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

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.

Conditions

Alopecia Areata
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Related Conditions:

Alopecia Areata

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Alopecia Areata
Intervention / Treatment

-

Contacts and Locations

Birmingham

Total Skin And Beauty Dermatology Center, Birmingham, Alabama, United States, 35203

Los Angeles

Dermatology Research Associates, Los Angeles, California, United States, 90045

San Diego

Paradigm Clinical Research - San Diego, San Diego, California, United States, 92108

Coral Gables

Pediatric Skin Research Llc, Coral Gables, Florida, United States, 33146

Jacksonville

Solutions Through Advanced Research, Inc., Jacksonville, Florida, United States, 32256

Sanford

International Clinical Research Us Llc - Sanford, Sanford, Florida, United States, 32771

Sweetwater

Lenus Research & Medical Group Llc., Sweetwater, Florida, United States, 33172

Macon

Skin Care Physicians Of Georgia, Macon, Georgia, United States, 31217

Indianapolis

Dawes Fretzin Clinical Research Group Llc., Indianapolis, Indiana, United States, 46250

Rockville

U.S. Dermatology Partners - Rockville, Rockville, Maryland, United States, 20850

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

12 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sun Pharmaceutical Industries, Inc.,

Study Record Dates

2028-05