Health TrialsbyHealthPanel

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

ConditionLichen Planopilaris
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPriovant Therapeutics, Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Oral Brepocitinib

    Drug

    Oral

  • Placebo

    Drug

    Oral

Treatment groups

342 Participants
are divided into 2 treatment groups
Group A: Brepocitinib Dose Level 1Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Week 24

Secondary outcomes

1

Change from baseline in LPP symptom numerical rating scale scores at Week 24

Time frame
Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Priovant Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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