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

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What is this study about?

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.

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)

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

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

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

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 Study?

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
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
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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
AZ Sint-Lucas & Volkskliniek	Gent	Belgium
Hopital Beaujon	Clichy	France
Undiybuugjvkdvrsvpzhn Dgcrbppmyxo Acj	Duesseldorf	Germany

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	22.08.2025
France	Not recruiting	22.08.2025
Germany	Not recruiting	22.08.2025

Trial locations

Investigated drugs:

ULVIPRUBART

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.

Investigated diseases:

Inclusion body myositis

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.

Trial ID:

2024-517623-39-00

Protocol code:

ABC008-IBM-202

NCT ID:

NCT06450886

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?