A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus (PHOENYCS GO)
A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus (PHOENYCS GO)
The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
Actual Study Start Date: August 12, 2020
Estimated Primary Completion Date: February 2023
Estimated Study Completion Date: April 2023
Arm:
- Experimental: Dapirolizumab pegol
- Placebo Comparator: Placebo
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Expected enrolment | 450 |
| Actual Study start date | 12 August 2020 |
| Estimated Study Completion Date | 01 April 2023 |