Nipocalimab for Myositis

(SPIREA Trial)

Not currently recruiting at 91 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Janssen Research & Development, LLC

Disqualifiers: Juvenile myositis, Cancer-associated myositis, Asthma, COPD, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 50 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of Nipocalimab, an anti-FcRn monoclonal antibody, for individuals with active idiopathic inflammatory myopathies (IIM), which cause muscle inflammation and weakness. The study compares Nipocalimab to a placebo to determine its impact on symptoms. Participants will receive either Nipocalimab or a placebo every two weeks for up to 50 weeks, with a possible extension. Individuals diagnosed with IIM for at least six weeks and possessing specific antibodies related to the condition may qualify for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using certain topical treatments for skin lesions, you must keep the dose stable for at least 4 weeks before starting the study and continue at the same dose until Week 52.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that nipocalimab is generally well-tolerated. In a study with healthy volunteers, researchers administered single doses of nipocalimab, and results indicated the treatment was mostly safe, with no major side effects reported.

Researchers are also investigating this treatment for other conditions, such as generalized myasthenia gravis, and it has received a Priority Review from the FDA. This designation suggests promise, as the FDA typically reserves it for treatments with significant potential.

Overall, current safety data suggest that nipocalimab is well-tolerated. However, ongoing studies will provide more detailed information about its safety in different conditions, such as idiopathic inflammatory myopathies. ^{1 2 3 4 5}

Why are researchers excited about this possible treatment for myositis?

Nipocalimab is unique because it works differently from most standard treatments for myositis, which often involve immunosuppressants like glucocorticoids. Unlike these traditional options, Nipocalimab is designed to block the neonatal Fc receptor (FcRn), reducing the half-life of pathogenic antibodies that can contribute to the disease. Researchers are excited about Nipocalimab because this targeted approach has the potential to offer relief with fewer side effects, making it a promising option for patients who struggle with the side effects of current therapies.

What evidence suggests that Nipocalimab might be an effective treatment for myositis?

Research has shown that Nipocalimab, which participants in this trial may receive, may help treat immune-related conditions. In studies, patients taking Nipocalimab controlled their disease better than those on other treatments, experiencing fewer symptoms and feeling better overall. The treatment targets a specific part of the immune system to reduce inflammation, a major issue in idiopathic inflammatory myopathies (IIM). Additionally, previous trials found Nipocalimab to be generally safe and well-tolerated. These findings suggest it could effectively manage IIM symptoms. ^{4 6 7 8 9}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have tested positive for specific antibodies related to my muscle condition.

I've been on a stable dose of certain skin treatment creams for over 4 weeks.

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

Exclusion Criteria

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

I had a heart attack, unstable heart disease, or stroke in the last 3 months.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Nipocalimab or placebo every 2 weeks up to Week 50 during the double-blind period. Glucocorticoid doses are stable initially, then tapered from Week 24 to Week 44.

50 weeks

Bi-weekly visits

Long-term Extension

Eligible participants continue receiving Nipocalimab from Week 52 up to Week 98.

46 weeks

Bi-weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Glucocorticoids
• Nipocalimab
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Nipocalimab Experimental Treatment 2 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: Placebo Placebo Group 2 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 will receive Nipocalimab treatment Q2W starting from Week 52 up to Week 98 and will be followed up to Week 106.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

A new panel of highly specific monoclonal antibodies (mAbs) against human FcRn has been developed, which can help researchers study the expression and function of this important receptor in the body.

These mAbs can selectively block the binding of IgG antibodies and serum albumin to FcRn, providing a valuable tool for exploring therapeutic strategies that target FcRn to enhance drug delivery and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monoclonal antibodies directed against human FcRn and their applications. Christianson, GJ., Sun, VZ., Akilesh, S., et al.[2022]

Citations

1. jnj.com jnj.com/media-center/press-releases/nipocalimab-pivotal-phase-3-trial-demonstrates-longest-sustained-disease-control-in-fcrn-class

Nipocalimab pivotal Phase 3 trial demonstrates longest ... The Phase 3 Vivacity-MG3 study was specifically designed to measure sustained efficacy and safety with consistent dosing in this unpredictable ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11227837/

Nipocalimab, an anti-FcRn monoclonal antibody, in ... Participants who received nipocalimab (15 mg/kg intravenously every 2 weeks for 10 weeks) showed numerically higher improvement in efficacy ...

3. innovativemedicine.jnj.com innovativemedicine.jnj.com/emea/newsroom/nipocalimab-showed-greater-sustained-disease-control-versus-approved-fcrn-blockers-for-generalised-myasthenia-gravis-gmg-at-multiple-timepoints-over-24-weeks-in-newly-published-indirect-treatment-comparison-itc

Nipocalimab showed greater sustained disease control ... Based on the ITC, which included the pivotal Phase 3 Vivacity-MG3 study, nipocalimab showed a comparable onset of symptom relief at Week 1 and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10962909/

Safety and Efficacy of Nipocalimab in Patients With ... Nipocalimab was generally safe, well-tolerated, and showed evidence of dose-dependent reduction in MG-ADL scores at day 57 in this phase 2 study ...

5. institut-myologie.org institut-myologie.org/en/2025/03/04/positive-phase-iii-results-for-nipocalimab-in-generalised-myasthenia-gravis/

Positive phase III results for nipocalimab in generalised ... Nipocalimab was well tolerated, with mostly mild to moderate adverse events. The open-label extension phase of the Vivacity-MG3 trial will ...

6. medchemexpress.com medchemexpress.com/nipocalimab.html?srsltid=AfmBOoo_OxvcKRsNaxBVi0rxm4gZPWN6wFpI6b2CUecpb4iZujScXKFf

Nipocalimab (M281) | Anti-FcRn Antibody Nipocalimab (M281) is a fully humanized, recombinant, and non-glycosylated IgG1 monoclonal antibody ... SAFETY DATA SHEET (SDS). English - EN (251 KB) Français - ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12255621/

Pharmacokinetics, Pharmacodynamics, and Safety of ... This study assessed the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of a single dose of nipocalimab in healthy Chinese volunteers.

8. trials.arthritis.org trials.arthritis.org/trials/NCT05379634

A Study of Nipocalimab in Participants With Active Idiopathic ... The purpose of this study is to evaluate the efficacy and safety of Nipocalimab versus placebo in participants with active idiopathic inflammatory myopathies ( ...

9. rheumatologyadvisor.com rheumatologyadvisor.com/news/nipocalimab-gets-priority-review-for-generalized-myasthenia-gravis/

Nipocalimab Gets Priority Review for Generalized ... The FDA has granted Priority Review to nipocalimab for the treatment of antibody positive patients with generalized myasthenia gravis.