Phase 2b/3 Study Begins for LPP With Brepocitinib

Priovant Therapeutics has initiated a phase 2b/3 clinical trial evaluating brepocitinib in patients with lichen planopilaris (LPP), a rare but highly morbid inflammatory disorder of the scalp.¹ LPP, which affects an estimated 100,000 adults in the United States, is characterized by inflammation of the hair follicle’s bulge region—the permanent portion responsible for hair regeneration. This inflammation often leads to irreversible hair loss and permanent scarring. In addition to alopecia, patients frequently report burning, pain, pruritus, and scaling, and the condition has been associated with increased risk of other autoimmune diseases and certain skin cancers.²

Currently, there are no FDA-approved therapies for LPP, leaving clinicians reliant on off-label systemic and topical immunomodulators, which demonstrate variable efficacy and carry potential safety concerns.

“Lichen planopilaris is what my colleagues and I refer to as a ‘trichologic emergency,’” said Kristen Lo Sicco, MD, FAAD, chief of the skin and cancer unit at NYU Langone Health and a board member of the Scarring Alopecia Foundation. “Absent early diagnosis and aggressive intervention, patients experience rapid hair loss that is generally irreversible and often accompanied by erythema, scaling, pain, itching, and burning sensations. Untreated LPP also leads to increased risk of skin cancers and other comorbidities. Efficacious FDA-approved treatments are urgently needed.”

Priovant’s new study employs a seamless phase 2b/3 design, with patient enrollment beginning in March 2026. This development represents the company’s fourth late-stage clinical program for brepocitinib, following ongoing programs in dermatomyositis (DM), non-infectious uveitis (NIU), and cutaneous sarcoidosis (CS). Brepocitinib, a selective dual inhibitor of TYK2 and JAK1, is designed to modulate key cytokine pathways implicated in autoimmune disorders, including type I and II interferons, IL-6, IL-12, and IL-23.

The FDA has granted Priority Review to brepocitinib’s New Drug Application in DM, with a Prescription Drug User Fee Act (PDUFA) target action date set for the third quarter of 2026. Topline data from the phase 3 program in NIU and initiation of the phase 3 program in CS are anticipated in the second half of 2026.

“Expanding brepocitinib into lichen planopilaris continues our strategy of developing therapies in highly morbid orphan conditions with limited treatment options and distinctive mechanistic benefits,” said Ben Zimmer, CEO of Priovant. “As we anticipate a product launch for DM later this year, LPP represents a strategic extension of our multi-indication rheum-derm rare disease portfolio, with overlapping prescriber networks and thought leader engagement.”

Priovant describes brepocitinib as a first-in-class oral therapy with once-daily dosing. In addition to its ongoing trials in LPP, brepocitinib has demonstrated positive phase 3 results in DM, while phase 3 studies in NIU and CS are either ongoing or forthcoming. The compound’s dual inhibition of TYK2 and JAK1 provides targeted suppression of multiple cytokine pathways involved in autoimmune and inflammatory processes, positioning it as a potential therapeutic option across a spectrum of immune-mediated dermatologic and rheumatologic disorders.

LPP remains a challenging condition to manage, with progressive hair loss often resulting in permanent cosmetic and psychosocial consequences. The initiation of a robust clinical program investigating brepocitinib may address a critical unmet need in this patient population. Should the program demonstrate favorable efficacy and safety outcomes, brepocitinib could represent the first FDA-approved pharmacologic therapy specifically for LPP.

Priovant Therapeutics, a subsidiary of Roivant Sciences, is focused on developing therapies for rare and high-morbidity autoimmune diseases with limited treatment options. Brepocitinib is the company’s lead asset and currently under investigation across multiple late-stage clinical programs targeting dermatologic and systemic autoimmune indications.

References

1. Priovant expands brepocitinib development program with new phase 2b/3 trial in lichen planopilaris (LPP). News release. Priovant. Published April 2, 2026. Accessed April 2, 2026. https://www.globenewswire.com/news-release/2026/04/02/3267158/34323/en/Priovant-Expands-Brepocitinib-Development-Program-with-New-Phase-2b-3-Trial-in-Lichen-Planopilaris-LPP.html?_gl=1*11qz3dq*_up*MQ..*_ga*MTgyMjcxNzg2My4xNzc1MTM1MTE0*_ga_B6167QB2TF*czE3NzUxMzUxMTQkbzEkZzAkdDE3NzUxMzUxMTQkajYwJGwwJGgw*_ga_ERWPGTJ5X8*czE3NzUxMzUxMTQkbzEkZzAkdDE3NzUxMzUxMTQkajYwJGwwJGgw
2. Soares VC, Mulinari-Brenner F, Souza TE. Lichen planopilaris epidemiology: a retrospective study of 80 cases. An Bras Dermatol. 2015;90(5):666-670. doi:10.1590/abd1806-4841.20153923