20 Participants NeededMy employer runs this trial

Deucravacitinib for Hair Loss

SM
GS
Overseen ByGiselle Singer
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 trial aims to test a new treatment, deucravacitinib, for two types of hair loss: Central Centrifugal Cicatricial Alopecia (CCCA) and Frontal Fibrosing Alopecia (FFA). Participants will take deucravacitinib daily for 48 weeks to evaluate its effectiveness in promoting hair regrowth and reducing symptoms. The trial seeks individuals who have experienced moderate-to-severe hair loss from CCCA or FFA for at least 6 months and are generally in good health. Researchers will monitor participants at the Icahn School of Medicine at Mount Sinai to ensure safety and effectiveness. As a Phase 2 trial, the research focuses on assessing the treatment's efficacy in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

Yes, you may need to stop certain medications before joining the trial. Specifically, you cannot use systemic immunosuppressive medications, certain non-biologic systemic agents, intralesional corticosteroids, oral JAK inhibitors, or topical corticosteroids close to the start of the trial. There are specific timeframes for stopping these medications, such as 8 weeks for some and 4 weeks for others before the baseline visit.

Is there any evidence suggesting that deucravacitinib is likely to be safe for humans?

Studies have shown that deucravacitinib is generally well-tolerated by patients. Real-world research indicates that most people handle the treatment well, though some new risks have been identified. Common side effects include mild issues like headaches or stomach upset, but these do not affect everyone. No major safety concerns would prevent most people from trying the treatment safely. However, as with any medication, monitoring for unexpected reactions is important.12345

Why do researchers think this study treatment might be promising for hair loss?

Deucravacitinib is unique because it targets the JAK-STAT signaling pathway, which is not the focus of most current treatments for hair loss conditions like Frontal Fibrosing Alopecia and Central Centrifugal Cicatricial Alopecia. Existing treatments often rely on anti-inflammatory medications or topical steroids. However, Deucravacitinib, a selective TYK2 inhibitor, offers a more targeted approach by specifically modulating immune pathways involved in these conditions. Researchers are excited about this treatment due to its potential for greater effectiveness and fewer side effects compared to traditional options.

What evidence suggests that deucravacitinib might be an effective treatment for hair loss?

Research has shown that deucravacitinib, a treatment targeting a specific enzyme, might help manage conditions like Frontal Fibrosing Alopecia (FFA). In this trial, participants with FFA will receive deucravacitinib to evaluate its effectiveness. Patients with similar conditions have experienced significant symptom improvements with treatments that work similarly, such as JAK inhibitors. For Central Centrifugal Cicatricial Alopecia (CCCA), another group in this trial will receive deucravacitinib, although its effectiveness for CCCA remains unclear. Some studies did not achieve their goals for hair regrowth, suggesting it might not work well for CCCA. However, responses to treatments can vary among individuals.16789

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?

This trial is for adults (18+) with moderate-to-severe central centrifugal cicatricial alopecia or frontal fibrosing alopecia, who are generally healthy. Women must not be pregnant or breastfeeding and must use effective birth control if of childbearing age. Participants need a negative TB test and must commit to study visits.

Inclusion Criteria

I am in good overall health based on recent exams and tests.
I am not pregnant or breastfeeding, and I use effective birth control if I can have children.
I am 18 years old or older.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive deucravacitinib 12mg once-daily for 48 weeks

48 weeks
Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Deucravacitinib

Trial Overview

All participants will take deucravacitinib, an oral medication, once daily for 48 weeks to see how it affects certain types of scarring hair loss. The study is open-label, meaning everyone knows what treatment they receive.

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
Christopher Boerner profile image

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

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

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

Citations

Deucravacitinib in the Treatment of Cicatricial Alopecias

... Deucravacitinib will have tolerable side effects & efficacy for patients with Hair Loss and Central Centrifugal Alopecia. Learn more about the study.

Deucravacitinib in the Treatment of Cicatricial Alopecias

This is a prospective, open-label clinical trial, in which all participants will be treated with deucravacitinib for 48 weeks. Approximately 20 participants ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41905775/

Deucravacitinib, an oral, selective, allosteric tyrosine ...

This trial did not meet the efficacy endpoints and TYK2 inhibition by deucravacitinib may not play a major role in hair regrowth in patients ...

Exploring Treatment Outcomes in Central Centrifugal ...

After one year of treatment, 50% of patients were stable, 36% improved, and 14% worsened. This research points out that personal health and hair ...

Central Centrifugal Cicatricial Alopecia: A Survey of Treatment ...

We conducted a cross-sectional survey study of the commonly prescribed/recommended treatments for CCCA in 31 residents and attending physicians ...

A Study to Evaluate Efficacy and Safety of Deucravacitinib in ...

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

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40782323/

Safety evaluation of deucravacitinib: a real-world analysis ...

This study provides new safety data for deucravacitinib in real-world settings, uncovering previously unrecognized risks and identifying several ...

NCT05556265 | A Study to Evaluate Efficacy and Safety of ...

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 ...

Deucravacitinib Safety Data and Treatment Selection ...

Bruce Strober, MD, PhD, and Linda Stein Gold, MD, provide clinical insights on long-term safety data for deucravacitinib and selecting the ...