Upadacitinib tablets for severe alopecia areata in adolescents and adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3, randomized, placebo-controlled trial tests oral upadacitinib tablets in adolescents and adults with severe alopecia areata. Eligible participants have a SALT score ≥ 50, a current episode under 8 years, and no spontaneous regrowth in the past 6 months. Participants are randomized into one of three treatment arms with a 1-in-5 chance of receiving placebo in the initial period; active-dose participants generally continue the same treatment into the second period while some placebo recipients may remain on placebo or be re-randomized to an active dose based on severity. The trial is sponsored by AbbVie and is enrolling at several US dermatology centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

• First Oc Dermatology /ID# 259220
  Fountain Valley, California, United States Recruiting
• Dermatology Research Associates /ID# 258033
  Los Angeles, California, United States Recruiting
• Integrative Skin Science and Research /ID# 258114
  Sacramento, California, United States Recruiting
• University of California Davis Health /ID# 258112
  Sacramento, California, United States Recruiting
• Clinical Trials Research Institute /ID# 258021
  Thousand Oaks, California, United States Recruiting
• Skin Care Research Boca Raton /ID# 258012
  Boca Raton, Florida, United States Recruiting

+222 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.