Nipocalimab for Myositis
(SPIREA Trial)

Recruiting in Palo Alto (17 mi)

+81 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Janssen Research & Development, LLC

Prior Safety Data

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.

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.

+3 more

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.

+2 more

Participant Groups

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.

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.