Dianthus Therapeutics
The purpose of this Phase 3 study is to demonstrate the efficacy, safety, and tolerability of claseprubart in participants with generalized myasthenia gravis (gMG).
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)
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.…
IV loading dose on Day 1
IV infusion on Day 1
Prefilled syringe containing claseprubart for SC administration
Prefilled syringe containing placebo for SC administration
Arctuva estimate
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