What side effects are associated with this type of intervention?

Common treatments for myositis include corticosteroids, immunosuppressants (such as methotrexate and azathioprine), intravenous immunoglobulin (IVIG), and monoclonal antibodies like rituximab. Corticosteroids can cause weight gain, osteoporosis, and increased infection risk. Immunosuppressants may lead to liver toxicity, bone marrow suppression, and increased susceptibility to infections. IVIG is generally well-tolerated but can cause headaches, fever, and allergic reactions. Rituximab, a monoclonal antibody, can result in infusion reactions, infections, and rare cases of progressive multifocal leukoencephalopathy. Nipocalimab, being a monoclonal antibody, may have similar side effects, including infusion reactions and increased infection risk.

What prior FDA approvals exist?

The FDA has approved intravenous immunoglobulin (IVIG) for the treatment of dermatomyositis, particularly for patients with refractory disease. IVIG works by modulating the immune system, similar to the mechanism of action of monoclonal antibodies like Nipocalimab, which targets FcRn to reduce IgG levels. Additionally, rituximab, a monoclonal antibody targeting CD20, has shown efficacy in treating refractory polymyositis and dermatomyositis, although it is not specifically FDA-approved for these conditions.

What other types of research exist?

Promising alternatives to Nipocalimab for Myositis patients include intravenous immunoglobulin (IVIg) and Rituximab. IVIg has shown efficacy and safety in treating juvenile dermatomyositis and polymyositis. Rituximab has been effective in cases with hyper-gammaglobulinemia and multiple autoantibodies, enabling return to normal muscle function within six months.

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Monoclonal Antibodies

Nipocalimab for Myositis (SPIREA Trial)

Q: What is the mechanism of action of this treatment?

The most common treatments for Myositis include monoclonal antibodies like Nipocalimab, which target the neonatal Fc receptor (FcRn) to reduce IgG levels, thereby decreasing the autoimmune response. Glucocorticoids, such as prednisone, work by broadly suppressing inflammation and the immune system. Immunosuppressants like methotrexate inhibit the proliferation of immune cells that attack muscle tissue. Intravenous immunoglobulin (IVIG) provides a high dose of antibodies that can modulate the immune system and reduce inflammation. These treatments are crucial for Myositis patients as they help manage symptoms, reduce muscle inflammation, and improve muscle strength and function, thereby enhancing the quality of life.

Phase 2

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant meets the diagnostic criteria of probable or definite idiopathic inflammatory myopathies (IIM) based on 2017 The European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for adult IIM at least 6 weeks prior to first administration of the study intervention

Be older than 18 years old

Must not have

Has a juvenile myositis diagnosis and now >=18 years old

Has comorbidities (example, asthma, chronic obstructive pulmonary disease [COPD]) which have required 3 or more courses of oral GC within 1 year prior to screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 44 through week 52

Summary

This trial is testing Nipocalimab, a medicine that blocks harmful antibodies, in patients with muscle weakness and other issues due to idiopathic inflammatory myopathies (IIM). The goal is to see if it can improve their condition by lowering harmful antibody levels.

Who is the study for?

This trial is for adults with active idiopathic inflammatory myopathies (IIM) who have certain antibodies indicating specific types of IIM. They must meet the EULAR/ACR criteria for IIM and have stable skin treatment doses for at least 4 weeks before starting the study. People with juvenile myositis, cancer-associated myositis, frequent oral steroid use due to other diseases, or recent severe heart issues cannot join.

What is being tested?

The trial is testing Nipocalimab's effectiveness compared to a placebo in treating IIM. Participants will also receive glucocorticoids as part of their therapy. The goal is to see if Nipocalimab can help manage symptoms better than a non-active treatment.

What are the potential side effects?

Possible side effects of Nipocalimab may include reactions at the injection site, increased risk of infections due to immune system suppression, allergic responses, and potential impacts on blood cell counts leading to anemia or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a type of muscle inflammation disease at least 6 weeks ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I was diagnosed with juvenile myositis and am now 18 or older.

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I have had to take oral steroids 3 or more times in the last year for my asthma or COPD.

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I have a history of immune system problems not caused by my current treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 44 through week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 44 through week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 44 through week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants who Achieve at Least Minimal Improvement (Greater Than or Equal to [>=] 20) in IMACS TIS and on Less Than or Equal to (<=) 5 Milligrams per day (mg/day) of Oral Prednisone (or Equivalent) From Week 44 Through Week 52

Secondary study objectives

Change From Baseline in Extramuscular Global Assessment (Myositis Disease Activity Assessment Tool [MDAAT]) at Weeks 24 and 52

Change From Baseline in Functional Disability Using the Health Assessment Questionnaire-disability Index (HAQ-DI)

Change From Baseline in MMT-8 at Week 24

+23 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NipocalimabExperimental Treatment2 Interventions

Participants will receive Nipocalimab at Week 0 (Baseline) and then every 2 weeks (Q2W) up to Week 50 during double-blind period. Participants on glucocorticoids (GC) at baseline will receive a stable dose of oral GC (prednisone or equivalent) from 4 weeks prior to the first administration of study intervention to Week 0. No changes in GC doses are allowed between Week 0 and Week 24. From Week 24 to Week 44, GC doses will be tapered. No changes to GC doses will be allowed from Week 44 to Week 52. Eligible participants will enter long-term extension (LTE) period and continue receiving Nipocalimab starting from Week 52 up to Week 98 and will be followed up to Week 106.

Group II: PlaceboPlacebo Group2 Interventions

Participants will receive Nipocalimab matching placebo at Week 0 (Baseline) and then Q2W up to Week 50 during double-blind period. Participants on GC at baseline will receive a stable dose of oral GC (prednisone or equivalent) from 4 weeks prior to the first administration of study intervention to Week 0. No changes in GC doses are allowed between Week 0 and Week 24. From Week 24 to Week 44, GC doses will be tapered. No changes to GC doses will be allowed from Week 44 to Week 52. Eligible participants will enter LTE period and continue receiving Nipocalimab matching placebo Q2W starting from Week 52 up to Week 98 and will be followed up to Week 106.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nipocalimab

2022

Completed Phase 2

~520

Glucocorticoids

2011

Completed Phase 4

~1340

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Myositis include monoclonal antibodies like Nipocalimab, which target the neonatal Fc receptor (FcRn) to reduce IgG levels, thereby decreasing the autoimmune response. Glucocorticoids, such as prednisone, work by broadly suppressing inflammation and the immune system. Immunosuppressants like methotrexate inhibit the proliferation of immune cells that attack muscle tissue. Intravenous immunoglobulin (IVIG) provides a high dose of antibodies that can modulate the immune system and reduce inflammation. These treatments are crucial for Myositis patients as they help manage symptoms, reduce muscle inflammation, and improve muscle strength and function, thereby enhancing the quality of life.

Efficacy of Rituximab in Refractory Inflammatory Myopathy Associated With Coexistence of Behçet's Disease and Antiphospholipid Syndrome.