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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
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Lupus Nephritis Drug: secukinumab Phase 3

Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Secukinumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: secukinumab
secukinumab 300 mg s.c.
 Drug: secukinumab
STUDY DRUG
Other Name: AIN457
Placebo Comparator: placebo
secukinumab placebo s.c.
 Drug: secukinumab
STUDY DRUG
Other Name: AIN457


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of subjects achieving Complete Renal Response (CRR) [ Time Frame: Week 52 ]
    Proportion of subjects achieving protocol-defined CRR


Secondary Outcome Measures :
  1. Change in 24-hour Urine Protein-to Creatinine Ratio (UPCR) [ Time Frame: Week 52 ]
    Change from Baseline in 24-hour UPCR

  2. Proportion of subjects achieving Partial Renal Response (PRR) [ Time Frame: Week 52 ]
    Proportion of subjects achieving protocol-defined PRR

  3. Average daily dose of oral corticosteroids [ Time Frame: Week 16 to Week 52 ]
    Average daily dose of oral corticosteroids compared to placebo

  4. Proportion of subjects achieving PRR [ Time Frame: Week 24 ]
    Proportion of subjects achieving PRR

  5. Time to achieve CRR [ Time Frame: Baseline to Week 52 ]
    Time to achieve CRR

  6. Time to achieve PRR [ Time Frame: Baseline to Week 52 ]
    Time to achieve PRR

  7. 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

  8. Improvement in FACIT-Fatigue© [ Time Frame: Baseline to Week 52 ]
    Improvement in FACIT-Fatigue© mean change of score compared to placebo

  9. Improvement in SF-36 PCS mean [ Time Frame: Baseline to Week 52 ]
    Improvement in SF-36 PCS mean change compared to placebo

  10. Improvement in LupusQoL Physical Health mean [ Time Frame: Baseline to Week 52 ]
    Improvement in LupusQoL Physical Health mean change of score compared to placebo

  11. 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

  12. 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

  13. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult male and female subjects 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 at Screening.
    • Estimated Glomerular Filtration Rate (eGFR) >30 mL/min/1.73 m2.
    • Active urinary sediment.

Exclusion Criteria:

  1. Severe renal impairment and subjects requiring dialysis 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 inclusion and exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com

Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04181762    
Other Study ID Numbers: CAIN457Q12301
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
Plan Description:

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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
SLE
LN
secukinumab
renal biopsy
 eGFR
UPCR
SoC background therapy
Additional relevant MeSH terms:
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Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
 Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases