Actively Recruiting
A Phase 2, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of DNTH103 in Adults With Multifocal Motor Neuropathy
Led by Dianthus Therapeutics · Updated on 2026-05-26
36
Participants Needed
26
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
A Clinical Study to Evaluate DNTH103 in Adults With Multifocal Motor Neuropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must have given written informed consent before any study-related activities
- Adult males and females, 18 to 75 years of age (inclusive)
- Weight range between 40 to 120 kilograms
- Confirmed diagnosis of definite or probable multifocal motor neuropathy (MMN)
- Evidence of responsiveness to immunoglobulin (Ig) treatment and receiving a stable Ig regimen
- Documented vaccinations against encapsulated bacteria according to local requirements
- Female participants must be nonchildbearing or agree to use highly effective contraception if of childbearing potential
- Male participants must agree not to donate sperm and use acceptable contraception or be surgically sterile for at least 90 days prior to screening
You will not qualify if you...
- History or presence of significant medical or surgical conditions that could impact study assessments
- Any coexisting conditions interfering with outcome assessments, such as severe diabetic neuropathy
- Use of rituximab, cyclophosphamide, mycophenolate mofetil, azathioprine, or cyclosporine within 6 months prior to randomization
- Current or prior treatment with complement inhibitors, including in clinical trials
- Prior history of Neisseria meningitidis infection
- Diagnosis of autoimmune disorders other than MMN
- Positive tests for active HIV, hepatitis B surface antigen, or hepatitis C antibodies during screening
- History of active malignancy within 5 years before screening, except certain skin or prostate cancers
- Participation in another investigational drug study within 90 days or 5 half-lives before randomization
- Any overlapping condition or mental illness making the participant unsuitable or likely noncompliant with study requirements
Research Team
D
Dianthus Clinical Contact Center
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