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

Sun Pharmaceutical Industries, Inc.

Status and phase: Enrolling; Phase 3

Conditions: Alopecia Areata

Treatments: Drug: Placebo; Drug: Deuruxolitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT07133308

CP543.3101

Details and patient eligibility

About

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.

Full description

The efficacy and safety of deuruxolitinib in adolescent subjects with severe alopecia areata will be evaluated in this study, beginning with a double-blind, randomized, placebo-controlled Treatment Period of 24 weeks. Subjects 12 to <18 years of age having at least 50% hair loss as measured by SALT and meeting eligibility criteria will be randomized to deuruxolitinib or placebo treatment. In the Open-label Extension part of the study, participants from the Treatment Period will receive deuruxolitinib for 52 weeks.

Enrollment: 355 estimated patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

355 participants in 3 patient groups, including a placebo group

Treatment Period: Deuruxolitinib 8 mg

Experimental group

Description:

Deuruxolitinib tablets, orally, twice daily (BID) for up to 24 weeks

Treatment:

Drug: Deuruxolitinib

Treatment Period: Placebo

Placebo Comparator group

Description:

Deuruxolitinib-matched placebo tablets, orally, BID for up to 24 weeks

Treatment:

Drug: Placebo

Open-Label Extension: Deuruxolitinib 8 mg BID

Experimental group

Description:

Deuruxolitinib tablets, orally, BID for up to 52 weeks

Treatment:

Drug: Deuruxolitinib