NIPH Clinical Trials Search

[M24-600] A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants in Japan With Alopecia Areata

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Alopecia Areata
Date of first enrollment	23/06/2025
Target sample size	123
Countries of recruitment
Study type	Interventional
Intervention(s)	Group 1A: Upadacitinib Dose A. Participants will receive upadacitinib dose A once daily for 52 weeks in Period A and Period B. Group 2A: Upadacitinib Dose B. Participants will receive upadacitinib dose B once daily for 52 weeks in Period A and Period B. Group 3A: Upadacitinib Placebo. Participants will receive upadacitinib placebo once daily for 24 weeks in Period A. Group 1B: Upadacitinib Dose A. Participants initially randomized to placebo (Period A) will be re-randomized to receive upadacitinib dose A once daily for 28 weeks in Period B. Group 2B: Upadacitinib Dose B. Participants initially randomized to placebo (Period A) will be re-randomized to receive upadacitinib dose B once daily for 28 weeks in Period B. Period C: Upadacitinib Dose A Remains Dose A. For participants initially randomized to dose A in Periods A and B and participants initially randomized to placebo who switched to dose A in Period B: participants with a Severity of Alopecia Tool (SALT) score <= 10 at Week 52 (end of Period B) will remain on blinded upadacitinib dose A once daily in Period C for 52 weeks. Period C: Upadacitinib Dose A to Dose B. For participants initially randomized to dose A in Periods A and B and participants initially randomized to placebo who switched to dose A in Period B: participants with a SALT score > 10 at Week 52 (end of Period B) will dose escalate to blinded upadacitinib dose B once daily in Period C for 52 weeks. Period C: Upadacitinib Dose B Non-Sustained Responders. For participants initially randomized to dose B in Periods A and B and participants initially randomized to placebo who switched to dose B in Period B: participants with a SALT score > 10 at Week 40 or Week 52 will remain on blinded upadacitinib dose B once daily in Period C for 52 weeks. Period C: Upadacitinib Dose B Sustained Responders. For participants initially randomized to dose B in Periods A and B and participants initially randomized to placebo who switched to dose B in Period B: participants with a SALT score <= 10 at Week 40 and Week 52 will receive blinded upadacitinib dose A once daily in Period C for 52 weeks. Period C: Open-Label Upadacitinib Dose B. Participants with no improvement or worsening from Baseline in their SALT score at the Week 40 visit or any scheduled visit thereafter will receive open-label upadacitinib dose B once daily for 52 weeks.

Outcome(s)

Primary Outcome	- Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 10 at Week 24 - Number of Participants with Adverse Events (AEs)
Secondary Outcome	- Percentage of Participants with the Achievement of Patient-Reported Outcome (PRO) for Scalp Hair Assessment of 0 or 1 at 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" at Week 24

Key inclusion & exclusion criteria

Age minimum	>= 12age old
Age maximum	<= 63age old
Gender	Both
Include criteria	- Participant is judged to be in good health as determined by the Principal Investigator, based upon the results of the Screening assessments and medical history. - Diagnosis of severe alopecia areata (AA) with Severity of Alopecia Tool (SALT) score >= 25 (>= 25% scalp hair loss) at Screening and Baseline. - Current episode of AA of less than 8 years.
Exclude 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. - Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral/intramuscular anti-infectives within 14 days prior to the Baseline Visit. - Chronic recurring infection and/or active viral infection that, based on the investigator's clinical assessment, makes the participant an unsuitable candidate for the study.