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A Phase 3 Study to Evaluate Claseprubart in Adults With Generalized Myasthenia Gravis (EMERGE)
Sponsor: Dianthus Therapeutics
Summary
The purpose of this Phase 3 study is to demonstrate the efficacy, safety, and tolerability of claseprubart in participants with generalized myasthenia gravis (gMG).
Official title: A Phase 3 Global, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Demonstrate the Efficacy, Safety, and Tolerability of Claseprubart (DNTH103) in Patients With Generalized Myasthenia Gravis (EMERGE)
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
195
Start Date
2026-06-29
Completion Date
2031-09
Last Updated
2026-10-30
Healthy Volunteers
No
Conditions
Interventions
Claseprubart
IV loading dose on Day 1
Placebo
IV infusion on Day 1
Claseprubart
Prefilled syringe containing claseprubart for SC administration
Placebo
Prefilled syringe containing placebo for SC administration
Locations (12)
Clinical Study Site
Pasadena, California, United States
Cinical Study Site
Boca Raton, Florida, United States
Cinical Study Site
Fayetteville, North Carolina, United States
Cinical Study Site
Houston, Texas, United States
Cinical Study Site
Kutaisi, Georgia
Clinical Study Site #2
Tbilisi, Georgia
Clinical Study Site #3
Tbilisi, Georgia
Clinical Study Site #4
Tbilisi, Georgia
Clinical Study Site #5
Tbilisi, Georgia
Clinical Study Site
Tbilisi, Georgia
Cinical Study Site
Dnipro, Ukraine
Cinical Study Site
Vinnytsia, Ukraine