Roivant’s Brepocitinib Yields 100% Response, 22.3-Point CSAMI-A Gain
Roivant’s brepocitinib achieved 100% response in the 45 mg arm of the 31-patient BEACON Phase 2 cutaneous sarcoidosis trial, delivering a 22.3-point mean CSAMI-A improvement versus 0.7 for placebo over 16 weeks. Pulmovant completed enrollment in its Phase 2 PHocus PH-ILD trial, with topline data due H2 2026.
1. BEACON Phase 2 Trial Design
The BEACON study randomized 31 cutaneous sarcoidosis patients into brepocitinib 45 mg, 15 mg, or placebo arms over a 16-week treatment period, enrolling a highly treatment-refractory cohort with longstanding, plaque-predominant lesions in the high-dose group.
2. Efficacy Endpoints and Outcomes
Patients receiving 45 mg achieved 100% response across multiple endpoints, including a 22.3-point mean improvement on the CSAMI-A score versus a 0.7-point gain on placebo, and 69% of high-dose patients met the two-point IGA improvement threshold to Clear/Almost Clear.
3. Safety and Tolerability
Brepocitinib was well tolerated with no serious adverse events during the trial; all reported events were mild or moderate, and patient-reported PGI-C outcomes showed 100% of the 45 mg cohort perceived improvement versus 29% for placebo.
4. Next Steps and Pipeline Progress
Roivant’s Priovant plans to initiate a pivotal Phase 3 CS program in 2026 following FDA engagement, while its Pulmovant unit has completed enrollment in the PHocus Phase 2 PH-ILD trial, targeting topline results in the second half of 2026.