ALPINE

ALPINE looks at whether the new drug brepocitinib is safe and effective for the treatment of lichen planopilaris in adults.

Category
Skin

Age Requirement
Adults (18 years and older)

About This Study

Summary

Lichen planopilaris (LPP) is an uncommon condition where cells of the immune system (T cells) abnormally attack healthy hair follicles. This autoimmune disease can cause tenderness or pain, itching, scarring, and patchy hair loss on the arms, legs, or head. This hair loss is sometimes permanent, and the scalp is the most common site for LPP. This condition typically affects women 40 – 60 years old but can occur in people of either sex and at any age. Current treatment options include steroid-containing creams, injections, and pills, to counteract the inflammation associated with LPP.

In the ALPINE study, researchers are evaluating the safety and effectiveness of a new medication (brepocitinib) in adults with LPP. Participants eligible to join ALPINE are assigned randomly (50:50, like a coin toss) to receive either brepocitinib or pills that look the same but that don’t contain any medication. Neither the lead scientist nor the participants can choose or know which treatment they get. Throughout the study, members of the research team will check in with participants for health assessments and follow-up activities. Participants can expect to be involved in ALPINE for 24 weeks.

To be included in ALPINE, participants must be / have

  • Adult (18 years or older)
  • Scalp biopsy consistent with LPP
  • Symptoms of active LPP present at screening and baseline

To be included in ALPINE, participants must not be / have

  • High risk of thrombosis or cardiovascular disease
  • Lymphoproliferative disorders and various cancers
  • Active or recent infection
  • High risk of herpes zoster
Keywords
Autoimmune disease; Hair loss; Lichen planopilaris; LPP

For More About This Study or To Ask About Participation

MacKenzie Eubank, MPH
Clinical Research Coordinator

Additional Information

Lead scientist at Carilion Clinic


undefined image

Zachary Holcomb, MD

Official title of study

A Phase 2/3 Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults with Lichen Planopilaris (ALPINE)

Funding mechanism

Industry sponsored by Priovant Therapeutics

National Clinical Trials listing