Roivant披露IMVT-1402治疗皮肤型红斑狼疮概念验证研究未达主要终点
Roivant Announces Topline Results from Proof-of-Concept Study of IMVT-1402 in Cutaneous Lupus Erythematosus
Immunovant的IMVT-1402（imeroprubart）治疗皮肤型红斑狼疮（CLE）的概念验证研究未在12周CLASI-A评分较基线变化百分比的主要终点上达到统计学显著。57例患者中观察到多项终点数值趋势，IgG降幅更深者临床应答更佳，但公司因竞争格局与结果计划停止CLE开发，安全性与此前研究一致。
关注FcRn抑制剂在CLE的失败信号，以及IgG降幅与疗效关联对其他自身免疫适应症的参考价值。
- 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.
补充资料（5 节）药物、疾病与研究背景 · 法律与声明 · 投资者与媒体联系
药物、疾病与研究背景
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.
法律与声明
Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act.
Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product and product candidates, the availability and success of topline results from our ongoing clinical trials, any commercial potential of our product and product candidates following applicable regulatory approvals and the outcome of any pending litigation. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors.
Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
投资者与媒体联系
来源：Roivant Sciences｜罗万特科学 · investor.roivant.com