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

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).

Study Overview

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

Detailed Description

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

• 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
    • São 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
  • Shanghai, China, 200025
    • Novartis Investigative Site
  • Shanghai, China, 200040
    • Novartis Investigative Site
  • Wuhan, China, 430022
    • Novartis Investigative Site
  • Guangdong
    • Guangzhou, Guangdong, China, 510280
      • Novartis Investigative Site
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Novartis Investigative Site
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Novartis Investigative Site
  • Hunan
    • Changsha, Hunan, China, 410011
      • 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
  • Prague 2, Czechia, 128 50
    • Novartis Investigative Site
  • Praha, Czechia, 12808
    • Novartis Investigative Site
  • Praha 5, Czechia, 150 06
    • Novartis Investigative Site
• Denmark
  • Odense, 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
  • Macedoni
    • Thessaloniki, Macedoni, Greece, 56403
      • 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-city, 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-city, 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
  • Lisbon, 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, 171 76
    • Novartis Investigative Site
• Switzerland
  • St Gallen, Switzerland, CH 9007
    • Novartis Investigative Site
• Taiwan
  • Kaohsiung, Taiwan, 81346
    • Novartis Investigative Site
  • Taichung, Taiwan, 40447
    • Novartis Investigative Site
  • Taichung, Taiwan, 40705
    • Novartis Investigative Site
  • Tao Yuan, Taiwan, 333
    • Novartis Investigative Site
• Thailand
  • Bangkok, Thailand, 10700
    • Novartis Investigative Site
  • Bangkok, Thailand, 10400
    • Novartis Investigative Site
• Turkey
  • Istanbul, Turkey, 34093
    • Novartis Investigative Site
  • Istanbul, Turkey, 34300
    • Novartis Investigative Site
  • Zuhuratbaba / Istanbul, Turkey, 34147
    • Novartis Investigative Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Novartis Investigative Site
  • California
    • Fontana, California, United States, 92335
      • Novartis Investigative Site
    • Los Angeles, California, United States, 90095
      • Novartis Investigative Site
  • Florida
    • Aventura, Florida, United States, 33180
      • Novartis Investigative Site
    • Plantation, Florida, United States, 33324
      • Novartis Investigative Site
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Novartis Investigative Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Novartis Investigative Site
  • Michigan
    • Grand Blanc, Michigan, United States, 48439
      • Novartis Investigative Site
• 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

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.

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; secukinumab 300 mg s.c.	Drug: secukinumab; STUDY DRUG; Other Names: AIN457
Placebo Comparator: placebo; secukinumab placebo s.c.	Drug: secukinumab; STUDY DRUG; Other Names: AIN457

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects achieving Complete Renal Response (CRR)	Proportion of subjects achieving protocol-defined CRR	Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 24-hour Urine Protein-to Creatinine Ratio (UPCR)	Change from Baseline in 24-hour UPCR	Week 52
Proportion of subjects achieving Partial Renal Response (PRR)	Proportion of subjects achieving protocol-defined PRR	Week 52
Average daily dose of oral corticosteroids	Average daily dose of oral corticosteroids compared to placebo	Week 16 to Week 52
Proportion of subjects achieving PRR	Proportion of subjects achieving PRR	Week 24
Time to achieve CRR	Time to achieve CRR	Baseline to Week 52
Time to achieve PRR	Time to achieve PRR	Baseline to Week 52
Time to achieve UPCR ≤ 0.5 mg/mg	Time to achieve first morning void UPCR ≤ 0.5 mg/mg	Baseline to Week 52
Improvement in SF-36 PCS mean	Improvement in SF-36 PCS mean change compared to placebo	Baseline to Week 52
Improvement in LupusQoL Physical Health mean	Improvement in LupusQoL Physical Health mean change of score compared to placebo	Baseline to Week 52
Incidence of Treatment-emergent AEs (TEAEs) / SAEs	Incidence of Treatment-emergent AEs (TEAEs) / SAEs from Baseline to Week 52; vital signs and body measurements, standard chemistry and hematology	Baseline to Week 52
Proportion of subjects with CRR at Week 104 within subjects who had achieved CRR at Week 52	Estimate the proportion of subjects with CRR at Week 104 within subjects who had achieved CRR at Week 52 in the secukinumab group	Week 52 to Week 104
Proportion of subjects with improved or maintained renal response at 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	Week 52 to Week 104
Improvement in FACIT-Fatigue©	Improvement in FACIT-Fatigue© mean change of score compared to placebo The FACIT Fatigue Scale measures an individual's level of fatigue during their usual daily activities. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued)	Baseline to Week 52

Collaborators and Investigators

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

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): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: SLE; eGFR; UPCR; secukinumab; renal biopsy; LN; SoC background therapy
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Kidney Diseases; Urologic Diseases; Connective Tissue Diseases; Glomerulonephritis; Lupus Erythematosus, Systemic; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; 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