RecruitingPhase 2

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

United States36 participantsStarted 2024-09-17

Plain-language 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).

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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
✓. Receiving a stable Ig regimen
✓. Documented vaccinations against encapsulated bacteria in accordance with local requirements and vaccine availability.

Exclusion criteria

✕. 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.
✕. 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.

What they're measuring

Incidence of Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)

Timeframe: Baseline to Week 17

Trial details

NCT IDNCT06537999

SponsorDianthus Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Dianthus Clinical Contact Center

929-999-4055 clinicaltrials@dianthustx.com

View on ClinicalTrials.gov More Multifocal Motor Neuropathy trials