Ongoing Clinical Trials for Inclusion Body Myositis
There are currently 3 ongoing clinical trials investigating new treatments for Inclusion Body Myositis, a progressive muscle disorder that causes muscle weakness and wasting. These trials are being conducted in Belgium, France, and Germany, testing different investigational medications aimed at improving muscle function and slowing disease progression.
Clinical trial locations
- Belgium
- France
- Germany
Study on Ruxolitinib for Treating Inclusion Body Myositis in Patients
This trial is investigating whether ruxolitinib, a medication that works by blocking certain proteins involved in inflammation, can help improve movement and muscle function in people living with this condition. The study is taking place in France and will last for one year.
Who can join: This study is open to adults aged 45 years or older who have a confirmed diagnosis based on specific criteria, including muscle biopsy results showing inflammation and characteristic changes in muscle tissue. Participants must have weakness in their finger flexor muscles or thigh muscles, and be able to walk for six minutes without assistance from another person, though walking aids like canes or walkers are permitted. Women who can become pregnant must use effective birth control during the study.
Who cannot join: People without a confirmed diagnosis, those outside the specified age range, and individuals considered part of vulnerable populations are not eligible for this trial.
What the trial involves: Participants will take ruxolitinib tablets or a placebo by mouth for one year. The main goal is to see if patients can walk at least 60 meters farther during a six-minute walking test after one year of treatment compared to when they started. Researchers will also measure muscle strength using special equipment, assess overall muscle function using various scales, and evaluate quality of life throughout the study.
Investigational medication: Ruxolitinib is a JAK inhibitor that blocks enzymes responsible for signaling pathways that lead to inflammation and muscle damage. This medication is being tested to see if reducing inflammation can help preserve muscle function and improve mobility.
Study on the Safety and Effectiveness of ABC008 for Patients with Inclusion Body Myositis
This trial is examining ABC008, a monoclonal antibody designed to target specific immune cells that may be involved in the disease process. The study is being conducted in Germany, France, and Belgium over a period of 76 weeks.
Who can join: Adults over 40 years old who weigh between 40 kg and 150 kg and have a confirmed diagnosis are eligible. Participants must be able to stand up from a standard armchair using their arms without help from another person or device, and be able to walk three meters, turn around, walk back, and sit down with or without a walking aid. A negative COVID-19 test within 48 hours before starting the study is required. Women of childbearing potential must have negative pregnancy tests, and both men and women must agree to use highly effective birth control methods during the study and for 180 days afterward.
Who cannot join: People with other muscle conditions, those outside the specified age range, pregnant or breastfeeding women, individuals with allergies to the study medication, those unable to give informed consent, people with serious health conditions that might interfere with the study, and recent participants in other clinical trials may not be eligible.
What the trial involves: Participants will receive ABC008 or a placebo through injections under the skin. The primary goal is to evaluate whether ABC008 improves muscle function as measured by the IBM Functional Rating Scale. The study will also carefully monitor safety and tolerability, tracking any side effects or reactions. Additionally, researchers will observe how the body’s immune system recovers after treatment ends.
Investigational medication: ABC008 is an immunomodulatory agent that works by targeting and depleting specific immune cells called KLRG1+ cells, which are believed to play a role in the disease process. This approach aims to reduce the inflammation and muscle damage associated with the condition.
Long-term safety and effectiveness study of Ulviprubart in patients with inclusion body myositis who completed previous treatment
This is a long-term follow-up study for patients who have already participated in previous trials of ulviprubart (also known as ABC008). The study is being conducted in Belgium, Germany, and France, and may last up to 152 weeks.
Who can join: This trial is specifically for patients who have completed participation in previous ulviprubart studies and showed good compliance with study procedures. Participants must be able to travel to the study site for regular assessments and receive subcutaneous injections. Women who can become pregnant and men with female partners who can become pregnant must use highly effective birth control throughout the study and for 180 days after the last dose. Women of childbearing potential must have a negative pregnancy test when starting the study, and male participants must not donate sperm during the study and for 180 days afterward.
Who cannot join: Individuals aged below 18 or above 80 years, those with a history of severe allergic reactions to medications, people currently participating in other clinical trials, pregnant or breastfeeding women, those with uncontrolled medical conditions, recent surgery within the past three months, current active infections, history of cancer in the past five years (except successfully treated skin cancer), significant kidney or liver problems, mental conditions that could interfere with providing consent, and those with a history of drug or alcohol abuse within the past year are not eligible.
What the trial involves: Participants will receive regular injections of ulviprubart under the skin at doses up to 2.0 milligrams per kilogram of body weight. The main goal is to evaluate the long-term safety and how well patients tolerate the medication over an extended period. Throughout the study, researchers will monitor for any side effects, perform regular laboratory tests and vital sign checks, and track changes in muscle function and physical abilities compared to baseline measurements.
Investigational medication: Ulviprubart is a targeted therapy specifically designed for managing the symptoms and progression of this muscle disorder. While the exact molecular mechanism is still under investigation, it represents a novel therapeutic approach in the field of neuromuscular disorders, where treatment options are currently limited.
Summary
The three ongoing clinical trials for Inclusion Body Myositis are testing different therapeutic approaches to address this challenging muscle disorder. Two of the trials focus on ABC008/ulviprubart, with one being a long-term extension study for patients who have already received this treatment, while another trial is investigating ruxolitinib, a different type of medication.
Geographically, the trials are concentrated in Western Europe, with France participating in all three studies, while Germany and Belgium are involved in the ABC008/ulviprubart trials. This concentration of research efforts in these countries suggests strong scientific and clinical infrastructure for studying rare neuromuscular disorders in these regions.
All three trials share similar goals of improving muscle function and assessing safety, though they use different approaches. The ruxolitinib trial focuses on reducing inflammation through JAK inhibition, while the ABC008/ulviprubart trials target specific immune cells thought to be involved in the disease process. These different mechanisms of action reflect the ongoing search for effective treatments for this progressive and currently incurable condition.
Patients interested in participating should note that each trial has specific eligibility requirements, including age restrictions, functional abilities, and the need for effective birth control in those of childbearing potential. The trials vary in duration from one year to nearly three years, representing both shorter efficacy studies and longer-term safety assessments.
