Recruiting NCT06012240

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

Phase III Interventional Alopecia Areata

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Upadacitinib, Placebo.
Who it may be relevant to: Registry conditions: Alopecia Areata. Basic parameters: 12 years — 63 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Belgium, Brazil +23
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

Drug Upadacitinib
Oral Tablets
Drug Placebo
Oral Tablets

Primary outcome measures

Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 20 [Time frame: Week 24]
Number of Participants with Adverse Events (AEs) [Time frame: Up to approximately 164 weeks]

Secondary outcome measures (12)

Achievement of SALT score <= 20 for the Comparison of Upadacitinib Dose A QD Versus Placebo [Time frame: Week 24]
Percentage of Participants with the Achievement of SALT Score <= 10 [Time frame: Up to Week 24]
Percentage of Participants with the Achievement of SALT Score <= 20 [Time frame: Up to Week 12]
Percentage of Participants with the Achievement of Clinician-Reported Outcome (ClinRO) Measure for Eyebrow Hair Loss of 0 or 1 [Time frame: Baseline to Week 24]
Percentage of Participants with the Achievement of ClinRO Measure for Eyelash Hair Loss of 0 or 1 [Time frame: Baseline to Week 24]
Percentage of Participants with the Achievement of SALT 75 [Time frame: Baseline to Week 24]
Percentage of Participants with the Achievement of SALT 90 [Time frame: Baseline to Week 24]
Percent Change from Baseline in SALT Score [Time frame: Baseline to Week 24]
Percentage of Participants with the Achievement of Patients' Global Impression of Change of Alopecia Areata (PaGIC-AA) Score of 1 "Much Better" or 2 "Moderately Better" [Time frame: Up to Week 24]
Percentage of Participants with the Achievement of Patient-Reported Outcome (PRO) for Scalp Hair Assessment 0/1 with ≥ 2-Point Improvement (Reduction) [Time frame: Baseline to Week 24]
Change from Baseline in Alopecia Areata Symptom Impact Scale (AASIS) Interference Subscale Score [Time frame: Week 24]
Change from Baseline in AASIS Symptoms Subscale Score [Time frame: Week 24]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Sequential
Masking: Quadruple blind
Primary purpose: Treatment