Recruiting

Phase 3

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

Sponsor:

Sun Pharmaceutical Industries, Inc.

Code:

NCT07133308

Conditions

Alopecia Areata

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Deuruxolitinib

Placebo

Study Details

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.

Conditions

Alopecia Areata

Study ID

NCT07133308

Start date

Aug 5, 2025

Status verified date

Aug, 2025

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

355 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Period: Deuruxolitinib 8 mg

Deuruxolitinib tablets, orally, twice daily (BID) for up to 24 weeks

placebo comparator: Treatment Period: Placebo

Deuruxolitinib-matched placebo tablets, orally, BID for up to 24 weeks

experimental: Open-Label Extension: Deuruxolitinib 8 mg BID

Deuruxolitinib tablets, orally, BID for up to 52 weeks

Interventions

Deuruxolitinib

Deuruxolitinib will be dosed orally as tablets at a dose of 8 mg

Placebo

Deuruxolitinib matching placebo will be dosed orally as tablets

Primary outcome measure

Percentage of subjects achieving an absolute Severity of Alopecia Tool (SALT) score ≤20 [ Time Frame: Week 24 ]
Safety and tolerability of deuruxolitinib will be assessed by evaluating adverse events, vital signs, electrocardiograms, and clinical laboratory results, as well as physical examinations [ Time Frame: Week 24 ]

Central Contacts and Locations

Central contacts

Head Regulatory Affairs

9122 66455645 Clinical.Trial@sunpharma.com

Locations

Total Skin And Beauty Dermatology Center

Recruiting

Birmingham, Alabama, United States, 35203

Avacare - Cct Research - Center For Dermatology And Plastic Surgery

Recruiting

Scottsdale, Arizona, United States, 85260

Dermatology Trial Associates

Recruiting

Bryant, Arkansas, United States, 72022

Kern Research Inc.

Recruiting

Bakersfield, California, United States, 93301

Center For Dermatology Clinical Research Inc.

Recruiting

Fremont, California, United States, 94538

Dermatology Research Associates

Recruiting

Los Angeles, California, United States, 90045

Palmtree Clinical Research

Recruiting

Palm Springs, California, United States, 92262

Paradigm Clinical Research - San Diego

Recruiting

San Diego, California, United States, 92108

Colorado Medical Research Center

Recruiting

Denver, Colorado, United States, 80210

Paradigm Clinical Research - Wheat Ridge

Recruiting

Wheat Ridge, Colorado, United States, 80033

D&H Doral Research Center

Recruiting

Doral, Florida, United States, 33122

Skin Care Research, Llc - Hollywood

Recruiting

Hollywood, Florida, United States, 33021

Ilumina Medical Research Llc

Recruiting

Kissimmee, Florida, United States, 34744

All X Ray Diagnostic Services Corp

Recruiting

Miami, Florida, United States, 33126

Millennium Medical Research Llc

Recruiting

Miami, Florida, United States, 33126

Florida International Medical Research

Recruiting

Miami, Florida, United States, 33134

Florida Pharmaceutical Research And Associates, Inc.

Recruiting

Miami, Florida, United States, 33143

L&C Professional Medical Research Institute

Recruiting

Miami, Florida, United States, 33144

Pediatric Skin Research Llc

Recruiting

Miami, Florida, United States, 33156

Valencia Medical & Research Center

Recruiting

Miami, Florida, United States, 33174

Advance Research Center, Llc

Recruiting

Miami, Florida, United States, 33183

Barroso Medical Services Llc

Recruiting

Miami Lakes, Florida, United States, 33014

Nexus Research Llc

Recruiting

Pompano Beach, Florida, United States, 33063

International Clinical Research Us Llc - Sanford

Recruiting

Sanford, Florida, United States, 32771

Lenus Research & Medical Group Llc.

Recruiting

Sweetwater, Florida, United States, 33172

Cleaver Medical Group Dermatology

Recruiting

Cumming, Georgia, United States, 30040

Skin Care Physicians Of Georgia

Recruiting

Macon, Georgia, United States, 31217

Georgia Skin & Cancer Clinic

Recruiting

Savannah, Georgia, United States, 31419

Asr, Llc

Recruiting

Boise, Idaho, United States, 83702

Denova Research

Recruiting

Chicago, Illinois, United States, 60611

Ds Research - Indiana

Recruiting

Clarksville, Indiana, United States, 47129

Dawes Fretzin Clinical Research Group Llc.

Recruiting

Indianapolis, Indiana, United States, 46250

Ds Research - Kentucky

Recruiting

Louisville, Kentucky, United States, 40241

U.S. Dermatology Partners - Rockville

Recruiting

Rockville, Maryland, United States, 20850

Oakland Hills Dermatology

Recruiting

Auburn Hills, Michigan, United States, 48326

Revival Research Institute, Llc - Troy, Mi

Recruiting

Troy, Michigan, United States, 48084

Medisearch Clinical Trials

Recruiting

Saint Joseph, Missouri, United States, 64506

Boeson Research Mso

Recruiting

Missoula, Montana, United States, 59804

Skin Specialists, Pc

Recruiting

Omaha, Nebraska, United States, 68144

Schweiger Dermatology & Allergy - Verona

Recruiting

Verona, New Jersey, United States, 07044

Vitality Clinical Trials

Recruiting

Woodbury, New York, United States, 11797

Revival Research Institute, Llc - Cary, Nc

Recruiting

Cary, North Carolina, United States, 27511

Darst Dermatology

Recruiting

Charlotte, North Carolina, United States, 28277

Dermatologists Of Southwest Ohio

Recruiting

Mason, Ohio, United States, 45040

Dermatology Associates Of Plymouth Meeting

Recruiting

Plymouth Meeting, Pennsylvania, United States, 19462

Tribe Clinical Research, Llc

Recruiting

Greenville, South Carolina, United States, 29607

Delricht Research - Smyrna

Recruiting

Smyrna, Tennessee, United States, 37167

Dermatology Treatment And Research Center - Dallas

Recruiting

Dallas, Texas, United States, 75230

North Texas Center For Clinical Research

Recruiting

Frisco, Texas, United States, 75034

Austin Institute For Clinical Research Inc.

Recruiting

Pflugerville, Texas, United States, 78660

Texas Dermatology And Laser Specialists

Recruiting

San Antonio, Texas, United States, 78218

Jordan Valley Dermatology

Recruiting

South Jordan, Utah, United States, 84095

Avacare - Cct Research - Springville Dermatology

Recruiting

Springville, Utah, United States, 84663

National Eagle Research, Llc

Recruiting

Lynnwood, Washington, United States, 98036

Kirk Barber Research

Recruiting

Calgary, Alberta, Canada, T2G 1B1

Dermatology Research Institute (Calgary)

Recruiting

Calgary, Alberta, Canada, T2J 7E1

Alberta Dermasurgery Centre

Recruiting

Edmonton, Alberta, Canada, T6G 1C3

Care Clinic Ltd.

Recruiting

Red Deer, Alberta, Canada, T4P 1K4

Medical Arts Health Research Group - Kelowna

Recruiting

Kelowna, British Columbia, Canada, V1Y4N7

Enverus Medical Research

Recruiting

Surrey, British Columbia, Canada, V3V 0C6

Lynderm Research Inc.

Recruiting

Markham, Ontario, Canada, L3P 1X3

Dr. S. K. Siddha Medicine Professional Corporation

Recruiting

Newmarket, Ontario, Canada, L3Y 5G8

Research Toronto

Recruiting

Toronto, Ontario, Canada, M4W 2N4

Facet Dermatology

Recruiting

Toronto, Canada, M4E 1R7

More Information

Sponsor

Sun Pharmaceutical Industries, Inc.

Last update posted

Jan 28, 2026

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-28. This information was provided to ClinicalTrials.gov by Sun Pharmaceutical Industries, Inc. on 2026-01-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.