Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis (SELUNE)

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

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).

Study Overview

• Status: Terminated
• Conditions: Lupus Nephritis
• Intervention / Treatment: Drug: Placebo; Drug: secukinumab

Detailed Description

The study consisted of the following parts:

• Screening (up to 42 days/6 weeks)
• Run-in period (optional): For subjects who received Mycophenolic acid (MPA) as SoC induction therapy as per investigator's decision and who were not already on MPA at Screening, MPA dosing was initiated during a run-in period before Randomization (for up to 4 weeks prior to the first dose of secukinumab)
• Treatment Period: Duration of 104 weeks of treatment with secukinumab/placebo in addition to SoC treatment (with last dose given at Week 100)
• Secukinumab dosing was started with initial dosing of 300 mg s.c. injections at Baseline, Weeks 1, 2, 3, and 4, followed by dosing every 4 weeks
• Follow-up period: Duration of 8 weeks (last visit performed 12 weeks after last dose of study medication) for all except for subjects entering extension study CAIN457Q12301E1 (NCT05232864).

A total of 275 subjects were enrolled and were randomized to secukinumab 300 mg (n = 137) or placebo (n = 138) until study termination. Recruitment in this study was stopped on 26-May-2023. The CAIN457Q12301 study was terminated early by Novartis due to futile results from interim analysis 1 (IA1). There was no safety related reasons for early termination or concerns for the subjects in the study. The decision was made to terminate both the core and the related extension study in view of treatment futility of the core study.

• Study Type: Interventional
• Enrollment (Actual): 275
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Cordoba, Argentina, X5016JDA
    • Novartis Investigative Site
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1280AEB
      • Novartis Investigative Site
    • Ciudad Autonoma de Bs As, Buenos Aires, Argentina, C1015ABO
      • Novartis Investigative Site
• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Novartis Investigative Site
• Brazil
  • Sao Jose do Rio Preto, Brazil, 15090 000
    • Novartis Investigative Site
  • CE
    • Fortaleza, CE, Brazil, 60430 370
      • Novartis Investigative Site
  • RS
    • Porto Alegre, RS, Brazil, 90020-090
      • Novartis Investigative Site
  • SP
    • Santo Andre, SP, Brazil, 09090-790
      • Novartis Investigative Site
    • Sao Paulo, SP, Brazil, 05403 000
      • Novartis Investigative Site
    • Sao Paulo, SP, Brazil, 04038-002
      • Novartis Investigative Site
  • Santa Catarina
    • Joinville, Santa Catarina, Brazil, 893227-680
      • Novartis Investigative Site
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Novartis Investigative Site
• Chile
  • Concepcion, Chile, 6740
    • Novartis Investigative Site
  • Santiago, Chile, 7500710
    • Novartis Investigative Site
  • Los Rios
    • Valdivia, Los Rios, Chile, 5100238
      • Novartis Investigative Site
  • RM
    • Santiago, RM, Chile, 7500588
      • Novartis Investigative Site
• China
  • Beijing, China, 100730
    • Novartis Investigative Site
  • Beijing, China, 100034
    • Novartis Investigative Site
  • Chongqing, China, 400037
    • Novartis Investigative Site
  • Guangzhou, China, 510280
    • Novartis Investigative Site
  • Shanghai, China, 200025
    • Novartis Investigative Site
  • Shanghai, China, 200040
    • Novartis Investigative Site
  • Wuhan, China, 430022
    • Novartis Investigative Site
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Novartis Investigative Site
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Novartis Investigative Site
  • Hunan
    • Changsha, Hunan, China, 410008
      • Novartis Investigative Site
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Novartis Investigative Site
  • Shandong
    • Binzhou, Shandong, China, 256603
      • Novartis Investigative Site
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Novartis Investigative Site
• Colombia
  • Barranquilla, Colombia, 080020
    • Novartis Investigative Site
  • Cali, Colombia, 760012
    • Novartis Investigative Site
  • Cundinamarca, Colombia, 111121
    • Novartis Investigative Site
  • Antioquia
    • Medellin, Antioquia, Colombia, 050001
      • Novartis Investigative Site
• Croatia
  • Zagreb, Croatia, 10000
    • Novartis Investigative Site
• Czechia
  • Praha, Czechia, 12808
    • Novartis Investigative Site
  • Praha 2, Czechia, 128 50
    • Novartis Investigative Site
  • Praha 5, Czechia, 150 06
    • Novartis Investigative Site
• Denmark
  • Odense C, Denmark, 5000
    • Novartis Investigative Site
• France
  • Marseille, France, 13385
    • Novartis Investigative Site
• Germany
  • Mainz, Germany, 55131
    • Novartis Investigative Site
• Greece
  • Athens, Greece, 115 27
    • Novartis Investigative Site
  • Thessaloniki, Greece, GR-54642
    • Novartis Investigative Site
• Guatemala
  • Guatemala, Guatemala, 01010
    • Novartis Investigative Site
  • Guatemala City, Guatemala, 01011
    • Novartis Investigative Site
  • Quetzaltenango, Guatemala, 9001
    • Novartis Investigative Site
• India
  • Delhi
    • New Delhi, Delhi, India, 110 060
      • Novartis Investigative Site
    • New Delhi, Delhi, India, 110 017
      • Novartis Investigative Site
• Italy
  • PD
    • Padova, PD, Italy, 35128
      • Novartis Investigative Site
• Japan
  • Aichi
    • Toyoake city, Aichi, Japan, 470 1192
      • Novartis Investigative Site
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan, 807-8556
      • Novartis Investigative Site
  • Miyagi
    • Sendai city, Miyagi, Japan, 980 8574
      • Novartis Investigative Site
  • Okayama
    • Kurashiki, Okayama, Japan, 701-0192
      • Novartis Investigative Site
  • Yamanashi
    • Chuo, Yamanashi, Japan, 409-3898
      • Novartis Investigative Site
• Korea, Republic of
  • Seoul, Korea, Republic of, 04763
    • Novartis Investigative Site
  • Seocho Gu
    • Seoul, Seocho Gu, Korea, Republic of, 06591
      • Novartis Investigative Site
• Mexico
  • Mexico, Mexico, 06726
    • Novartis Investigative Site
  • Baja California Norte
    • Mexicali, Baja California Norte, Mexico, 21200
      • Novartis Investigative Site
  • Mexico CP
    • Ciudad De Mexico, Mexico CP, Mexico, 14080
      • Novartis Investigative Site
  • Yucatan
    • Merida, Yucatan, Mexico, 97070
      • Novartis Investigative Site
• Norway
  • Oslo, Norway, 0372
    • Novartis Investigative Site
• Peru
  • Lima
    • Santiago de Surco, Lima, Peru, 33
      • Novartis Investigative Site
• Philippines
  • Iloilo, Philippines, 5000
    • Novartis Investigative Site
  • Manila, Philippines, 1008
    • Novartis Investigative Site
  • Quezon, Philippines, 1102
    • Novartis Investigative Site
  • Batangas
    • Lipa City, Batangas, Philippines, 4217
      • Novartis Investigative Site
• Portugal
  • Coimbra, Portugal, 3000 075
    • Novartis Investigative Site
  • Guimaraes, Portugal, 4835-044
    • Novartis Investigative Site
  • Lisboa, Portugal, 1069 166
    • Novartis Investigative Site
  • Porto, Portugal, 4099-001
    • Novartis Investigative Site
• Romania
  • Bucharest, Romania, 022328
    • Novartis Investigative Site
  • Bucuresti, Romania, 011172
    • Novartis Investigative Site
  • Bucuresti, Romania, 010 731
    • Novartis Investigative Site
  • Jud Bihor
    • Oradea, Jud Bihor, Romania, 410619
      • Novartis Investigative Site
  • Valcea
    • Ramnicu Valcea, Valcea, Romania, 240672
      • Novartis Investigative Site
• Russian Federation
  • Kazan, Russian Federation, 420012
    • Novartis Investigative Site
  • Kemerovo, Russian Federation, 650070
    • Novartis Investigative Site
  • Rostov On Don, Russian Federation, 344022
    • Novartis Investigative Site
  • Saint Petersburg, Russian Federation, 197022
    • Novartis Investigative Site
  • Yaroslavl, Russian Federation, 150062
    • Novartis Investigative Site
• Slovakia
  • Piestany, Slovakia, 92101
    • Novartis Investigative Site
• Spain
  • Catalunya
    • Barcelona, Catalunya, Spain, 08036
      • Novartis Investigative Site
  • Galicia
    • Santiago De Compostela, Galicia, Spain, 15706
      • Novartis Investigative Site
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36200
      • Novartis Investigative Site
• Sweden
  • Stockholm, Sweden, 17176
    • Novartis Investigative Site
• Switzerland
  • St Gallen, Switzerland, 9007
    • Novartis Investigative Site
• Taiwan
  • Kaohsiung, Taiwan, 81346
    • Novartis Investigative Site
  • Taichung, Taiwan, 40447
    • Novartis Investigative Site
  • Taichung, Taiwan, 407219
    • Novartis Investigative Site
  • Taoyuan, Taiwan, 33305
    • Novartis Investigative Site
• Thailand
  • Bangkok, Thailand, 10700
    • Novartis Investigative Site
  • Bangkok, Thailand, 10400
    • Novartis Investigative Site
• Turkey
  • Bakırkoy Istanbul, Turkey, 34147
    • Novartis Investigative Site
  • Istanbul, Turkey, 34093
    • Novartis Investigative Site
  • Istanbul, Turkey, 35100
    • Novartis Investigative Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama
  • California
    • Fontana, California, United States, 92335
      • Kaiser Permanente Fontana
    • Los Angeles, California, United States, 90095
      • University of California LA
  • Florida
    • Aventura, Florida, United States, 33180
      • Arthritis and Rheum Dise Spec
    • Plantation, Florida, United States, 33324
      • Integral Rheumatology and Immunology Specialists IRIS
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Hospital
  • Michigan
    • Grand Blanc, Michigan, United States, 48439
      • Ahmed Arif Medical Research Center
• Vietnam
  • Hanoi, Vietnam, 100000
    • Novartis Investigative Site
  • Ho Chi Minh, Vietnam, 700000
    • Novartis Investigative Site
  • VNM
    • Ho Chi Minh, VNM, Vietnam, 700000
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Key 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: secukinumab; STUDY DRUG; Other Names: AIN457
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.	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Complete Renal Response (CRR) at Week 52	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.	Baseline, Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in 24-hour Urine Protein-to Creatinine Ratio (UPCR)	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).	Baseline, Week 52
Percentage of Participants Achieving Partial Renal Response (PRR) at Week 52	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	Baseline, Week 52
Average Daily Dose of Oral Corticosteroids	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.	Week 16 to Week 52
Percentage of Participants Achieving Partial Renal Response (PRR) at Week 24	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	Baseline, Week 24
Incidence Rate of Participants Achieving Complete Renal Response (CRR) up to Week 52	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.	Baseline to Week 52
Incidence Rate of Participants Achieving Partial Renal Response (PRR) up to Week 52	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.	Baseline to Week 52
Time to Achieve First Morning Void Urine Protein-to-Creatinine Ratio (UPCR) <= 0.5 mg/mg up to Week 52	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.	Baseline to Week 52
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Mean Change From Baseline up to Week 52	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.	Baseline, Week 12, Week 24, Week 36, Week 52
Short Form Health Survey (SF-36) Version 2 (Acute Form) Mean Change From Baseline in Physical Component Score (PCS) up to Week 52	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).	Baseline, Week 12, Week 24, Week 36, Week 52
Lupus Quality of Life (LupusQoL) Physical Health Score Mean Change From Baseline up to Week 52	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).	Baseline, Week 12, Week 24, Week 36, Week 52
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs)	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.	From first dose of study treatment up to approximately 2 years
Percentage of Participants With Complete Renal Response (CRR) at Week 104 Within Those Who Had Achieved CRR at Week 52 in the Secukinumab Group	The percentage of participants with maintained renal response (CRR) at Week 104 in the secukinumab group was evaluated	Week 52 to Week 104
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	The percentage of participants with improved or maintained renal response (CRR) at Week 104 in the secukinumab group was evaluated	Week 52 to Week 104

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• A Plain Language Trial Summary is available on www.novctrd.com

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2020
• Primary Completion (Actual): September 13, 2023
• Study Completion (Actual): September 13, 2023

Study Registration Dates

• First Submitted: November 27, 2019
• First Submitted That Met QC Criteria: November 27, 2019
• First Posted (Actual): November 29, 2019

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Systemic Lupus Erythematosus (SLE); secukinumab; renal biopsy; Lupus Nephritis (LN); estimated Glomerular Filtration Rate (eGFR); Urine Protein-to-Creatinine Ratio (UPCR); Standard of Care (SoC) background therapy
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Lupus Erythematosus, Systemic; Nephritis; Lupus Nephritis
• Other Study ID Numbers: CAIN457Q12301; 2019-003211-57 (EudraCT Number); PACTR202211748997845 (Other Identifier: PACTR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No