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

ConditionMultifocal Motor Neuropathy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorDianthus Therapeutics

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Claseprubart

    Drug

    * Day 1: IV loading dose * Week 1 to Week 15: Claseprubart administered SC every 2 weeks

  • Placebo

    Drug

    * Day 1: IV infusion of placebo * Week 1 to Week 15: placebo administered SC every 2 weeks

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: Claseprubart 300 mg Q2WExperimental treatment 1 intervention
Group C: Claseprubart 600 mg Q2WExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
Baseline to Week 17

Secondary outcomes

1

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

Time frame
Baseline to Week 17
2

Time to Clinical Deterioration (CD)

The time it takes a participant to meet defined criteria for worsening of symptoms in the study

Time frame
Baseline to Week 17
3

Mean Value, Mean Change, and Percentage Change From Baseline in Grip Strength

Grip strength measured in kilopascal (kPa) using a vigorimeter

Time frame
Baseline to Week 17
4

Area Under Curve (AUC) of the Change From Baseline in Grip Strength

Grip strength measured in kPa using a vigorimeter

Time frame
Baseline to Week 17

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dianthus Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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