Not recruitingRare disease

Study on the Safety and Effects of DNTH103 for Adults with Multifocal Motor Neuropathy

Verified siteInvestigational

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called Multifocal Motor Neuropathy (MMN). MMN is a rare disorder that affects the nerves, leading to muscle weakness, especially in the arms and hands. The study will evaluate a new treatment called DNTH103, which is a type of medication known as a monoclonal antibody. Monoclonal antibodies are proteins designed to target specific parts of the immune system. In this study, DNTH103 will be given as a solution for injection, either through a vein (intravenous) or under the skin (subcutaneous).

The purpose of the study is to assess the safety and tolerability of DNTH103 in adults with MMN. Participants will be randomly assigned to receive either DNTH103 or a matching placebo. The study will be conducted in a double-blinded manner, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. The study will last up to 17 weeks, during which participants will be closely monitored for any side effects and changes in their condition.

Throughout the study, various assessments will be conducted to evaluate the effects of DNTH103. These assessments will include measuring grip strength, monitoring any changes in the participants' ability to perform daily activities, and tracking any adverse events that may occur. The study aims to provide valuable information on the potential benefits and risks of DNTH103 for individuals with MMN.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, weight, and a confirmed diagnosis of multifocal motor neuropathy.
Participants must have documented vaccinations against certain bacteria and meet specific health criteria.
Step 2
Randomization
Participants are randomly assigned to receive either the investigational drug DNTH103 or a matching placebo.
The study is double-blinded, meaning neither the participants nor the researchers know who receives the drug or placebo.
Step 3
Treatment administration
The investigational drug DNTH103 is administered as a solution for injection, either intravenously (IV) or subcutaneously (SC).
The treatment period lasts up to 17 weeks, during which the safety and tolerability of the drug are evaluated.
Step 4
Monitoring and evaluation
Participants are monitored for any adverse events or side effects throughout the study.
Regular assessments are conducted to measure grip strength, overall disability, and other health indicators.
Step 5
Completion of treatment phase
At the end of the treatment phase, participants undergo a final evaluation to assess the effects of the treatment.
The study aims to determine the time to first retreatment with immunoglobulin and any clinical deterioration.

Who can join the trial?

9 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 kg.
Confirmed diagnosis of definite or probable Multifocal Motor Neuropathy (MMN). MMN is a condition that affects the nerves controlling muscles.
Evidence of:
- Responsiveness to Ig treatment. Ig treatment involves using immunoglobulins, which are proteins that help the immune system.
- Receiving a stable Ig regimen, meaning the treatment plan with immunoglobulins is consistent and not changing.
- Documented vaccinations against encapsulated bacteria in accordance with local requirements and vaccine availability. Encapsulated bacteria are types of bacteria that have a protective outer layer.
- 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 be surgically sterile for at least 90 days prior to Screening or 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.

Who cannot join the trial?

9 criteria

Participants with any other serious health condition that could interfere with the study.
Individuals who have had a recent infection or illness that could affect the study results.
People who are currently taking medications that might interfere with the study treatment.
Participants who have a history of allergic reactions to similar treatments.
Individuals who are pregnant or breastfeeding.
People who have participated in another clinical trial recently.
Participants with a history of drug or alcohol abuse.
Individuals who have a mental health condition that could affect their ability to participate.
People who have been diagnosed with a different type of neuropathy, which is a condition affecting the nerves.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliero-Universitaria Sant Andre
Responsive
Rome, Italy
Neurologia Slaska Centrum Medyczne
Responsive
Katowice, Poland
Universitair Medisch Centrum Utrecht
Responsive
Utrecht, The Netherlands

Trial locations

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Investigated drugs

DNTH103 is an investigational medication being studied for its potential to help people with multifocal motor neuropathy (MMN). This condition affects the nerves and can lead to muscle weakness. The trial aims to see how safe and tolerable this medication is for patients, as well as to understand how it works in the body. Participants in the study will receive this medication to assess its effects over a period of time.

Dnth103

What is already known about the treatment

DNTH103 – DNTH103 is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials, specifically in a Phase 2 trial, to assess its safety and effectiveness for treating multifocal motor neuropathy (MMN). This condition affects the nerves that control muscles, leading to muscle weakness. DNTH103 is being evaluated for its ability to improve muscle function by targeting specific pathways involved in nerve inflammation and damage. It is classified as an investigational drug, meaning it is not yet approved for general medical use and is still under research to determine its potential benefits and risks.

Investigated diseases

Multifocal Motor Neuropathy – This is a rare neurological disorder that primarily affects the motor nerves, leading to muscle weakness. It is characterized by the presence of multifocal conduction blocks, which disrupt the normal flow of electrical signals along the nerves. The condition typically begins in the hands and arms, causing weakness and muscle wasting. As it progresses, it may also affect the legs, leading to difficulties in movement. Unlike some other neuropathies, it does not usually cause sensory loss or pain. The progression of muscle weakness can vary, with some individuals experiencing a slow progression over many years.