RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08-05

Study Completion:2028-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07133308

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Head Regulatory Affairs

CONTACT

9122 66455645

Clinical.Trial@sunpharma.com

Study Locations (Sites)

Total Skin And Beauty Dermatology Center

Birmingham, Alabama, 35203

United States

Dermatology Research Associates

Los Angeles, California, 90045

United States

Paradigm Clinical Research - San Diego

San Diego, California, 92108

United States

Pediatric Skin Research Llc

Coral Gables, Florida, 33146

United States

Solutions Through Advanced Research, Inc.

Jacksonville, Florida, 32256

United States

International Clinical Research Us Llc - Sanford

Sanford, Florida, 32771

United States

Lenus Research & Medical Group Llc.

Sweetwater, Florida, 33172

United States

Skin Care Physicians Of Georgia

Macon, Georgia, 31217

United States

Dawes Fretzin Clinical Research Group Llc.

Indianapolis, Indiana, 46250

United States

U.S. Dermatology Partners - Rockville

Rockville, Maryland, 20850

United States

Oakland Hills Dermatology

Auburn Hills, Michigan, 48326

United States

Boeson Research Mso

Missoula, Montana, 59804

United States

Vitality Clinical Trials

Woodbury, New York, 11797

United States

Djl Clinical Research, Pllc

Charlotte, North Carolina, 28211

United States

Dermatology Associates Of Plymouth Meeting

Plymouth Meeting, Pennsylvania, 19462

United States

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

Charleston, South Carolina, 29403

United States

University Of Utah Health - Dermatology At Midvalley Health Center

Murray, Utah, 84107

United States

Avacare - Cct Research - Springville Dermatology

Springville, Utah, 84663

United States

Collaborators and Investigators

Sponsor: Sun Pharmaceutical Industries, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-05

Study Completion Date2028-05

Study Record Updates

Study Start Date2025-08-05

Study Completion Date2028-05

Terms related to this study

Additional Relevant MeSH Terms

Alopecia Areata