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)
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).
Description
The study includes the following periods: * Screening (up to 12 weeks) * Randomized, blinded, controlled treatment (RCT) period (17 weeks) * Extended treatment period (ETP) (104 weeks) (optional) for eligible participants \[includes blinded extension period (BEP) and open-label extension (OLE) period\] * Safety Follow-Up period (40 weeks)
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Must have given written informed consent before any study-related activities are carried out 2. Weight range between 40-130 kg at Screening 3. Diagnosis of gMG by the following tests: 1. Acetylcholine receptor antibody (AChR Ab) positive, and 2. One of the following: i. History of abnormal neuromuscular transmission test; ii. History of positive anticholinesterase test; iii. Clinical response to acetylcholinesterase inhibitors. 4. Myasthenia Gravis Foundation of America (MGFA) Class II-IVa 5. MG-ADL scale score of 6 or more 6. QMG scale score of 10 or more 7.…
Interventions
- DrugClaseprubart
IV loading dose on Day 1
- DrugPlacebo
IV infusion on Day 1
- Combination ProductClaseprubart
Prefilled syringe containing claseprubart for SC administration
- Combination ProductPlacebo
Prefilled syringe containing placebo for SC administration
Location
- Cinical Study SiteFayetteville, North Carolina