Efficacy and Safety of Deucravacitinib in Adults with Alopecia Areata

Phase 1

• Conditions: Alopecia Areata; MedDRA version: 20.0Level: PTClassification code 10001761Term: Alopecia areataSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2020-000113-33-FR
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-27
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Men and non-pregnant non-breastfeeding women aged = 18 years to = 65 years at the time of the Screening visit.
• SALT score = 50 at Screening and Day 1
• Alopecia Areata Investigator Global Assessment ( AA-IGA) grade = 3 at Screening and Day 1
• Duration of current episode of scalp hair loss (at Screening) must be at least 6 months, and not > 8 years, must affect = 50% of the scalp, and scalp hair loss should be stable (ie, no significant spontaneous regrowth [> 10%] over the last 6 months).

Other protocol defined inclusion criteria apply

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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
• History of lack of response to ustekinumab, in the opinion of the investigator, (or any other therapeutic agent targeted to IL-12, IL-17, or IL-23) after at least 3 months of therapy
• History of lack of response to a JAK inhibitor (eg, tofacitinib, ruxolitinib), in the opinion of the investigator
• Thyroid medication or thyroid replacement therapies, if used, must be stable for 2 months and be maintained as such throughout the study
• Any ongoing treatment known to affect hair growth including, but not limited to, topical steroids (applied to the scalp), intralesional steroids, systemic steroids, anthralin, squaric acid, diphenylcyclopropenone, tacrolimus, cyclosporine, finasteride/minoxidil (oral or topical) or other medication that cannot be discontinued at least 4 weeks prior to study intervention initiation (Day 1) and throughout the study.

Other protocol defined exclusion criteria apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified