Nipocalimab for Myositis

(SPIREA Trial)

Recruiting at 81 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

36 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug Nipocalimab for Myositis?

Research shows that blocking the FcRn receptor, which Nipocalimab targets, can reduce levels of certain immune proteins (IgG) that are involved in autoimmune diseases. This suggests that Nipocalimab might help in conditions like Myositis by reducing harmful immune responses. ^{1 2 3 4 5}

How is the drug Nipocalimab different from other treatments for myositis?

Nipocalimab is unique because it targets the FcRn receptor, which is responsible for extending the lifespan of IgG antibodies in the body. By blocking this receptor, Nipocalimab reduces the levels of IgG antibodies, potentially decreasing the immune response that contributes to autoimmune diseases like myositis. ^{1 2 5 6 7}

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Blocking FcRn in humans reduces circulating IgG levels and inhibits IgG immune complex-mediated immune responses. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Monoclonal antibodies directed against human FcRn and their applications. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Impact of FCGR2A R131H, FCGR3A F158V and FCGR3B NA1/NA2 polymorphisms on response to Fc-containing TNF inhibitors in Tunisian rheumatoid arthritis patients. [2023]

4. Tunisia pubmed.ncbi.nlm.nih.gov

Functional polymorphisms of PTPN22 and FcgR genes in Tunisian patients with rheumatoid arthritis. [2011]

5. United States pubmed.ncbi.nlm.nih.gov

Therapeutic antibody targeting of indoleamine-2,3-dioxygenase (IDO2) inhibits autoimmune arthritis. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of NI-0101, an anti-toll-like receptor 4 monoclonal antibody, in patients with rheumatoid arthritis after inadequate response to methotrexate: a phase II study. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Role of Fc receptor gamma chain in inflammation and cartilage damage during experimental antigen-induced arthritis. [2003]