A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Alopecia Areata and at Least 25% Scalp Hair Loss

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 63
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Japan
Nagomi Dermatology Clinic /ID# 275418
RECRUITING
Ebina-shi
Hamamatsu University Hospital /ID# 274639
RECRUITING
Hamamatsu
Kanazawa Medical University Hospital /ID# 275521
RECRUITING
Kahoku-gun
Kurume University Hospital /ID# 275519
RECRUITING
Kurume-shi
Kyorin University Hospital /ID# 274882
RECRUITING
Mitaka-shi
Rifu Dermatology Allergy Clinic /ID# 274875
RECRUITING
Miyagi-gun
Nagoya City University Hospital /ID# 275409
RECRUITING
Nagoya
Niigata University Medical & Dental Hospital /ID# 274775
RECRUITING
Niigata
Osaka Metropolitan University Hospital /ID# 274956
RECRUITING
Osaka
Shinsaibashi Inui Dermatology Clinic /ID# 274851
RECRUITING
Osaka
Keio University Hospital /ID# 275640
RECRUITING
Shinjuku-ku
Tokyo Medical University Hospital /ID# 274844
RECRUITING
Shinjuku-ku
Juntendo Tokyo Koto Geriatric Medical Center /ID# 275424
RECRUITING
Tokyo
Yamaguchi University Hospital /ID# 274638
RECRUITING
Ube
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2025-06-19
Estimated Completion Date: 2029-02
Participants
Target number of participants: 123
Treatments
Experimental: Group 1A: Upadacitinib Dose A
Participants will receive upadacitinib dose A once daily for 52 weeks in Period A and Period B.
Experimental: Group 2A: Upadacitinib Dose B
Participants will receive upadacitinib dose B once daily for 52 weeks in Period A and Period B.
Placebo_comparator: Group 3A: Upadacitinib Placebo
Participants will receive upadacitinib placebo once daily for 24 weeks in Period A.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov