What is upadacitinib studying for alopecia areata?

Upadacitinib is being studied to assess its safety, effectiveness, and tolerability in treating severe alopecia areata in adolescents and adults. The study aims to understand how this approved drug impacts hair loss caused by the immune system attacking hair follicles. This research is sponsored by AbbVie and involves participants worldwide.

Who may be eligible for this alopecia areata clinical trial?

Participants aged 12 to 63 years with severe alopecia areata causing at least 50% scalp hair loss may be eligible. They must have had no scalp hair regrowth in the past 6 months and the current episode should be less than 8 years. The trial accepts all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this alopecia areata clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional expenses.

Actively Recruiting

Phase 3

Age: 12Years - 63Years

All Genders

ID06012240

A Phase 3 Randomized, Placebo-controlled, Double-blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Severe Alopecia Areata

Led by AbbVie · Updated on 2026-05-12

1500

Participants Needed

269

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Alopecia areata AA is a condition where the immune system attacks hair follicles causing hair loss, typically on the head and face but possibly anywhere on the body. This research aims to evaluate how safe, effective, and tolerable the drug upadacitinib is for adolescents and adults with severe AA. The study is a Phase 3 randomized, placebo-controlled trial involving about 1500 participants worldwide with severe AA, sponsored by AbbVie. Participants will be randomly assigned to one of three groups receiving either one of two doses of upadacitinib or a placebo. In the initial period, some participants receive placebo for 24 weeks, then based on their hair loss severity measured by the Severity of Alopecia Tool SALT score, they may be re-randomized to continue placebo or start one of the upadacitinib doses. Those on upadacitinib continue their assigned dose. Participants who complete the first studies can join an extension study with upadacitinib treatment for up to 108 weeks. Tablets are taken orally once daily for up to 160 weeks. Throughout the study, participants will attend regular hospital or clinic visits for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers will measure changes in hair loss using the SALT score and track any adverse events during treatment and up to 30 days after the last dose. The study also evaluates other patient-reported outcomes related to hair growth and quality of life over time.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 12Years - 63Years

All Genders

Eligibility Criteria

You may qualify if you...

Adults younger than 64 years old at baseline.
Adolescents at least 12 years old may participate in certain study sites.
Diagnosis of severe alopecia areata with at least 50% scalp hair loss.
No spontaneous scalp hair regrowth in the past 6 months.
Current episode of alopecia areata lasting less than 8 years.

You will not qualify if you...

Current diagnosis of primarily diffuse alopecia areata.
Diagnosis of other types of hair loss that interfere with evaluation, including female or male pattern hair loss (androgenetic alopecia) Stage III or greater, traction alopecia, lichen planopilaris, discoid lupus, frontal fibrosing alopecia, central centrifugal cicatricial alopecia, folliculitis decalvans, trichotillomania, and telogen effluvium.
Other inflammatory scalp, eyebrow, or eyelash disorders interfering with evaluation, such as seborrheic dermatitis, scalp psoriasis, atopic dermatitis, and tinea capitis.

Research Team

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