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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported