A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Nipocalimab in Participants with Active Idiopathic Inflammatory Myopathies

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505314-20-00

Acronym

80202135IIM2001

Enrollment

Registered

2024-02-01

Start date

2023-01-20

Completion date

Unknown

Last updated

2025-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Active Idiopathic Inflammatory Myopathies (IIM)

Brief summary

Proportion Percentage of participants who achieve at least minimal improvement (≥ 20-point improvement) in IMACS TIS (International myositis assessment and clinical studies total improvement score) at Week 52 and on ≤5 mg/day of oral prednisone (or equivalent) from week 44 through week 52.

Interventions

DRUGSaline

DRUG0.9% Sodium Chloride Solution for Injection

DRUGJNJ-80202135

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion Percentage of participants who achieve at least minimal improvement (≥ 20-point improvement) in IMACS TIS (International myositis assessment and clinical studies total improvement score) at Week 52 and on ≤5 mg/day of oral prednisone (or equivalent) from week 44 through week 52.	—

Countries

Czechia, France, Germany, Hungary, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026