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Clinical trial

Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

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Last updated:15th Dec 2021
Status: Recruiting
Identifier: NCT04564339
Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

Brief Summary:

The objectives of this study are to evaluate the safety and efficacy of ravulizumab administered by intravenous (IV) infusion compared to placebo and demonstrate proof-of-concept of the efficacy of terminal complement inhibition in participants with LN (LN Cohort) or IgAN (IgAN Cohort).

Detailed Description:
This study consists of a 6-week Screening Period, 26-week Initial Evaluation Period, a 24-week Extension Period, and a 36-week post-treatment Follow-up Period.

Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Participants, all investigative site personnel, and any Alexion employee, or designee, directly associated with the conduct of the study will be blinded to participant treatment assignments during the 26-week Initial Evaluation Period. Both the participants and the investigative site personnel will remain blinded for the remaining 24-week Extension Period.
Primary Purpose: Treatment
Official Title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
Actual Study Start Date: December 11, 2020
Estimated Primary Completion Date: June 30, 2023
Estimated Study Completion Date: July 31, 2024

- Experimental: Ravulizumab: LN Cohort
- Placebo Comparator: Placebo: LN Cohort
- Experimental: Ravulizumab: IgAN Cohort
- Placebo Comparator: Placebo: IgAN Cohort

Category Value
Study type(s) Interventional
Estimated enrolment 120
Actual Study start date 11 December 2020
Estimated Study Completion Date 31 July 2024

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