Not recruitingRare disease

Study on the Safety and Effectiveness of ABC008 for Patients with Inclusion Body Myositis

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 disease called Inclusion Body Myositis (IBM), which is a condition that causes muscle weakness and wasting. The study is testing a new treatment called ABC008, 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 case, ABC008 is designed to bind to a specific receptor on certain immune cells, potentially helping to manage the symptoms of IBM.

The purpose of the study is to determine how effective and safe ABC008 is for people with IBM. Participants in the study will receive either the ABC008 treatment or a placebo, which is a substance with no active medication. The study will last for a period of 76 weeks, during which participants will receive the treatment through injections under the skin. Throughout the study, researchers will monitor the participants' muscle function and overall health to assess the impact of the treatment.

In addition to evaluating the effectiveness of ABC008, the study will also look at the safety and tolerability of the treatment. This means that researchers will carefully observe any side effects or reactions participants may experience. The study aims to provide valuable information about the potential benefits and risks of using ABC008 for treating Inclusion Body Myositis, which could lead to new treatment options for those affected by this condition.

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
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including age, weight, and a diagnosis of inclusion body myositis (IBM).
A negative COVID-19 test is required within 48 hours before the first day of the study.
Step 2
Baseline assessments
Initial assessments are conducted to establish baseline measurements. These include the IBM Functional Rating Scale (IBMFRS) and other physical tests.
Women of childbearing potential must have a negative pregnancy test at this stage.
Step 3
Treatment phase
Participants receive either the test product ABC008 or a placebo through subcutaneous injection. The dosage and frequency are determined by the study protocol.
The primary goal is to evaluate the effectiveness of ABC008 in improving IBM symptoms over a period of 76 weeks.
Step 4
Monitoring and follow-up
Regular monitoring is conducted to assess the safety and tolerability of the treatment. This includes tracking any adverse effects.
Participants are evaluated periodically using the IBMFRS and other measures to track changes from the baseline.
Step 5
End of treatment and recovery
At the end of the treatment phase, the recovery of specific immune cells is assessed to understand the long-term effects of the treatment.
Participants are monitored for any lasting effects or recovery of symptoms after the treatment ends.

Who can join the trial?

12 criteria

Must be an adult male or female over 40 years old at the time of the first dose of the study medication.
Must be able to read, understand, and sign a consent form before any study-related procedures begin.
Must have a diagnosis of **inclusion body myositis (IBM)**, which is a specific muscle condition, confirmed by certain medical criteria and tests.
Must weigh more than 40 kg and less than 150 kg.
Must be able to stand up from a standard armchair using their arms but without help from another person or device, like a cane, during the screening and at the start of the study.
Must be able to walk three meters, turn around, walk back to the chair, and sit down, with or without a walking aid, but without support from another person, furniture, or a wall.
Must agree to follow local guidelines to reduce exposure to the virus that causes COVID-19 from the first screening visit until the end of the study.
Must have a negative COVID-19 test result within 48 hours before the start of the study.
Must agree to avoid contact with anyone suspected or known to have an infectious disease from the first screening visit until the end of the study.
Women who can have children and men with female partners who can have children must agree to use highly effective birth control methods for at least 30 days before the first dose, during the study, and for 180 days after the study ends.
Men must agree not to donate sperm during the study and for 180 days after the study ends.
Women who can have children must have a negative blood pregnancy test at the screening and a negative urine pregnancy test at the start of the study.

Who cannot join the trial?

8 criteria

Patients who have a different condition than inclusion body myositis cannot participate. This is a specific muscle disease.
Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
Patients who are not able to follow the study procedures or attend the required visits cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who have allergies or reactions to the study medication or similar medications cannot participate.
Patients who are unable to give informed consent, meaning they cannot understand and agree to the study details, cannot participate.

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Verified sites

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

Universitaetsklinikum Duesseldorf AöR
Verified
Duesseldorf, Germany
University Hospitals Pitie Salpetriere Charles Foix
Verified
Paris, France

Trial locations

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Investigated drugs

ABC008 is an investigational medication being studied for its potential to treat Inclusion Body Myositis (IBM). This medication is administered through subcutaneous injections. The trial aims to assess how effective ABC008 is in improving muscle function in patients with IBM, as measured by a specific scale called the IBM Functional Rating Scale. Additionally, the study is evaluating the safety and tolerability of ABC008, ensuring that it is safe for patients to use. Another aspect of the trial is to observe how the body recovers after treatment, particularly focusing on certain immune cells affected by the medication.

ULVIPRUBART

What is already known about the treatment

ABC008 – This medication is administered subcutaneously, meaning it is injected under the skin. It is currently being studied in clinical trials for its effectiveness and safety in treating inclusion body myositis, a muscle disorder. The main therapeutic indication for ABC008 is to improve muscle function in patients with this condition. At the molecular level, ABC008 works by targeting and depleting specific immune cells known as KLRG1+ cells, which are thought to play a role in the disease. It is classified pharmacologically as an immunomodulatory agent.

Investigated diseases

Inclusion Body Myositis – Inclusion Body Myositis is a progressive muscle disorder characterized by muscle weakness and wasting. It primarily affects the muscles of the thighs, wrists, and fingers, leading to difficulties in walking, climbing stairs, and performing fine motor tasks. The disease progresses slowly over time, often resulting in significant muscle weakness and disability. It is more common in older adults and is considered a rare condition. The exact cause of Inclusion Body Myositis is not well understood, but it involves inflammation and degeneration of muscle fibers.