bio

Study Description

  • Brief Summary:

    This is a multi-center, parallel-group, open-label, randomized, Phase 1b study to explore the safety, clinical activity, pharmacokinetics and pharmacodynamics of DR-01 in adults with Alopecia Areata or Vitiligo.

  • Condition or Disease:

    Alopecia Areata, Vitiligo

  • Intervention/Treatment:

    Drug: DR-01 Drug: DR-01 Drug: DR-01
  • Phase:

    PHASE 1

  • 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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