Active not recruitingPHASE2INTERVENTIONAL

A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies

This research study is investigating an experimental drug named Nipocalimab for adults who have idiopathic inflammatory myopathies (IIM), also known as myositis. These conditions cause muscle weakness and inflammation. The main goal is to find out if Nipocalimab is effective and safe compared to a placebo (a dummy treatment). Participants will also be receiving standard treatments like glucocorticoids. By comparing the new drug to a placebo, researchers hope to understand if Nipocalimab could be a helpful new option for managing the symptoms of active IIM. It's a 'Phase 2' study, meaning it's still in the earlier stages of testing.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Janssen Research & Development, LLC

Enrolment target

Start

05 Jul 2022

Estimated completion

16 Sep 2026

Myositis

What is this study about?

This study is designed to explore a new treatment called Nipocalimab for people who have a group of conditions known as idiopathic inflammatory myopathies (IIMs), or myositis. These are conditions where your body's immune system mistakenly attacks your muscles (and sometimes other parts of the body), leading to weakness, pain, and inflammation. The aim is to see if Nipocalimab can help improve symptoms and is safe to use in people whose condition is currently active.

You might be wondering what Nipocalimab is. It's an experimental drug, which means it's still being tested and isn't yet available as a standard treatment. In this study, some people will receive Nipocalimab, while others will receive a placebo – which looks exactly like the study drug but contains no active medicine. This is a common way to accurately test if a new drug works better than no treatment at all. All participants will also continue with their usual care, which may include steroid medications (glucocorticoids).

This is a 'Phase 2' study. This means it's an important step in developing new medicines. Researchers are looking for early signs of how well the drug works and checking its safety in a larger group of people than in a Phase 1 study. The findings from this study will help decide if Nipocalimab should be studied further in even larger trials.

Key takeaways

This study is for adults with active inflammatory myopathies (myositis).
It's testing a new medication called Nipocalimab against a dummy treatment (placebo).
You'll continue your existing steroid medications (glucocorticoids) if prescribed.
The study involves regular clinic visits for assessments and monitoring.
Your myositis diagnosis will be confirmed using specific criteria, including blood antibody tests.

Who may be eligible?

To join this study, you must be an adult aged 18 or over. You need to have been diagnosed with an idiopathic inflammatory myopathy (IIM), or myositis, for at least six weeks before the study starts, and your condition must be active. Doctors will use specific guidelines to confirm your diagnosis.

An important part of eligibility is having certain 'myositis-specific' antibodies in your blood. These antibodies help doctors understand the specific type of myositis you have. You'll have blood tests to check for these antibodies. If you're using certain skin creams for your condition, such as mild steroid creams or tacrolimus, the dose needs to have been stable for at least four weeks before starting the study and kept the same throughout most of the study.

There are also reasons why you might not be able to join. For example, if you were diagnosed with myositis when you were a child and are now an adult, you wouldn't be eligible. Also, if you have myositis linked to cancer, you wouldn't be able to take part in this particular 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.

Are you 18 years old or older?
Have you been diagnosed with inflammatory myopathy (myositis) for at least six weeks, and is your condition currently active?
Have your doctors identified specific 'myositis-specific' antibodies in your blood?
If you use skin creams for myositis, has the dose been stable for at least four weeks?
Have you *not* been diagnosed with juvenile myositis (myositis diagnosed in childhood)?

Answer every question to see your result.

What does participation involve?

The study involves several visits to the clinic over a period of time. You will be assigned to either receive the study drug (Nipocalimab) or a placebo, and you won't know which one you're getting. You'll also continue to receive any steroid medications (glucocorticoids) your doctor has prescribed for your condition. During your visits, the research team will perform various assessments, including blood tests, physical examinations, and asking you questions about how you're feeling and how your symptoms are changing. These assessments help the researchers understand how the study drug affects your condition and to monitor your health. The total duration of your participation in the study, including follow-up, will be determined by the study design, potentially up to 52 weeks.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and risks. A potential benefit is that Nipocalimab might help improve your myositis symptoms, and you would receive close medical monitoring throughout the study. However, it's also possible that Nipocalimab might not help you, or you might receive the placebo. There could also be side effects from the study drug, some of which may be unknown. The research team will explain all known potential risks before you decide to join. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (57)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Arizona Arthritis and Rheumatology Research PLLC
Verified postcode
Phoenix, United States
HonorHealth Neurology
Verified postcode
Scottsdale, United States
Attune Health Autoimmune and Inflamation Care and Research
Verified postcode
Beverly Hills, United States
University of California Irvine Medical Center
Verified postcode
Orange, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Verified postcode
Torrance, United States
FM Clinical Research, LLC South Florida Neurology Associates, P. A.
Verified postcode
Boca Raton, United States
Integral Rheumatology And Immunology Specialists
Verified postcode
Plantation, United States
University of South Florida
Verified postcode
Tampa, United States
Augusta University
Verified postcode
Augusta, United States
University of Kansas Medical Center
Verified postcode
Kansas City, United States
Johns Hopkins University
Verified postcode
Baltimore, United States
The Brigham and Women's Hospital, Inc.
Verified postcode
Boston, United States

Common questions

What is myositis?

Myositis is a group of conditions where your body's immune system mistakenly attacks your muscles, causing weakness and inflammation.

What is Nipocalimab?

Nipocalimab is an experimental medication being tested to see if it can help people with inflammatory myopathies. It's not yet available as a standard treatment.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the real study drug but contains no active medicine. It helps researchers compare the effects of the new drug.

Will I still take my regular medicines?

Yes, you will continue with your usual treatments for myositis, such as steroid medications, alongside the study drug or placebo.

Can I leave the study if I change my mind?

Absolutely. You are free to withdraw from the study at any time, for any reason, without it affecting your regular medical care.