Study on Ruxolitinib for Treating Inclusion Body Myositis in Patients

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What is this study about?

This clinical trial is focused on studying the effects of a medication called ruxolitinib, also known by its code name INCB018424, in treating a condition called Inclusion Body Myositis (IBM). IBM is a rare muscle disease that causes muscle weakness and inflammation. The purpose of the study is to see if ruxolitinib can improve the ability of patients with IBM to move around after one year of treatment.

Participants in the study will receive either ruxolitinib or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for one year, during which participants will take the medication in the form of tablets. The main goal is to see if there is an improvement in the distance patients can walk in six minutes after the treatment period. Additionally, the study will monitor the safety and tolerance of ruxolitinib in patients with IBM, as well as any changes in muscle strength and overall muscle health.

Throughout the study, various assessments will be conducted to evaluate the effects of the treatment on the quality of life and muscle function of the participants. These assessments will include measurements of muscle strength, walking distance, and other indicators of muscle health. The study aims to provide valuable information on whether ruxolitinib can be an effective treatment option for people living with Inclusion Body Myositis.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of inclusion body myositis (IBM), and ability to walk for 6 minutes without assistance from another person.

Consent for participation is required, which may be assisted by a trusted person.

2 treatment initiation

The treatment involves taking Jakavi 15 mg tablets or a placebo orally. The medication is administered in tablet form.

The main objective is to evaluate whether ruxolitinib can improve overall movement performance in patients with IBM over a one-year treatment period.

3 treatment duration

The treatment period lasts for one year. During this time, the patient continues to take the assigned medication as directed.

4 evaluation of primary endpoint

The primary endpoint is the improvement of 60 meters in the distance walked during a 6-minute walk test from the start of the study to 12 months later.

5 evaluation of secondary endpoints

Secondary endpoints include assessing the safety and tolerance of ruxolitinib in IBM patients, measuring muscle strength, overall muscle status, and quality of life.

Muscle strength is evaluated using a dynamometer to measure the maximal voluntary isometric muscle strength for hand grip, knee extension and flexion, and elbow flexion and extension.

Overall muscle status is assessed through various indices and scales, including the IBM Weakness Composite Index and the IBM Functional Rating Scale.

Quality of life is evaluated using the Health Assessment Questionnaire without Disability Index and the Duke health profile.

6 completion of the study

The study is estimated to end on January 30, 2028. At this point, all evaluations and assessments are completed, and the data is analyzed to determine the effectiveness and safety of the treatment.

Who Can Join the Study?

Must be 45 years or older.
Women who can have children must use effective birth control during the study and agree to follow the birth control rules in the study plan.
Must have a confirmed diagnosis of Inclusion Body Myositis (IBM) based on specific criteria, which include:
- Weakness in the finger flexor muscles or quadriceps (thigh muscles).
- A muscle biopsy (a small sample of muscle tissue) showing endomysial inflammation (inflammation within the muscle tissue).
- A muscle biopsy showing invasion of nonnecrotic muscle fibers (muscle fibers that are not dead) or rimmed vacuoles (small cavities in the muscle fibers).
Must be able to walk for 6 minutes without help from another person. You can use devices like canes, walkers, or rollators.
Must be informed about the study and have signed a consent form to participate, possibly with help from a trusted person.

Who Cannot Join the Study?

Patients who are not diagnosed with Inclusion Body Myositis cannot participate. Inclusion Body Myositis is a condition that affects the muscles, causing weakness.
Patients who are not within the specified age range cannot participate. The trial is open to adults and older adults.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups that may need special protection, like children or those unable to make decisions for themselves.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier De La Cote Basque	Bayonne	France
Cnlupq Hcejnvulnzz Uavmuvwdltdxn Rpjuf	Reims	France
Chexjb Hxyghjwpwkd Ey Ufqvizbikuxjr Dy Ldwzlxx	Limoges	France
Awgxgwcfbi Puthunhs Hxzcukmm Dy Mtenzefkq	Marseille	France
Ciik De Nbzsb	Vandoeuvre Les Nancy	France
Imybudik dl Cksyznyscfxx Hiixoufpqsl Ucygepkqxzllw dl Sjpal Excchec (crcjyiy	Saint Priest En Jarez	France
Bcqhkaeb Uckhunvhdo Hbqivqhf Cjfckd	Besançon	France
Cyygcs Hnfzyotbckp Rjigzfqg Dnopuvgfpunczn	Angers	France
Hdeeyvto Ulsamuopdpksfj Szsuovdzxl &jfcwbb Hidrpdd dc Hkilbzholbh	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	16.09.2024

Trial locations

Investigated drugs:

Ruxolitinib

Ruxolitinib is a medication being studied in this trial to see if it can help improve movement abilities in patients with Inclusion Body Myositis (IBM). It works by blocking certain proteins in the body that can cause inflammation and muscle damage. The goal is to see if taking ruxolitinib for one year can make it easier for patients to move and perform daily activities.

Investigated diseases:

Inclusion body myositis

Inclusion Body Myositis – Inclusion Body Myositis is a progressive muscle disorder characterized by muscle weakness and wasting. It primarily affects the muscles of the arms and legs, leading to difficulties in walking, climbing stairs, and performing tasks that require fine motor skills. The disease progresses slowly, often over many years, and can lead to significant disability. Muscle weakness typically begins in the quadriceps and finger flexors, and over time, other muscles may become involved. The exact cause of Inclusion Body Myositis is not fully understood, but it is believed to involve both inflammatory and degenerative processes.

Trial ID:

2023-507666-32-00

Protocol code:

APHP220829

NCT ID:

NCT06536166

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Ruxolitinib for Treating Inclusion Body Myositis in Patients

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