A Clinical Study to Evaluate DNTH103 in Adults With Multifocal Motor Neuropathy (MOMENTUM)

August 6, 2026 updated by: Dianthus Therapeutics

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Toronto, Canada
        • Cinical Study Site
  • China
      • Beijing, China, 100053
        • Cinical Study Site
      • Beijing, China, 100730
        • Clinical Study Site
      • Shanghai, China, 200031
        • Cinical Study Site
  • Denmark
      • Aarhus, Denmark, 8200
        • Clinical Study Site
      • Copenhagen, Denmark, 1172
        • Clinical Study Site
  • France
      • Marseille, France, 13005
        • Clinical Study Site
      • Paris, France, 94000
        • Clinical Study Site
  • Italy
      • Rome, Italy, 00189
        • Clinical Study Site
  • Malaysia
      • Kota Kinabalu, Malaysia, 88200
        • Clinical Study Site
      • Kuala Lumpur, Malaysia, 50586
        • Cinical Study Site
      • Kuala Lumpur, Malaysia, 59100
        • Cinical Study Site
      • Permatang Pauh, Malaysia, 13700
        • Cinical Study Site
      • Sarawak, Malaysia, 93586
        • Cinical Study Site
  • Netherlands
      • Amsterdam, Netherlands, 1105
        • Clinical Study Site
      • Utrecht, Netherlands
        • Clinical Study Site
  • North Macedonia
      • Skopje, North Macedonia
        • Clinical Study Site
  • Poland
      • Bydgoszcz, Poland, 85-090
        • Clinical Study Site
      • Katowice, Poland, 40-689
        • Clinical Study Site
      • Krakow, Poland, 31-202
        • Clinical Study Site
      • Krakow, Poland, 30-688
        • Clinical Study Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Study Site
  • South Korea
      • Daegu, South Korea
        • Cinical Study Site
      • Seoul, South Korea
        • Cinical Study Site #2
      • Seoul, South Korea
        • Clinical Study Site
  • Spain
      • Alicante, Spain, 03010
        • Cinical Study Site
      • Barcelona, Spain, 08035
        • Clinical Study Site
      • Barcelona, Spain, 08041
        • Cinical Study Site
  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34093
        • Cinical Study Site
  • United Kingdom
    • England
      • London, England, United Kingdom
        • Clinical Study Site
      • Oxford, England, United Kingdom
        • Clinical Study Site
      • Salford, England, United Kingdom
        • Clinical Study Site
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Clinical Study Site
    • California
      • Los Angeles, California, United States, 90048
        • Clinical Study Site
    • Florida
      • Bradenton, Florida, United States, 34205
        • Clinical Study Site
      • Tampa, Florida, United States, 33620
        • Clinical Study Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Clinical Study Site
    • Kansas
      • Kansas City, Kansas, United States, 66103
        • Clinical Study Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Clinical Study Site
      • Columbus, Ohio, United States, 43210
        • Clinical Study Site
    • Texas
      • Houston, Texas, United States, 77030
        • Clinical Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
  • Day 1: IV infusion of placebo
  • Week 1 to Week 15: placebo administered SC every 2 weeks
Experimental: Claseprubart 300 mg Q2W
Drug: Claseprubart
  • Day 1: IV loading dose
  • Week 1 to Week 15: Claseprubart administered SC every 2 weeks
Other Names:
  • DNTH103
Experimental: Claseprubart 600 mg Q2W
Drug: Claseprubart
  • Day 1: IV loading dose
  • Week 1 to Week 15: Claseprubart administered SC every 2 weeks
Other Names:
  • DNTH103

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)
Time Frame: Baseline to Week 17
Incidence of treatment-emergent adverse events (TEAEs) and treatment emergent serious adverse events (SAEs)
Baseline to Week 17

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Retreatment With Immunoglobulin (Ig) Since the Final Ig Treatment Before Randomization
Time Frame: Baseline to Week 17
Time between the participant's last dose of Ig and when they require the next dose of Ig after entering the randomized, controlled treatment period of the study
Baseline to Week 17
Time to Clinical Deterioration (CD)
Time Frame: Baseline to Week 17
The time it takes a participant to meet defined criteria for worsening of symptoms in the study
Baseline to Week 17
Mean Value, Mean Change, and Percentage Change From Baseline in Grip Strength
Time Frame: Baseline to Week 17
Grip strength measured in kilopascal (kPa) using a vigorimeter
Baseline to Week 17
Area Under Curve (AUC) of the Change From Baseline in Grip Strength
Time Frame: Baseline to Week 17
Grip strength measured in kPa using a vigorimeter
Baseline to Week 17
AUC of the Change From Baseline in Medical Research Council (MRC)-10 Sum Score
Time Frame: Baseline to Week 17
MRC-10 evaluates motor strength/weakness from a predetermined set of 10 muscle pairs (upper and lower limbs) on a scale of 0 to 5
Baseline to Week 17
Mean Value and Mean Change From Baseline in MRC-10 Sum Score
Time Frame: Baseline to Week 17
MRC-10 evaluates motor strength/weakness from a predetermined set of 10 muscle pairs (upper and lower limbs) on a scale of 0 to 5
Baseline to Week 17
Mean Value and Mean Change From Baseline in MRC-14 Sum Score
Time Frame: Baseline to Week 17
MRC-14 evaluates motor strength/weakness from a predetermined set of 14 muscle pairs (upper and lower limbs) on a scale of 0 to 5
Baseline to Week 17
Mean Value and Mean Change From Baseline in Multifocal Motor Neuropathy Rasch-Built Overall Disability Scale (MMN-RODS) Score
Time Frame: Baseline to Week 17
MMN-RODS consists of 25 items scored on a 3-point scale
Baseline to Week 17
Mean Value and Mean Change From Baseline in Average Time to Complete the 9-Hole Peg Test (9-HPT)
Time Frame: Baseline to Week 17
9-HPT is a quantitative measure of upper extremity (arm and hand) function and dexterity
Baseline to Week 17
Mean Change From Baseline in Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score
Time Frame: Baseline to Week 17
INCAT comprises 2 parts, the arm score and the leg score. Each part is scored between 0 and 5 points, resulting in an INCAT total score between 0 and 10. Adjusted INCAT disability score excludes changes in upper limb function from 0 (normal) to 1 (minor symptoms)
Baseline to Week 17
Mean Change From Baseline in Euro-Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L) Scale
Time Frame: Baseline to Week 17
EQ-5D-5L is comprised of 5 dimensions: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression
Baseline to Week 17
Mean Change From Baseline in EQ-5D-5L Visual Analog Scale (VAS)
Time Frame: Baseline to Week 17
A vertical VAS is included in the EQ 5D 5L. Participants mark their health status from 0 to 100
Baseline to Week 17
Count and Proportion of Participants With Patient Global Impression of Change (PGIC) Score of Improved or Better
Time Frame: Baseline to Week 17
PGIC is a 7-point scale depicting a participant's rating of overall improvement
Baseline to Week 17
Mean Change From Baseline in Fatigue Severity Scale (FSS) Score
Time Frame: Baseline to Week 17
FSS assesses disabling fatigue in participants with chronic illness
Baseline to Week 17
Mean Change From Baseline in Health-Related Productivity Questionnaire (HRPQ) Outcomes
Time Frame: Baseline to Week 17
HRPQ is a participant diary tool designed to provide data on health-related impacts to labor force participation
Baseline to Week 17
Effectiveness, Side Effects, Convenience, and Overall Satisfaction Scores as Assessed by Treatment Satisfaction Questionnaire for Medications (TSQM)-14
Time Frame: Baseline to Week 17
TSQM-14 is a 14-item treatment satisfaction questionnaire that evaluates the following domains: effectiveness, side effects, convenience, and global satisfaction
Baseline to Week 17
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)
Time Frame: Up to Week 52 of OLE
Incidence of treatment-emergent adverse events (TEAEs) and treatment emergent serious adverse events (SAEs)
Up to Week 52 of OLE
Serum Concentrations of Claseprubart
Time Frame: Baseline to Week 17
Blood samples will be collected for measurement of serum concentrations of Claseprubart at various timepoints both pre- and post-dose
Baseline to Week 17
Incidence and Titer of Antidrug Antibody (ADA) Levels Against Claseprubart
Time Frame: Baseline to Week 17
Blood samples will be collected to measure ADA against Claseprubart at various timepoints
Baseline to Week 17

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dianthus Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

July 31, 2024

First Submitted That Met QC Criteria

July 31, 2024

First Posted (Actual)

August 5, 2024

Study Record Updates

Last Update Posted (Actual)

August 10, 2026

Last Update Submitted That Met QC Criteria

August 6, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DNTH103-MMN-201
  • 2024-513128-40-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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