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Janus Kinase (JAK) Inhibitor

Deucravacitinib for Lichen Planopilaris

Phase 2
Waitlist Available
Led By Aaron Mangold, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must be able to understand and comply with the requirements of the study and communicate with the investigator
Subjects must have biopsy proven LPP/FFA and active disease
Must not have
Had any major surgery within 8 weeks prior to screening or will require major surgery during the study that would pose an unacceptable risk to the patient
Evidence of active TB or untreated/inadequately or inappropriately treated latent TB
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial studies Deucravacitinib to see if it helps treat Lichen Planopilaris, a scalp skin condition.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects of Deucravacitinib in this context are not listed here, common ones may include potential immune system effects due to its nature as an immunomodulatory therapy. Patients might experience reactions at the site of administration or general symptoms like fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can follow the study's requirements and communicate with the researcher.
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I have a confirmed diagnosis of LPP/FFA with active symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had major surgery in the last 8 weeks and don't need any during the study.
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I have active TB or my latent TB was not properly treated.
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I have had blood clots in my veins at least twice.
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I have not had a live vaccine in the last 12 weeks and do not plan to during the study.
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I have not donated more than one unit of blood in the last 4 weeks and do not plan to donate during the study.
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I was in close contact with someone who has active TB and did not get treatment to prevent it.
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I am a woman who could become pregnant.
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My kidneys do not work well.
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I have a condition that weakens my immune system significantly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Complete and Partial responders
Secondary study objectives
Change in Numerical Rating Scale (NRS) for itch
Change in Physician Global Assessment (PGA) score
Change in Pruritus Verbal Rating Scale (VRS)
+3 more

Side effects data

From 2023 Phase 2 trial • 67 Patients • NCT04877990
25%
COVID-19
13%
Pneumonia
13%
Nasopharyngitis
8%
Upper respiratory tract infection
8%
Cough
8%
Pyrexia
8%
Mouth ulceration
4%
Urinary tract infection
4%
Small intestinal obstruction
4%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
CROHN'S DISEASE
ULCERATIVE COLITIS

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deucravacitinib
2021
Completed Phase 4
~160

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,682 Previous Clinical Trials
4,129,557 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,339 Previous Clinical Trials
3,062,395 Total Patients Enrolled
Aaron Mangold, MDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
16 Total Patients Enrolled
~6 spots leftby Nov 2025
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