342 Participants NeededMy employer runs this trial

Brepocitinib for Hair Loss

(ALPINE Trial)

Recruiting at 55 trial locations
CT
Overseen ByClinical Trial Administrator
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Priovant Therapeutics, Inc.
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of an oral medication, brepocitinib, for treating hair loss caused by lichen planopilaris (LPP), a condition where the immune system attacks hair follicles. Participants will receive either brepocitinib or a placebo (a harmless pill with no active medicine) to evaluate its effectiveness. Individuals diagnosed with active LPP through a scalp biopsy and experiencing symptoms may be suitable for this study. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Previous studies found brepocitinib to be well tolerated by patients. Research has shown it to be safe for individuals with various types of hair loss, including alopecia. Participants in these studies did not experience any serious side effects. The treatment also led to noticeable hair regrowth and reduced inflammation. This suggests that brepocitinib could be a safe choice for those considering participation in a clinical trial for hair loss treatments.12345

Why do researchers think this study treatment might be promising for hair loss?

Unlike the standard treatments for hair loss, which often include topical solutions like minoxidil or oral medications such as finasteride, Brepocitinib offers a novel approach. Brepocitinib works by targeting specific enzymes involved in the body's immune response, potentially reducing inflammation and promoting hair regrowth. Researchers are excited because this new mechanism of action may provide an alternative for those who haven't seen results with conventional therapies. Additionally, by acting on different biological pathways, Brepocitinib could offer a more personalized treatment option, addressing hair loss at its root cause for certain individuals.

What evidence suggests that brepocitinib might be an effective treatment for lichen planopilaris?

This trial will evaluate brepocitinib's effectiveness for hair loss. Studies have shown that brepocitinib effectively treats various conditions by blocking certain proteins called TYK2 and JAK1. This action reduces inflammation, which is crucial in conditions like dermatomyositis and cutaneous sarcoidosis. In one study, patients with cutaneous sarcoidosis experienced significant improvement after taking brepocitinib. Although lichen planopilaris is a different condition, it also involves inflammation, so brepocitinib might help reduce symptoms by targeting the same pathways. The drug's mechanism and past successes in similar inflammatory conditions offer hope for its effectiveness in treating lichen planopilaris.678910

Are You a Good Fit for This Trial?

This trial is for adults 18 and older who have active lichen planopilaris (a type of hair loss) confirmed by a scalp biopsy. Participants must weigh between 40 and 130 kg, with a BMI of 45 or less.

Inclusion Criteria

I am 18 years old or older.
2. Scalp biopsy consistent with LPP
I currently have active and noticeable symptoms of LPP.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral brepocitinib or placebo to evaluate safety and efficacy

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Brepocitinib

Trial Overview

The study is testing an oral medication called brepocitinib against a placebo to see if it helps treat lichen planopilaris. Participants are randomly assigned to receive either the drug or the placebo.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Brepocitinib Dose Level 1Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Priovant Therapeutics, Inc.

Lead Sponsor

Trials
4
Recruited
570+

Citations

A Phase 3 Trial of Brepocitinib in Dermatomyositis

Brepocitinib is a first-in-class, oral, selective TYK2–JAK1 inhibitor that blocks cytokine signaling, which has been implicated in ...

Priovant Therapeutics Pipeline Page

ABOUT BREPOCITINIB. Priovant's lead investigational medicine is brepocitinib, a dual TYK2/JAK1 inhibitor administered as a once-daily oral therapy.

FDA to Review Brepocitinib for Treatment of Dermatomyositis

The FDA accepted a New Drug Application with Priority Review for brepocitinib, an oral TYK2/JAK1 inhibitor, for the treatment of ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39008325/

Brepocitinib, a potent and selective TYK2/JAK1 inhibitor

Brepocitinib is an oral, once-daily, novel, and specific TYK2/JAK1 inhibitor. Brepocitinib's potent inhibition of TYK2 and JAK1 reduces the signalling of pro- ...

NCT05437263 | A Study to Investigate the Efficacy and ...

The primary objective of this study is to assess the efficacy of two dose levels of brepocitinib in comparison to placebo, as measured by differences in the ...

Safety and Efficacy of Ritlecitinib and Brepocitinib in Alopecia ...

The data suggest that some patients with alopecia areata and inadequate response to ritlecitinib after ≥24 weeks show benefit after switching to brepocitinib.

A phase 2a randomized, placebo-controlled study to ...

Treatment with ritlecitinib and brepocitinib for 24 weeks was well tolerated and resulted in clinically significant hair regrowth in patients ...

LB1245 Brepocitinib improves inflammation and fibrosis in ...

Brepocitinib was well tolerated and consistent with safety reported in other clinical studies. Taken together, brepocitinib significantly reduced markers of ...

A phase 2a trial of brepocitinib for cicatricial alopecia

1). Brepocitinib was well tolerated and improved clinical severity scores. Limitations: Single-dose regimen, small placebo group. Conclusion: Brepocitinib ...

A phase 2a randomized, placebo-controlled study to ...

Treatment with ritlecitinib and brepocitinib for 24 weeks was well tolerated and resulted in clinically significant hair regrowth in patients who had alopecia ...