A new Phase 3 clinical trial is underway to evaluate the efficacy and safety of IMVT-1402, a neonatal Fc receptor (FcRn) inhibitor, in patients with mild to severe generalized myasthenia gravis (MG). Details on the program were recently published on clinicaltrials.org.
“This is a 26-week study to assess the efficacy, safety and tolerability of IMVT-1402 in adult participants with mild to severe generalized myasthenia gravis,” the authors wrote.
MG is caused by autoantibodies targeting proteins in the neuromuscular junction, such as acetylcholine receptor (AChR), muscle-specific kinase (MuSK) or lipoprotein receptor-related protein 4 (LRP4). While treatments exist, there remains an unmet need for targeted therapies that offer rapid symptom relief with a favorable safety profile.
Read more about MG therapies
IMVT-1402 is a subcutaneously administered FcRn inhibitor; it is intended to reduce immunoglobulin G (IgG) autoantibodies by blocking their recycling, thereby decreasing autoimmune activity in the body. IMVT-1402 is currently being studied in several autoimmune diseases.
The study is sponsored by Immunovant Sciences GmbH, the maker of IMVT-1402. The randomized, placebo-controlled double-blind study is enrolling 231 adult participants across 25 U.S. sites. The trial officially began on May 27, 2025, with completion expected by December 2027.
This interventional study will randomize eligible participants to receive either the drug or a placebo. The trial comprises two treatment periods. In Period 1 (weeks 1-12), participants will receive either one of two dose levels of IMVT-1402 or a placebo once weekly via subcutaneous injection. In Period 2 (weeks 13-26), all participants will transition to active IMVT-1402 treatment.
The primary endpoint is the change in MG Activities of Daily Living (MG-ADL) score from baseline to week 12 among antibody-positive participants. Key secondary outcomes include improvements in Quantitative Myasthenia Gravis (QMG) scores, the proportion of patients achieving MG-ADL scores of 0 or 1 and those with ≥50% improvement in MG-ADL scores.
To participate in the trial, patients must not have had a recent myasthenic crisis, a recent thymectomy, a planned thymectomy during the trial or the presence of malignant thymoma. The study does not accept healthy volunteers.
Sign up here to get the latest news, perspectives, and information about MG sent directly to your inbox. Registration is free and only takes a minute.
