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Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescents With Severe Alopecia Areata | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

A Double-Blind, Randomized, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescent Patients With Severe Alopecia Areata With an Open-label Extension Period

NCT07133308•Sun Pharmaceutical Industries, Inc.

View on ClinicalTrials.gov

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

Age

12 - 17 years

Sex

ALL

Healthy Volunteers

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.

Locations (64)

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

Key Dates

Start Date

August 5, 2025

Primary Completion Date

May 1, 2028

Completion Date

May 1, 2028

Last Updated

January 28, 2026

Enrollment

355

ESTIMATED participants

Conditions

Alopecia Areata

Interventions

Deuruxolitinib

DRUG

Placebo

DRUG

Contacts

Head Regulatory Affairs

CONTACT

9122 66455645 Clinical.Trial@sunpharma.com

A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ALD-102 Solution in Subjects With Alopecia Areata

NCT06826196

Alopecia Areata (AA)

View study

RECRUITING

CorEvitas International Adolescent Alopecia Areata (AA) Drug Safety and Effectiveness Registry

NCT06562270

Alopecia Areata

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RECRUITINGNA

Combined Microneedling With Either 1% Lactic Acid Solution or Vitamin D3 or Triamcinolone Acetonide in The Treatment of Alopecia Areata

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ALD-102 Solution in Subjects With Alopecia Areata

CorEvitas International Adolescent Alopecia Areata (AA) Drug Safety and Effectiveness Registry

Combined Microneedling With Either 1% Lactic Acid Solution or Vitamin D3 or Triamcinolone Acetonide in The Treatment of Alopecia Areata

A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants in Japan With Alopecia Areata

A Study to Learn About Litfulo Capsule in People With Severe Alopecia Areata in Routine Clinical Practice.

A Long-Term Study to Learn About The Study Medicine Called Ritlecitinib in Children With Severe Alopecia Areata.