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A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants with Severe Alopecia Areata
EU CTIS ID: 2023-505061-82-01
What this study is testing
Objective: Study 1 and Study 2: Double-blind Period, Baseline to Week 24 (Period A): To assess the efficacy, safety, and tolerability of upadacitinib 15 mg once daily (QD) and 30 mg QD compared with placebo for the treatment of signs and symptoms of severe AA in adult subjects and adolescent subjects Blinded Extension Period, Week 24 to Week 52 (Period B): To evaluate the efficacy, safety, and tolerability of upadacitinib 15 mg QD and 30 mg QD in extended treatment in adult and adolescent subjects with severe AA Study 3 Randomized Blinded Extension Period, Week 52 to Week 160: To assess the long-term safety and efficacy of the following treatments in adult and adolescent subjects with severe AA: Continuous upadacitinib 30 mg QD treatment Dose reduction to 15 mg QD in subjects who achieve sustained response in Study 1, Study 2 or study 4 defined as a Severity of Alopecia Tool (SALT) score ≤ 20 at Week 40 and Week 52 Continuous upadacitinib 15 mg QD treatment Dose escalation to 30 mg QD in subjects who have not achieved a SALT score ≤ 20 at Week 52 in Study 1, Study 2 or study 4 or who lose response during Study 3 Study 4 (US only): Double-blind Period, Baseline to Week 24 (Period A): To assess the efficacy, safety, and tolerability of upadacitinib 15 mg QD and 30 mg QD and placebo for the treatment of signs and symptoms of severe AA in adolescent subjects in the US Blinded Extension Period, Week 24 to Week 52 (Period B): To evaluate the efficacy, safety, and tolerability of upadacitinib 15 mg QD and 30 mg QD in extended treatment in adolescent subjects with severe AA in the US
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Eligible subjects will be adults < 64 years old at Baseline and, where permitted outside US/EU adolescents at least 12 years old at Screening with a diagnosis of severe AA with SALT score ≥ 50 scalp hair loss at Screening and Baseline and no spontaneous scalp hair regrowth over the past 6 months AND no significant scalp hair loss over the past 3 months
- Must have current episode of AA of less than 8 years.
You likely can't join if
- Subject has a diagnosis of primarily diffuse type of AA
- Subject has a 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, discoid lupus, frontal fibrosing alopecia, central centrifugal cicatricial alopecia, folliculitis decalvans, trichotillomania, and telogen effluvium.
- Subject has a 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, AD, and tinea capitis.
The study team makes the final eligibility decision.
Where it's taking place
- China
- New Zealand
- Puerto Rico
- Turkey
- Australia
- Canada
- Mexico
- United Kingdom
- Argentina
- Taiwan
- United States
- Korea, Republic of
- Israel
- Japan
- Chile
- Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; New Zealand; Puerto Rico; Turkey; Australia; Canada and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.