Immunovant drops cutaneous lupus program after IMVT-1402 trial miss
The 57-patient study missed its Week 12 skin disease endpoint, leaving five other autoimmune indications on Immunovant's development calendar.
Adrian Kessler· Sep 23, 2026
Development in cutaneous lupus will stop after Immunovant, Inc. NASDAQIMVT reported Wednesday that its 57-patient Phase 2b trial of IMVT-1402, or imeroprubart, missed its Week 12 primary endpoint. The decision leaves five other indications on schedule, including Graves' disease and myasthenia gravis trials with topline results expected in 2027.
The Sept. 23 company release said the randomized, placebo-controlled study failed to show a statistically significant difference in the CLASI-A score, a measure of active skin disease. Immunovant described numerical trends favouring treatment.
Immunovant is a Durham, North Carolina, clinical-stage immunology company with 315 full-time employees at March 31, 2026, majority-owned by Roivant Sciences Ltd. NASDAQROIV.
Immunovant shares fell 6.14 per cent to US$35.00 in Nasdaq premarket trading at 8:55 a.m. EDT on Wednesday. The shares closed at US$37.29 at 4 p.m. EDT on Sept. 22, before the readout.
The Release Omitted Arm-Level Results
The company's annual report identifies the study, NCT06980805, as Phase 2b. In its first period, patients were assigned to weekly injections of IMVT-1402 or placebo for 12 weeks. The main measure was percentage change from baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity score, known as CLASI-A, at Week 12.
The Sept. 23 release gave no treatment-arm change, p value or confidence interval. It also omitted the number of participants in each arm. Immunovant said patients with deeper reductions in immunoglobulin G, or IgG, were likelier to show clinical improvement.
The company described safety and tolerability as favourable and consistent with earlier IMVT-1402 studies. It did not provide adverse-event rates or serious-event counts for this trial. The release also did not report an FDA assessment of the study design.
“However, due to the competitive landscape and the clinical results observed, Immunovant plans to stop development in CLE,” the company said in its Sept. 23 release.
An earlier Mugglehead report on IGM Biosciences covered its decision to end development after studies in rheumatoid arthritis and systemic lupus erythematosus. Immunovant studied cutaneous lupus, a separate skin disease, using a different drug.
Read more: IGM Biosciences slides by 66% on discontinued drug development and lay offs
Five Autoimmune Programs Continue
Immunovant's Sept. 23 release lists Graves' disease, difficult-to-treat rheumatoid arthritis, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy and Sjögren's disease as continuing programs. It announced no changes to their trial calendars.
An Aug. 6 financial release put Immunovant's June 30 cash and equivalents at US$797.8 million. Management said that balance, under its then-current operating plan, should last until a potential launch in Graves' disease, without giving a fixed cash-runway date. The same release projected 2027 topline data from potentially registrational Graves' disease and myasthenia gravis studies.
In cutaneous lupus, Biogen Inc. NASDAQBIIB reported on March 28, 2026 that its litifilimab Phase 2 study met its Week 16 skin disease endpoint. On one erythema measure, 14.7 per cent of treated patients were rated clear or almost clear, compared with 2.9 per cent on placebo. Biogen's Week 16 measure and Immunovant's Week 12 CLASI-A measure assess different endpoints.
Alumis Inc. NASDAQALMS reported on Sept. 1 that its Phase 2b systemic lupus trial missed the primary and secondary endpoints in the overall population. Alumis cited responses in a prespecified subgroup and has described cutaneous lupus as a potential indication, though its reported study involved systemic lupus patients.
The iShares Biotechnology ETF NASDAQIBB closed at US$210.81 at 4 p.m. EDT on Sept. 22, before Immunovant announced its result.
Immunovant expects an update on its difficult-to-treat rheumatoid arthritis program in the second half of 2026. The placebo-controlled phase described in the annual report will test whether patients who responded during open-label treatment maintain an ACR20 joint response at Week 28.
