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

Last updated: January 27, 2026
Sponsor: Sun Pharmaceutical Industries, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Hair Loss

Alopecia

Treatment

Placebo

Deuruxolitinib

Clinical Study ID

NCT07133308
CP543.3101
  • Ages 12-17
  • All Genders

Study 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

Inclusion Criteria:

  • Clinical presentation compatible with alopecia areata with a current episode lastingat 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

Exclusion Criteria:

  • Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topicaltreatment to the scalp, significant trauma to the scalp, or other scalp conditionthat may interfere with the SALT assessment, or untreated actinic keratosis atScreening and/or Baseline

  • Treatment with other medications or agents within 28 days of Baseline or during thestudy that may affect hair regrowth or immune response.

  • Females who are nursing, pregnant, or planning to become pregnant while in thestudy, 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 ofstudy participation, adversely affect study compliance, or confound interpretationof study results.

Study Design

Total Participants: 355
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
August 05, 2025
Estimated Completion Date:
May 31, 2028

Study 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.

Connect with a study center

  • Alberta Dermasurgery Centre

    Edmonton, Alberta T6G 1C3
    Canada

    Site Not Available

  • Care Clinic Ltd.

    Red Deer, Alberta T4P1K4
    Canada

    Site Not Available

  • Dermatology Research Institute (Calgary)

    Calgary 5913490, Alberta 5883102 T2J 7E1
    Canada

    Active - Recruiting

  • Kirk Barber Research

    Calgary 5913490, Alberta 5883102 T2G 1B1
    Canada

    Active - Recruiting

  • Alberta Dermasurgery Centre

    Edmonton 5946768, Alberta 5883102 T6G 1C3
    Canada

    Active - Recruiting

  • Care Clinic Ltd.

    Red Deer 6118158, Alberta 5883102 T4P 1K4
    Canada

    Active - Recruiting

  • Medical Arts Health Research Group - Kelowna

    Kelowna 5990579, British Columbia 5909050 V1Y4N7
    Canada

    Active - Recruiting

  • Enverus Medical Research

    Surrey 6159905, British Columbia 5909050 V3V 0C6
    Canada

    Active - Recruiting

  • Lynderm Research Inc.

    Markham 6066513, Ontario 6093943 L3P 1X3
    Canada

    Active - Recruiting

  • Dr. S. K. Siddha Medicine Professional Corporation

    Newmarket 6087701, Ontario 6093943 L3Y 5G8
    Canada

    Active - Recruiting

  • Research Toronto

    Toronto 6167865, Ontario 6093943 M4W 2N4
    Canada

    Active - Recruiting

  • Universite De Montreal-Centre Hospitalier Universitaire Sainte-Justine

    Montreal, Quebec H3T 1C5
    Canada

    Site Not Available

  • Centre De Recherche Saint-Louis

    Quebec, G1W4R4
    Canada

    Site Not Available

  • Facet Dermatology

    Toronto 6167865, M4E 1R7
    Canada

    Active - Recruiting

  • Total Skin And Beauty Dermatology Center

    Birmingham, Alabama 35203
    United States

    Site Not Available

  • Total Skin And Beauty Dermatology Center

    Birmingham 4049979, Alabama 4829764 35203
    United States

    Active - Recruiting

  • Avacare - Cct Research - Center For Dermatology And Plastic Surgery

    Scottsdale 5313457, Arizona 5551752 85260
    United States

    Active - Recruiting

  • Dermatology Trial Associates

    Bryant 4103448, Arkansas 4099753 72022
    United States

    Active - Recruiting

  • Dermatology Research Associates

    Los Angeles, California 90045
    United States

    Site Not Available

  • Paradigm Clinical Research - San Diego

    San Diego, California 92108
    United States

    Site Not Available

  • Kern Research Inc.

    Bakersfield 5325738, California 5332921 93301
    United States

    Active - Recruiting

  • Center For Dermatology Clinical Research Inc.

    Fremont 5350734, California 5332921 94538
    United States

    Active - Recruiting

  • Dermatology Research Associates

    Los Angeles 5368361, California 5332921 90045
    United States

    Active - Recruiting

  • Palmtree Clinical Research

    Palm Springs 5380668, California 5332921 92262
    United States

    Active - Recruiting

  • Paradigm Clinical Research - San Diego

    San Diego 5391811, California 5332921 92108
    United States

    Active - Recruiting

  • Colorado Medical Research Center

    Denver 5419384, Colorado 5417618 80210
    United States

    Active - Recruiting

  • Paradigm Clinical Research - Wheat Ridge

    Wheat Ridge 5443948, Colorado 5417618 80033
    United States

    Active - Recruiting

  • Pediatric Skin Research Llc

    Coral Gables, Florida 33146
    United States

    Site Not Available

  • Solutions Through Advanced Research, Inc.

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • International Clinical Research Us Llc - Sanford

    Sanford, Florida 32771
    United States

    Site Not Available

  • Lenus Research & Medical Group Llc.

    Sweetwater, Florida 33172
    United States

    Site Not Available

  • D&H Doral Research Center

    Doral 4153471, Florida 4155751 33122
    United States

    Active - Recruiting

  • Skin Care Research, Llc - Hollywood

    Hollywood 4158928, Florida 4155751 33021
    United States

    Active - Recruiting

  • Ilumina Medical Research Llc

    Kissimmee 4160983, Florida 4155751 34744
    United States

    Active - Recruiting

  • Advance Research Center, Llc

    Miami 4164138, Florida 4155751 33183
    United States

    Active - Recruiting

  • All X Ray Diagnostic Services Corp

    Miami 4164138, Florida 4155751 33126
    United States

    Active - Recruiting

  • Florida International Medical Research

    Miami 4164138, Florida 4155751 33134
    United States

    Active - Recruiting

  • Florida Pharmaceutical Research And Associates, Inc.

    Miami 4164138, Florida 4155751 33143
    United States

    Active - Recruiting

  • L&C Professional Medical Research Institute

    Miami 4164138, Florida 4155751 33144
    United States

    Active - Recruiting

  • Millennium Medical Research Llc

    Miami 4164138, Florida 4155751 33126
    United States

    Active - Recruiting

  • Pediatric Skin Research Llc

    Miami 4164138, Florida 4155751 33156
    United States

    Active - Recruiting

  • Valencia Medical & Research Center

    Miami 4164138, Florida 4155751 33174
    United States

    Active - Recruiting

  • Barroso Medical Services Llc

    Miami Lakes 4164186, Florida 4155751 33014
    United States

    Active - Recruiting

  • Nexus Research Llc

    Pompano Beach 4169014, Florida 4155751 33063
    United States

    Active - Recruiting

  • International Clinical Research Us Llc - Sanford

    Sanford 4172086, Florida 4155751 32771
    United States

    Active - Recruiting

  • Lenus Research & Medical Group Llc.

    Sweetwater 4174600, Florida 4155751 33172
    United States

    Active - Recruiting

  • Skin Care Physicians Of Georgia

    Macon, Georgia 31217
    United States

    Site Not Available

  • Cleaver Medical Group Dermatology

    Cumming 4190396, Georgia 4197000 30040
    United States

    Active - Recruiting

  • Skin Care Physicians Of Georgia

    Macon 4207400, Georgia 4197000 31217
    United States

    Active - Recruiting

  • Georgia Skin & Cancer Clinic

    Savannah 4221552, Georgia 4197000 31419
    United States

    Active - Recruiting

  • Asr, Llc

    Boise 5586437, Idaho 5596512 83702
    United States

    Active - Recruiting

  • Denova Research

    Chicago 4887398, Illinois 4896861 60611
    United States

    Active - Recruiting

  • Dawes Fretzin Clinical Research Group Llc.

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Ds Research - Indiana

    Clarksville 4255836, Indiana 4921868 47129
    United States

    Active - Recruiting

  • Dawes Fretzin Clinical Research Group Llc.

    Indianapolis 4259418, Indiana 4921868 46250
    United States

    Active - Recruiting

  • Ds Research - Kentucky

    Louisville 4299276, Kentucky 6254925 40241
    United States

    Active - Recruiting

  • U.S. Dermatology Partners - Rockville

    Rockville, Maryland 20850
    United States

    Site Not Available

  • U.S. Dermatology Partners - Rockville

    Rockville 4367175, Maryland 4361885 20850
    United States

    Active - Recruiting

  • Oakland Hills Dermatology

    Auburn Hills, Michigan 48326
    United States

    Site Not Available

  • Oakland Hills Dermatology

    Auburn Hills 4984565, Michigan 5001836 48326
    United States

    Active - Recruiting

  • Revival Research Institute, Llc - Troy, Mi

    Troy 5012639, Michigan 5001836 48084
    United States

    Active - Recruiting

  • Medisearch Clinical Trials

    Saint Joseph 4407010, Missouri 4398678 64506
    United States

    Active - Recruiting

  • Boeson Research Mso

    Missoula, Montana 59804
    United States

    Site Not Available

  • Boeson Research Mso

    Missoula 5666639, Montana 5667009 59804
    United States

    Active - Recruiting

  • Skin Specialists, Pc

    Omaha 5074472, Nebraska 5073708 68144
    United States

    Active - Recruiting

  • Schweiger Dermatology & Allergy - Verona

    Verona 5105809, New Jersey 5101760 07044
    United States

    Active - Recruiting

  • Vitality Clinical Trials

    Woodbury, New York 11797
    United States

    Site Not Available

  • Vitality Clinical Trials

    Woodbury 5144948, New York 5128638 11797
    United States

    Active - Recruiting

  • Djl Clinical Research, Pllc

    Charlotte, North Carolina 28211
    United States

    Site Not Available

  • Revival Research Institute, Llc - Cary, Nc

    Cary 4459467, North Carolina 4482348 27511
    United States

    Active - Recruiting

  • Darst Dermatology

    Charlotte 4460243, North Carolina 4482348 28277
    United States

    Active - Recruiting

  • Dermatologists Of Southwest Ohio

    Mason 4517698, Ohio 5165418 45040
    United States

    Active - Recruiting

  • Dermatology Associates Of Plymouth Meeting

    Plymouth Meeting, Pennsylvania 19462
    United States

    Site Not Available

  • Dermatology Associates Of Plymouth Meeting

    Plymouth Meeting 5206666, Pennsylvania 6254927 19462
    United States

    Active - Recruiting

  • Medical University Of South Carolina: Dermatology Clinic - Rutledge Tower Location

    Charleston, South Carolina 29403
    United States

    Site Not Available

  • Tribe Clinical Research, Llc

    Greenville 4580543, South Carolina 4597040 29607
    United States

    Active - Recruiting

  • Delricht Research - Smyrna

    Smyrna 4658590, Tennessee 4662168 37167
    United States

    Active - Recruiting

  • Dermatology Treatment And Research Center - Dallas

    Dallas 4684888, Texas 4736286 75230
    United States

    Active - Recruiting

  • North Texas Center For Clinical Research

    Frisco 4692559, Texas 4736286 75034
    United States

    Active - Recruiting

  • Austin Institute For Clinical Research Inc.

    Pflugerville 4718711, Texas 4736286 78660
    United States

    Active - Recruiting

  • Texas Dermatology And Laser Specialists

    San Antonio 4726206, Texas 4736286 78218
    United States

    Active - Recruiting

  • University Of Utah Health - Dermatology At Midvalley Health Center

    Murray, Utah 84107
    United States

    Site Not Available

  • Avacare - Cct Research - Springville Dermatology

    Springville, Utah 84663
    United States

    Site Not Available

  • Jordan Valley Dermatology

    South Jordan 5781770, Utah 5549030 84095
    United States

    Active - Recruiting

  • Avacare - Cct Research - Springville Dermatology

    Springville 5781993, Utah 5549030 84663
    United States

    Active - Recruiting

  • National Eagle Research, Llc

    Lynnwood 5802049, Washington 5815135 98036
    United States

    Active - Recruiting

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