A Clinical Study to Evaluate DNTH103 in Adults With Multifocal Motor Neuropathy
NCT Number: NCT06537999
Acronym: MOMENTUM
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Multifocal Motor Neuropathy
Interventions: DRUG: DNTH103|DRUG: Placebo
Sponsor: Dianthus Therapeutics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-31
Completion Date: 2028-03-31

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).

Primary Outcome Measures: 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), Baseline to Week 17
Secondary Outcome Measures: Time to first 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, Baseline to Week 17|Time to first clinical deterioration (CD), The time it takes a participant to meet defined criteria for worsening of symptoms in the study, Baseline to Week 17|Time between first retreatment with Ig and second retreatment with Ig, The amount of time between a participant receiving one dose of Ig and then requiring a second dose of Ig during the study for worsening of symptoms, Baseline to Week 17|Mean value, mean change, and percentage change from baseline in grip strength, Grip strength measured in kPa using a vigorimeter, Baseline to Week 17|Area under curve (AUC) of the change from baseline in grip strength, 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, 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, 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, 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, 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), 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, 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, 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), 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, 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, FSS assesses disabling fatigue in participants with chronic illness, 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, 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, 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), Up to Week 52 of OLE|Serum concentrations of DNTH103, Blood samples will be collected for measurement of serum concentrations of DNTH103 at various timepoints both pre- and post-dose, Baseline to Week 17|Incidence and titer of antidrug antibody (ADA) levels against DNTH103, Blood samples will be collected to measure ADA against DNTH103 at various timepoints, Baseline to Week 17