Alopecia Areata
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Alopecia Areata
M23-716 Enrolling

Adult-Adolescent Alopecia Areata Research Trial (169 Weeks)


Treatment: Oral Age: 12 Years


Who Can Participate?

Adults (<64 years old) or adolescents (at least 12 years old) with alopecia areata (AA), may be eligible to participate.

 

Eligibility Criteria:

      • Diagnosis of severe AA with ≥ 50% scalp hair loss
      • Severe AA with no spontaneous scalp hair regrowth over the past 6 months AND no significant scalp hair loss over the past 3 months
      • Current episode of AA of less than 8 years
      • Not have a diagnosis of primarily diffuse type of AA
      • Not have a diagnosis of other types of alopecia

 

What Are The Benefits?

      • No cost to participate or receive treatment
      • Regular visits with study doctors who specialize in treating alopecia areata (AA)
      • Will receive either an investigational oral treatment (active study drug) or placebo
      • Reimbursement for study-related expenses will be provided

 

How Long Will The Study Last?

      • 169 weeks (16 visits, plus a 30-day follow-up phone call or a site visit)

Participating Locations

COUNTRY
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Australia

Participating Experts

Dr. Kurt Gebauer

Dermatologist

Dr. Esther Hong

Dermatologist

Dr. Stephen Shumack

Dermatologist

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The following information is from ClinicalTrials.gov

Last Update Posted: June 09, 2024

Official Title

A Phase 3 Randomized, Placebo-controlled, Double-blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Severe Alopecia Areata

ClinicalTrials.gov ID

NCT06012240

Sponsor

AbbVie

Study Description

  • Brief Summary:

    Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles and causes hair loss. AA usually affects the head and face, but hair loss can happen on any part of the body. The purpose of this study is to assess how safe, effective, and tolerable upadacitinib is in adolescent and adult participants with severe AA. Upadacitinib is an approved drug being investigated for the treatment of AA. In Study 1 and Study 2 Period A, participants are placed in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 5 chance that participants will be assigned to placebo. In Study 1 and Study 2 Period B, participants originally randomized to upadacitinib dose group in Period A will continue their same treatment in Period B. Participants originally randomized to Placebo in Period A will either remain on placebo in Period B, or be randomized in 1 of 2 groups, based off of their Severity of Alopecia Tool (SALT) score. Participants who complete Study 1 or Study 2, can join Study 3 and may be re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks. Around 1500 participants with severe AA will be enrolled in the study at approximately 240 sites worldwide. Participants will receive oral tablets of either upadacitinib or placebo once daily for up to 160 weeks with the potential of being re-randomized into a different treatment group at Weeks 24 and 52. Participants will be followed up for up to 30 days after last study drug dose. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

  • Condition or Disease:

    Alopecia Areata

  • Intervention/Treatment:

    Drug: Upadacitinib
    Drug: Upadacitinib
    Drug: Placebo
    Drug: Upadacitinib
    Drug: Upadacitinib
    Drug: Placebo
    Drug: Upadacitinib
    Drug: Upadacitinib
    Drug: Placebo
    Drug: Upadacitinib
    Drug: Upadacitinib
    Drug: Placebo
    Drug: Upadacitinib
    Drug: Upadacitinib
    Drug: Upadacitinib
    Drug: Upadacitinib
    Drug: Upadacitinib
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    12 Years and 63 Years (Child)

  • Sexes Eligible for Study:

    All

Inclusion Criteria:

Adult individuals must be < 64 years old at Baseline Visit. Where permitted outside United States (OUS), adolescent individuals who are at least 12 years old at Screening may participate. Diagnosis of severe alopecia areata (AA) with Severity of Alopecia Tool (SALT) score >= 50 scalp hair loss at Screening and Baseline.
Severe AA with no spontaneous scalp hair regrowth over the past 6 months AND no significant scalp hair loss over the past 3 months.
Current episode of AA of less than 8 years.

Exclusion Criteria:

Diagnosis of primarily diffuse type of AA.
Diagnosis of other types of alopecia that would interfere with evaluation of AA, including but not limited to female pattern hair loss, male pattern hair loss (androgenetic alopecia) Stage III or greater based on Hamilton-Norwood classification, traction alopecia, lichen planopilaris (LPP), discoid lupus, frontal fibrosing alopecia (FFA), central centrifugal cicatricial alopecia (CCCA), folliculitis decalvans, trichotillomania, and telogen effluvium.
Diagnosis of other types of inflammatory scalp, eyebrow, or eyelash disorders that would interfere with evaluation of AA, including but not limited to seborrheic dermatitis, scalp psoriasis, atopic dermatitis (AD), and tinea capitis.


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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