Deucravacitinib in the Treatment of Cicatricial Alopecias

SM
Overseen BySharlene Martin, MPH
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Icahn School of Medicine at Mount Sinai
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a prospective, open-label clinical trial, in which all participants will be treated with deucravacitinib for 48 weeks. Approximately 20 participants will be enrolled: 10 Central Centrifugal Cicatricial Alopecia (CCCA) and 10 Frontal Fibrosing Alopecia (FFA). The study will take place at the Icahn School of Medicine at Mount Sinai (ISMMS). At the Baseline/Day 0 visit, participants will initiate treatment with deucravacitinib. All participants will receive deucravacitinib 12mg once-daily for 48 weeks. The treatment period will conclude at week 48.

Who Is on the Research Team?

BU

Benjamin Ungar, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

Inclusion Criteria

* Participants of any gender, age 18 years or older, at the time of informed consent at Screening
* Participants who are willing and able to adhere to the study visit schedule and comply with protocol requirements.
* Participant self-reports a history of at least 6 months of moderate-to-severe CA (FFA or CCCA). Diagnosis will be made clinically, and severity assessed with according to the FFASI32 ≥30 and/or CHLG ≥3.
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What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Frontal Fibrosing AlopeciaExperimental Treatment1 Intervention
Group II: Central Centrifugal Cicatricial AlopeciaExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials
933
Recruited
579,000+

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
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Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

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Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania