Roivant’s FcRn Drug Misses Phase 2b Goal in Cutaneous Lupus

Roivant subsidiary Immunovant said it will discontinue development of its anti-FcRn antibody IMVT-1402 (imeroprubart) in cutaneous lupus erythematosus (CLE) after a Phase 2b/proof-of-concept study missed its primary endpoint.

The 57-patient trial compared IMVT-1402 with placebo over 12 weeks. It did not show a statistically significant improvement in the CLE Disease Area and Severity Index Activity score at Week 12.

Immunovant cited some numerical efficacy trends and an apparent association between deeper IgG reductions and response, but said the overall clinical result and competitive landscape did not support advancing the drug in CLE.

The setback is indication-specific:
IMVT-1402 remains in development across other IgG-mediated autoimmune diseases, including Graves’ disease, myasthenia gravis, CIDP, difficult-to-treat rheumatoid arthritis and Sjögren’s disease.

The headline refers to cutaneous lupus—a skin-predominant form of lupus—not a successful or failed registrational study in systemic lupus erythematosus.