Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis (SELUNE)
Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis (SELUNE)
The purpose of this trial is to evaluate the efficacy and safety of subcutaneous secukinumab 300 mg compared to placebo, in combination with standard of care therapy (SoC), in subjects with active lupus nephritis (ISN/RPS Class III or IV, with or without co-existing class V features).
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double-blind
Primary Purpose: Treatment
Official Title: A Two-year, Phase III Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Evaluate the Safety, Efficacy, and Tolerability of 300 mg s.c. Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis
Actual Study Start Date: July 7, 2020
Estimated Primary Completion Date: January 14, 2025
Estimated Study Completion Date: January 8, 2026
Arm:
- Experimental: secukinumab
- Placebo Comparator: placebo
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 460 |
| Actual Study start date | 07 July 2020 |
| Estimated Study Completion Date | 08 January 2026 |