Deuruxolitinib for adolescents with severe alopecia areata
Official title: A Double-Blind, Randomized, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescent Patients With Severe Alopecia Areata With an Open-label Extension Period
Run by Sun Pharmaceutical Industries Limited · NCT07133308 · Data updated 2026-11-12
This trial will see if deuruxolitinib can safely help adolescents aged 12 to 17 who have lost at least half their scalp hair from alopecia areata.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Enrollment | 355 (estimated) |
| Sponsor | Sun Pharmaceutical Industries Limited Industry-sponsored |
| Drugs / interventions | deuruxolitinib |
| Locations | 64 sites (Birmingham, Alabama and 63 other locations) |
| Status | Recruiting |
| Started | August 5, 2025 |
| Main results expected | May 2028 |
| Study ends | May 2028 |
| Registry record updated | January 28, 2026 |
| Trial ID | NCT07133308 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are 12–17-year-olds with alopecia areata causing at least 50% scalp hair loss for between 6 months and 10 years who can attend study visits and meet safety requirements.
✕Probably not a fit
Patients with active scalp conditions that affect hair assessment, recent immune- or hair-growth therapies, significant medical or psychiatric conditions, or who are pregnant or nursing are unlikely to benefit from participating.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adolescents 12 to <18 years with at least 50% scalp hair loss (SALT ≥50) are randomized in a double-blind, placebo-controlled 24-week treatment period to receive deuruxolitinib or placebo. After the randomized period, participants may enter a 52-week open-label extension in which all receive deuruxolitinib. Key exclusions include active scalp inflammatory conditions that interfere with assessment, recent use of other hair-regrowth or immunomodulatory therapies, and significant medical or psychiatric comorbidities. The study tracks hair regrowth measures and safety outcomes during treatment and long-term exposure.
Why it matters
Potential benefit: If successful, the treatment could restore scalp hair and improve daily life for adolescents with severe alopecia areata.
How similar studies have gone: Other oral JAK inhibitors have produced hair regrowth in alopecia areata patients, so this approach has prior supportive evidence although deuruxolitinib in adolescents is being specifically tested.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Total Skin And Beauty Dermatology Center
Birmingham, Alabama, United States Recruiting -
Avacare - Cct Research - Center For Dermatology And Plastic Surgery
Scottsdale, Arizona, United States Recruiting -
Dermatology Trial Associates
Bryant, Arkansas, United States Recruiting -
Kern Research Inc.
Bakersfield, California, United States Recruiting -
Center For Dermatology Clinical Research Inc.
Fremont, California, United States Recruiting -
Dermatology Research Associates
Los Angeles, California, United States Recruiting
Show 44 more locations
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Palmtree Clinical Research
Palm Springs, California, United States Recruiting -
Paradigm Clinical Research - San Diego
San Diego, California, United States Recruiting -
Colorado Medical Research Center
Denver, Colorado, United States Recruiting -
Paradigm Clinical Research - Wheat Ridge
Wheat Ridge, Colorado, United States Recruiting -
D&H Doral Research Center
Doral, Florida, United States Recruiting -
Skin Care Research, Llc - Hollywood
Hollywood, Florida, United States Recruiting -
Ilumina Medical Research Llc
Kissimmee, Florida, United States Recruiting -
All X Ray Diagnostic Services Corp
Miami, Florida, United States Recruiting -
Millennium Medical Research Llc
Miami, Florida, United States Recruiting -
Florida International Medical Research
Miami, Florida, United States Recruiting -
Florida Pharmaceutical Research And Associates, Inc.
Miami, Florida, United States Recruiting -
L&C Professional Medical Research Institute
Miami, Florida, United States Recruiting -
Pediatric Skin Research Llc
Miami, Florida, United States Recruiting -
Valencia Medical & Research Center
Miami, Florida, United States Recruiting -
Advance Research Center, Llc
Miami, Florida, United States Recruiting -
Barroso Medical Services Llc
Miami Lakes, Florida, United States Recruiting -
Nexus Research Llc
Pompano Beach, Florida, United States Recruiting -
International Clinical Research Us Llc - Sanford
Sanford, Florida, United States Recruiting -
Lenus Research & Medical Group Llc.
Sweetwater, Florida, United States Recruiting -
Cleaver Medical Group Dermatology
Cumming, Georgia, United States Recruiting -
Skin Care Physicians Of Georgia
Macon, Georgia, United States Recruiting -
Georgia Skin & Cancer Clinic
Savannah, Georgia, United States Recruiting -
Asr, Llc
Boise, Idaho, United States Recruiting -
Denova Research
Chicago, Illinois, United States Recruiting -
Ds Research - Indiana
Clarksville, Indiana, United States Recruiting -
Dawes Fretzin Clinical Research Group Llc.
Indianapolis, Indiana, United States Recruiting -
Ds Research - Kentucky
Louisville, Kentucky, United States Recruiting -
U.S. Dermatology Partners - Rockville
Rockville, Maryland, United States Recruiting -
Oakland Hills Dermatology
Auburn Hills, Michigan, United States Recruiting -
Revival Research Institute, Llc - Troy, Mi
Troy, Michigan, United States Recruiting -
Medisearch Clinical Trials
Saint Joseph, Missouri, United States Recruiting -
Boeson Research Mso
Missoula, Montana, United States Recruiting -
Skin Specialists, Pc
Omaha, Nebraska, United States Recruiting -
Schweiger Dermatology & Allergy - Verona
Verona, New Jersey, United States Recruiting -
Vitality Clinical Trials
Woodbury, New York, United States Recruiting -
Revival Research Institute, Llc - Cary, Nc
Cary, North Carolina, United States Recruiting -
Darst Dermatology
Charlotte, North Carolina, United States Recruiting -
Dermatologists Of Southwest Ohio
Mason, Ohio, United States Recruiting -
Dermatology Associates Of Plymouth Meeting
Plymouth Meeting, Pennsylvania, United States Recruiting -
Tribe Clinical Research, Llc
Greenville, South Carolina, United States Recruiting -
Delricht Research - Smyrna
Smyrna, Tennessee, United States Recruiting -
Dermatology Treatment And Research Center - Dallas
Dallas, Texas, United States Recruiting -
North Texas Center For Clinical Research
Frisco, Texas, United States Recruiting -
Austin Institute For Clinical Research Inc.
Pflugerville, Texas, United States Recruiting
+14 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Head Regulatory Affairs
- Email: Clinical.Trial@sunpharma.com
- Phone: 9122 66455645
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.