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

NCT07023302 | Recruiting Phase 3 DMC

• 1 other identifier: M24-600
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 15

Brief Summary

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 in Japan with severe AA. Upadacitinib is an approved drug being investigated for the treatment of AA. In Period A, participants are placed in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. In Period B, participants originally randomized to a upadacitinib dose group in Period A will continue their same treatment in Period B. Participants originally randomized to Placebo in Period A will be re-randomized in 1 of 2 groups receiving upadacitinib. Participants who complete Period B can join Period C and will receive 1 of 2 doses of upadacitinib for up to 52 weeks based on their SALT score. Around 123 adolescent and adult participants with severe AA will be enrolled in the study at approximately 20 sites in Japan. Participants will receive oral tablets of either upadacitinib or placebo once daily for up to 104 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 their 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.

Conditions

Alopecia Areata

Keywords

Alopecia Areata; Upadacitinib; JUMP-UP; AA

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 10

  The SALT is a global alopecia areata (AA) severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%. A SALT score of \<= 10 is defined as less than or equal to 10% hair loss.

  Week 24

• Number of Participants with Adverse Events (AEs)

  An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

  Up to approximately 108 weeks

Secondary Outcomes (2)

• Percentage of Participants with the Achievement of Patient-Reported Outcome (PRO) for Scalp Hair Assessment of 0 or 1

  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"

  Week 24

Study Arms (10)

Group 1A: Upadacitinib Dose A

EXPERIMENTAL

Participants will receive upadacitinib dose A once daily for 52 weeks in Period A and Period B.

Drug: Upadacitinib

Group 2A: Upadacitinib Dose B

EXPERIMENTAL

Participants will receive upadacitinib dose B once daily for 52 weeks in Period A and Period B.

Drug: Upadacitinib

Group 3A: Upadacitinib Placebo

PLACEBO COMPARATOR

Participants will receive upadacitinib placebo once daily for 24 weeks in Period A.

Drug: Upadacitinib Placebo

Group 1B: Upadacitinib Dose A

EXPERIMENTAL

Participants initially randomized to placebo (Period A) will be re-randomized to receive upadacitinib dose A once daily for 28 weeks in Period B.

Drug: Upadacitinib

Group 2B: Upadacitinib Dose B

EXPERIMENTAL

Participants initially randomized to placebo (Period A) will be re-randomized to receive upadacitinib dose B once daily for 28 weeks in Period B.

Drug: Upadacitinib

Period C: Upadacitinib Dose A Remains Dose A

EXPERIMENTAL

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.

Drug: Upadacitinib

Period C: Upadacitinib Dose A to Dose B

EXPERIMENTAL

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.

Drug: Upadacitinib

Period C: Upadacitinib Dose B Non-Sustained Responders

EXPERIMENTAL

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.

Drug: Upadacitinib

Period C: Upadacitinib Dose B Sustained Responders

EXPERIMENTAL

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.

Drug: Upadacitinib

Period C: Open-Label Upadacitinib Dose B

EXPERIMENTAL

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.

Drug: Upadacitinib

Interventions

Upadacitinib DRUG

Oral Tablets

Group 1A: Upadacitinib Dose A; Group 1B: Upadacitinib Dose A; Group 2A: Upadacitinib Dose B; Group 2B: Upadacitinib Dose B; Period C: Open-Label Upadacitinib Dose B; Period C: Upadacitinib Dose A Remains Dose A; Period C: Upadacitinib Dose A to Dose B; Period C: Upadacitinib Dose B Non-Sustained Responders; Period C: Upadacitinib Dose B Sustained Responders

Upadacitinib Placebo DRUG

Oral Tablets

Group 3A: Upadacitinib Placebo

Eligibility Criteria

• Age: 12 Years - 63 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (15)

Nagoya City University Hospital /ID# 275409

Nagoya, Aichi-ken, 467-8602, Japan

RECRUITING

Kurume University Hospital /ID# 275519

Kurume-shi, Fukuoka, 830-0011, Japan

RECRUITING

Kanazawa Medical University Hospital /ID# 275521

Kahoku-gun, Ishikawa-ken, 920-0265, Japan

RECRUITING

Nagomi Dermatology Clinic /ID# 275418

Ebina-shi, Kanagawa, 243-0432, Japan

RECRUITING

Rifu Dermatology Allergy Clinic /ID# 274875

Miyagi-gun, Miyagi, 981-0112, Japan

RECRUITING

Tohoku University Hospital /ID# 274931

Sendai, Miyagi, 980-8574, Japan

RECRUITING

Niigata University Medical & Dental Hospital /ID# 274775

Niigata, Niigata, 951-8520, Japan

RECRUITING

Shinsaibashi Inui Dermatology Clinic /ID# 274851

Osaka, Osaka, 542-0081, Japan

RECRUITING

Osaka Metropolitan University Hospital /ID# 274956

Osaka, Osaka, 545-8586, Japan

RECRUITING

Hamamatsu University Hospital /ID# 274639

Hamamatsu, Shizuoka, 431-3192, Japan

RECRUITING

Kyorin University Hospital /ID# 274882

Mitaka-shi, Tokyo, 181-8611, Japan

RECRUITING

Tokyo Medical University Hospital /ID# 274844

Shinjuku-ku, Tokyo, 160-0023, Japan

RECRUITING

Keio University Hospital /ID# 275640

Shinjuku-ku, Tokyo, 160-8582, Japan

RECRUITING

Yamaguchi University Hospital /ID# 274638

Ube, Yamaguchi, 755-8505, Japan

RECRUITING

Juntendo Tokyo Koto Geriatric Medical Center /ID# 275424

Tokyo, 136-0075, Japan

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Alopecia Areata

Interventions

upadacitinib

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 16, 2025
• Study Start: June 19, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

JP (15)