Immunovant's FcRn Antibody IMVT-1402 Misses Primary Endpoint in Cutaneous Lupus

Immunovant's anti-FcRn monoclonal antibody IMVT-1402 (imeroprubart) did not achieve statistical significance on its primary endpoint in a proof-of-concept study in cutaneous lupus erythematosus (CLE), parent company Roivant announced on September 23, 2026.¹ The primary endpoint was the percent change from baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score at Week 12.¹

Roivant reported numerical trends favoring IMVT-1402 over placebo across multiple endpoints, and said patients who achieved deeper immunoglobulin G (IgG) reductions from baseline were more likely to achieve improved clinical responses.¹ However, the company said the results did not meet Immunovant's internal bar to continue development, and that, due to the competitive environment and the clinical results observed, Immunovant plans to stop development in CLE.¹ IMVT-1402 demonstrated a favorable safety and tolerability profile consistent with prior studies, according to the company.¹ The release did not report CLASI-A values, effect sizes, or p-values.

How was the study designed?

The randomized, double-blind, placebo-controlled global trial (NCT06980805) enrolled 57 adult patients with CLE.¹ In Period 1, patients were randomized to IMVT-1402 or placebo for a 12-week treatment period.¹ The topline results reported are from Period 1.¹ The release did not specify the IMVT-1402 dose tested or describe what followed Period 1 for enrolled patients.

How does IMVT-1402 work?

IMVT-1402 is a fully human monoclonal antibody targeting the neonatal Fc receptor (FcRn) that Roivant is developing across several IgG-mediated autoimmune indications through Immunovant, its majority-owned subsidiary.¹ FcRn normally binds IgG inside cells and recycles it back into circulation, extending IgG half-life, and this salvage pathway also contributes to the persistence of disease-causing autoantibodies.² FcRn antagonists such as argenx's efgartigimod (Vyvgart) reduce pathogenic IgG autoantibodies and are used as a targeted therapeutic approach in generalized myasthenia gravis and other antibody-mediated autoimmune diseases.²

Immunovant introduced IMVT-1402 in 2022 as a next-generation anti-FcRn antibody following its earlier FcRn antibody batoclimab.³ The company reported that animal studies showed deep IgG lowering similar to batoclimab with no or minimal impact on albumin and low-density lipoprotein (LDL).³ Pete Salzmann, MD, then chief executive officer of Immunovant, said in the 2022 announcement, "As with batoclimab, IMVT-1402 may offer deep, potentially best-in-class IgG reduction formulated for the same simple subcutaneous route of administration delivered in a matter of seconds."³

Why was CLE a test case for FcRn blockade?

CLE is an autoimmune skin disease driven by genetic predisposition, environmental triggers, and immune dysregulation.⁴ Environmental factors such as ultraviolet radiation, smoking, and certain drugs can initiate disease by inducing keratinocyte apoptosis, and the nucleic acids released activate pattern recognition receptors, leading to production of type I and type III interferons.⁴ B cells and plasma cells produce autoantibodies that form immune complexes and perpetuate inflammation.⁴ Neutrophils also contribute by releasing neutrophil extracellular traps that expose autoantigens and further stimulate interferon pathways.⁴ Roivant has not released the data behind its observation that deeper IgG reductions were associated with improved clinical responses, so the size of that association is not yet known.¹

"Their contributions advance our understanding of FcRn inhibition in autoimmune disease and will inform our work going forward," said Eric Venker, MD, PharmD, chief executive officer of Immunovant, referring to the patients and investigators who took part in the study.¹

What happens next for IMVT-1402?

Roivant said all other clinical development timelines remain on track.¹ Immunovant is continuing to develop IMVT-1402 in Graves' disease, difficult-to-treat rheumatoid arthritis, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and Sjögren's disease.¹ Immunovant has previously said it expects topline data from its potentially registrational studies of IMVT-1402 in Graves' disease in calendar year 2027.⁵

The company has not said whether it will present or publish the full CLE results.

References

1. Roivant Sciences. Roivant Announces Topline Results from Proof-of-Concept Study of IMVT-1402 in Cutaneous Lupus Erythematosus. Press release. Published September 23, 2026. Accessed September 24, 2026.
2. Mansour GK, Alangari L, Khosyfan L, Alhammad R, Hajjar AW. Efgartigimod for generalized myasthenia gravis and beyond: a narrative review of its pharmacological profile, clinical utility, and expanding applications. Biomedicines. 2025;13(12):2975.
3. Immunovant. Immunovant Announces IMVT-1402, a Next Generation Anti-FcRn. Press release. Published September 28, 2022. Accessed September 24, 2026.
4. Verdelli A, Barletta E, Mariotti EB, et al. An overview of the pathogenesis of cutaneous lupus erythematosus. J Clin Med. 2025;14(23):8285.
5. Immunovant. Immunovant Announces Phase 3 Study Results for Batoclimab in Thyroid Eye Disease (TED). Press release. Published April 2, 2026. Accessed September 24, 2026.