A Phase 2/3 Study of Brepocitinib in Adults With Lichen Planopilaris (ALPINE)

April 9, 2026 updated by: Priovant Therapeutics, Inc.

A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults With Lichen Planopilaris

This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with lichen planopilaris

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

342

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Clinical Trial Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Recruiting
        • Clinical Trial Site
    • Tennessee
      • Smyrna, Tennessee, United States, 37167
        • Recruiting
        • Clinical Trial Site
    • Texas
      • Austin, Texas, United States, 78613
        • Recruiting
        • Clinical Trial Site
      • Cedar Park, Texas, United States, 78613
        • Recruiting
        • Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Scalp biopsy consistent with LPP
  3. Active and symptomatic LPP at screening and baseline-
  4. Weight > 40 kg to < 130 kg with BMI ≤ 45 kg/m2

Exclusion Criteria:

  1. History of: Lymphoproliferative disorder; Active malignancy; History of cancer within 5 years prior to baseline (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid cancer).
  2. High risk of thrombosis or cardiovascular disease
  3. High risk of herpes zoster
  4. Active or recent infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Oral
Experimental: Brepocitinib Dose Level 1
Drug: Oral Brepocitinib
Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants achieving IGA score 0/1 and ≥ 2-step reduction from baseline at Week 24
Time Frame: Week 24
Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in LPP symptom numerical rating scale scores at Week 24
Time Frame: Week 24
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Priovant Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

July 31, 2029

Study Registration Dates

First Submitted

April 3, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PVT-2201-304

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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