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

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.

Interventional study

Alopecia Areata
1500 patients
  • 1
  • 2
  • 3
  • 4
Protocol ID:
Intervention model:
Sequential Assignment
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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Eligibility criteria

Participant attributes:
Male and Female


From 12 Years to 63 Years.

Inclusion Criteria:

- Adult individuals < 64 years old at Baseline Visit. Where permitted outside United
States (OUS), adolescent individuals who are at least 12 years old at Screening may

- Diagnosis of severe AA with 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.

All the cities where the clinical studies are located

Barrie - L4M 7G1
Markham - L3P 1X3
Ottawa - K1H 7X3
Peterborough - K9J 5K2
Waterloo - N2J 1C4