Recruiting

Study on Daratumumab for Reducing Symptoms in Patients with Moderate to Severe Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Verified siteRegistered drugNo placebo

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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 the effects of a medication called daratumumab on individuals with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). ME/CFS is a condition characterized by extreme fatigue that doesn't improve with rest and can worsen with physical or mental activity. The study will compare the effects of daratumumab, which is an anti-CD38 antibody, to a placebo. Daratumumab is administered as a solution for injection.

The purpose of the study is to evaluate how effective daratumumab is in reducing the symptoms of ME/CFS in patients who have moderate to severe forms of the condition. Participants in the study will receive either daratumumab or a placebo through subcutaneous injections, which means the medication is injected under the skin. The study will last for a period of 26 weeks, during which the participants' symptoms and overall health will be monitored closely.

Throughout the study, the participants' progress will be assessed using various measures, including their physical function and daily activity levels. The study aims to provide valuable insights into whether daratumumab can help alleviate the symptoms of ME/CFS and improve the quality of life for those affected by this challenging condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be informed about the trial's purpose, procedures, and potential risks and benefits. The patient will be required to sign an informed consent form, confirming understanding and willingness to participate.
Step 2
Initial assessment
The patient will undergo an initial assessment to confirm eligibility. This includes verifying the diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) according to specific criteria, ensuring the patient is between 18 and 64 years old, and confirming the duration of the disease is at least two years.
For women of childbearing potential, a negative serum pregnancy test is required, and effective contraception must be used for a specified period before and after the treatment.
Step 3
Baseline measurements
Baseline measurements will be taken to assess the patient's current health status. This includes recording the DSQ-SF total score, which measures the severity of symptoms, and other health indicators such as physical function and activity levels.
Step 4
Treatment administration
The patient will receive the treatment through subcutaneous injection. The medications used are daratumumab and hyaluronidase. The specific dosage and frequency will be determined by the study protocol and communicated to the patient.
The treatment aims to evaluate the efficacy of daratumumab in reducing ME/CFS symptoms compared to a placebo.
Step 5
Follow-up assessments
The patient will undergo regular follow-up assessments to monitor the course of the DSQ-SF total score and other health indicators. These assessments will continue until week 60 of the study.
Safety and any potential side effects will be continuously monitored throughout the trial period.
Step 6
Completion of the study
Upon completion of the study, the patient will have a final assessment to evaluate the overall response to the treatment. This includes measuring any changes in symptoms and physical function.
The study results will contribute to understanding the effectiveness of daratumumab in treating ME/CFS.

Who can join the trial?

8 criteria

Have a diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) based on Canadian guidelines, with symptoms that are moderate (mostly staying at home) to severe (partly bedridden).
Be between the ages of 18 and 64 years.
Provide a signed informed consent form, which means you agree to participate after understanding the study details.
Have had ME/CFS for at least two years.
Have a clear start of ME/CFS symptoms, which began after an infection or another trigger affecting the immune system.
For women who can have children: Have a negative blood pregnancy test.
For women who can have children: Use highly effective birth control for at least four weeks before starting treatment and continue for at least 24 weeks after the last injection.
Have a certain level of NK-cells (a type of immune cell) in your blood, specifically at least 125 x10⁹/L.

Who cannot join the trial?

10 criteria

Patients with any other serious medical condition that might interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent infection or illness that could affect the study results.
Patients who are pregnant or breastfeeding.
Patients who have a history of allergic reactions to the study medication or similar drugs.
Patients who have a history of substance abuse or dependency.
Patients who are unable to comply with the study procedures or follow-up visits.
Patients who have been diagnosed with a psychiatric disorder that could interfere with the study.
Patients who have received certain medications or treatments that could affect the study results.
Patients who have a history of cancer, except for certain types of skin cancer.

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Verified sites

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Verified
Helse Bergen HF
Bergen, Norway
Verified
Oslo Universitetssykehus HF
Oslo, Norway

Trial locations

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Investigated drugs

Daratumumab is a medication used in this clinical trial. It is an antibody that targets a specific protein called CD38, which is found on the surface of certain cells in the body. In this study, daratumumab is being tested to see if it can help reduce symptoms in patients with Myalgic Encephalomyelitis, also known as Chronic Fatigue Syndrome (ME/CFS). The goal is to see if this medication can improve the condition of people who have moderate to severe symptoms of ME/CFS.

What is already known about the treatment

Daratumumab – Daratumumab is administered as an injection, typically given intravenously, meaning it's delivered directly into the bloodstream through a vein. It is currently being studied in clinical trials for its potential use in treating Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), a condition characterized by extreme fatigue and other symptoms. The main therapeutic goal is to see if daratumumab can help reduce the symptoms of ME/CFS. At the molecular level, daratumumab works by targeting a specific protein called CD38 found on the surface of certain cells, which helps the immune system to attack and destroy these cells. It is classified as a monoclonal antibody, a type of medication designed to target specific proteins in the body.

Investigated diseases

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome – This disease is characterized by extreme fatigue that does not improve with rest and may worsen with physical or mental activity. It often includes symptoms such as muscle pain, memory problems, headaches, and unrefreshing sleep. The condition can lead to a significant reduction in daily activities and quality of life. Symptoms can vary in intensity and may come and go, making it difficult to predict the course of the disease. Over time, individuals may experience periods of improvement followed by relapses. The exact cause of the disease is not well understood, and it can affect people of all ages.