Trials / Active Not Recruiting
Active Not RecruitingNCT05138133
Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis
A Multicentre Randomized Double-Blind Placebo Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 359 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis
Detailed description
This Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled study with OLE is to evaluate the efficacy and safety of anifrolumab versus placebo as added to SOC (MMF and glucocorticoids) in adults with active proliferative Class III or Class IV LN (both with or without concomitant Class V). The total study duration may be up to approximately 142 weeks, including screening and follow-up. Double-blind period will be 76 weeks. Participants who complete double-blind treatment period may enter open-label extension to receive anifrolumab for up 52 weeks. Approximately 360 of the enrolled participants will be randomly assigned to study intervention (anifrolumab or placebo) at a ratio of 1:1 during double-blind treatment period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Anifrolumab | Anifrolumab intravenous infusion (IV) |
| DRUG | Placebo | Placebo intravenous infusion (IV) |
Timeline
- Start date
- 2022-02-15
- Primary completion
- 2027-02-26
- Completion
- 2028-12-05
- First posted
- 2021-11-30
- Last updated
- 2026-02-24
Locations
167 sites across 24 countries: United States, Argentina, Belgium, Brazil, Bulgaria, China, Colombia, France, Germany, Hungary, India, Italy, Japan, Malaysia, Mexico, Netherlands, Peru, Poland, Puerto Rico, Russia, Taiwan, Thailand, Turkey (Türkiye), Vietnam
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05138133. Inclusion in this directory is not an endorsement.