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

Conditions

• Alopecia Areata

Eligibility Criteria

Sex

ALL

Age

12 Years - 63 Years

Healthy Volunteers

Not accepted

Interventions

• Upadacitinib — DRUG
  Oral Tablets
• Placebo — DRUG
  Oral Tablets

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 with severe AA. Upadacitinib is an approved drug being investigated for the treatment of AA. In Study 1 and Study 2 and Study 4 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 and Study 4 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, Study 2 or Study 4, 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 280 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.

Key Dates

Start date

Oct 11, 2023

Status verified

May 2026

Primary completion

Apr 30, 2030

Completion

Apr 30, 2030

Study Design

Enrollment

1,500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Study 1: Group 1 Upadacitinib Dose A
  Participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.
• Experimental: Study 1: Group 2 Upadacitinib Dose B
  Participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.
• Experimental: Study 1: Group 3 Placebo
  Participants will receive matching placebo once daily for 24 weeks in Period A.
• Experimental: Study 1: Group 4 Upadacitinib Dose A
  Participants initially randomized to placebo (Period A) with a SALT score \> 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B.
• Experimental: Study 1: Group 5 Upadacitinib Dose B
  Participants initially randomized to placebo (Period A) with a SALT score \> 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B.
• Experimental: Study 1: Group 6 Placebo
  Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 160.
• Experimental: Study 2: Group 1 Upadacitinib Dose A
  Participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.
• Experimental: Study 2: Group 2 Upadacitinib Dose B
  Participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.
• Experimental: Study 2: Group 3 Placebo
  Participants will receive matching placebo once daily for 24 weeks in Period A.
• Experimental: Study 2: Group 4 Upadacitinib Dose A
  Participants initially randomized to placebo (Period A) with a SALT score \> 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B.
• Experimental: Study 2: Group 5 Upadacitinib Dose B
  Participants initially randomized to placebo (Period A) with a SALT score \> 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B.
• Experimental: Study 2: Group 6 Placebo
  Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 160.
• Experimental: Study 3: Group 1 Upadacitinib Dose B (SALT > 20)
  Participants receiving upadacitinib Dose A with a SALT score \> 20 at Week 52 (end of Period B) of Study 1 or Study 2 will dose escalate to upadacitinib Dose B once daily for 108 weeks.
• Experimental: Study 3: Group 2 Upadacitinib Dose A (SALT ≤ 20)
  Participants receiving upadacitinib Dose A with a SALT score ≤ 20 at Week 52 (end of Period B) of Study 1 or Study 2 will remain on upadacitinib Dose A once daily for 108 weeks.
• Experimental: Study 3: Group 3 Upadacitinib Dose B (Non-Sustained)
  Participants who end Period B on upadacitinib Dose B with a with a SALT score \> 20 at Week 40 or Week 52 of Study 1 or Study 2 will remain on upadacitinib Dose B once daily for 108 weeks.
• Experimental: Study 3: Group 4 Upadacitinib Dose B (Sustained)
  Participants who end Period B on upadacitinib Dose B with a with a SALT score ≤ 20 at Week 40 and Week 52 of Study 1 or Study 2 will be re-randomized to receive upadacitinib Dose B once daily for 108 weeks.
• Experimental: Study 3: Group 5 Upadacitinib Dose A (Sustained)
  Participants who end Period B on upadacitinib Dose B with a with a SALT score ≤ 20 at Week 40 and Week 52 of Study 1 or Study 2 will be re-randomized to receive upadacitinib Dose A once daily for 108 weeks.
• Experimental: Study 4: Group 1 Upadacitinib Dose A
  US only adolescent participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.
• Experimental: Study 4: Group 2 Upadacitinib Dose B
  US only adolescent participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.
• Experimental: Study 4: Group 3 Placebo
  US only adolescent participants will receive matching placebo once daily for 24 weeks in Period A.
• Experimental: Study 4: Group 4 Upadacitinib Dose A
  Participants initially randomized to placebo (Period A) with a SALT score \> 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B.
• Experimental: Study 4: Group 5 Upadacitinib Dose B
  Participants initially randomized to placebo (Period A) with a SALT score \> 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B.
• Experimental: Study 4: Group 6 Placebo
  Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 160.

Primary Outcome Measure

Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 20 [ Time Frame: Week 24 ]

Central Contacts

• ABBVIE CALL CENTER
  844-663-3742
  [email protected]

Locations (75)

Find similar trials in Birmingham, AL

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