Study on Nipocalimab for Adults with Active Inflammatory Muscle Diseases

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What is this study about?

This clinical trial is focused on studying a group of diseases known as Idiopathic Inflammatory Myopathies (IIM). These are rare conditions that cause muscle inflammation and weakness. The study will evaluate a treatment called nipocalimab, which is being tested to see if it can help people with active IIM. Nipocalimab is given as a solution for infusion, meaning it is administered directly into the bloodstream through a vein.

The purpose of the study is to assess how effective and safe nipocalimab is compared to a placebo in treating IIM. Participants in the study will receive either nipocalimab or a placebo, and the effects will be monitored over a period of time. The study will last for up to 52 weeks, during which participants will have regular check-ups to track their progress and any changes in their condition.

Throughout the study, researchers will look for improvements in muscle strength and overall health. The goal is to determine if nipocalimab can provide significant benefits for those living with IIM, potentially offering a new treatment option for managing this challenging condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm the diagnosis of idiopathic inflammatory myopathies (IIM). This involves meeting specific diagnostic criteria established by medical guidelines.

The assessment includes checking for the presence of certain antibodies related to the condition. If the initial test results are inconclusive, a retest may be required.

2 stabilization of current treatment

If currently using low potency topical treatments for skin lesions, the dosage and frequency must remain stable for at least four weeks before starting the study medication. This stability must be maintained until Week 52 of the study.

3 medication administration

The study involves the administration of nipocalimab or a placebo. Nipocalimab is given as a solution for infusion, which means it is administered directly into the bloodstream through a vein.

The specific dosage and frequency of administration will be determined by the study protocol and communicated during the trial.

4 monitoring and evaluation

Throughout the study, regular monitoring is conducted to evaluate the effectiveness and safety of the treatment. This includes assessing improvements in symptoms and any potential side effects.

The primary goal is to achieve at least a minimal improvement in the condition by Week 52, with a reduction in the use of oral prednisone or its equivalent.

5 completion of study

The study is expected to conclude by March 2027. At the end of the study, a final assessment will be conducted to determine the overall effectiveness and safety of the treatment.

Who Can Join the Study?

The participant must have a condition called Active Idiopathic Inflammatory Myopathies (IIM), which is a type of muscle inflammation.
The participant must meet specific criteria for diagnosing IIM, based on guidelines from 2017, at least 6 weeks before starting the study treatment.
If the participant is using certain skin treatments like low-strength topical glucocorticoids or topical tacrolimus, the dose and frequency must be stable for at least 4 weeks before starting the study treatment and should remain the same until Week 52 of the study.
The participant must have specific antibodies related to muscle inflammation. These are proteins in the blood that can indicate certain types of muscle inflammation. If the tests for these antibodies are negative or show more than one type, they will be repeated. If the same results occur again, the participant cannot join the study.
Both male and female participants are eligible for the study.
The study includes participants from vulnerable populations, which means people who might need extra protection or care.

Who Cannot Join the Study?

Having any other serious health condition that could interfere with the study.
Being pregnant or breastfeeding.
Having a history of severe allergic reactions to medications.
Using certain medications that might affect the study results.
Having a recent infection that requires treatment.
Having a history of drug or alcohol abuse.
Participating in another clinical trial recently.
Having a condition that affects the immune system, which is the body’s defense against illness.
Having a history of cancer, except for some types of skin cancer.
Having a blood disorder, which is a problem with the blood.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Revmatologicky Ustav	Prague	Czechia
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy	Bydgoszcz	Poland
University Of Debrecen	Debrecen	Hungary
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Centre Hospitalier Universitaire De Nice	Nice	France
Hopital Beaujon	Clichy	France
Himryesf Umvqebhidjkun Mkqzgog Dh Vntnmxtbok	Santander	Spain
Ivsxwnrn Kfwdpd Reimwbkaoqy	Rüdersdorf	Germany
Njthusmm Iosxayle Ghfywuczy Rvnhgzbhfxxb I Rzhrwwgyosruc Ix Pzaof Dx Hyrm Mbfo Echepkyy Rfwuzev	Warsaw	Poland
Kkarller dzv Uxwftxykcgod Mwgzwrjm Aqa	Munich	Germany
Hcqwumbb Ukfupdtkxjiwpf Svidykcpyn &rxjhzi Havuman dq Hhmcffclfmn	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	30.01.2023
France	Not recruiting	30.01.2023
Germany	Not recruiting	30.01.2023
Hungary	Not recruiting	30.01.2023
Italy	Not recruiting	30.01.2023
Poland	Not recruiting	30.01.2023
Spain	Not recruiting	30.01.2023

Trial locations

Investigated drugs:

Nipocalimab

Nipocalimab is a medication being studied for its potential to help people with active idiopathic inflammatory myopathies, which are a group of diseases that cause muscle inflammation and weakness. The trial aims to see how effective and safe nipocalimab is for treating these conditions.

Idiopathic Inflammatory Myopathies – These are a group of rare muscle diseases characterized by chronic muscle inflammation and weakness. The exact cause is unknown, but they are believed to involve the immune system attacking the body’s own muscle tissues. Symptoms often include muscle pain, fatigue, and difficulty with movements such as climbing stairs or lifting objects. Over time, the muscle weakness can progress, affecting daily activities and quality of life. The condition can vary greatly in severity and may involve other organs, such as the skin or lungs. Diagnosis is typically based on clinical evaluation, muscle biopsy, and other tests to rule out other conditions.

Trial ID:

2023-505314-20-00

Protocol code:

80202135IIM2001

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Nipocalimab for Adults with Active Inflammatory Muscle Diseases

What is this study about?

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