Roivant stops CLE study of IMVT-1402
- Roivant (NASDAQ:ROIV) reported that Immunovant’s IMVT-1402 trial in cutaneous lupus erythematosus did not meet its primary endpoint.
- The company plans to stop development of IMVT-1402 in cutaneous lupus erythematosus after the Phase 1 proof-of-concept study results.
- Roivant said other IMVT-1402 clinical programs in autoimmune diseases remain on track.
Roivant (NASDAQ:ROIV) reported topline results from Immunovant’s proof-of-concept trial of IMVT-1402 in cutaneous lupus erythematosus, with the study failing to meet its primary endpoint.
The trial did not achieve statistical significance for the percent change from baseline in CLASI-A score at Week 12, leading Immunovant to discontinue development of IMVT-1402 in cutaneous lupus erythematosus.
Immunovant said numerical trends favored IMVT-1402 compared with placebo across multiple trial measures, and greater reductions in IgG levels were associated with stronger clinical responses.
IMVT-1402 demonstrated a safety and tolerability profile consistent with previous studies, according to the company, with no changes announced for other autoimmune disease development programs.
Roivant said Immunovant’s remaining IMVT-1402 clinical development timelines in other autoimmune indications remain on track.
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