Multifocal Motor NeuropathyPhase 2MOMENTUMNCT06537999
A Clinical Study to Evaluate DNTH103 in Adults With Multifocal Motor Neuropathy
A Phase 2 study testing Claseprubart in people with Multifocal Motor Neuropathy, run by Dianthus Therapeutics at 41 sites in 15 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multifocal Motor Neuropathy
- What is being tested?
- Claseprubart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 41 sitesin 15 countries
- Study dates
- 17 Sep 2024to 31 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
- Any coexisting conditions which may interfere with outcome assessments (eg, severe diabetic neuropathy).
- 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.
- Currently or previously on complement inhibitors including in a clinical trial setting.
- Prior history (at any time) of N. meningitidis infection.
- Diagnosis of an autoimmune disorder other than MMN.
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- 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.
- 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.
- 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).
- Any other overlapping condition for which the condition or treatment of the condition may affect the study assessments or outcomes.
- 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.
Trial locations and contacts
41 sites in 15 countries.
41 sites in 15 countries
United States9 sites
Clinical Study Site
Bradenton, Florida, 34205
Clinical Study Site
Cincinnati, Ohio, 45219
Clinical Study Site
Columbus, Ohio, 43210
Clinical Study Site
Honolulu, Hawaii, 96817
Clinical Study Site
Houston, Texas, 77030
Clinical Study Site
Kansas City, Kansas, 66103
Clinical Study Site
Los Angeles, California, 90048
Clinical Study Site
Scottsdale, Arizona, 85251
Clinical Study Site
Tampa, Florida, 33620
Malaysia5 sites
Clinical Study Site
Kota Kinabalu, 88200
Cinical Study Site
Kuala Lumpur, 50586
Cinical Study Site
Kuala Lumpur, 59100
Cinical Study Site
Permatang Pauh, 13700
Cinical Study Site
Sarawak, 93586
Poland4 sites
Clinical Study Site
Bydgoszcz, 85-090
Clinical Study Site
Katowice, 40-689
Clinical Study Site
Krakow, 30-688
Clinical Study Site
Krakow, 31-202
China3 sites
Cinical Study Site
Beijing, 100053
Clinical Study Site
Beijing, 100730
Cinical Study Site
Shanghai, 200031
South Korea3 sites
Cinical Study Site
Daegu
Cinical Study Site #2
Seoul
Clinical Study Site
Seoul
Spain3 sites
Cinical Study Site
Alicante, 03010
Clinical Study Site
Barcelona, 08035
Cinical Study Site
Barcelona, 08041
United Kingdom3 sites
Clinical Study Site
London, England
Clinical Study Site
Oxford, England
Clinical Study Site
Salford, England
Denmark2 sites
Clinical Study Site
Aarhus, 8200
Clinical Study Site
Copenhagen, 1172
France2 sites
Clinical Study Site
Marseille, 13005
Clinical Study Site
Paris, 94000
Netherlands2 sites
Clinical Study Site
Amsterdam, 1105
Clinical Study Site
Utrecht
About this study
Official title: 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).
- Conditions
- Multifocal Motor Neuropathy
- Being tested
- Claseprubart, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClaseprubartDrug
Also called DNTH103
- Day 1: IV loading dose
- Week 1 to Week 15: Claseprubart administered SC every 2 weeks
PlaceboDrug
- Day 1: IV infusion of placebo
- Week 1 to Week 15: placebo administered SC every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Claseprubart 300 mg Q2W | Experimental | Not described Receives: Drug: Claseprubart |
| Claseprubart 600 mg Q2W | Experimental | Not described Receives: Drug: Claseprubart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)
Incidence of treatment-emergent adverse events (TEAEs) and treatment emergent serious adverse events (SAEs)
Measured: Baseline to Week 17
Secondary outcomes (19)
Time to Retreatment With Immunoglobulin (Ig) Since the Final Ig Treatment Before Randomization
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
Measured: Baseline to Week 17
Time to Clinical Deterioration (CD)
The time it takes a participant to meet defined criteria for worsening of symptoms in the study
Measured: Baseline to Week 17
Mean Value, Mean Change, and Percentage Change From Baseline in Grip Strength
Grip strength measured in kilopascal (kPa) using a vigorimeter
Measured: Baseline to Week 17
Area Under Curve (AUC) of the Change From Baseline in Grip Strength
Grip strength measured in kPa using a vigorimeter
Measured: Baseline to Week 17
AUC of the Change From Baseline in Medical Research Council (MRC)-10 Sum Score
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
Measured: Baseline to Week 17
Mean Value and Mean Change From Baseline in MRC-10 Sum Score
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
Measured: Baseline to Week 17
Mean Value and Mean Change From Baseline in MRC-14 Sum Score
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
Measured: Baseline to Week 17
Mean Value and Mean Change From Baseline in Multifocal Motor Neuropathy Rasch-Built Overall Disability Scale (MMN-RODS) Score
MMN-RODS consists of 25 items scored on a 3-point scale
Measured: Baseline to Week 17
Mean Value and Mean Change From Baseline in Average Time to Complete the 9-Hole Peg Test (9-HPT)
9-HPT is a quantitative measure of upper extremity (arm and hand) function and dexterity
Measured: Baseline to Week 17
Mean Change From Baseline in Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score
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)
Measured: Baseline to Week 17
Mean Change From Baseline in Euro-Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L) Scale
EQ-5D-5L is comprised of 5 dimensions: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression
Measured: Baseline to Week 17
Mean Change From Baseline in EQ-5D-5L Visual Analog Scale (VAS)
A vertical VAS is included in the EQ 5D 5L. Participants mark their health status from 0 to 100
Measured: Baseline to Week 17
Count and Proportion of Participants With Patient Global Impression of Change (PGIC) Score of Improved or Better
PGIC is a 7-point scale depicting a participant's rating of overall improvement
Measured: Baseline to Week 17
Mean Change From Baseline in Fatigue Severity Scale (FSS) Score
FSS assesses disabling fatigue in participants with chronic illness
Measured: Baseline to Week 17
Mean Change From Baseline in Health-Related Productivity Questionnaire (HRPQ) Outcomes
HRPQ is a participant diary tool designed to provide data on health-related impacts to labor force participation
Measured: Baseline to Week 17
Effectiveness, Side Effects, Convenience, and Overall Satisfaction Scores as Assessed by Treatment Satisfaction Questionnaire for Medications (TSQM)-14
TSQM-14 is a 14-item treatment satisfaction questionnaire that evaluates the following domains: effectiveness, side effects, convenience, and global satisfaction
Measured: Baseline to Week 17
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)
Incidence of treatment-emergent adverse events (TEAEs) and treatment emergent serious adverse events (SAEs)
Measured: Up to Week 52 of OLE
Serum Concentrations of Claseprubart
Blood samples will be collected for measurement of serum concentrations of Claseprubart at various timepoints both pre- and post-dose
Measured: Baseline to Week 17
Incidence and Titer of Antidrug Antibody (ADA) Levels Against Claseprubart
Blood samples will be collected to measure ADA against Claseprubart at various timepoints
Measured: Baseline to Week 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start17 Sep 2024
- Primary completionDec 2026 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multifocal Motor NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dianthus Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537999
- Sponsor's protocol ID
- DNTH103-MMN-201
- Other IDs
- 2024-513128-40-00
- Acronym
- MOMENTUM
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06537999
- Acronym / sponsor ID
- MOMENTUM / DNTH103-MMN-201
- Conditions
- Multifocal Motor Neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Dianthus TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Claseprubart 300 mg Q2W | Experimental | Drug: Claseprubart |
| Claseprubart 600 mg Q2W | Experimental | Drug: Claseprubart |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (11 listed)
- 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.
- Any coexisting conditions which may interfere with outcome assessments (eg, severe diabetic neuropathy).
- 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.
- Currently or previously on complement inhibitors including in a clinical trial setting.
- Prior history (at any time) of N. meningitidis infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClaseprubartAlso: DNTH103* Day 1: IV loading dose * Week 1 to Week 15: Claseprubart administered SC every 2 weeks | Drug | Claseprubart 300 mg Q2W, Claseprubart 600 mg Q2W |
| Placebo* Day 1: IV infusion of placebo * Week 1 to Week 15: placebo administered SC every 2 weeks | Drug | Placebo |
Primary outcome
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)
19 secondary outcomes
Time to Retreatment With Immunoglobulin (Ig) Since the Final Ig Treatment Before Randomization
Time frame: Baseline to Week 17
Time to Clinical Deterioration (CD)
Time frame: Baseline to Week 17
Mean Value, Mean Change, and Percentage Change From Baseline in Grip Strength
Time frame: Baseline to Week 17
Area Under Curve (AUC) of the Change From Baseline in Grip Strength
Time frame: Baseline to Week 17
AUC of the Change From Baseline in Medical Research Council (MRC)-10 Sum Score
Time frame: Baseline to Week 17
Mean Value and Mean Change From Baseline in MRC-10 Sum Score
Time frame: Baseline to Week 17
Mean Value and Mean Change From Baseline in MRC-14 Sum Score
Time frame: 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
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
Mean Change From Baseline in Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score
Time frame: 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
Mean Change From Baseline in EQ-5D-5L Visual Analog Scale (VAS)
Time frame: 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
Mean Change From Baseline in Fatigue Severity Scale (FSS) Score
Time frame: Baseline to Week 17
Mean Change From Baseline in Health-Related Productivity Questionnaire (HRPQ) Outcomes
Time frame: 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
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)
Time frame: Up to Week 52 of OLE
Serum Concentrations of Claseprubart
Time frame: Baseline to Week 17
Incidence and Titer of Antidrug Antibody (ADA) Levels Against Claseprubart
Time frame: Baseline to Week 17
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
41 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Claseprubart in people with Multifocal Motor Neuropathy, run by Dianthus Therapeutics at 41 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Malaysia, Poland, China, South Korea and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) (time frame: Baseline to Week 17). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.