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A Clinical Study to Evaluate DNTH103 in Adults With Multifocal Motor Neuropathy | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Clinical Study to Evaluate DNTH103 in 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)

NCT06537999•Dianthus Therapeutics

View on ClinicalTrials.gov

Summary

The purpose of this Phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of DNTH103 in participants with multifocal motor neuropathy (MMN).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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 be surgically sterile for at least 90 days prior to Screening or 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.

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.
+1 more criteria

Locations (26)

Clinical Study Site

Scottsdale, Arizona, United States

Clinical Study Site

Los Angeles, California, United States

Clinical Study Site

Bradenton, Florida, United States

Clinical Study Site

Tampa, Florida, United States

Clinical Study Site

Honolulu, Hawaii, United States

Clinical Study Site

Kansas City, Kansas, United States

Clinical Study Site

Chapel Hill, North Carolina, United States

Clinical Study Site

Cincinnati, Ohio, United States

Clinical Study Site

Columbus, Ohio, United States

Clinical Study Site

Houston, Texas, United States

Key Dates

Start Date

September 17, 2024

Primary Completion Date

June 30, 2026

Completion Date

March 31, 2028

Last Updated

October 6, 2025

Enrollment

ESTIMATED participants

Conditions

Multifocal Motor Neuropathy

Interventions

DNTH103

DRUG

Placebo

DRUG

Contacts

Dianthus Clinical Contact Center

CONTACT

929-999-4055 clinicaltrials@dianthustx.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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