Roivant Announces Topline Results from Proof-of-Concept Study of IMVT-1402 in Cutaneous Lupus Erythematosus
IMVT-1402 misses the primary endpoint in CLE, prompting program discontinuation there while development in other autoimmune diseases continues.
Rhea-AI Summary
Roivant (ROIV)/b) reported topline results from Period 1 of Immunovant’s proof-of-concept trial of IMVT-1402 (imeroprubart) in cutaneous lupus erythematosus (CLE).The study did not achieve statistical significance on its primary endpoint of percent change from baseline in CLASI-A score at Week 12, and Immunovant plans to stop development of IMVT-1402 in CLE. Numerical trends favored IMVT-1402 over placebo across multiple endpoints, with deeper IgG reductions associated with better clinical responses. IMVT-1402 showed a favorable safety and tolerability profile consistent with prior studies, and all other IMVT-1402 clinical development timelines in autoimmune indications remain on track.
Positive
- Favorable safety profile for IMVT-1402 consistent with prior studies
- Numerical efficacy trends favored IMVT-1402 over placebo on multiple endpoints
- All other IMVT-1402 clinical development timelines remain on track
- Ongoing development of IMVT-1402 in multiple autoimmune diseases with significant unmet need
Negative
- CLE proof-of-concept trial did not achieve statistical significance on the primary CLASI-A endpoint at Week 12
- Immunovant plans to stop development of IMVT-1402 in cutaneous lupus erythematosus
Key Figures
- Primary endpoint assessment
- Week 12
- CLASI-A percent change from baseline
Key Terms
primary endpoint medical
statistical significance medical
igg medical
fcrn inhibition medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Immunovant’s proof-of-concept study of IMVT-1402 (imeroprubart) in cutaneous lupus erythematosus (CLE) did not achieve statistical significance on the primary endpoint of Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) percent change from baseline at Week 12
- Positive trends were observed on multiple endpoints, with deeper IgG reductions resulting in improved clinical outcomes, but the study did not meet Immunovant’s internal bar to continue development of IMVT-1402 in CLE
- IMVT-1402 demonstrated a favorable safety and tolerability profile, consistent with prior studies
- All other clinical development timelines remain on track
BASEL, Switzerland and LONDON and NEW YORK, Sept. 23, 2026 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today announced topline results from Period 1 of Immunovant’s proof-of-concept trial evaluating IMVT-1402 (imeroprubart) for the treatment of cutaneous lupus erythematosus (CLE).
The study did not achieve statistical significance on its primary endpoint of percent change from baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score at Week 12. Numerical trends favoring IMVT-1402 over placebo were observed across multiple endpoints, and patients who achieved deeper IgG reductions from baseline were more likely to achieve improved clinical responses. However, due to the competitive landscape and the clinical results observed, Immunovant plans to stop development in CLE.
“On behalf of everyone at Immunovant, I want to thank the patients living with CLE who volunteered for this study and the investigators and clinical site teams who conducted it with such care. Their contributions advance our understanding of FcRn inhibition in autoimmune disease and will inform our work going forward,” said Eric Venker, M.D., Pharm.D., Chief Executive Officer of Immunovant.
Immunovant remains focused on rapidly advancing the clinical development of IMVT-1402 across multiple autoimmune diseases with significant unmet need, including Graves’ disease, difficult-to-treat rheumatoid arthritis, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and Sjogren’s disease.
About the Proof-of-Concept Study of IMVT-1402 in CLE
The proof-of-concept clinical study (NCT06980805) of IMVT-1402 (imeroprubart) in CLE is a randomized, double-blind, placebo-controlled, global trial that assessed the safety and efficacy of IMVT-1402 in adult patients with CLE. The study enrolled 57 patients. In Period 1, patients were randomized to IMVT-1402 vs. placebo for a 12-week treatment period. The primary endpoint was the percent change from Period 1 baseline in CLASI-A score at Week 12.
About Immunovant
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases and is a majority-owned subsidiary of Roivant (Nasdaq: ROIV). As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. For additional information on the Company, please visit immunovant.com.
About Roivant
Roivant (Nasdaq: ROIV) is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes LISRAYA™ (brepocitinib), a potent small molecule inhibitor of JAK1 and TYK2 FDA-approved for the treatment of dermatomyositis in adult patients and also in late-stage development for the treatment of non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris; IMVT-1402, a fully human monoclonal antibody targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. For more information, visit www.roivant.com.
Forward-Looking Statements
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Contacts:
Investors
Keyur Parekh
keyur.parekh@roivant.com
Media
Stephanie Lee
stephanie.lee@roivant.com
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
Why is Immunovant stopping development of IMVT-1402 in cutaneous lupus erythematosus?
Immunovant plans to stop development of IMVT-1402 in CLE due to the combination of the clinical results observed, including not achieving statistical significance on the primary endpoint, and the competitive landscape in this indication.
Which other diseases will IMVT-1402 continue to be developed for?
Immunovant remains focused on advancing IMVT-1402 in several autoimmune diseases with unmet need, including Graves’ disease, difficult-to-treat rheumatoid arthritis, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and Sjogren’s disease.
Did the CLE study raise new safety concerns for IMVT-1402?
No new safety concerns were highlighted; IMVT-1402 demonstrated a favorable safety and tolerability profile in CLE, which was consistent with prior studies.
Are other IMVT-1402 clinical development timelines affected by the CLE results?
The company stated that all other clinical development timelines for IMVT-1402 remain on track despite the decision to stop development in CLE.