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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2

Conditions: Alopecia Areata

Treatments: Drug: Deucravacitinib; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05556265

2020-000113-33 (EudraCT Number)

U1111-1246-1767 (Registry Identifier)

IM011-134

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 3 patient groups, including a placebo group

Deucravacitinib Dose 1

Experimental group

Treatment:

Other: Placebo

Drug: Deucravacitinib

Deucravacitinib Dose 2

Experimental group

Treatment:

Other: Placebo

Drug: Deucravacitinib

Placebo, followed by Deucravacitinib Dose 1 or Dose 2.

Placebo Comparator group

Treatment:

Other: Placebo

Drug: Deucravacitinib