Deucravacitinib for Lichen Planopilaris

No longer recruiting at 1 trial location

Overseen By Aaron Mangold, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Active infections, Severe renal impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Deucravacitinib, an experimental treatment, to determine its effectiveness for individuals with Lichen Planopilaris, a condition causing hair loss and scalp irritation. The goal is to assess whether this medication can alleviate symptoms for those affected. It suits individuals diagnosed with Lichen Planopilaris through a biopsy and experiencing active symptoms. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

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.

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

Research has shown that Deucravacitinib is generally safe for people with lichen planopilaris. Studies have found that most individuals tolerate it well, with no serious side effects reported. Some participants experienced mild side effects, likely related to the treatment, but these were not severe. Overall, Deucravacitinib appears to be a promising treatment with manageable safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Lichen Planopilaris?

Most treatments for Lichen Planopilaris (LP) involve steroids or immunosuppressants that aim to reduce inflammation and slow down the immune response. However, Deucravacitinib is unique because it targets a specific enzyme called TYK2, which plays a crucial role in the immune system's signaling pathways. By specifically inhibiting TYK2, Deucravacitinib may offer a more targeted approach, potentially reducing side effects compared to broader immunosuppressants. Researchers are excited about this treatment because it represents a novel mechanism of action that could provide more effective symptom relief for patients with LP.

What evidence suggests that Deucravacitinib might be an effective treatment for Lichen Planopilaris?

Research has shown that Deucravacitinib, the treatment under study in this trial for Lichen Planopilaris (LPP), may help treat the condition. One study found that patients experienced improvements at weeks 12 and 16. Another small study reported that Deucravacitinib reduced the signs and symptoms of LPP. Additionally, a case demonstrated that Deucravacitinib successfully treated a similar condition, extensive skin Lichen Planus. These findings suggest that Deucravacitinib could effectively ease symptoms and improve LPP. ^{1 6 7 8 9}

Who Is on the Research Team?

Aaron Mangold, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Deucravacitinib

Trial Overview The 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.

How Is the Trial Designed?

Group I: Deucravacitinib Treatment for Lichen Planopilaris Experimental Treatment 1 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

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

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

Bristol-Myers Squibb

Chief Medical Officer since 2024

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

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/56/NCT06091956/Prot_SAP_002.pdf

Deucravacitinib (BMS-986165) in the Treatment of Lichen ... Our preliminary results of Deucravacitinib (BMS-. 986165) 6mg BID (Cohort A) improved disease activity by the LPPAI and PGA at weeks 12 and 16.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06091956

A Study of Deucravacitinib to Treat LPP and FFA The purpose of this clinical research study is to learn more about the use of Deucravacitinib in the treatment of Lichen Planopilaris. Official Title.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11576074/

A Case of Extensive Lichen Planus Treated With ... This report aims to highlight the clinical efficacy of deucravacitinib in treating a case of extensive cutaneous LP and to discuss its potential as a novel ...

4. conferences.medicom-publishers.com conferences.medicom-publishers.com/content/conference-reports/deucravacitinib-treatment-in-lichen-planopilaris/

Deucravacitinib treatment in lichen planopilaris In a small phase 2 study with patients with lichen planopilaris (LPP), deucravacitinib led to ameliorations in signs and symptoms.

5. s3.eu-central-1.amazonaws.com s3.eu-central-1.amazonaws.com/m-anage.com.storage.eadv/abstracts_congress_2024/49336.pdf

7862 Deucravacitinib in the treatment of lichen planopilaris Our aim is to evaluate the safety and efficacy of Deucravacitinib in LPP as assessed by the change in. Physician Global Assessment (PGA) and the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05556265

NCT05556265 | A Study to Evaluate Efficacy and Safety of ... A Study to Evaluate Efficacy and Safety of Deucravacitinib ... lichen planopilaris, central centrifugal cicatricial alopecia, frontal fibrosing alopecia, etc.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10929110/

The efficacy and safety of deucravacitinib compared to ... This randomised controlled trial will be the first double-blinded study comparing systemic treatments in VLP and aims to investigate the safety and efficacy of ...

8. conferences.medicom-publishers.com conferences.medicom-publishers.com/specialisation/dermatology/aad-2025/nearly-all-participants-respond-to-deucravacitinib-in-lichen-planopilaris-study/

Nearly all participants respond to deucravacitinib in lichen ... As for safety, the investigators documented 13 mild adverse events (AEs) deemed “likely to be related to treatment.” These side effects ...

9. jidonline.org jidonline.org/article/S0022-202X(25)01034-6/abstract

0468 Deucravacitinib in the treatment of lichen planopilaris There was significant improvement in mean Skindex-16 score (-22.5, p=0.020) at Week 24 compared to baseline. Deucravacitinib was well tolerated, with no serious ...