Dianthus Therapeutics Launches 195-Patient Phase 3 EMERGE Trial Dosing Q2W/Q4W
DNTH•EMERGE will enroll approximately 195 AChR+ generalized Myasthenia Gravis patients in a global, randomized, placebo-controlled Phase 3 trial evaluating subcutaneous 300mg claseprubart administered every two or four weeks, with top-line results due 2H 2028. Primary endpoint is change in MG-ADL score, with secondary measures including QMG, MGC, MSE and MG-QoL-15r.
1. Trial Initiation
Dianthus Therapeutics has initiated the global Phase 3 EMERGE trial in approximately 195 acetylcholine receptor antibody–positive generalized Myasthenia Gravis patients, comparing subcutaneous 300mg claseprubart administered every two weeks or every four weeks against placebo.
2. Study Design and Endpoints
EMERGE is a randomized, multicenter, placebo-controlled study with a primary endpoint of change from baseline in MG-ADL score; secondary endpoints include Quantitative Myasthenia Gravis (QMG), Minimal Symptom Expression (MSE), Myasthenia Gravis Composite (MGC) and MG-QoL-15r, with top-line data expected in the second half of 2028.
3. Phase 2 Efficacy and Safety
The prior MaGic Phase 2 trial demonstrated that 300mg Q2W claseprubart achieved rapid and sustained, statistically significant improvements in MG-ADL and QMG scores at Week 1 and Week 13, along with significant benefits on MSE, MGC and MG-QoL-15r, and no drug-related serious adverse events or discontinuations.
4. Upcoming Milestones
Dianthus plans to report Phase 2 MoMeNtum top-line data in Multifocal Motor Neuropathy by Q4 2026, provide an update on Part B of its Phase 3 CIDP trial by year-end 2026, and position claseprubart as a best-in-disease candidate across neuromuscular autoimmune disorders.
