A clinical trial to evaluate the safety, efficacy, and tolerability of secukinumab versus placebo, in combination with SoC therapy, in patients with active lupus nephritis

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 - SELUNE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003211-57-SE

Enrollment

400

Registered

2020-03-06

Start date

2020-06-09

Completion date

Unknown

Last updated

2023-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Nephritis MedDRA version: 21.1 Level: PT Classification code 10025140 Term: Lupus nephritis System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Trade Name: Cosentyx Product Name: Secukinumab Product Code: AIN457 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: secukinumab CAS Number: 1229022-83-6 Current

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult male and female participants aged 18 - 75 years old at the time of Baseline. 2. Confirmed diagnosis of: - SLE as defined by the American College of Rheumatology (ACR), OR - LN as the sole clinical criterion in the presence of ANA or anti-dsDNA antibodies. 3. Active lupus nephritis: - International Society of Neurology/Renal Pathology Society (ISN/RPS) Class III or IV LN [excluding III (C), IV-S (C) and IV-G (C)]; subjects are permitted to have co-existing Class V. - UPCR =1 mg/mg at Screening. - Estimated Glomerular Filtration Rate (eGFR) >30 mL/min/1.73 m2. - Active urinary sediment. Other protocol-defined inclusion criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 380 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: 1. Severe renal impairment and participants requiring dialysis within the previous 12 months before Screening. 2. Significant medical Problems like myocarditis, pericarditis, severe manifestations of neuropsychiatric SLE (NPSLE). 3. Cyclophosphamide (CYC) use (i.v. or oral) or more than 3000 mg i.v. pulse methylprednisolone (cumulative dose) within the month prior to Baseline. 4. Active ongoing inflammatory diseases. 5. Previous exposure to secukinumab (AIN457) or any other biologic drug targeting IL-17 or the IL-17 receptor. 6. Ongoing infections or malignant process. 7. Pregnant or lactating women. Other protocol-defined exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate that secukinumab 300 mg is superior to placebo in Complete Renal Response (CRR) rate at Week 52 in active lupus nephritis (ISN/RPS Class III or IV, with or without co-existing Class V features) patients on a background of SoC therapy. ;Secondary Objective: To demonstrate superiority of secukinumab compared to placebo in: Change from baseline in 24-hour Urine Protein-to Creatinine ratio (UPCR) at Week 52; Proportion of patients achieving Partial Renal Response (PRR) at Week 52; Average daily dose of oral corticosteroids administered between Week 16 and Week 52; Proportion of patients achieving PRR at Week 24; Tine to achieve CRR; Time to achieve PRR; Time to achieve first morning void UPCR = 0.5 mg/mg; Change in FACIT-Fatigue© score at Week 52; Patient’s health related quality of life via Medical Outcome Short Form Health Survey (SF-36 Physical Component Summary (PCS)) score at Week 52; Change of Lupus QoL score at Week 52; To evaluate the safety and tolerability of secukinumab s.c. as an add-on therapy to Standard of Care in lupus nephritis subjects; To estimate the proportion of patients with maintained response at Week 104; To estimate the proportion of patients with improved or maintained response at Week 104;Primary end point(s): Proportion of participants achieving Complete Renal Response;Timepoint(s) of evaluation of this end point: 52 Weeks	—

Measure

Time frame

Main Objective: To demonstrate that secukinumab 300 mg is superior to placebo in Complete Renal Response (CRR) rate at Week 52 in active lupus nephritis (ISN/RPS Class III or IV, with or without co-existing Class V features) patients on a background of SoC therapy. ;Secondary Objective: To demonstrate superiority of secukinumab compared to placebo in: Change from baseline in 24-hour Urine Protein-to Creatinine ratio (UPCR) at Week 52; Proportion of patients achieving Partial Renal Response (PRR) at Week 52; Average daily dose of oral corticosteroids administered between Week 16 and Week 52; Proportion of patients achieving PRR at Week 24; Tine to achieve CRR; Time to achieve PRR; Time to achieve first morning void UPCR = 0.5 mg/mg; Change in FACIT-Fatigue© score at Week 52; Patient’s health related quality of life via Medical Outcome Short Form Health Survey (SF-36 Physical Component Summary (PCS)) score at Week 52; Change of Lupus QoL score at Week 52; To evaluate the safety and tolerability of secukinumab s.c. as an add-on therapy to Standard of Care in lupus nephritis subjects; To estimate the proportion of patients with maintained response at Week 104; To estimate the proportion of patients with improved or maintained response at Week 104;Primary end point(s): Proportion of participants achieving Complete Renal Response;Timepoint(s) of evaluation of this end point: 52 Weeks

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Secondary

Measure	Time frame
Secondary end point(s): 1. Change in 24-hour Urine Protein-to Creatinine Ratio (UPCR) at Week 52 2. Proportion of participants achieving Partial Renal Response (PRR) at Week 52 3. Average daily dose of oral corticosteroids administered between Week 16 and Week 52 compared to placebo 4. Proportion of participants achieving PRR at Week 24 5. Time to achieve CRR from Baseline to Week 52 6. Time to achieve PRR from Baseline to Week 52 7. Time to achieve first morning void UPCR = 0.5 mg/mg from Baseline to Week 52 8. Change in FACIT-Fatigue©, mean change of score compared to placebo from Baseline to Week 52 9. Change in SF-36 PCS mean change compared to placebo from Baseline to Week 52 10. Change in LupusQoL mean change of score compared to placebo from Baseline to Week 52 11. Incidence of Treatment-emergent AEs (TEAEs) / SAEs from Baseline to Week 52; vital signs and body measurements, standard chemistry and hematology from Baseline to Week 52 12. Estimate the proportion of participants with CRR at Week 104 within participants who had achieved CRR at Week 52 in the secukinumab group (Week 52 to Week 104) 13. Estimate the proportion of participants with improved or mainatined response (PRR or CRR) in participants who had achieved at least PRR at week 52 in the secukinumab group;Timepoint(s) of evaluation of this end point: 1. Week 52 2. Week 52 3. Week 16 to Week 52 4. Week 24 5. Baseline to Week 52 6. Baseline to Week 52 7. Baseline to Week 52 8. Baseline to Week 52 9. Baseline to Week 52 10. Baseline to Week 52 11. Baseline to Week 52 12. Week 52 to Week 104 13. Week 52 to Week 104	—

Measure

Time frame

Secondary end point(s): 1. Change in 24-hour Urine Protein-to Creatinine Ratio (UPCR) at Week 52 2. Proportion of participants achieving Partial Renal Response (PRR) at Week 52 3. Average daily dose of oral corticosteroids administered between Week 16 and Week 52 compared to placebo 4. Proportion of participants achieving PRR at Week 24 5. Time to achieve CRR from Baseline to Week 52 6. Time to achieve PRR from Baseline to Week 52 7. Time to achieve first morning void UPCR = 0.5 mg/mg from Baseline to Week 52 8. Change in FACIT-Fatigue©, mean change of score compared to placebo from Baseline to Week 52 9. Change in SF-36 PCS mean change compared to placebo from Baseline to Week 52 10. Change in LupusQoL mean change of score compared to placebo from Baseline to Week 52 11. Incidence of Treatment-emergent AEs (TEAEs) / SAEs from Baseline to Week 52; vital signs and body measurements, standard chemistry and hematology from Baseline to Week 52 12. Estimate the proportion of participants with CRR at Week 104 within participants who had achieved CRR at Week 52 in the secukinumab group (Week 52 to Week 104) 13. Estimate the proportion of participants with improved or mainatined response (PRR or CRR) in participants who had achieved at least PRR at week 52 in the secukinumab group;Timepoint(s) of evaluation of this end point: 1. Week 52 2. Week 52 3. Week 16 to Week 52 4. Week 24 5. Baseline to Week 52 6. Baseline to Week 52 7. Baseline to Week 52 8. Baseline to Week 52 9. Baseline to Week 52 10. Baseline to Week 52 11. Baseline to Week 52 12. Week 52 to Week 104 13. Week 52 to Week 104

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Countries

Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, France, Germany, Greece, Guatemala, India, Italy, Japan, Kenya, Korea, Republic of, Latvia, Mauritius, Mexico, Norway, Peru, Philippines, Portugal, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States, Viet Nam

Contacts

Public ContactMedical information

Novartis Sverige AB

medinfo.se@novartis.com+46 8 7323200

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026