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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Alopecia Areata

In brief

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.

Key facts

Study ID

NCT07133308

Run by

Sun Pharmaceutical Industries, Inc.

People needed

355

Starts

2025-08-05

Expected to finish

2028-05-01

Last updated by the study team

2026-01-28

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Avacare - Cct Research - Center For Dermatology And Plastic Surgery — Scottsdale, Arizona, United States (enrolling)
• Dermatology Trial Associates — Bryant, Arkansas, United States (enrolling)
• Kern Research Inc. — Bakersfield, California, United States (enrolling)
• Center For Dermatology Clinical Research Inc. — Fremont, California, United States (enrolling)
• Dermatology Research Associates — Los Angeles, California, United States (enrolling)
• Palmtree Clinical Research — Palm Springs, California, United States (enrolling)
• Paradigm Clinical Research - San Diego — San Diego, California, United States (enrolling)
• Colorado Medical Research Center — Denver, Colorado, United States (enrolling)
• Paradigm Clinical Research - Wheat Ridge — Wheat Ridge, Colorado, United States (enrolling)
• D&H Doral Research Center — Doral, Florida, United States (enrolling)
• Skin Care Research, Llc - Hollywood — Hollywood, Florida, United States (enrolling)
• Ilumina Medical Research Llc — Kissimmee, Florida, United States (enrolling)
• All X Ray Diagnostic Services Corp — Miami, Florida, United States (enrolling)
• Millennium Medical Research Llc — Miami, Florida, United States (enrolling)
• Florida International Medical Research — Miami, Florida, United States (enrolling)
• Florida Pharmaceutical Research And Associates, Inc. — Miami, Florida, United States (enrolling)
• L&C Professional Medical Research Institute — Miami, Florida, United States (enrolling)
• Pediatric Skin Research Llc — Miami, Florida, United States (enrolling)
• Valencia Medical & Research Center — Miami, Florida, United States (enrolling)
• Advance Research Center, Llc — Miami, Florida, United States (enrolling)
• Barroso Medical Services Llc — Miami Lakes, Florida, United States (enrolling)
• Nexus Research Llc — Pompano Beach, Florida, United States (enrolling)
• International Clinical Research Us Llc - Sanford — Sanford, Florida, United States (enrolling)
• Lenus Research & Medical Group Llc. — Sweetwater, Florida, United States (enrolling)
• Total Skin And Beauty Dermatology Center — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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