An Open-label, Multicenter Study to Evaluate the Long-term Safety and Efficacy of Ulviprubart (ABC008) in Subjects Who Have Completed a Trial of Ulviprubart for the Treatment of Inclusion Body Myositis
Inclusion body myositis (IBM) is a rare, long-term condition that causes progressive muscle weakness, particularly in the arms and legs. This Phase 3 clinical trial is testing a medicine called ulviprubart (also called ABC008) to understand how safe and effective it is over a longer period. The study is 'open-label', meaning there is no dummy treatment (placebo). Everyone who joins will receive ulviprubart. The trial is only open to adults who have already completed an earlier study testing the same medicine. Doctors will keep a very close eye on participants' health. They will track any side effects, perform regular blood tests, and measure muscle strength and daily physical function. The goal is to see whether ulviprubart can safely help slow down muscle weakness and support daily living for people with IBM over time.
At a glance
What is this study about?
Inclusion body myositis (IBM) is a condition that leads to slow, steady muscle weakening. It often affects the hands, forearms, and thighs, which can make simple tasks like climbing stairs, standing up, or gripping objects difficult. At present, there are very few treatments that can stop or reverse this muscle loss, so finding new medicines is vital.
This study is testing an experimental medicine known as ulviprubart (ABC008). Ulviprubart is designed to target specific cells in the immune system that attack muscle tissue in people with IBM. Researchers want to know if treating patients with this medicine over a longer period can safely protect muscle function and help them stay independent.
Because this is an extension study, it offers continued treatment to patients who have already completed an earlier trial with ulviprubart. It will give researchers important information about whether the drug continues to work well over time and whether any new or unexpected side effects appear with long-term use.
Key takeaways
- Tests the long-term safety and benefit of ulviprubart for inclusion body myositis (IBM).
- Only open to adults aged 18 and older who completed a previous ulviprubart trial.
- This is an open-label trial, so all participants receive the active study medicine.
- Doctors will regularly monitor side effects, muscle strength, and daily physical function.
- Taking part is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is not open to the general public. To be eligible, you must be aged 18 or older and have already taken part in and fully completed a previous clinical trial for ulviprubart.
Because this is a follow-on trial, your study doctor will also check that your health remains stable enough to continue receiving the medicine. Both men and women can participate, provided they meet the original medical requirements from the previous trial.
If you have not taken part in an earlier ulviprubart trial, you will not be able to join this specific study. Your hospital doctor or trial team can confirm whether you took part in the qualifying study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have a confirmed diagnosis of inclusion body myositis (IBM).
- I have already taken part in and completed an earlier clinical trial for ulviprubart (ABC008).
- I am able and willing to attend regular hospital check-ups and safety visits.
What does participation involve?
Taking part involves attending regular clinic visits at a hospital or trial centre. During these visits, you will receive your dose of ulviprubart. The study team will check your general health, measure your blood pressure and pulse, and take regular blood and urine samples to make sure the medicine is not causing harm. You will also have gentle physical checks to test your muscle strength and answer questions about how well you manage everyday activities like walking or dressing. The study will last for an extended period, and the study team will explain the exact schedule of visits and follow-up checks before you decide to continue.
Potential risks and benefits
Locations (3)
- —UnverifiedGermany
- —UnverifiedBelgium
- —UnverifiedFrance
Common questions
What is an open-label study?
An open-label study means that both you and your medical team know which medicine you are receiving. There are no dummy drugs or placebos used in this trial.
Can anyone with inclusion body myositis join?
No. This trial is only open to people who have already taken part in and completed an earlier clinical trial testing ulviprubart.
Will I have to pay for the study medicine?
No, the study medication and all trial-related tests are provided free of charge.
What happens if I experience side effects?
The study team will monitor you closely at every visit. If you feel unwell or develop side effects, you should contact the trial team straight away, and they will give you appropriate medical care.
Can I leave the study early?
Yes, you have the right to withdraw from the study at any point. Your decision will not change the standard of healthcare you receive from the NHS.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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