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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Alopecia Areata

In brief

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 facts

Study ID: NCT06012240
Run by: AbbVie
People needed: 1500
Starts: 2023-10-11
Expected to finish: 2030-04-01
Last updated by the study team: 2026-08-03

Who can join

Age: 12 and older, up to 63. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adult individuals must be < 64 years old at Baseline Visit. Where permitted outside United States (US)/European Union (EU), adolescent individuals who are at least 12 years old at Screening may participate in Study 1 and Study 2. Adolescent individuals in the US who are at least 12 years old at Screening may participate in Study 4.
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.
Current episode of AA of less than 8 years.

You may not qualify if…

Current diagnosis of primarily diffuse type of AA.
Current 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 as determined by the investigator, including but not limited to seborrheic dermatitis, scalp psoriasis, atopic dermatitis (AD), and tinea capitis.

Where it is running

Sadick Research Group LLC /ID# 266790 — New York, New York, United States (enrolling)
International Clinical Research - Tennessee LLC /ID# 259552 — Murfreesboro, Tennessee, United States (enrolling)
Skin Specialists /ID# 259237 — Omaha, Nebraska, United States (enrolling)
Equity Medical /ID# 266680 — New York, New York, United States (enrolling)
Oregon Dermatology and Research Center /ID# 258243 — Portland, Oregon, United States (enrolling)
Advanced Dermatology And Cosmetic Surgery - Spartanburg /ID# 278359 — Spartanburg, South Carolina, United States (enrolling)
Indiana University Health University Hospital /ID# 259827 — Indianapolis, Indiana, United States (enrolling)
Clarkston Dermatology /ID# 258018 — Clarkston, Michigan, United States (enrolling)
Dermatology Research Associates /ID# 258033 — Los Angeles, California, United States (enrolling)
Skin Cancer and Dermatology Institute - Reno /ID# 259208 — Reno, Nevada, United States (enrolling)
Dermatologists of Southwest Ohio, Inc /ID# 260116 — Mason, Ohio, United States (enrolling)
University of California Davis Health /ID# 258112 — Sacramento, California, United States (enrolling)
Clinical Trials Research Institute /ID# 258021 — Thousand Oaks, California, United States (enrolling)
Skin Care Research Boca Raton /ID# 258012 — Boca Raton, Florida, United States (enrolling)
First Oc Dermatology /ID# 259220 — Fountain Valley, California, United States (enrolling)
Advanced Clinical Research Institute - Tampa /ID# 259204 — Tampa, Florida, United States (enrolling)
Tulane University School of Medicine /ID# 259799 — New Orleans, Louisiana, United States (enrolling)
Derm Institute of West Michigan /ID# 259546 — Caledonia, Michigan, United States (enrolling)
Skin Care Research - Hollywood /ID# 259210 — Hollywood, Florida, United States (enrolling)
GSI Clinical Research, LLC /ID# 259352 — Margate, Florida, United States (enrolling)
Las Vegas Dermatology /ID# 279317 — Las Vegas, Nevada, United States (enrolling)
Lenus Research and Medical Group /ID# 259356 — Miami, Florida, United States (enrolling)
Integrative Skin Science and Research /ID# 258114 — Sacramento, California, United States (enrolling)
Cleveland Clinic - Cleveland /ID# 258113 — Cleveland, Ohio, United States (enrolling)
Arlington Research Center, Inc /ID# 258028 — Arlington, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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