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Monoclonal Antibodies

DNTH103 for Neuropathy (MOMENTUM Trial)

Phase 2
Recruiting
Research Sponsored by Dianthus Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
2. Receiving a stable Ig regimen
3. Weight range between 40 to 120 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 52 of ole

Summary

"This trial aims to see if DNTH103 is safe and effective for treating multifocal motor neuropathy in participants."

Who is the study for?
Adults aged 18-75 with a confirmed diagnosis of multifocal motor neuropathy (MMN) who respond to Ig treatment and are on a stable Ig regimen can join. They must weigh between 40-120 kg, have had the required vaccinations, and agree to contraception if they can have children. Women must not be able to become pregnant or use effective birth control; men must either be sterile or use contraception.
What is being tested?
The trial is testing DNTH103's safety, how well it's tolerated by patients, its pharmacometrics (how the drug moves through and affects the body), and effectiveness in treating MMN. Participants will randomly receive either DNTH103 or a placebo for comparison.
What are the potential side effects?
While specific side effects of DNTH103 aren't listed here, common ones for new treatments may include reactions at injection sites, flu-like symptoms, headaches, nausea, fatigue, and potential allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am on a consistent treatment plan for my immune system.
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My weight is between 40 to 120 kg.
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I have been diagnosed with MMN.
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I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 52 of ole
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 52 of ole for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
AUC of the change from baseline in Medical Research Council (MRC)-10 sum score
Area under curve (AUC) of the change from baseline in grip strength
Count and proportion of participants with Patient Global Impression of Change (PGIC) score of improved or better
+17 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: DNTH103 low dose Q2WExperimental Treatment1 Intervention
Group II: DNTH103 high dose Q2WExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

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Who is running the clinical trial?

Dianthus TherapeuticsLead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
~24 spots leftby Jun 2026
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