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Search / Trial NCT07133308

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

Launched by SUN PHARMACEUTICAL INDUSTRIES, INC. · Aug 13, 2025

Trial Information

Current as of August 22, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a medicine called deuruxolitinib to see if it is safe and effective for treating severe alopecia areata in teenagers. Alopecia areata is a condition that causes hair loss, and this study focuses on adolescents aged 12 to under 18 years who have lost at least half of the hair on their scalp. The goal is to find out if deuruxolitinib can help these young people regrow their hair and improve their condition.

To join the study, participants need to have had alopecia areata for at least six months but no more than ten years, and their hair loss must cover 50% or more of their scalp. Teens who have other scalp problems or are using certain medications that might affect hair growth cannot take part. Female participants who are pregnant, nursing, or planning to become pregnant during the study are also not eligible. Those who join will be asked to follow the study’s schedule and requirements, which includes regular visits to check their progress and safety. This trial is currently recruiting participants, and it welcomes teens of all genders who meet the criteria.

Gender

ALL

Eligibility criteria

  • 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.

About Sun Pharmaceutical Industries, Inc.

Sun Pharmaceutical Industries, Inc. is a global pharmaceutical company specializing in the development, manufacturing, and marketing of a broad range of branded and generic formulations, active pharmaceutical ingredients, and over-the-counter products. With a strong commitment to innovation and quality, Sun Pharma focuses on delivering affordable, high-quality medicines across various therapeutic areas, including dermatology, cardiology, neurology, and oncology. The company actively engages in clinical research to advance healthcare solutions and improve patient outcomes worldwide.

Locations

Plymouth Meeting, Pennsylvania, United States

Los Angeles, California, United States

Quebec, , Canada

Jacksonville, Florida, United States

Edmonton, Alberta, Canada

Macon, Georgia, United States

Auburn Hills, Michigan, United States

Missoula, Montana, United States

Charlotte, North Carolina, United States

Coral Gables, Florida, United States

Birmingham, Alabama, United States

San Diego, California, United States

Woodbury, New York, United States

Sanford, Florida, United States

Sweetwater, Florida, United States

Indianapolis, Indiana, United States

Rockville, Maryland, United States

Charleston, South Carolina, United States

Murray, Utah, United States

Springville, Utah, United States

Red Deer, Alberta, Canada

Montreal, Quebec, Canada

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported