Psoriasis Clinical Trial
A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata
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.
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 participate.
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.
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.
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There are 30 Locations for this study
Birmingham Alabama, 35205, United States
Glendale Arizona, 85308, United States
Phoenix Arizona, 85018, United States
Phoenix Arizona, 85032, United States
Fort Smith Arkansas, 72916, United States
Los Angeles California, 90045, United States
Sacramento California, 95815, United States
Thousand Oaks California, 91320, United States
Boca Raton Florida, 33486, United States
Doral Florida, 33122, United States
Margate Florida, 33063, United States
Tampa Florida, 33613, United States
Marietta Georgia, 30060, United States
Leawood Kansas, 66211, United States
Clarkston Michigan, 48346, United States
Lee's Summit Missouri, 64064, United States
Omaha Nebraska, 68144, United States
Reno Nevada, 89052, United States
East Windsor New Jersey, 08520, United States
Columbus Ohio, 43215, United States
Portland Oregon, 97210, United States
Arlington Texas, 76011, United States
Bellaire Texas, 77401, United States
Dallas Texas, 75230, United States
Houston Texas, 77065, United States
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