A Phase 2, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of DNTH103 in Adults With Multifocal Motor Neuropathy

What this Trial Is About

Researchers are evaluating Claseprubart (DNTH103) in adults with multifocal motor neuropathy (MMN) to assess its safety, tolerability, pharmacometrics, and effectiveness. This Phase 2 randomized, double-blinded, placebo-controlled study aims to better understand how this drug works for people with MMN and to monitor any treatment-related side effects. The sponsor of this trial is Dianthus Therapeutics. Participants receive either Claseprubart or a placebo. On the first day, they get an intravenous loading dose, followed by subcutaneous doses every two weeks from Week 1 to Week 15. The study includes multiple groups receiving either 300 mg or 600 mg doses of Claseprubart, or placebo, to compare outcomes. This design helps researchers evaluate different doses and their effects. During the study, participants will be closely monitored from baseline up to Week 17 for side effects and treatment response, including grip strength, muscle function scores, disability scales, and quality of life measures. Some assessments continue up to Week 52 in an open-label extension period. Blood samples will be collected to analyze drug concentration and immune responses. Safety and effectiveness data are gathered through various clinical tests and questionnaires, ensuring comprehensive participant evaluation throughout the study.

A Clinical Study to Evaluate DNTH103 in Adults With Multifocal Motor Neuropathy