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)
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).
• Must have given written informed consent before any study-related activities are carried out
• Adult males and females, 18 to 75 years of age (inclusive).
• Weight range between 40 to 120 kilograms (kg).
• Confirmed diagnosis of definite or probable MMN.
• Evidence of:
‣ Responsiveness to Ig treatment; and
⁃ Receiving a stable Ig regimen
• Documented vaccinations against encapsulated bacteria in accordance with local requirements and vaccine availability.
• Female participants must be of nonchildbearing potential or if of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception.
• Male participants must agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception or be surgically sterile for at least 90 days prior to Screening.