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Evaluating DNTH103 for adults with multifocal motor neuropathy

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)

Phase 2 Interventional Dianthus Therapeutics · NCT06537999

This study is testing a new treatment called DNTH103 to see if it can help adults with multifocal motor neuropathy feel better compared to a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment36 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorDianthus Therapeutics Industry-sponsored
Drugs / interventionsrituximab, cyclophosphamide
Locations26 sites (Scottsdale, Arizona and 25 other locations)
Trial IDNCT06537999 on ClinicalTrials.gov

What this trial studies

This Phase 2 clinical study aims to assess the safety, tolerability, pharmacometrics, and efficacy of DNTH103 in adults diagnosed with multifocal motor neuropathy (MMN). Participants will receive either DNTH103 or a placebo to determine the treatment's effectiveness. The study will involve monitoring participants' responses and any adverse effects throughout the trial period. The goal is to gather data that could support the potential use of DNTH103 as a therapeutic option for MMN.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with a confirmed diagnosis of multifocal motor neuropathy who have shown responsiveness to immunoglobulin treatment.

Not a fit: Patients who do not have a confirmed diagnosis of multifocal motor neuropathy or those who are not responsive to immunoglobulin treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from multifocal motor neuropathy.

How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in treating conditions with immunomodulatory therapies.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 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.
8. 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.

Exclusion Criteria:

1. History or presence of significant medical/surgical condition including any acute illness or major surgery considered to be clinically significant or that could impact efficacy assessments.
2. Any coexisting conditions which may interfere with outcome assessments (eg, severe diabetic neuropathy).
3. Concurrent or previous use of rituximab, cyclophosphamide, mycophenolate mofetil, azathioprine, or cyclosporine. If a participant has previously used these medications, the last dose must be at least 6 months prior to randomization.
4. Currently or previously on complement inhibitors including in a clinical trial setting.
5. Prior history (at any time) of N. meningitidis infection.
6. Diagnosis of an autoimmune disorder other than MMN.
7. Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies during Screening.
8. History of active malignancy within 5 years prior to Screening, except basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of the skin, cervical carcinoma in situ curatively treated or low-grade prostate adenocarcinoma for which appropriate management is observation alone.
9. Participation in another clinical study of an investigational drug within 90 days or 5 half-lives of the investigational agent (whichever is longer) prior to randomization (Day 1).
10. Any other overlapping condition for which the condition or treatment of the condition may affect the study assessments or outcomes.
11. Any other condition, including mental illness or prior therapy, that in the opinion of the Investigator would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.

Where this trial is running

Scottsdale, Arizona and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multifocal Motor Neuropathy
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.