[M23-716] A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants with Severe Alopecia Areata

JRCT ID: jRCT2041230114

Registered date:04/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Alopecia Areata
• Date of first enrollment: 11/12/2023
• Target sample size: 1400
• Countries of recruitment: United States,Japan
• Study type: Interventional

Intervention(s)

Study 1: Group 1 Upadacitinib Dose A [Oral Tablets]. Participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.
Study 1: Group 2 Upadacitinib Dose B [Oral Tablets]. Participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.
Study 1: Group 3 Placebo [Oral Tablets]. Participants will receive matching placebo once daily for 24 weeks in Period A.
Study 1: Group 4 Upadacitinib Dose A [Oral Tablets]. Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B.
Study 1: Group 5 Upadacitinib Dose B [Oral Tablets]. Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B.
Study 1: Group 6 Placebo [Oral Tablets]. Participants initially randomized to placebo with a SALT score <= 20 at Week 24 will continue on placebo through Week 52.

Study 2: Group 1 Upadacitinib Dose A [Oral Tablets]. Participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.
Study 2: Group 2 Upadacitinib Dose B [Oral Tablets]. Participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.
Study 2: Group 3 Placebo [Oral Tablets]. Participants will receive matching placebo once daily for 24 weeks in Period A.
Study 2: Group 4 Upadacitinib Dose A [Oral Tablets]. Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B.
Study 2: Group 5 Upadacitinib Dose B [Oral Tablets]. Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B.
Study 2: Group 6 Placebo [Oral Tablets]. Participants initially randomized to placebo with a SALT score <= 20 at Week 24 will continue on placebo through Week 52.

Study 3: Group 1 Upadacitinib Dose B (SALT > 20) [Oral Tablets]. Participants receiving upadacitinib Dose A with a SALT score > 20 at Week 52 (end of Period B) of Study 1 or Study 2 will dose escalate to upadacitinib Dose B once daily for 108 weeks.
Study 3: Group 2 Upadacitinib Dose A (SALT <= 20) [Oral Tablets]. Participants receiving upadacitinib Dose A with a SALT score <= 20 at Week 52 (end of Period B) of Study 1 or Study 2 will remain on upadacitinib Dose A once daily for 108 weeks.
Study 3: Group 3 Upadacitinib Dose B (Non-Sustained) [Oral Tablets]. Participants who end Period B on upadacitinib Dose B with a with a SALT score > 20 at Week 40 or Week 52 of Study 1 or Study 2 will remain on upadacitinib Dose B once daily for 108 weeks.
Study 3: Group 4 Upadacitinib Dose B (Sustained) [Oral Tablets]. Participants who end Period B on upadacitinib Dose B with a with a SALT score <= 20 at Week 40 and Week 52 of Study 1 or Study 2 will be re-randomized to receive upadacitinib Dose B once daily for 108 weeks.
Study 3: Group 5 Upadacitinib Dose A (Sustained) [Oral Tablets]. Participants who end Period B on upadacitinib Dose B with a with a SALT score <= 20 at Week 40 and Week 52 of Study 1 or Study 2 will be re-randomized to receive upadacitinib Dose A once daily for 108 weeks.

Outcome(s)

• Primary Outcome: Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 20 (Time frame: Week 24)

Secondary Outcome

- Percentage of Participants with the Achievement of SALT Score <= 10 (Time frame: 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 (SALT 75 is defined as at least a 75% improvement [decrease] from Baseline in SALT score) (Time frame: Baseline to Week 24)
- Percentage of Participants with the Achievement of SALT 90 (SALT 75 is defined as at least a 90% improvement [decrease] from Baseline in SALT score) (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)
- Percentage of Participants with the Achievement of SALT Score 0 (Time frame: Week 24)

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: <= 63age old
• Gender: Both

Include criteria

- Adult individuals < 64 years old at Baseline Visit. Where permitted outside United States (OUS), adolescent individuals who are at least 12 years old at Screening may participate.
-Diagnosis of severe AA with SALT score 50 scalp hair loss at Screening and Baseline.
-Severe AA with no spontaneous scalp hair regrowth over the past 6 months AND no significant scalp hair loss over the past 3 months.
-Current episode of AA of less than 8 years.

Exclude criteria

-Diagnosis of primarily diffuse type of AA.
-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, includin g but not limited to seborrheic dermatitis, scalp psoriasis, atopic dermatitis (AD), and tinea capitis.

Related Information

• Primary Sponsor: Tetsuya Otani
• Secondary ID(s): NCT06012240