A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Study to Evaluate Safety, Tolerability, Pharmacometrics, and Efficacy of DNTH103 in Adults With Multifocal Motor Neuropathy (MOMENTUM)
Dianthus Therapeutics
Summary
The purpose of this Phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of Claseprubart (DNTH103) in participants with multifocal motor neuropathy (MMN).
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Must have given written informed consent before any study-related activities are carried out 2. Adult males and females, 18 to 75 years of age (inclusive). 3. Weight range between 40 to 120 kilograms (kg). 4. Confirmed diagnosis of definite or probable MMN. 5. Evidence of: 1. Responsiveness to Ig treatment; and 2. Receiving a stable Ig regimen 6. Documented vaccinations against encapsulated bacteria in accordance with local requirements and vaccine availability. 7. Female participants must be of nonchildbearing potential or if of childbearing potential, must agre…