Not recruitingRare disease

Title: Long-term safety and effectiveness study of Ulviprubart in patients with inclusion body myositis who completed previous treatment

Verified siteInvestigational

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on evaluating a treatment for people with inclusion body myositis, a rare muscle disorder that causes progressive muscle weakness and wasting. The medication being tested is called ulviprubart (also known as ABC008), which is given as a subcutaneous injection under the skin. This is a long-term study to understand how safe and effective the treatment is over an extended period.

The study is designed for patients who have already completed previous trials of ulviprubart. During the study, participants will receive regular injections of the medication and will be monitored for any side effects. The treatment period may last up to 152 weeks, with participants receiving 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 ulviprubart. The study will track any changes in muscle strength and function throughout the treatment period. The medication being tested is a specialized type of antibody that has been designed to target specific proteins involved in the disease process of inclusion body myositis.

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
Initial visit and qualification
You will be asked to provide signed informed consent before any study procedures begin
A pregnancy test will be performed if you are a woman who can become pregnant
Your eligibility will be confirmed based on your completion of previous studies (ABC008-IBM-101 or ABC008-IBM-201)
Step 2
Treatment initiation
You will receive ulviprubart, a medication given by injection under the skin (subcutaneous injection)
Regular visits to the study site will be required for injections and assessments
The study will continue from August 2025 to September 2028
Step 3
Ongoing safety monitoring
Your health will be monitored throughout the study for any side effects
Regular laboratory tests and vital signs checks will be performed
Any unusual health events will be recorded and evaluated
Step 4
Effectiveness measurements
Your muscle function will be evaluated regularly using specific tests
Changes in your physical abilities will be tracked throughout the study
Your progress will be measured compared to your starting condition
Step 5
Safety requirements
If you can become pregnant or have a partner who can become pregnant, you must use reliable birth control during the study and for 180 days after the last dose
Male participants must not donate sperm during the study and for 180 days after the last dose
Regular attendance at scheduled study visits is required

Who can join the trial?

10 criteria

Must be able to read, understand, and sign an informed consent form before any study procedures begin
Must have completed participation in either study ABC008-IBM-101 or study ABC008-IBM-201, including all required follow-up visits
Must have shown good compliance with study procedures during previous participation, as determined by the study doctor
check
Must be willing and able to:
- Travel to the study site for assessments
- Receive subcutaneous (under the skin) injections of the study medication
- Follow all study requirements
- check
  For women who can become pregnant and men with female partners who can become pregnant:
  - Must use highly effective birth control (less than 1% failure rate)
  - Must continue birth control throughout the study and for 180 days after the last dose
  - Women who can become pregnant must have a negative pregnancy test when starting the study
  - Male participants must not donate sperm during the study and for 180 days after the last dose

Who cannot join the trial?

15 criteria

Age below 18 years old or above 80 years old
History of severe allergic reactions to medications
Currently participating in other clinical trials
Pregnant or breastfeeding women
Having uncontrolled medical conditions (such as high blood pressure, diabetes, or heart disease that is not well managed)
Recent surgery within the past 3 months
Current active infection requiring treatment
History of cancer in the past 5 years (except for successfully treated skin cancer)
Significant kidney or liver problems
Taking medications that could interact with the study drug
Unable to follow study procedures or attend scheduled visits
History of drug or alcohol abuse within the past year
Mental conditions that could interfere with providing informed consent
Abnormal laboratory test results that could indicate health issues
Previous treatment with similar medications to the study drug

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Verified sites

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

Verified
Hopital Beaujon
Clichy, France
Verified
Universitaetsklinikum Duesseldorf AöR
Duesseldorf, Germany

Trial locations

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Investigated drugs

Ulviprubart (also known as ABC008) is an investigational medication being studied for the treatment of inclusion body myositis, a progressive muscle disorder. This medication is being evaluated to understand its long-term safety and effectiveness in patients who have previously participated in trials using this treatment. The medication is designed to help manage the symptoms of inclusion body myositis, a condition that causes muscle weakness and wasting.

ULVIPRUBART

What is already known about the treatment

Ulviprubart (ABC008) – An investigational medication administered for the treatment of inclusion body myositis, a rare progressive muscle disorder. This drug is currently being studied in clinical trials to evaluate its long-term safety and effectiveness in patients who have previously participated in ulviprubart trials. While the exact molecular mechanism is still under investigation, it is being developed as a targeted therapy specifically for managing the symptoms and progression of inclusion body myositis. The medication represents a novel therapeutic approach in the field of neuromuscular disorders, where treatment options are currently limited.

Investigated diseases

Inclusion Body Myositis - A progressive muscle disorder that primarily affects skeletal muscles, particularly those of the arms, legs, and throat. It is characterized by the gradual weakening and wasting of muscles, especially those in the thighs, fingers, and wrists. The condition typically develops slowly over years, with muscle weakness becoming more noticeable over time. People with this condition may experience difficulty with activities like gripping objects, climbing stairs, or rising from seated positions. The disease usually affects people over 50 years of age and is more common in men than women.