NCT07617597 Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Japanese Adults With Severe Alopecia Areata
| NCT ID | NCT07617597 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sun Pharma Japan Limited |
| Condition | Alopecia Areata |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2026-06-19 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 78 participants in total. It began in 2026-06-19 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study evaluates the efficacy and safety of deuruxolitinib in Japanese Adults between 18 and 65 years of age who have 50% or greater scalp hair loss.
Eligibility Criteria
Inclusion Criteria: * Written informed consent has been obtained. * Japanese subjects with severe alopecia areata who are between 18 and 65 years of age, inclusive, at the time of informed consent. * Definitive diagnosis of alopecia areata with a current episode of scalp hair loss lasting at least 6 months. * SALT score of 50 or more at both Screening and Baseline. Exclusion Criteria: * Treatment with systemic immunosuppressive medications or agents, including Janus kinase inhibitors, within 4 months prior to randomization. * Treatment with biologics within 6 months prior to Screening. * Positive test results for hepatitis B virus, hepatitis C virus, or human immunodeficiency virus at Screening. * History of active tuberculosis, a positive interferon gamma release assay at Screening, or evidence of tuberculosis-related lesions on chest radiography. * Clinically significant hematologic abnormalities, hepatic impairment, or renal impairment at Screening.
Frequently Asked Questions
Who can join the NCT07617597 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Alopecia Areata. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07617597 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 78 participants.
Is NCT07617597 currently recruiting?
Yes, NCT07617597 is actively recruiting participants. Visit ClinicalTrials.gov or contact Sun Pharma Japan Limited to inquire about joining.
Where is the NCT07617597 trial being conducted?
This trial is being conducted at Asahikawa, Japan, Bunkyō City, Japan, Ebina, Japan, Hamamatsu, Japan and 11 additional locations.
Who is sponsoring the NCT07617597 clinical trial?
NCT07617597 is sponsored by Sun Pharma Japan Limited. The trial plans to enroll 78 participants.