300 mg Dose of IMVT-1402 Does Not Outperform Placebo in Arthritis
Key Facts
Immunovant said a 300 mg dose of IMVT-1402 showed no difference from placebo in the second period of a trial in difficult-to-treat rheumatoid arthritis. ACR20 response was maintained at week 28 by 75.0% of participants who received the dose, and the p-value for the comparison was 0.9426. The trial’s primary endpoint was the proportion of participants maintaining an ACR20 response at week 28. In May 2026, the company reported ACR20, ACR50 and ACR70 responses at week 16 of 72.7%, 54.5% and 35.8%, respectively. Those results were for patients with difficult-to-treat rheumatoid arthritis, while the newer results concern maintenance of response in the trial’s second period.
In exploratory analyses at week 28, ACR50 response with the 600 mg dose was 80.0%, compared with 56.1% for placebo. ACR70 response in the same analysis was 52.5% with the dose, compared with 36.6% for placebo. The company said the trial was not designed to detect differences on either measure, placing these results in an exploratory context. On the secondary CDAI and SDAI measures, the 600 mg dose showed numerical changes in its favor compared with placebo. However, neither comparison reached statistical significance based on the p-values reported by the company.
From the second-period baseline to week 28, the CDAI showed a least-squares mean change of -0.3 with the 600 mg dose, compared with +3.1 with placebo, and the p-value for the comparison was 0.1096. The SDAI showed a change of +0.1 with the dose, compared with +3.5 with placebo, with a p-value of 0.1299. Immunovant said the drug was generally well tolerated during the second period. According to the company, no serious adverse events or treatment-emergent adverse events of grade 3 or higher were reported in either arm. No adverse events leading to treatment discontinuation were reported in any trial arm.
The arthritis results are part of a broader development portfolio for IMVT-1402. Immunovant said it expects topline data in 2027 from potentially registrational trials for Graves’ disease and myasthenia gravis. The company also expects topline data in 2028 from the potentially registrational trial for chronic inflammatory demyelinating polyneuropathy. By contrast, the drug’s proof-of-concept trial in cutaneous lupus erythematosus did not achieve statistical significance on its primary endpoint. The company said the trial results did not meet its criteria for continuing development of the drug for this indication. The decision provides context for the differing paths of the indications under study, without changing the announced timing of expected data in the other diseases.
Immunovant had about $722.3 million in cash and cash equivalents on September 30, 2026. The company said this balance provides funding through the potential commercial launch of IMVT-1402 for Graves’ disease under its current operating plan. The company recorded a net loss of $97.2 million for the three months ended September 30, 2026, compared with a loss of $126.5 million in the same period of 2025. Loss per common share was $0.47 in the latest quarter, compared with $0.73 a year earlier. Roivant’s fiscal 2027 second-quarter results call was listed on the company’s calendar for November 9, 2026, at 8:00 a.m. Eastern time. In the market, IMVT shares closed at $30.53 on November 6, 2026.