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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Sun Pharmaceutical Industries, Inc.
Study ID
NCT07133308
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Deuruxolitinib — DRUG
    Deuruxolitinib will be dosed orally as tablets at a dose of 8 mg
  • Placebo — DRUG
    Deuruxolitinib matching placebo will be dosed orally as tablets

Study Details

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.

Key Dates

Start date
Aug 5, 2025
Status verified
Aug 2025
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
355 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Percentage of subjects achieving an absolute Severity of Alopecia Tool (SALT) score ≤20 [ Time Frame: Week 24 ]

Central Contacts

Locations (54)

FacilityCityStateZIPSite coordinators
Total Skin And Beauty Dermatology CenterBirminghamAlabama35203-
Avacare - Cct Research - Center For Dermatology And Plastic SurgeryScottsdaleArizona85260-
Dermatology Trial AssociatesBryantArkansas72022-
Kern Research Inc.BakersfieldCalifornia93301-
Center For Dermatology Clinical Research Inc.FremontCalifornia94538-
Dermatology Research AssociatesLos AngelesCalifornia90045-
Palmtree Clinical ResearchPalm SpringsCalifornia92262-
Paradigm Clinical Research - San DiegoSan DiegoCalifornia92108-
Colorado Medical Research CenterDenverColorado80210-
Paradigm Clinical Research - Wheat RidgeWheat RidgeColorado80033-
D&H Doral Research CenterDoralFlorida33122-
Skin Care Research, Llc - HollywoodHollywoodFlorida33021-
Ilumina Medical Research LlcKissimmeeFlorida34744-
Advance Research Center, LlcMiamiFlorida33183-
All X Ray Diagnostic Services CorpMiamiFlorida33126-
Florida International Medical ResearchMiamiFlorida33134-
Florida Pharmaceutical Research And Associates, Inc.MiamiFlorida33143-
L&C Professional Medical Research InstituteMiamiFlorida33144-
Millennium Medical Research LlcMiamiFlorida33126-
Pediatric Skin Research LlcMiamiFlorida33156-
Valencia Medical & Research CenterMiamiFlorida33174-
Barroso Medical Services LlcMiami LakesFlorida33014-
Nexus Research LlcPompano BeachFlorida33063-
International Clinical Research Us Llc - SanfordSanfordFlorida32771-
Lenus Research & Medical Group Llc.SweetwaterFlorida33172-
Cleaver Medical Group DermatologyCummingGeorgia30040-
Skin Care Physicians Of GeorgiaMaconGeorgia31217-
Georgia Skin & Cancer ClinicSavannahGeorgia31419-
Asr, LlcBoiseIdaho83702-
Denova ResearchChicagoIllinois60611-
Ds Research - IndianaClarksvilleIndiana47129-
Dawes Fretzin Clinical Research Group Llc.IndianapolisIndiana46250-
Ds Research - KentuckyLouisvilleKentucky40241-
U.S. Dermatology Partners - RockvilleRockvilleMaryland20850-
Oakland Hills DermatologyAuburn HillsMichigan48326-
Revival Research Institute, Llc - Troy, MiTroyMichigan48084-
Medisearch Clinical TrialsSaint JosephMissouri64506-
Boeson Research MsoMissoulaMontana59804-
Skin Specialists, PcOmahaNebraska68144-
Schweiger Dermatology & Allergy - VeronaVeronaNew Jersey07044-
Vitality Clinical TrialsWoodburyNew York11797-
Revival Research Institute, Llc - Cary, NcCaryNorth Carolina27511-
Darst DermatologyCharlotteNorth Carolina28277-
Dermatologists Of Southwest OhioMasonOhio45040-
Dermatology Associates Of Plymouth MeetingPlymouth MeetingPennsylvania19462-
Tribe Clinical Research, LlcGreenvilleSouth Carolina29607-
Delricht Research - SmyrnaSmyrnaTennessee37167-
Dermatology Treatment And Research Center - DallasDallasTexas75230-
North Texas Center For Clinical ResearchFriscoTexas75034-
Austin Institute For Clinical Research Inc.PflugervilleTexas78660-
Texas Dermatology And Laser SpecialistsSan AntonioTexas78218-
Jordan Valley DermatologySouth JordanUtah84095-
Avacare - Cct Research - Springville DermatologySpringvilleUtah84663-
National Eagle Research, LlcLynnwoodWashington98036-

Find similar trials in Birmingham, AL

By research site
Total Skin And Beauty Dermatology Center· Birmingham, ALAvacare - Cct Research - Center For Dermatology And Plastic Surgery· Scottsdale, AZDermatology Trial Associates· Bryant, ARKern Research Inc.· Bakersfield, CACenter For Dermatology Clinical Research Inc.· Fremont, CADermatology Research Associates· Los Angeles, CA

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