Not recruitingRare disease

Study on the Safety and Efficacy of Empasiprubart for Adults with Dermatomyositis

Fast replyInvestigationalNo 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 a condition called Dermatomyositis, which is a rare inflammatory disease that affects the skin and muscles. The study will evaluate a treatment called Empasiprubart, also known by its code name ARGX-117. This treatment is given as a concentrate for solution for infusion, meaning it is administered directly into the bloodstream through a vein. The purpose of the study is to assess the safety and tolerability of Empasiprubart compared to a placebo in adults with Dermatomyositis.

Participants in the study will receive either Empasiprubart or a placebo. The study is designed to be double-blinded, which means neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are not biased. The study will take place over a period of up to 90 weeks, with participants being monitored for any adverse events, which are any unwanted effects that might occur during the study. The study will also measure how many participants stop taking the study medication due to these adverse events within the first 25 weeks.

Throughout the study, researchers will also evaluate the improvement in participants' conditions using a measure called the Total Improvement Score (TIS) at specific intervals, such as weeks 13 and 25. This score helps determine how well the treatment is working in improving the symptoms of Dermatomyositis. The study aims to provide valuable information on the potential benefits and risks of using Empasiprubart as a treatment option for this 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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of dermatomyositis and ensuring compliance with background treatment requirements.
Participants must have received specific vaccinations at least 14 days before the first administration of the study drug.
Step 2
Randomization and treatment assignment
Participants are randomly assigned to receive either the study drug empasiprubart or a placebo. This process is double-blinded, meaning neither the participant nor the study team knows which treatment is being administered.
Step 3
Treatment administration
The study drug, ARGX-117, or placebo is administered through an intravenous infusion. The frequency and dosage are determined by the study protocol and are monitored by the study team.
Step 4
Monitoring and follow-up
Participants are monitored for any adverse events throughout the study period, which can last up to 90 weeks. Regular follow-up visits are scheduled to assess safety and tolerability.
The primary focus is on the incidence of adverse events and the percentage of participants discontinuing the treatment due to these events.
Step 5
Efficacy evaluation
The efficacy of the treatment is evaluated using the Total Improvement Score (TIS) at weeks 13 and 25. This score helps determine the effectiveness of the treatment in improving symptoms of dermatomyositis.
Step 6
Study completion
Upon completion of the study, participants undergo a final assessment to evaluate overall outcomes and any long-term effects of the treatment.

Who can join the trial?

8 criteria

Must be at least 18 years old and meet the local legal age for giving consent to participate in clinical studies.
Must be able to provide signed consent and follow the study's rules.
Must agree to use birth control methods as required by local laws. Women who can have children must have a negative pregnancy test before starting the study.
Must have a clinical diagnosis of **dermatomyositis** or **juvenile dermatomyositis**. If diagnosed with juvenile dermatomyositis, it should have been diagnosed 5 years or less before joining the study.
Must have active muscle disease related to classic dermatomyositis or juvenile dermatomyositis. This means having at least one of the following: high levels of certain enzymes in the blood (like creatine kinase, aldolase, lactate dehydrogenase, aspartate aminotransaminase, or alanine aminotransferase), an **electromyography** test showing muscle issues, an **MRI** showing muscle inflammation, or a muscle biopsy showing active inflammation, all within 18 weeks before starting the study.
Must have at least mild skin disease at the time of joining the study.
Must follow the allowed treatments for dermatomyositis at the time of joining the study.
Must have received certain vaccines (meningococcal, pneumococcal, and Haemophilus influenza type B) at least 14 days before starting the study.

Who cannot join the trial?

8 criteria

Patients who have a different condition than dermatomyositis cannot participate. Dermatomyositis is a condition that causes muscle weakness and skin rash.
Patients who are not adults are excluded. This means only people who are 18 years or older can join.
Patients who are not able to understand or follow the study instructions will not be able to participate.
Patients who have other serious health issues that might interfere with the study will be excluded.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who are currently participating in another clinical trial are not allowed to join.
Patients who have had a recent change in their medication for dermatomyositis may not be eligible.
Patients who have a history of allergic reactions to similar medications will be excluded.

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Verified sites

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

Responsive
Azienda Ospedaliero-Universitaria Sant Andre
Rome, Italy
Verified
Azienda Unita Sanitaria Locale Di Bologna
Bologna, Italy
Verified
Hospital Del Mar
Barcelona, Spain

Trial locations

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Investigated drugs

Empasiprubart is a medication being studied for its potential to help adults with dermatomyositis, a condition that causes muscle weakness and skin rashes. The trial aims to see how safe and tolerable this medication is for patients, as well as how effective it might be in treating the symptoms of dermatomyositis.

Empasiprubart

What is already known about the treatment

Empasiprubart – Empasiprubart is administered orally and is currently being studied in clinical trials for its safety and effectiveness in treating dermatomyositis, a type of inflammatory muscle disease. It is not yet widely recognized in medical literature as it is still under investigation. The main therapeutic indication for empasiprubart is dermatomyositis, where it aims to reduce inflammation and improve muscle function. At the molecular level, empasiprubart works by modulating immune responses, potentially reducing the activity of immune cells that contribute to muscle inflammation. It is classified pharmacologically as an immunomodulatory agent.

Investigated diseases

Dermatomyositis – Dermatomyositis is an inflammatory disease characterized by muscle weakness and a distinctive skin rash. The condition primarily affects the muscles and skin, leading to symptoms such as muscle pain, fatigue, and difficulty with physical activities. The skin rash often appears as a purplish or red discoloration, typically on the face, knuckles, and other areas exposed to sunlight. Over time, the muscle weakness can progress, affecting the ability to perform everyday tasks. The exact cause of dermatomyositis is not well understood, but it is believed to involve an autoimmune response. The disease can vary in severity, with some individuals experiencing mild symptoms and others facing more significant challenges.