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Janus Kinase (JAK) Inhibitor

Deucravacitinib for Lichen Planopilaris

Phase 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I can follow the study's requirements and communicate with the researcher.

Select...

I have a confirmed diagnosis of LPP/FFA with active symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Complete and Partial responders

Secondary outcome measures

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 2022 Phase 3 trial • 220 Patients • NCT04167462

18%

Upper respiratory tract infection

Mouth ulceration

Nasopharyngitis

Pruritus

Headache

Folliculitis

Psoriasis

Cholecystitis

Gastroenteritis shigella

Gastroenteritis

Pharyngitis

Diabetes mellitus

Accidental overdose

Hepatobiliary procedural complication

Psoriatic arthropathy

100%

80%

60%

40%

20%

Study treatment Arm

Placebo Week 0 up to Week 16

BMS-986165 Week 0 up to Week 52

BMS-986165 Week 16 up to Week 52

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,216 Previous Clinical Trials

3,767,478 Total Patients Enrolled

1 Trials studying Lichen Planopilaris

12 Patients Enrolled for Lichen Planopilaris

Bristol-Myers SquibbIndustry Sponsor

2,641 Previous Clinical Trials

4,130,054 Total Patients Enrolled

Aaron Mangold, MDPrincipal InvestigatorMayo Clinic

1 Previous Clinical Trials

4 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What adverse effects, if any, may be associated with Deucravacitinib Treatment for Lichen Planopilaris?

"Due to the lack of efficacy data, deucravacitinib treatment for lichen planopilaris received a 2 on our safety scale. Nonetheless, there is some evidence that this treatment is safe and secure."

Answered by AI

Are there any remaining vacancies in this clinical trial?

"Per the information currently posted on clinicaltrials.gov, this medical trial is not actively recruiting candidates as of October 16th 2023. This study was first published November 1st 2023 and has since been inactive; however there are presently 16 other trials seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Deucravacitinib to Treat LPP and FFA

Aaron R. Mangold 2023. "A Study of Deucravacitinib to Treat LPP and FFA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06091956.

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