A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants in Japan With Alopecia Areata

Sponsor
AbbVie
Study ID
NCT07023302
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 63 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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 in Japan with severe AA. Upadacitinib is an approved drug being investigated for the treatment of AA. In Period A, participants are placed in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. In Period B, participants originally randomized to a upadacitinib dose group in Period A will continue their same treatment in Period B. Participants originally randomized to Placebo in Period A will be re-randomized in 1 of 2 groups receiving upadacitinib. Participants who complete Period B can join Period C and will receive 1 of 2 doses of upadacitinib for up to 52 weeks based on their SALT score. Around 123 adolescent and adult participants with severe AA will be enrolled in the study at approximately 20 sites in Japan. Participants will receive oral tablets of either upadacitinib or placebo once daily for up to 104 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 their 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.

Key Dates

Start date
Jun 19, 2025
Status verified
Dec 2025
Primary completion
Feb 28, 2029
Completion
Feb 28, 2029

Study Design

Enrollment
123 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1A: Upadacitinib Dose A
    Participants will receive upadacitinib dose A once daily for 52 weeks in Period A and Period B.
  • Experimental: Group 2A: Upadacitinib Dose B
    Participants will receive upadacitinib dose B once daily for 52 weeks in Period A and Period B.
  • Placebo Comparator: Group 3A: Upadacitinib Placebo
    Participants will receive upadacitinib placebo once daily for 24 weeks in Period A.
  • Experimental: Group 1B: Upadacitinib Dose A
    Participants initially randomized to placebo (Period A) will be re-randomized to receive upadacitinib dose A once daily for 28 weeks in Period B.
  • Experimental: Group 2B: Upadacitinib Dose B
    Participants initially randomized to placebo (Period A) will be re-randomized to receive upadacitinib dose B once daily for 28 weeks in Period B.
  • Experimental: Period C: Upadacitinib Dose A Remains Dose A
    For participants initially randomized to dose A in Periods A and B and participants initially randomized to placebo who switched to dose A in Period B: participants with a Severity of Alopecia Tool (SALT) score \<= 10 at Week 52 (end of Period B) will remain on blinded upadacitinib dose A once daily in Period C for 52 weeks.
  • Experimental: Period C: Upadacitinib Dose A to Dose B
    For participants initially randomized to dose A in Periods A and B and participants initially randomized to placebo who switched to dose A in Period B: participants with a SALT score \> 10 at Week 52 (end of Period B) will dose escalate to blinded upadacitinib dose B once daily in Period C for 52 weeks.
  • Experimental: Period C: Upadacitinib Dose B Non-Sustained Responders
    For participants initially randomized to dose B in Periods A and B and participants initially randomized to placebo who switched to dose B in Period B: participants with a SALT score \> 10 at Week 40 or Week 52 will remain on blinded upadacitinib dose B once daily in Period C for 52 weeks.
  • Experimental: Period C: Upadacitinib Dose B Sustained Responders
    For participants initially randomized to dose B in Periods A and B and participants initially randomized to placebo who switched to dose B in Period B: participants with a SALT score \<= 10 at Week 40 and Week 52 will receive blinded upadacitinib dose A once daily in Period C for 52 weeks.
  • Experimental: Period C: Open-Label Upadacitinib Dose B
    Participants with no improvement or worsening from Baseline in their SALT score at the Week 40 visit or any scheduled visit thereafter will receive open-label upadacitinib dose B once daily for 52 weeks.

Primary Outcome Measure

Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 10 [ Time Frame: Week 24 ]

Central Contacts

Related Studies