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NCT06537999PHASE2Recruiting

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

Dianthus Therapeutics

Start Date

9/17/2024

Completion Date

3/31/2028

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).

Eligibility Criteria

Age Range: 18 years to 75 years

Inclusion Criteria: 1. Must have given written informed consent before any study-related activities are carried out 2. Adult males and females, 18 to 75 years of age (inclusive). 3. Weight range between 40 to 120 kilograms (kg). 4. Confirmed diagnosis of definite or probable MMN. 5. Evidence of: 1. Responsiveness to Ig treatment; and 2. Receiving a stable Ig regimen 6. Documented vaccinations against encapsulated bacteria in accordance with local requirements and vaccine availability. 7. 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. 8. 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. Exclusion Criteria: 1. 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. 2. Any coexisting conditions which may interfere with outcome assessments (eg, severe diabetic neuropathy). 3. 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. 4. Currently or previously on complement inhibitors including in a clinical trial setting. 5. Prior history (at any time) of N. meningitidis infection. 6. Diagnosis of an autoimmune disorder other than MMN. 7. 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. 8. 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. 9. 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). 10. Any other overlapping condition for which the condition or treatment of the condition may affect the study assessments or outcomes. 11. 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.

Interventions

DRUG

Claseprubart

DRUG

Placebo

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Conditions

Multifocal Motor Neuropathy

Locations

Clinical Study Site

Scottsdale, Arizona 85251

United States

Clinical Study Site

Los Angeles, California 90048

United States

Clinical Study Site

Bradenton, Florida 34205

United States

Clinical Study Site

Tampa, Florida 33620

United States

Clinical Study Site

Honolulu, Hawaii 96817

United States

Clinical Study Site

Kansas City, Kansas 66103

United States

Clinical Study Site

Cincinnati, Ohio 45219

United States

Clinical Study Site

Columbus, Ohio 43210

United States

Clinical Study Site

Houston, Texas 77030

United States

Cinical Study Site

Toronto,

Canada

Cinical Study Site

Beijing, 100053

China

Clinical Study Site

Beijing, 100730

China

Cinical Study Site

Shanghai, 200031

China

Clinical Study Site

Aarhus, 8200

Denmark

Clinical Study Site

Copenhagen, 1172

Denmark

Clinical Study Site

Marseille, 13005

France

Clinical Study Site

Paris, 94000

France

Clinical Study Site

Rome, 00189

Italy

Clinical Study Site

Kota Kinabalu, 88200

Malaysia

Cinical Study Site

Kuala Lumpur, 50586

Malaysia

Cinical Study Site

Kuala Lumpur, 59100

Malaysia

Cinical Study Site

Permatang Pauh, 13700

Malaysia

Cinical Study Site

Sarawak, 93586

Malaysia

Clinical Study Site

Amsterdam, 1105

Netherlands

Clinical Study Site

Utrecht,

Netherlands

Clinical Study Site

Skopje,

North Macedonia

Clinical Study Site

Bydgoszcz, 85-090

Poland

Clinical Study Site

Katowice, 40-689

Poland

Clinical Study Site

Krakow, 30-688

Poland

Clinical Study Site

Krakow, 31-202

Poland

Clinical Study Site

Belgrade, 11000

Serbia

Cinical Study Site

Daegu,

South Korea

Cinical Study Site #2

Seoul,

South Korea

Clinical Study Site

Seoul,

South Korea

Cinical Study Site

Alicante, 03010

Spain

Clinical Study Site

Barcelona, 08035

Spain

Cinical Study Site

Barcelona, 08041

Spain

Cinical Study Site

Istanbul, 34093

Turkey (Türkiye)

Clinical Study Site

London, England

United Kingdom

Clinical Study Site

Oxford, England

United Kingdom

Clinical Study Site

Salford, England

United Kingdom