This study focuses on Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a condition that affects the nerves outside the brain and spinal cord, causing weakness, numbness, and tingling in the arms and legs. The study will test a new medication called DNTH103, which is given as an injection, compared to placebo. The purpose is to determine how long it takes for symptoms to return (relapse) after treatment with DNTH103.
The study involves two main parts. In the first part, all participants receive DNTH103 to check if they respond to the treatment. In the second part, participants who showed improvement will be randomly assigned to continue receiving either DNTH103 or placebo. The treatment period lasts several months, during which participants will receive regular injections and undergo various assessments to monitor their condition.
Throughout the study, doctors will measure participants’ muscle strength, ability to perform daily activities, and overall quality of life. They will also monitor for any side effects and check how the medication works in the body. The maximum daily dose of DNTH103 will be 1200 mg, and participants may receive treatment for up to 172 days.
1Initial phase – Part A
You will receive DNTH103 through injection to evaluate your initial response to the treatment.
Your condition will be monitored using several assessment tools, including the adjusted INCAT score (a measure of disability in daily activities) and grip strength tests.
2Treatment phase – Part B
You will be randomly assigned to receive either DNTH103 or a placebo (a substance with no active medication).
The main focus will be monitoring how long it takes before any symptoms return (relapse).
Regular assessments will measure your muscle strength, daily activity abilities, and overall quality of life.
Your grip strength in both hands will be tested regularly.
You will complete questionnaires about fatigue levels and quality of life.
3Extended treatment – OLE phase
This phase allows for continued treatment and monitoring.
Regular assessments will continue to track your progress.
Your response to the medication will be monitored through blood tests.
The presence of antibodies against the medication will be checked.
4Safety monitoring
Throughout the study, you will be monitored for any side effects or unexpected reactions.
Blood samples will be taken to measure the amount of medication in your system.
The study will continue until December 31, 2030.
Who Can Join the Study?
Must provide written informed consent before starting any study activities
Body weight must be between 40 kilograms and 120 kilograms
Must have confirmed diagnosis of CIDP (a type of nerve disorder) or possible CIDP, specifically either typical CIDP or motor/multifocal variants
Must have a CIDP Disease Activity Status (CDAS) score of 3 or higher during screening
Must be neurologically stable (no recent worsening of symptoms or other neurological events)
Must have an adjusted INCAT score (a measure of disability) between 2 and 9
Must meet one of these treatment conditions:
– Currently receiving or previously responded to immunoglobulin treatment
– Currently receiving or previously responded to corticosteroid treatment
– Had unsuccessful treatment with standard therapies
– Never received treatment for CIDP
Must have received vaccinations against certain bacteria as required by local guidelines
For male participants:
– Must be surgically sterile for at least 90 days before screening, or
– Must agree to use contraception and not donate sperm
For female participants:
– Must be unable to bear children, or
– Must agree to use effective contraception and not donate eggs
– Must not attempt to become pregnant during the study
Who Cannot Join the Study?
Age below 18 years or above 65 years
Any other neurological conditions besides Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Current participation in other clinical trials
History of severe allergic reactions to medications
Pregnant or breastfeeding women
Severe kidney or liver disease
Uncontrolled diabetes (high blood sugar levels)
Uncontrolled high blood pressure
History of blood clotting disorders
Active infections or ongoing treatment with antibiotics
Major surgery within the last 3 months
Cancer or history of cancer in the past 5 years
Substance abuse or alcohol dependency
Mental health conditions that could interfere with the study
Unable to provide informed consent
Use of immunosuppressive medications other than those specified in the study
DNTH103 is an investigational medication being studied for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). This medication is being tested to see how effective it is at preventing relapses in adults with CIDP. CIDP is a neurological disorder that affects the peripheral nerves, causing weakness, numbness, and tingling in various parts of the body.
Chronic Inflammatory Demyelinating Polyneuropathy – A neurological disorder that affects the peripheral nervous system, where the body’s immune system attacks and damages the protective covering (myelin sheath) of the nerves. The condition develops gradually over several weeks or months, causing progressive weakness and reduced sensation in the arms and legs. It can affect both motor and sensory nerves, leading to muscle weakness, numbness, tingling sensations, and problems with balance and coordination. The symptoms typically affect both sides of the body symmetrically, starting in the legs and potentially spreading to the arms. The condition can fluctuate in severity over time, with periods of worsening and improvement.
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