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BMS Active Not Yet Recruiting Study icon

Active, Not Recruiting

Trial ID IM011-134  |   NCT05556265

A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Alopecia Areata

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Summary

  • Phase 2
  • Male and Female Gender icon
  • 18-65
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

The purpose of this study is to evaluate the efficacy of Deucravacitinib versus placebo at Week 24 and safety and tolerability of Deucravacitinib versus placebo in adults with Alopecia Areata.

Key Eligibility Criteria

Inclusion Criteria: - Documented clinical diagnosis of Alopecia Areata (AA) for at least 6 months. - Current episode of scalp hair loss (at screening) must meet the following criteria: duration at least 6 months; duration of current hair loss episode of AA affecting ≥ 50% of the scalp not exceeding 8 years; scalp hair loss has been stable (no significant spontaneous regrowth [> 10%] over the last 6 months) - SALT score ≥ 50 at Screening and Day 1. Participant with complete scalp hair loss (SALT score of 100) with or without body hair involvement can be included. Exclusion Criteria: - Participant with diffuse-type AA or other forms of hair loss, including traction alopecia, lichen planopilaris, central centrifugal cicatricial alopecia, frontal fibrosing alopecia, etc. - Other active skin diseases affecting the scalp that in the opinion of the investigator may interfere with accurate assessment of SALT score. - Extensive tattooing of the scalp that, in the opinion of the investigator, may interfere with the accurate assessment of SALT score. Other protocol-defined inclusion/exclusion criteria apply.

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Deucravacitinib Dose 1

ASSIGNED INTERVENTION
  • Drug: Deucravacitinib
  • Other: Placebo

Study Arms

Experimental: Deucravacitinib Dose 2

ASSIGNED INTERVENTION
  • Drug: Deucravacitinib
  • Other: Placebo

Study Arms

Placebo Comparator: Placebo, followed by Deucravacitinib Dose 1 or Dose 2.

ASSIGNED INTERVENTION

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