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

Conditions

• Multifocal Motor Neuropathy

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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).

Key Dates

Start date

Sep 17, 2024

Status verified

May 2026

Primary completion

Jun 30, 2026

Completion

Mar 31, 2028

Study Design

Enrollment

36 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
• Experimental: Claseprubart 300 mg Q2W
• Experimental: Claseprubart 600 mg Q2W

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) [ Time Frame: Baseline to Week 17 ]

Central Contacts

• Dianthus Clinical Contact Center
  929-999-4055
  [email protected]

Locations (10)

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