12 Participants Needed

Deucravacitinib for Lichen Planopilaris

Recruiting at 1 trial location
NH
KS
Overseen ByKeegan Stewart
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Mayo Clinic
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
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The purpose of this clinical research study is to learn more about the use of Deucravacitinib in the treatment of Lichen Planopilaris.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it mentions that participants should not be on excluded therapies or should be on a stable dose of a therapy. It's best to discuss your specific medications with the trial team.

How is the drug Deucravacitinib unique for treating lichen planopilaris?

Deucravacitinib is unique because it is a selective TYK2 inhibitor, which targets specific pathways involved in immune responses, potentially offering a novel approach for treating lichen planopilaris compared to other treatments like hydroxychloroquine or tofacitinib, which have different mechanisms of action.12345

Research Team

AM

Aaron Mangold, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for individuals with biopsy-proven Lichen Planopilaris (LPP) or Frontal Fibrosing Alopecia (FFA) who can understand study requirements and give informed consent. It's not suitable for pregnant/nursing women, those with severe diseases, recent major heart events, certain malignancies within the last 5 years, drug/alcohol abuse history, immunocompromised conditions, hypersensitivity to Deucravacitinib or other scalp conditions that could affect results.

Inclusion Criteria

I can follow the study's requirements and communicate with the researcher.
I have a confirmed diagnosis of LPP/FFA with active symptoms.
Subjects must give written, signed, and dated informed consent before any study related activity is performed. When appropriate, a legal representative will sign the informed consent according to local laws and regulation

Exclusion Criteria

I am not currently on a stable dose of any medication, or I have not fully cleared a previous medication from my system.
You have a history of severe or widespread shingles.
I do not have scalp conditions or hair loss types that could affect the study's results.
See 22 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Deucravacitinib for the treatment of Lichen Planopilaris

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Deucravacitinib
Trial OverviewThe trial is testing Deucravacitinib's effectiveness in treating LPP and FFA. Participants will receive this medication to see how well it works against these skin conditions. The study aims to gather data on its safety and efficacy as a treatment option.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Deucravacitinib Treatment for Lichen PlanopilarisExperimental Treatment1 Intervention
Subjects diagnosed with Lichen Planopilaris (LP) will receive Deucravacitinib for 24 weeks.

Deucravacitinib is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Sotyktu for:
  • Moderate to severe plaque psoriasis
🇪🇺
Approved in European Union as Sotyktu for:
  • Moderate to severe plaque psoriasis
🇨🇦
Approved in Canada as Sotyktu for:
  • Moderate to severe plaque psoriasis

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

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

References

Failure of lichen planopilaris to respond to ustekinumab. [2015]
The role of hydroxychloroquine in the treatment of lichen planopilaris: A retrospective case series and review. [2018]
Lichen planopilaris: retrospective study on the characteristics and treatment of 291 patients. [2019]
Tofacitinib for the treatment of lichen planopilaris: A case series. [2021]
A case series of 46 patients with lichen planopilaris: Demographics, clinical evaluation, and treatment experience. [2018]