NCT07133308 Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescents With Severe Alopecia Areata
| NCT ID | NCT07133308 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sun Pharmaceutical Industries, Inc. |
| Condition | Alopecia Areata |
| Study Type | INTERVENTIONAL |
| Enrollment | 355 participants |
| Start Date | 2025-08-05 |
| Primary Completion | 2028-05 |
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 355 participants in total. It began in 2025-08-05 with a primary completion date of 2028-05.
⚠ 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 safety and effectiveness of deuruxolitinib in adolescents aged 12 to less than 18 years who have 50% or greater scalp hair loss.
Eligibility Criteria
Inclusion Criteria: * Clinical presentation compatible with alopecia areata with a current episode lasting at least 6 months and not exceeding 10 years. * Between 12 to \<18 years of age * At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score ≥50. * Willing to comply with the study visits and requirements of the study protocol Exclusion Criteria: * Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or other scalp condition that may interfere with the SALT assessment, or untreated actinic keratosis at Screening and/or Baseline * Treatment with other medications or agents within 28 days of Baseline or during the study that may affect hair regrowth or immune response. * Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug. * Clinically significant medical condition, psychiatric disease, or social condition, as determined by the Investigator, that may unfavorably alter the risk-benefit of study participation, adversely affect study compliance, or confound interpretation of study results.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07133308 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 17 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 NCT07133308 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 355 participants.
Is NCT07133308 currently recruiting?
Yes, NCT07133308 is actively recruiting participants. Contact the research team at Clinical.Trial@sunpharma.com for enrollment information.
Where is the NCT07133308 trial being conducted?
This trial is being conducted at Birmingham, United States, Scottsdale, United States, Bryant, United States, Bakersfield, United States and 11 additional locations.
Who is sponsoring the NCT07133308 clinical trial?
NCT07133308 is sponsored by Sun Pharmaceutical Industries, Inc.. The trial plans to enroll 355 participants.