Trials / Active Not Recruiting
Active Not RecruitingNCT05379634
A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of Nipocalimab versus placebo in participants with active idiopathic inflammatory myopathies (IIM).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nipocalimab | Nipocalimab will be administered intravenously in double-blind period and LTE period. |
| OTHER | Placebo | Nipocalimab matching placebo will be administered intravenously in double-blind period. |
| DRUG | Glucocorticoids | Prednisone or equivalent will be administered orally as Glucocorticoid. |
Timeline
- Start date
- 2022-07-05
- Primary completion
- 2025-09-04
- Completion
- 2026-09-16
- First posted
- 2022-05-18
- Last updated
- 2026-04-13
Locations
57 sites across 13 countries: United States, Canada, Czechia, France, Germany, Hungary, Italy, Japan, Mexico, Poland, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05379634. Inclusion in this directory is not an endorsement.