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Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescents With Severe Alopecia Areata

RecruitingPhase 3

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

Who can join

Ages 12 to 17 · All sexes

Full 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.

About the study

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.

What is being tested

Sponsor: Sun Pharmaceutical Industries, Inc. · Participants: 355 · Started: Aug 5, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07133308

Locations in the U.S.

AlabamaTotal Skin And Beauty Dermatology Center, Birmingham
ArizonaAvacare - Cct Research - Center For Dermatology And Plastic Surgery, Scottsdale
ArkansasDermatology Trial Associates, Bryant
CaliforniaKern Research Inc., Bakersfield
Center For Dermatology Clinical Research Inc., Fremont
Dermatology Research Associates, Los Angeles
Palmtree Clinical Research, Palm Springs
Paradigm Clinical Research - San Diego, San Diego
ColoradoColorado Medical Research Center, Denver
Paradigm Clinical Research - Wheat Ridge, Wheat Ridge
FloridaD&H Doral Research Center, Doral
Skin Care Research, Llc - Hollywood, Hollywood
Ilumina Medical Research Llc, Kissimmee
Advance Research Center, Llc, Miami
All X Ray Diagnostic Services Corp, Miami
Florida International Medical Research, Miami
Florida Pharmaceutical Research And Associates, Inc., Miami
L&C Professional Medical Research Institute, Miami
Millennium Medical Research Llc, Miami
Pediatric Skin Research Llc, Miami
Valencia Medical & Research Center, Miami
Barroso Medical Services Llc, Miami Lakes
Nexus Research Llc, Pompano Beach
International Clinical Research Us Llc - Sanford, Sanford
Lenus Research & Medical Group Llc., Sweetwater
GeorgiaCleaver Medical Group Dermatology, Cumming
Skin Care Physicians Of Georgia, Macon
Georgia Skin & Cancer Clinic, Savannah
IdahoAsr, Llc, Boise
IllinoisDenova Research, Chicago
IndianaDs Research - Indiana, Clarksville
Dawes Fretzin Clinical Research Group Llc., Indianapolis
KentuckyDs Research - Kentucky, Louisville
MarylandU.S. Dermatology Partners - Rockville, Rockville
MichiganOakland Hills Dermatology, Auburn Hills
Revival Research Institute, Llc - Troy, Mi, Troy
MissouriMedisearch Clinical Trials, Saint Joseph
MontanaBoeson Research Mso, Missoula
NebraskaSkin Specialists, Pc, Omaha
New JerseySchweiger Dermatology & Allergy - Verona, Verona
New YorkVitality Clinical Trials, Woodbury
North CarolinaRevival Research Institute, Llc - Cary, Nc, Cary
Darst Dermatology, Charlotte
OhioDermatologists Of Southwest Ohio, Mason
PennsylvaniaDermatology Associates Of Plymouth Meeting, Plymouth Meeting
South CarolinaTribe Clinical Research, Llc, Greenville
TennesseeDelricht Research - Smyrna, Smyrna
TexasDermatology Treatment And Research Center - Dallas, Dallas
North Texas Center For Clinical Research, Frisco
Austin Institute For Clinical Research Inc., Pflugerville
Texas Dermatology And Laser Specialists, San Antonio
UtahJordan Valley Dermatology, South Jordan
Avacare - Cct Research - Springville Dermatology, Springville
WashingtonNational Eagle Research, Llc, Lynnwood

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.