Lichen PlanopilarisPhase 2/3ALPINENCT07532603
A Phase 2/3 Study of Brepocitinib in Adults With Lichen Planopilaris
A Phase 2/3 study testing Oral Brepocitinib in people with Lichen Planopilaris, run by Priovant Therapeutics, Inc. at 61 sites in 4 countries.
Trial summary
This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with lichen planopilaris Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lichen Planopilaris
- What is being tested?
- Oral Brepocitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 342 participants
- Where
- 61 sitesin 4 countries
- Study dates
- 19 Mar 2026to 31 Jul 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Scalp biopsy consistent with LPP
- Active and symptomatic LPP at screening and baseline-
- Weight > 40 kg to < 130 kg with BMI ≤ 45 kg/m2
Who cannot join
- 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).
- High risk of thrombosis or cardiovascular disease
- High risk of herpes zoster
- Active or recent infection
Trial locations and contacts
61 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
61 sites in 4 countries
United States47 sites, 47 recruiting
- Recruiting
Clinical Trial Site
Ann Arbor, Michigan, 48103
- Recruiting
Clinical Trial Site
Ann Arbor, Michigan, 48109
- Recruiting
Clinical Trial Site
Austin, Texas, 78613
- Recruiting
Clinical Trial Site
Austin, Texas, 78660
- Recruiting
Clinical Trial Site
Birmingham, Alabama, 35244
- Recruiting
Clinical Trial Site
Boston, Massachusetts, 02115
- Recruiting
Clinical Trial Site
Burlington, Massachusetts, 01805
- Recruiting
Clinical Trial Site
Cedar Park, Texas, 78613
- Recruiting
Clinical Trial Site
Charleston, South Carolina, 29425
- Recruiting
Clinical Trial Site
Chicago, Illinois, 60611
- Recruiting
Clinical Trial Site
Clarksville, Indiana, 47129
- Recruiting
Clinical Trial Site
Cleveland, Ohio, 44195
- Recruiting
Clinical Trial Site
Columbus, Ohio, 43213
- Recruiting
Clinical Trial Site
Denver, Colorado, 80237
- Recruiting
Clinical Trial Site
Durham, North Carolina, 27713
- Recruiting
Clinical Trial Site
Farmington, Connecticut, 06032
- Recruiting
Clinical Trial Site
Indianapolis, Indiana, 46250
- Recruiting
Clinical Trial Site
Irvine, California, 92617
- Recruiting
Clinical Trial Site
Kansas City, Missouri, 66103
- Recruiting
Clinical Trial Site
Leawood, Kansas, 66211
- Recruiting
Clinical Trial Site
Lebanon, New Hampshire, 03766
- Recruiting
Clinical Trial Site
Lee's Summit, Missouri, 64064
- Recruiting
Clinical Trial Site
Louisville, Kentucky, 40241
- Recruiting
Clinical Trial Site
Medina, Minnesota, 55340
- Recruiting
Clinical Trial Site
Medina, Ohio, 44256
- Recruiting
Clinical Trial Site
Miami, Florida, 33136
- Recruiting
Clinical Trial Site
Mill Creek, Washington, 98012
- Recruiting
Clinical Trial Site
Minneapolis, Minnesota, 55455
- Recruiting
Clinical Trial Site
Murfreesboro, Tennessee, 37128
- Recruiting
Clinical Trial Site
Murray, Utah, 84107
- Recruiting
Clinical Trial Site
New Haven, Connecticut, 06519
- Recruiting
Clinical Trial Site
New Hyde Park, New York, 11042
- Recruiting
Clinical Trial Site
New York, New York, 10451
- Recruiting
Clinical Trial Site
Norfolk, Virginia, 23502
- Recruiting
Clinical Trial Site
Oakland, California, 94611
- Recruiting
Clinical Trial Site
Philadelphia, Pennsylvania, 19104
- Recruiting
Clinical Trial Site
Phoenix, Arizona, 85006
- Recruiting
Clinical Trial Site
Portland, Oregon, 97210
- Recruiting
Clinical Trial Site
Prosper, Texas, 75078
- Recruiting
Clinical Trial Site
Richmond, Virginia, 23235
- Recruiting
Clinical Trial Site
Roanoke, Virginia, 24016
- Recruiting
Clinical Trial Site
Sacramento, California, 95823
- Recruiting
Clinical Trial Site
San Francisco, California, 94115
- Recruiting
Clinical Trial Site
Scottsdale, Arizona, 85259
- Recruiting
Clinical Trial Site
Skokie, Illinois, 60077
- Recruiting
Clinical Trial Site
Smyrna, Tennessee, 37167
- Recruiting
Clinical Trial Site
Tyler, Texas, 75703
United Kingdom6 sites, 6 recruiting
- Recruiting
Clinical Trial Site
Brighton, BN21ES
- Recruiting
Clinical Trial Site
Glasgow, Scotland, G312ER
- Recruiting
Clinical Trial Site
London, SE19RT
- Recruiting
Clinical Trial Site
London, SW109NH
- Recruiting
Clinical Trial Site
Salford, Manchester, M68HD
- Recruiting
Clinical Trial Site
Wrexham, LL7YP
Canada5 sites, 5 recruiting
- Recruiting
Clinical Trial Site
Edmonton, Alberta, T6G1C3
- Recruiting
Clinical Trial Site
Guelph, Ontario, N1L0B7
- Recruiting
Clinical Trial Site
London, Ontario, M5M3Z8
- Recruiting
Clinical Trial Site
Toronto, Ontario, L4B1A5
- Recruiting
Clinical Trial Site
Toronto, Ontario, N6H5L4
Australia3 sites, 3 recruiting
- Recruiting
Clinical Trial Site
Adelaide, 5074
- Recruiting
Clinical Trial Site
Perth, 6018
- Recruiting
Clinical Trial Site
Sydney, 2217
About this study
Official title: 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
- Conditions
- Lichen Planopilaris
- Being tested
- Oral Brepocitinib, Placebo
- Keywords
- brepocitinib, lichen planopilaris
- Medical subject headings
- Lichen Planus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral BrepocitinibDrug
Oral
PlaceboDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| Brepocitinib Dose Level 1 | Experimental | Not described Receives: Drug: Oral Brepocitinib |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving IGA score 0/1 and ≥ 2-step reduction from baseline at Week 24
Measured: Week 24
Secondary outcomes (1)
Change from baseline in LPP symptom numerical rating scale scores at Week 24
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start19 Mar 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lichen PlanopilarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 342 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Priovant Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532603
- Sponsor's protocol ID
- PVT-2201-304
- Acronym
- ALPINE
- Status last verified
- Jul 2026
- First submitted
- 3 Apr 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults With Lichen Planopilaris
- ClinicalTrials.gov ID
- NCT07532603
- Acronym / sponsor ID
- ALPINE / PVT-2201-304
- Conditions
- Lichen Planopilaris
- Keywords
- brepocitinib, lichen planopilaris
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 342 participants (estimated)
- Lead sponsor
- Priovant Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with lichen planopilaris
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brepocitinib Dose Level 1 | Experimental | Drug: Oral Brepocitinib |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Scalp biopsy consistent with LPP
- Active and symptomatic LPP at screening and baseline-
- Weight > 40 kg to < 130 kg with BMI ≤ 45 kg/m2
Key exclusion criteria (4 listed)
- 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).
- High risk of thrombosis or cardiovascular disease
- High risk of herpes zoster
- Active or recent infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral BrepocitinibOral | Drug | Brepocitinib Dose Level 1 |
| PlaceboOral | Drug | Placebo |
Primary outcome
Proportion of participants achieving IGA score 0/1 and ≥ 2-step reduction from baseline at Week 24
Time frame: Week 24
1 secondary outcome
Change from baseline in LPP symptom numerical rating scale scores at Week 24
Time frame: Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Upadacitinib in Adult Patients With Erosive Mucosal Lichen Planus and Lichen Planopilaris: a Prospective Multicenter Randomized Placebo-controlled Study.
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Safety and Biomarker Responses of Delgocitinib (JAK1,2,3/TYK2 Inhibitor) in Central Centrifugal Cicatricial Alopecia and Lichen Planopilaris
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Nemolizumab to Treat Lichen Planopilaris, a Noncontrolled, Prospective, Pilot Study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
61 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Oral Brepocitinib in people with Lichen Planopilaris, run by Priovant Therapeutics, Inc. at 61 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States, United Kingdom, Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Administrator ((212) 634-9743, clinicaltrials@priovant.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving IGA score 0/1 and ≥ 2-step reduction from baseline at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.