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

NCT06537999 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: DNTH103-MMN-2012024-513128-40-00
• Study Type: interventional
• Target: 36
• Locations: 10 countries
• Sites: 26

Brief 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).

Conditions

Multifocal Motor Neuropathy

Outcome Measures

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)

  Baseline to Week 17

Secondary Outcomes (19)

• Time to Retreatment With Immunoglobulin (Ig) Since the Final Ig Treatment Before Randomization

  Baseline to Week 17

• Time to Clinical Deterioration (CD)

  Baseline to Week 17

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

  Baseline to Week 17

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

  Baseline to Week 17

• AUC of the Change From Baseline in Medical Research Council (MRC)-10 Sum Score

  Baseline to Week 17

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Claseprubart low dose Q2W

EXPERIMENTAL

Drug: Claseprubart

Claseprubart high dose Q2W

EXPERIMENTAL

Drug: Claseprubart

Interventions

Placebo DRUG

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

Placebo

Claseprubart DRUG

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

Also known as: DNTH103

Claseprubart high dose Q2W; Claseprubart low dose Q2W

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Female participants must be of nonchildbearing potential or if of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception.
• Male participants must agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception or be surgically sterile for at least 90 days prior to Screening.

You may not qualify if:

• 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.
• Participation in another clinical study of an investigational drug within 90 days or 5 half-lives of the investigational agent (whichever is longer) prior to randomization (Day 1).
• Any other overlapping condition for which the condition or treatment of the condition may affect the study assessments or outcomes.
• Any other condition, including mental illness or prior therapy, that in the opinion of the Investigator would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.

Sponsors & Collaborators

• Dianthus Therapeutics: lead

Study Sites (26)

Clinical Study Site

Scottsdale, Arizona, 85251, United States

RECRUITING

Clinical Study Site

Los Angeles, California, 90048, United States

RECRUITING

Clinical Study Site

Bradenton, Florida, 34205, United States

RECRUITING

Clinical Study Site

Tampa, Florida, 33620, United States

RECRUITING

Clinical Study Site

Honolulu, Hawaii, 96817, United States

RECRUITING

Clinical Study Site

Kansas City, Kansas, 66103, United States

RECRUITING

Clinical Study Site

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Clinical Study Site

Cincinnati, Ohio, 45219, United States

RECRUITING

Clinical Study Site

Columbus, Ohio, 43210, United States

RECRUITING

Clinical Study Site

Houston, Texas, 77030, United States

RECRUITING

Clinical Study Site

Aarhus, 8200, Denmark

RECRUITING

Clinical Study Site

Copenhagen, 1172, Denmark

RECRUITING

Clinical Study Site

Marseille, 13005, France

RECRUITING

Clinical Study Site

Paris, 94000, France

RECRUITING

Clinical Study Site

Rome, 00189, Italy

RECRUITING

Clinical Study Site

Amsterdam, 1105, Netherlands

RECRUITING

Clinical Study Site

Utrecht, Netherlands

RECRUITING

Clinical Study Site

Skopje, North Macedonia

RECRUITING

Clinical Study Site

Bydgoszcz, 85-090, Poland

RECRUITING

Clinical Study Site

Katowice, 40-689, Poland

RECRUITING

Clinical Study Site

Krakow, 30-688, Poland

RECRUITING

Clinical Study Site

Krakow, 31-202, Poland

RECRUITING

Clinical Study Site

Belgrade, 11000, Serbia

RECRUITING

Clinical Study Site

Barcelona, 08035, Spain

RECRUITING

Clinical Study Site

London, England, United Kingdom

RECRUITING

Clinical Study Site

Oxford, England, United Kingdom

RECRUITING

Central Study Contacts

Dianthus Clinical Contact Center

CONTACT

929-999-4055; clinicaltrials@dianthustx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 5, 2024
• Study Start: September 17, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): March 31, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

NL (2); SE (1); ES (1); DK (2); US (10); NO (1); FR (2); GB (2); IT (1); PL (4)