Roivant Starts Brepocitinib Phase 2b/3 Trial in LPP; Batoclimab Phase 3 TED Trial Fails

ROIVROIV

Roivant launched a Phase 2b/3 trial of brepocitinib in lichen planopilaris, enrolling first subjects in March 2026 for a condition impacting 100,000 adults as its fourth indication. Immunovant’s Phase 3 batoclimab trials in thyroid eye disease failed to meet the ≥2 mm proptosis responder rate at Week 24, though safety remained consistent.

1. Brepocitinib Phase 2b/3 Trial in Lichen Planopilaris

Roivant initiated a seamless Phase 2b/3 clinical program for brepocitinib in lichen planopilaris, enrolling the first subjects in March 2026. LPP affects approximately 100,000 US adults, causes irreversible scarring hair loss, and has no FDA-approved treatments. This marks brepocitinib’s fourth late-stage indication following dermatomyositis, non-infectious uveitis and cutaneous sarcoidosis, with a PDUFA target date for dermatomyositis in Q3 2026 and other readouts expected in H2 2026.

2. Batoclimab Phase 3 Trial Outcome in Thyroid Eye Disease

Immunovant reported that its two Phase 3 batoclimab studies in active moderate-to-severe thyroid eye disease did not achieve the predefined ≥2 mm proptosis responder rate at Week 24 after 12 weeks of high-dose and 12 weeks of low-dose treatment. Safety profiles were consistent with previous findings and no new signals emerged. Patients showed greater proptosis improvement during the high-dose period, and hyperthyroid subsets matched earlier thyroid hormone normalization rates, as the company pivots to advancing IMVT-1402 in Graves’ disease with topline data expected in 2027.

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