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RECRUITING
NCT07647510
PHASE3

A Phase 3 Study to Evaluate Claseprubart in Adults With Generalized Myasthenia Gravis (EMERGE)

Sponsor: Dianthus Therapeutics

View on ClinicalTrials.gov

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

2026-09-01

Healthy Volunteers

No

Interventions

DRUG

Claseprubart

IV loading dose on Day 1

DRUG

Placebo

IV infusion on Day 1

COMBINATION_PRODUCT

Claseprubart

Prefilled syringe containing claseprubart for SC administration

COMBINATION_PRODUCT

Placebo

Prefilled syringe containing placebo for SC administration

Locations (3)

Cinical Study Site

Boca Raton, Florida, United States

Cinical Study Site

Fayetteville, North Carolina, United States

Cinical Study Site

Houston, Texas, United States