Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescents With Severe Alopecia Areata
NCT ID: NCT07133308
Last Updated: 2026-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
355 participants
INTERVENTIONAL
2025-08-05
2028-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Model- Parallel Assignment, Number of Arms- 2
The Treatment period will be followed by the Open-Label Extension Period:
Model- Single Group Assignment, Number of Arms- 1
TREATMENT
QUADRUPLE
Study Groups
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Treatment Period: Deuruxolitinib 8 mg
Deuruxolitinib tablets, orally, twice daily (BID) for up to 24 weeks
Deuruxolitinib
Deuruxolitinib will be dosed orally as tablets at a dose of 8 mg
Treatment Period: Placebo
Deuruxolitinib-matched placebo tablets, orally, BID for up to 24 weeks
Placebo
Deuruxolitinib matching placebo will be dosed orally as tablets
Open-Label Extension: Deuruxolitinib 8 mg BID
Deuruxolitinib tablets, orally, BID for up to 52 weeks
Deuruxolitinib
Deuruxolitinib will be dosed orally as tablets at a dose of 8 mg
Interventions
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Deuruxolitinib
Deuruxolitinib will be dosed orally as tablets at a dose of 8 mg
Placebo
Deuruxolitinib matching placebo will be dosed orally as tablets
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
12 Years
17 Years
ALL
No
Sponsors
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Sun Pharmaceutical Industries, Inc.
INDUSTRY
Responsible Party
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Locations
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Total Skin And Beauty Dermatology Center
Birmingham, Alabama, United States
Avacare - Cct Research - Center For Dermatology And Plastic Surgery
Scottsdale, Arizona, United States
Dermatology Trial Associates
Bryant, Arkansas, United States
Kern Research Inc.
Bakersfield, California, United States
Center For Dermatology Clinical Research Inc.
Fremont, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Palmtree Clinical Research
Palm Springs, California, United States
Paradigm Clinical Research - San Diego
San Diego, California, United States
Colorado Medical Research Center
Denver, Colorado, United States
Paradigm Clinical Research - Wheat Ridge
Wheat Ridge, Colorado, United States
D&H Doral Research Center
Doral, Florida, United States
Skin Care Research, Llc - Hollywood
Hollywood, Florida, United States
Ilumina Medical Research Llc
Kissimmee, Florida, United States
All X Ray Diagnostic Services Corp
Miami, Florida, United States
Millennium Medical Research Llc
Miami, Florida, United States
Florida International Medical Research
Miami, Florida, United States
Florida Pharmaceutical Research And Associates, Inc.
Miami, Florida, United States
L&C Professional Medical Research Institute
Miami, Florida, United States
Pediatric Skin Research Llc
Miami, Florida, United States
Valencia Medical & Research Center
Miami, Florida, United States
Advance Research Center, Llc
Miami, Florida, United States
Barroso Medical Services Llc
Miami Lakes, Florida, United States
Nexus Research Llc
Pompano Beach, Florida, United States
International Clinical Research Us Llc - Sanford
Sanford, Florida, United States
Lenus Research & Medical Group Llc.
Sweetwater, Florida, United States
Cleaver Medical Group Dermatology
Cumming, Georgia, United States
Skin Care Physicians Of Georgia
Macon, Georgia, United States
Georgia Skin & Cancer Clinic
Savannah, Georgia, United States
Asr, Llc
Boise, Idaho, United States
Denova Research
Chicago, Illinois, United States
Ds Research - Indiana
Clarksville, Indiana, United States
Dawes Fretzin Clinical Research Group Llc.
Indianapolis, Indiana, United States
Ds Research - Kentucky
Louisville, Kentucky, United States
U.S. Dermatology Partners - Rockville
Rockville, Maryland, United States
Oakland Hills Dermatology
Auburn Hills, Michigan, United States
Revival Research Institute, Llc - Troy, Mi
Troy, Michigan, United States
Medisearch Clinical Trials
Saint Joseph, Missouri, United States
Boeson Research Mso
Missoula, Montana, United States
Skin Specialists, Pc
Omaha, Nebraska, United States
Schweiger Dermatology & Allergy - Verona
Verona, New Jersey, United States
Vitality Clinical Trials
Woodbury, New York, United States
Revival Research Institute, Llc - Cary, Nc
Cary, North Carolina, United States
Darst Dermatology
Charlotte, North Carolina, United States
Dermatologists Of Southwest Ohio
Mason, Ohio, United States
Dermatology Associates Of Plymouth Meeting
Plymouth Meeting, Pennsylvania, United States
Tribe Clinical Research, Llc
Greenville, South Carolina, United States
Delricht Research - Smyrna
Smyrna, Tennessee, United States
Dermatology Treatment And Research Center - Dallas
Dallas, Texas, United States
North Texas Center For Clinical Research
Frisco, Texas, United States
Austin Institute For Clinical Research Inc.
Pflugerville, Texas, United States
Texas Dermatology And Laser Specialists
San Antonio, Texas, United States
Jordan Valley Dermatology
South Jordan, Utah, United States
Avacare - Cct Research - Springville Dermatology
Springville, Utah, United States
National Eagle Research, Llc
Lynnwood, Washington, United States
Kirk Barber Research
Calgary, Alberta, Canada
Dermatology Research Institute (Calgary)
Calgary, Alberta, Canada
Alberta Dermasurgery Centre
Edmonton, Alberta, Canada
Care Clinic Ltd.
Red Deer, Alberta, Canada
Medical Arts Health Research Group - Kelowna
Kelowna, British Columbia, Canada
Enverus Medical Research
Surrey, British Columbia, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
Dr. S. K. Siddha Medicine Professional Corporation
Newmarket, Ontario, Canada
Research Toronto
Toronto, Ontario, Canada
Facet Dermatology
Toronto, , Canada
Countries
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Central Contacts
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Other Identifiers
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CP543.3101
Identifier Type: -
Identifier Source: org_study_id
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