Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus
Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus
The primary objective is to evaluate the efficacy and safety of efavaleukin alfa in subjects with active SLE.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy
Estimated Study Start Date: May 25, 2021
Estimated Primary Completion Date: June 19, 2024
Estimated Study Completion Date: June 19, 2024
Arm:
- Placebo Comparator: Placebo + Standard of Care
- Experimental: Efavaleukin Alfa Dose Level One + Standard of Care
- Experimental: Efavaleukin Alfa Dose Level Two + Standard of Care
- Experimental: Efavaleukin Alfa Dose Level Three + Standard of Care
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Expected enrolment | 320 |
| Actual Study start date | 25 May 2021 |
| Estimated Study Completion Date | 19 June 2024 |