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NCT07133308PHASE3Recruiting

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

Sun Pharmaceutical Industries, Inc.

Start Date

8/5/2025

Completion Date

5/1/2028

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.

Detailed Description

The efficacy and safety of deuruxolitinib in adolescent subjects with severe alopecia areata will be evaluated in this study, beginning with a double-blind, randomized, placebo-controlled Treatment Period of 24 weeks. Subjects 12 to \<18 years of age having at least 50% hair loss as measured by SALT and meeting eligibility criteria will be randomized to deuruxolitinib or placebo treatment. In the Open-label Extension part of the study, participants from the Treatment Period will receive deuruxolitinib for 52 weeks.

Eligibility Criteria

Age Range: 12 years to 17 years

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.

Interventions

DRUG

Deuruxolitinib

DRUG

Placebo

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Conditions

Alopecia Areata

Locations

Total Skin And Beauty Dermatology Center

Birmingham, Alabama 35203

United States

Avacare - Cct Research - Center For Dermatology And Plastic Surgery

Scottsdale, Arizona 85260

United States

Dermatology Trial Associates

Bryant, Arkansas 72022

United States

Kern Research Inc.

Bakersfield, California 93301

United States

Center For Dermatology Clinical Research Inc.

Fremont, California 94538

United States

Dermatology Research Associates

Los Angeles, California 90045

United States

Palmtree Clinical Research

Palm Springs, California 92262

United States

Paradigm Clinical Research - San Diego

San Diego, California 92108

United States

Colorado Medical Research Center

Denver, Colorado 80210

United States

Paradigm Clinical Research - Wheat Ridge

Wheat Ridge, Colorado 80033

United States

D&H Doral Research Center

Doral, Florida 33122

United States

Skin Care Research, Llc - Hollywood

Hollywood, Florida 33021

United States

Ilumina Medical Research Llc

Kissimmee, Florida 34744

United States

All X Ray Diagnostic Services Corp

Miami, Florida 33126

United States

Millennium Medical Research Llc

Miami, Florida 33126

United States

Florida International Medical Research

Miami, Florida 33134

United States

Florida Pharmaceutical Research And Associates, Inc.

Miami, Florida 33143

United States

L&C Professional Medical Research Institute

Miami, Florida 33144

United States

Pediatric Skin Research Llc

Miami, Florida 33156

United States

Valencia Medical & Research Center

Miami, Florida 33174

United States

Advance Research Center, Llc

Miami, Florida 33183

United States

Barroso Medical Services Llc

Miami Lakes, Florida 33014

United States

Nexus Research Llc

Pompano Beach, Florida 33063

United States

International Clinical Research Us Llc - Sanford

Sanford, Florida 32771

United States

Lenus Research & Medical Group Llc.

Sweetwater, Florida 33172

United States

Cleaver Medical Group Dermatology

Cumming, Georgia 30040

United States

Skin Care Physicians Of Georgia

Macon, Georgia 31217

United States

Georgia Skin & Cancer Clinic

Savannah, Georgia 31419

United States

Asr, Llc

Boise, Idaho 83702

United States

Denova Research

Chicago, Illinois 60611

United States

Ds Research - Indiana

Clarksville, Indiana 47129

United States

Dawes Fretzin Clinical Research Group Llc.

Indianapolis, Indiana 46250

United States

Ds Research - Kentucky

Louisville, Kentucky 40241

United States

U.S. Dermatology Partners - Rockville

Rockville, Maryland 20850

United States

Oakland Hills Dermatology

Auburn Hills, Michigan 48326

United States

Revival Research Institute, Llc - Troy, Mi

Troy, Michigan 48084

United States

Medisearch Clinical Trials

Saint Joseph, Missouri 64506

United States

Boeson Research Mso

Missoula, Montana 59804

United States

Skin Specialists, Pc

Omaha, Nebraska 68144

United States

Schweiger Dermatology & Allergy - Verona

Verona, New Jersey 07044

United States

Vitality Clinical Trials

Woodbury, New York 11797

United States

Revival Research Institute, Llc - Cary, Nc

Cary, North Carolina 27511

United States

Darst Dermatology

Charlotte, North Carolina 28277

United States

Dermatologists Of Southwest Ohio

Mason, Ohio 45040

United States

Dermatology Associates Of Plymouth Meeting

Plymouth Meeting, Pennsylvania 19462

United States

Tribe Clinical Research, Llc

Greenville, South Carolina 29607

United States

Delricht Research - Smyrna

Smyrna, Tennessee 37167

United States

Dermatology Treatment And Research Center - Dallas

Dallas, Texas 75230

United States

North Texas Center For Clinical Research

Frisco, Texas 75034

United States

Austin Institute For Clinical Research Inc.

Pflugerville, Texas 78660

United States

Texas Dermatology And Laser Specialists

San Antonio, Texas 78218

United States

Jordan Valley Dermatology

South Jordan, Utah 84095

United States

Avacare - Cct Research - Springville Dermatology

Springville, Utah 84663

United States

National Eagle Research, Llc

Lynnwood, Washington 98036

United States

Kirk Barber Research

Calgary, Alberta T2G 1B1

Canada

Dermatology Research Institute (Calgary)

Calgary, Alberta T2J 7E1

Canada

Alberta Dermasurgery Centre

Edmonton, Alberta T6G 1C3

Canada

Care Clinic Ltd.

Red Deer, Alberta T4P 1K4

Canada

Medical Arts Health Research Group - Kelowna

Kelowna, British Columbia V1Y4N7

Canada

Enverus Medical Research

Surrey, British Columbia V3V 0C6

Canada

Lynderm Research Inc.

Markham, Ontario L3P 1X3

Canada

Dr. S. K. Siddha Medicine Professional Corporation

Newmarket, Ontario L3Y 5G8

Canada

Research Toronto

Toronto, Ontario M4W 2N4

Canada

Facet Dermatology

Toronto, M4E 1R7

Canada