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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04181762
Registration number
NCT04181762
Ethics application status
Date submitted
27/11/2019
Date registered
29/11/2019
Date last updated
16/05/2025
Titles & IDs
Public title
Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis
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Scientific 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
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Secondary ID [1]
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2019-003211-57
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Secondary ID [2]
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CAIN457Q12301
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Universal Trial Number (UTN)
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Trial acronym
SELUNE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lupus Nephritis
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Condition category
Condition code
Renal and Urogenital
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Other renal and urogenital disorders
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - secukinumab
Treatment: Drugs - Placebo
Experimental: secukinumab - A blinded, weekly, subcutaneous (s.c.) secukinumab 300 mg loading regimen was administered for the first 4 weeks followed by a monthly maintenance dose in all randomized subjects thereafter.
Placebo comparator: placebo - A blinded, weekly, subcutaneous (s.c.) matching placebo loading regimen was administered for the first 4 weeks followed by a monthly maintenance dose in all randomized subjects thereafter.
Treatment: Drugs: secukinumab
STUDY DRUG
Treatment: Drugs: Placebo
Placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving Complete Renal Response (CRR) at Week 52
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Assessment method [1]
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Complete Renal Response (CRR) is a composite endpoint defined as: * Estimated Glomerular Filtration Rate (eGFR) \>= 60 mL/min/1.73 m\^2 or no less than 85% of core Baseline values and * 24-hour Urine-to-Protein Creatinine Ratio (UPCR) =\< 0.5mg/mg * No treatment discontinuation before Week 52 * The subject did not receive more than 10 mg/day prednisone or equivalent for \>= 3 consecutive days or for \>= 7 days in total during Week 44 through Week 52. Non-responder imputation (NRI) was used for participants who did not have the required data to compute responses at Week 52 or who had discontinued study treatment before Week 52. A logistic regression model was used for the analysis of this endpoint.
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Timepoint [1]
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Baseline, Week 52
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Secondary outcome [1]
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Change From Baseline in 24-hour Urine Protein-to Creatinine Ratio (UPCR)
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Assessment method [1]
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Urine Protein-to-Creatinine Ratio (UPCR) was determined by a central laboratory by dividing the protein concentration by the creatinine concentration as measured in the urine collected (24-hour urine collection sample).
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Timepoint [1]
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Baseline, Week 52
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Secondary outcome [2]
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Percentage of Participants Achieving Partial Renal Response (PRR) at Week 52
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Assessment method [2]
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Partial Renal Response (PRR) is a composite endpoint defined as: * \>= 50% reduction in 24-hour Urine-to-Protein Creatinine Ratio (UPCR) to sub-nephrotic levels (=\< 3 mg/mg) and * Estimated Glomerular Filtration Rate (eGFR) \>= 60 mL/min/1.73 m\^2 or no less than 85% of Baseline
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Timepoint [2]
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Baseline, Week 52
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Secondary outcome [3]
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Average Daily Dose of Oral Corticosteroids
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Assessment method [3]
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Average daily dose of oral corticosteroids doses was used to assess efficacy of secukinumab compared to placebo in the averaged daily dose of oral corticosteroids administered between Week 16 and Week 52.
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Timepoint [3]
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Week 16 to Week 52
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Secondary outcome [4]
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Percentage of Participants Achieving Partial Renal Response (PRR) at Week 24
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Assessment method [4]
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Partial Renal Response (PRR) is a composite endpoint defined as: * \>= 50% reduction in 24-hour Urine-to-Protein Creatinine Ratio (UPCR) to sub-nephrotic levels (=\< 3 mg/mg) and * Estimated Glomerular Filtration Rate (eGFR) \>= 60 mL/min/1.73 m\^2 or no less than 85% of Baseline
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Timepoint [4]
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Baseline, Week 24
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Secondary outcome [5]
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Incidence Rate of Participants Achieving Complete Renal Response (CRR) up to Week 52
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Assessment method [5]
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Time to achieve Complete Renal Response (CRR) up to week 52 was evaluated by 4-week interval by using Kaplan-Meier estimates. Participants who did not achieve CRR were censored at the date of their last non-missing CRR result (including participants who completed week 52 without achieving CRR). * Subjects at risk = Subjects who did not achieve CRR and were not censored before or at the start of the specified interval. Participants had an event when achieving CRR. * Incidence rate (%) = (number of subjects with event/number of subjects at risk) x 100.
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Timepoint [5]
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Baseline to Week 52
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Secondary outcome [6]
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Incidence Rate of Participants Achieving Partial Renal Response (PRR) up to Week 52
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Assessment method [6]
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Time to achieve Partial Renal Response (PRR) up to week 52 was evaluated by 4-week interval by using Kaplan-Meier estimates. Participants who did not achieve PRR were censored at the date of their last non-missing PRR result (including participants who completed week 52 without achieving PRR). Participants had event when achieving PRR. * Subjects at risk = Subjects who did not achieve PRR and were not censored before or at the start of the specified interval. * Incidence rate (%) = (number of subjects with event/ number of subjects at risk) x 100.
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Timepoint [6]
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Baseline to Week 52
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Secondary outcome [7]
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Time to Achieve First Morning Void Urine Protein-to-Creatinine Ratio (UPCR) <= 0.5 mg/mg up to Week 52
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Assessment method [7]
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Time to achieve first morning void Urine Protein-to-Creatinine Ratio (UPCR) \<= 0.5 mg/mg up to week 52 was evaluated by 4-week interval by using Kaplan-Meier estimates. Participants who did not achieve UCPR were censored at the date of their last non-missing UCPR result (including participants who completed week 52 without achieving UCPR). Participants had event when achieving UCPR. * Subjects at risk = Subjects who did not achieve UCPR and were not censored before or at the start of the specified interval. * Incidence rate (%) = (number of subjects with event/ number of subjects at risk) x 100.
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Timepoint [7]
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Baseline to Week 52
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Secondary outcome [8]
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Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Mean Change From Baseline up to Week 52
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Assessment method [8]
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The FACIT-Fatigue is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function over the past week. The purpose of the FACIT-Fatigue in this study was to assess the impact of fatigue on subjects with lupus nephritis (LN). The level of fatigue was measured on a 5-point Likert scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much) based on their experience of fatigue during the past 2 weeks. The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. FACIT-Fatigue scale score range from 0 to 52, where higher scores represent less fatigue.
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Timepoint [8]
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Baseline, Week 12, Week 24, Week 36, Week 52
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Secondary outcome [9]
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Short Form Health Survey (SF-36) Version 2 (Acute Form) Mean Change From Baseline in Physical Component Score (PCS) up to Week 52
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Assessment method [9]
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The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). In this trial, SF-36-PCS responder (improvement of \>= 2.5 points) were evaluated. Responses to items allow for direct calculation of scale scores, while the physical component summary (PCS) scores are computed from weighted scale scores. For all scales and summary measures, higher scores indicate better health outcomes (PCS scores range 0 to 100).
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Timepoint [9]
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Baseline, Week 12, Week 24, Week 36, Week 52
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Secondary outcome [10]
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Lupus Quality of Life (LupusQoL) Physical Health Score Mean Change From Baseline up to Week 52
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Assessment method [10]
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The LupusQoL is a disease-specific, 34-item, self-report questionnaire designed to measure the health-related quality of life (HRQoL) of subjects with SLE within 8 domains (i.e., physical health (8 items), emotional health (6 items), body image (5 items), pain (3 items), planning (3 items), fatigue (4 items), intimate relationships (2 items), and burden to others (3 items)). Responses are based on a 5-point Likert scale where 0 (all of the time) to 4 (never). Each domain of the LupusQoL was scored separately. Transformed scores range from 0 (worst HRQoL) to 100 (best HRQoL).
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Timepoint [10]
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Baseline, Week 12, Week 24, Week 36, Week 52
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Secondary outcome [11]
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Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs)
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Assessment method [11]
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The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
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Timepoint [11]
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From first dose of study treatment up to approximately 2 years
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Secondary outcome [12]
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Percentage of Participants With Complete Renal Response (CRR) at Week 104 Within Those Who Had Achieved CRR at Week 52 in the Secukinumab Group
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Assessment method [12]
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The percentage of participants with maintained renal response (CRR) at Week 104 in the secukinumab group was evaluated
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Timepoint [12]
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Week 52 to Week 104
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Secondary outcome [13]
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Percentage of Participants With Improved or Maintained Response (PRR or CRR) at Week 104 in Those Who Had Achieved at Least PRR at Week 52 in the Secukinumab Group
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Assessment method [13]
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The percentage of participants with improved or maintained renal response (CRR) at Week 104 in the secukinumab group was evaluated
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Timepoint [13]
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Week 52 to Week 104
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Eligibility
Key inclusion criteria
Key inclusion criteria:
1. Adult male and female subjects aged 18 - 75 years old at the time of Baseline.
2. Confirmed diagnosis of:
* SLE with documented history of at least 4 of the 11 criteria for SLE as defined by the American College of Rheumatology (ACR) (Tan et al 1982) revised by (Hochberg 1997). [NOTE: The 4 criteria did not have to be present at the time of Screening], OR
* LN as the sole clinical criterion in the presence of ANA or anti-dsDNA antibodies.
3. Active lupus nephritis, as defined by meeting the 4 following criteria:
* Biopsy within 6 months prior to Screening visit indicating active glomerulonephritis WHO or ISN/RPS Class III or IV LN [excluding III (C), IV-S (C) and IV-G (C)]; patients are permitted to have co-existing Class V. If no biopsy was performed within 6 months of screening, a biopsy was to be performed during the Screening period
* UPCR = 1 mg/mg at Screening.
* eGFR > 30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).
* Active urinary sediment (presence of cellular casts (RBC or WBC casts)) or hematuria (> 5 RBC per high power field or above the laboratory reference range).
4. Subjects must have currently been on MPA, or willing to initiate SoC induction therapy for LN according to the institutional practices using MPA or low-dose CYC in addition to corticosteroids. For guidance, see published guidelines such as by (Bertsias et al 2012, Hahn et al 2012).
5. Subjects must had been treated with anti-malarials (e.g. hydroxychloroquine), unless contra-indicated, and the dose had been stable for at least 10 days prior to Randomization.
6. Able to provide signed informed consent.
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Minimum age
18
Years
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Maximum age
75
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
1. Severe renal impairment as defined by i.) Stage 4 CKD, or ii.) presence of oliguria (defined as a documented urine volume < 400 mL/24 h), or iii.) ESRD required dialysis or transplantation.
2. Known intolerance/hypersensitivity to MPA, or oral corticosteroids, or any component of the study drug(s).
3. Subjects received any other biologic immunomodulatory therapy within 6 months prior to Screening, excluding belimumab where 3 months were acceptable.
4. Previous exposure to secukinumab (AIN457) or any other biologic drug targeting IL-17 or the IL-17 receptor.
5. Subjects received any investigational drug within 1 month or five times the half-life of enrollment, whichever was longer.
6. Receipt of more than 3000 mg i.v. pulse methylprednisolone (cumulative dose) within the 12 weeks prior to Baseline.
7. Treatment with a systemic calcineurin inhibitor (e.g. cyclosporine, tacrolimus) within 12 weeks prior to Baseline
8. CYC use (i.v. or oral) within the month prior to Baseline.
9. Subjects requiring dialysis within the previous 12 months before Screening.
10. History of renal transplant.
11. Any severe progressive or uncontrolled concurrent medical condition, including recent severe thromboembolic events, that, in the opinion of the principal investigator, renders the subject unsuitable for the trial.
12. Active ongoing inflammatory diseases that might confound the evaluation of the benefit of secukinumab therapy, including inflammatory bowel disease.
13. Presence of investigator-identified significant medical problems which at the investigator's discretion would prevent the subject from participating in the study, included but not limited to the following: myocarditis, pericarditis, poorly controlled seizure disorder, acute confusional state, depression, severe manifestations of neuropsychiatric SLE (NPSLE).
14. Chest X-ray, computerized tomography (CT) scan, or MRI with evidence of ongoing infectious or malignant process, obtained within 3 months preceding the Screening visit and evaluated by a qualified physician.
15. History of chronic, recurrent systemic infections, active tuberculosis infection, or active systemic infections during the last two weeks (exception: common cold) prior to Randomization.
16. Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C at Screening or Randomization.
17. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there was evidence of local recurrence or metastases (except for skin Bowen's disease or basal cell carcinoma or actinic keratoses that had been treated with no evidence of recurrence in the past 12 weeks, carcinoma in situ of the cervix or non-invasive malignant colon polyps that had been removed).
18. Any of the following abnormal laboratory values on Screening evaluations as reported by Central Laboratory:
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or amylase > 2.5xULN
* Hemoglobin < 8g/dL
* Neutrophils < 1.0 x 109/L
* Platelet count < 50 x 109/L
21. Pregnant or lactating women. 22. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they were using highly effective methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., in European Union (EU) 20 weeks). Of note: the highly effective methods of contraception were mandated due to SoC medications used as per protocol (MPA and CYC).
In case local regulations deviated from the contraception methods listed above, local regulations applied and were described in the informed consent form (ICF).
If stricter female or male contraception requirements were specified in the country-specific label for induction and maintenance standard of care medications, they had to be followed.
Note: Women were considered post-menopausal and not of childbearing potential if they had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks prior to enrollment. In the case of oophorectomy alone, only when the reproductive status of the woman had been confirmed by follow-up hormone level assessment was she considered not of childbearing potential.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/07/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
13/09/2023
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Sample size
Target
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Accrual to date
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Final
275
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Novartis Investigative Site - Westmead
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment outside Australia
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United States of America
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Alabama
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California
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Florida
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Georgia
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Massachusetts
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Michigan
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Brazil
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CE
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Brazil
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RS
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Brazil
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Santa Catarina
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Brazil
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SP
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Brazil
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Ontario
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Los Rios
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Santiago
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Guangxi
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Wuhan
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Colombia
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Antioquia
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Fukuoka
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Japan
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Yamanashi
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Seocho Gu
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Seoul
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Philippines
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Quezon
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Portugal
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Coimbra
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Portugal
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Guimaraes
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Lisboa
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Porto
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Romania
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Jud Bihor
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Romania
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Valcea
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Romania
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Bucharest
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Romania
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Bucuresti
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Russian Federation
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Kazan
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Russian Federation
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Kemerovo
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Russian Federation
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Rostov On Don
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Russian Federation
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Saint Petersburg
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Russian Federation
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Yaroslavl
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Stockholm
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St Gallen
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Kaohsiung
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Taichung
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Taoyuan
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Bangkok
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Turkey
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Bakirkoy Istanbul
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Turkey
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Istanbul
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VNM
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Vietnam
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Hanoi
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Vietnam
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Ho Chi Minh
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Summary
Brief summary
This was a pivotal, randomized, double-blind, placebo-controlled trial evaluating at Week 52 the efficacy and safety of secukinumab versus placebo in patients with active lupus nephritis (ISN/RPS Class III or IV, with or without co-existing class V features) also receiving background standard of care therapy (SoC).
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Trial website
https://clinicaltrials.gov/study/NCT04181762
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/62/NCT04181762/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/62/NCT04181762/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04181762
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