Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis (SELUNE)
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|ClinicalTrials.gov Identifier: NCT04181762|
Recruitment Status : Recruiting
First Posted : November 29, 2019
Last Update Posted : March 21, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Lupus Nephritis||Drug: secukinumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||460 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
secukinumab 300 mg s.c.
Other Name: AIN457
Placebo Comparator: placebo
secukinumab placebo s.c.
Other Name: AIN457
- Proportion of subjects achieving Complete Renal Response (CRR) [ Time Frame: Week 52 ]Proportion of subjects achieving protocol-defined CRR
- Change in 24-hour Urine Protein-to Creatinine Ratio (UPCR) [ Time Frame: Week 52 ]Change from Baseline in 24-hour UPCR
- Proportion of subjects achieving Partial Renal Response (PRR) [ Time Frame: Week 52 ]Proportion of subjects achieving protocol-defined PRR
- Average daily dose of oral corticosteroids [ Time Frame: Week 16 to Week 52 ]Average daily dose of oral corticosteroids compared to placebo
- Proportion of subjects achieving PRR [ Time Frame: Week 24 ]Proportion of subjects achieving PRR
- Time to achieve CRR [ Time Frame: Baseline to Week 52 ]Time to achieve CRR
- Time to achieve PRR [ Time Frame: Baseline to Week 52 ]Time to achieve PRR
- Time to achieve UPCR ≤ 0.5 mg/mg [ Time Frame: Baseline to Week 52 ]Time to achieve first morning void UPCR ≤ 0.5 mg/mg
- Improvement in FACIT-Fatigue© [ Time Frame: Baseline to Week 52 ]Improvement in FACIT-Fatigue© mean change of score compared to placebo
- Improvement in SF-36 PCS mean [ Time Frame: Baseline to Week 52 ]Improvement in SF-36 PCS mean change compared to placebo
- Improvement in LupusQoL Physical Health mean [ Time Frame: Baseline to Week 52 ]Improvement in LupusQoL Physical Health mean change of score compared to placebo
- Incidence of Treatment-emergent AEs (TEAEs) / SAEs [ Time Frame: Baseline to Week 52 ]Incidence of Treatment-emergent AEs (TEAEs) / SAEs from Baseline to Week 52; vital signs and body measurements, standard chemistry and hematology
- Proportion of subjects with CRR at Week 104 within subjects who had achieved CRR at Week 52 [ Time Frame: Week 52 to Week 104 ]Estimate the proportion of subjects with CRR at Week 104 within subjects who had achieved CRR at Week 52 in the secukinumab group
- Proportion of subjects with improved or maintained renal response at Week 104 [ Time Frame: Week 52 to Week 104 ]Estimate the proportion of subjects with improved or maintained response (PRR or CRR) in subjects who had achieved at least PRR at Week 52 in the secukinumab group
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Adult male and female subjects aged 18 - 75 years old at the time of Baseline.
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.
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 at Screening.
- Estimated Glomerular Filtration Rate (eGFR) >30 mL/min/1.73 m2.
- Active urinary sediment.
- Severe renal impairment and subjects requiring dialysis dialysis within the previous 12 months before Screening.
- Significant medical Problems like myocarditis, pericarditis, severe manifestations of neuropsychiatric SLE (NPSLE).
- Cyclophosphamide (CYC) use (i.v. or oral) or more than 3000 mg i.v. pulse methylprednisolone (cumulative dose) within the month prior to Baseline.
- Active ongoing inflammatory diseases.
- Previous exposure to secukinumab (AIN457) or any other biologic drug targeting IL-17 or the IL-17 receptor.
- Ongoing infections or malignant process.
- Pregnant or lactating women.
Other inclusion and exclusion criteria may apply.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04181762
|Contact: Novartis Pharmaceuticalsfirstname.lastname@example.org|
|Contact: Novartis Pharmaceuticalsemail@example.com|
|Responsible Party:||Novartis Pharmaceuticals|
|Other Study ID Numbers:||
2019-003211-57 ( EudraCT Number )
PACTR202211748997845 ( Other Identifier: PACTR )
|First Posted:||November 29, 2019 Key Record Dates|
|Last Update Posted:||March 21, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
SoC background therapy
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Immune System Diseases