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

NCT07133308 | Recruiting Phase 3 FDA Drug

• 1 other identifier: CP543.3101
• Study Type: interventional
• Target: 355
• Locations: 2 countries
• Sites: 64

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

Outcome Measures

Primary Outcomes (2)

• Percentage of subjects achieving an absolute Severity of Alopecia Tool (SALT) score ≤20

  SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).

  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

  Summary of participants who experience Treatment emergent adverse events (TEAEs) and serious TEAEs will be provided. An AE is defined as any untoward medical occurrence that may appear or worsen in a subject during the course of a study. Adverse events will be considered treatment-emergent if the onset is after the first dose of study drug. Summaries will be provided of participants who experience potentially clinically significant post-baseline changes in: hematology, chemistry and lipid results, vital signs (blood pressure, pulse rate, respiratory rate, temperature), electrocardiogram parameters (heart rate, PR, QT, QTcF, QRS, and RR) and physical examination findings.

  Week 24

Secondary Outcomes (23)

• Percentage of subjects achieving an absolute SALT score of ≤20

  Weeks 4, 8, 12, 16, and 20

• Mean percent change (ie, relative change) in SALT scores from baseline

  Weeks 4, 8, 12, 16, 20, and 24

• Percentage of responders (defined as "much improved" or "very much improved") using the Clinical Global Impression of Improvement (CGI-I)

  Weeks 12, 16, 20, and 24

• Percentage of responders (defined as "much improved" or "very much improved") using the Patient Global Impression of Improvement (PGI-I)

  Weeks 12, 16, 20, and 24

• Mean change from baseline in the Clinical Global Impression of Severity (CGI-S)

  Weeks 12, 16, 20, and 24

Study Arms (3)

Treatment Period: Deuruxolitinib 8 mg

EXPERIMENTAL

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

Drug: Deuruxolitinib

Treatment Period: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Open-Label Extension: Deuruxolitinib 8 mg BID

EXPERIMENTAL

Deuruxolitinib tablets, orally, BID for up to 52 weeks

Drug: Deuruxolitinib

Interventions

Deuruxolitinib DRUG

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

Open-Label Extension: Deuruxolitinib 8 mg BID; Treatment Period: Deuruxolitinib 8 mg

Placebo DRUG

Deuruxolitinib matching placebo will be dosed orally as tablets

Treatment Period: Placebo

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Pharmaceutical Industries, Inc.: lead

Study Sites (64)

Total Skin And Beauty Dermatology Center

Birmingham, Alabama, 35203, United States

RECRUITING

Avacare - Cct Research - Center For Dermatology And Plastic Surgery

Scottsdale, Arizona, 85260, United States

RECRUITING

Dermatology Trial Associates

Bryant, Arkansas, 72022, United States

RECRUITING

Kern Research Inc.

Bakersfield, California, 93301, United States

RECRUITING

Center For Dermatology Clinical Research Inc.

Fremont, California, 94538, United States

RECRUITING

Dermatology Research Associates

Los Angeles, California, 90045, United States

RECRUITING

Palmtree Clinical Research

Palm Springs, California, 92262, United States

RECRUITING

Paradigm Clinical Research - San Diego

San Diego, California, 92108, United States

RECRUITING

Colorado Medical Research Center

Denver, Colorado, 80210, United States

RECRUITING

Paradigm Clinical Research - Wheat Ridge

Wheat Ridge, Colorado, 80033, United States

RECRUITING

D&H Doral Research Center

Doral, Florida, 33122, United States

RECRUITING

Skin Care Research, Llc - Hollywood

Hollywood, Florida, 33021, United States

RECRUITING

Ilumina Medical Research Llc

Kissimmee, Florida, 34744, United States

RECRUITING

All X Ray Diagnostic Services Corp

Miami, Florida, 33126, United States

RECRUITING

Millennium Medical Research Llc

Miami, Florida, 33126, United States

RECRUITING

Florida International Medical Research

Miami, Florida, 33134, United States

RECRUITING

Florida Pharmaceutical Research And Associates, Inc.

Miami, Florida, 33143, United States

RECRUITING

L&C Professional Medical Research Institute

Miami, Florida, 33144, United States

RECRUITING

Pediatric Skin Research Llc

Miami, Florida, 33156, United States

RECRUITING

Valencia Medical & Research Center

Miami, Florida, 33174, United States

RECRUITING

Advance Research Center, Llc

Miami, Florida, 33183, United States

RECRUITING

Barroso Medical Services Llc

Miami Lakes, Florida, 33014, United States

RECRUITING

Nexus Research Llc

Pompano Beach, Florida, 33063, United States

RECRUITING

International Clinical Research Us Llc - Sanford

Sanford, Florida, 32771, United States

RECRUITING

Lenus Research & Medical Group Llc.

Sweetwater, Florida, 33172, United States

RECRUITING

Cleaver Medical Group Dermatology

Cumming, Georgia, 30040, United States

RECRUITING

Skin Care Physicians Of Georgia

Macon, Georgia, 31217, United States

RECRUITING

Georgia Skin & Cancer Clinic

Savannah, Georgia, 31419, United States

RECRUITING

Asr, Llc

Boise, Idaho, 83702, United States

RECRUITING

Denova Research

Chicago, Illinois, 60611, United States

RECRUITING

Ds Research - Indiana

Clarksville, Indiana, 47129, United States

RECRUITING

Dawes Fretzin Clinical Research Group Llc.

Indianapolis, Indiana, 46250, United States

RECRUITING

Ds Research - Kentucky

Louisville, Kentucky, 40241, United States

RECRUITING

U.S. Dermatology Partners - Rockville

Rockville, Maryland, 20850, United States

RECRUITING

Oakland Hills Dermatology

Auburn Hills, Michigan, 48326, United States

RECRUITING

Revival Research Institute, Llc - Troy, Mi

Troy, Michigan, 48084, United States

RECRUITING

Medisearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

RECRUITING

Boeson Research Mso

Missoula, Montana, 59804, United States

RECRUITING

Skin Specialists, Pc

Omaha, Nebraska, 68144, United States

RECRUITING

Schweiger Dermatology & Allergy - Verona

Verona, New Jersey, 07044, United States

RECRUITING

Vitality Clinical Trials

Woodbury, New York, 11797, United States

RECRUITING

Revival Research Institute, Llc - Cary, Nc

Cary, North Carolina, 27511, United States

RECRUITING

Darst Dermatology

Charlotte, North Carolina, 28277, United States

RECRUITING

Dermatologists Of Southwest Ohio

Mason, Ohio, 45040, United States

RECRUITING

Dermatology Associates Of Plymouth Meeting

Plymouth Meeting, Pennsylvania, 19462, United States

RECRUITING

Tribe Clinical Research, Llc

Greenville, South Carolina, 29607, United States

RECRUITING

Delricht Research - Smyrna

Smyrna, Tennessee, 37167, United States

RECRUITING

Dermatology Treatment And Research Center - Dallas

Dallas, Texas, 75230, United States

RECRUITING

North Texas Center For Clinical Research

Frisco, Texas, 75034, United States

RECRUITING

Austin Institute For Clinical Research Inc.

Pflugerville, Texas, 78660, United States

RECRUITING

Texas Dermatology And Laser Specialists

San Antonio, Texas, 78218, United States

RECRUITING

Jordan Valley Dermatology

South Jordan, Utah, 84095, United States

RECRUITING

Avacare - Cct Research - Springville Dermatology

Springville, Utah, 84663, United States

RECRUITING

National Eagle Research, Llc

Lynnwood, Washington, 98036, United States

RECRUITING

Kirk Barber Research

Calgary, Alberta, T2G 1B1, Canada

RECRUITING

Dermatology Research Institute (Calgary)

Calgary, Alberta, T2J 7E1, Canada

RECRUITING

Alberta Dermasurgery Centre

Edmonton, Alberta, T6G 1C3, Canada

RECRUITING

Care Clinic Ltd.

Red Deer, Alberta, T4P 1K4, Canada

RECRUITING

Medical Arts Health Research Group - Kelowna

Kelowna, British Columbia, V1Y4N7, Canada

RECRUITING

Enverus Medical Research

Surrey, British Columbia, V3V 0C6, Canada

RECRUITING

Lynderm Research Inc.

Markham, Ontario, L3P 1X3, Canada

RECRUITING

Dr. S. K. Siddha Medicine Professional Corporation

Newmarket, Ontario, L3Y 5G8, Canada

RECRUITING

Research Toronto

Toronto, Ontario, M4W 2N4, Canada

RECRUITING

Facet Dermatology

Toronto, M4E 1R7, Canada

RECRUITING

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Head Regulatory Affairs

CONTACT

9122 66455645; Clinical.Trial@sunpharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All study subjects, Investigators, and site study staff will be blinded to study \[Treatment Period\] followed by None \[Open-Label Extension\]
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Treatment period: 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

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 21, 2025
• Study Start: August 5, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: January 28, 2026

Record last verified: 2025-08

Locations

CA (10); US (54)