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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

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
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
Secondary ID [1] 0 0
2019-003211-57
Secondary ID [2] 0 0
CAIN457Q12301
Universal Trial Number (UTN)
Trial acronym
SELUNE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lupus Nephritis 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - secukinumab

Experimental: secukinumab - secukinumab 300 mg s.c.

Placebo comparator: placebo - secukinumab placebo s.c.


Treatment: Drugs: secukinumab
STUDY DRUG
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects achieving Complete Renal Response (CRR)
Timepoint [1] 0 0
Week 52
Secondary outcome [1] 0 0
Change in 24-hour Urine Protein-to Creatinine Ratio (UPCR)
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Proportion of subjects achieving Partial Renal Response (PRR)
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Average daily dose of oral corticosteroids
Timepoint [3] 0 0
Week 16 to Week 52
Secondary outcome [4] 0 0
Proportion of subjects achieving PRR
Timepoint [4] 0 0
Week 24
Secondary outcome [5] 0 0
Time to achieve CRR
Timepoint [5] 0 0
Baseline to Week 52
Secondary outcome [6] 0 0
Time to achieve PRR
Timepoint [6] 0 0
Baseline to Week 52
Secondary outcome [7] 0 0
Time to achieve UPCR = 0.5 mg/mg
Timepoint [7] 0 0
Baseline to Week 52
Secondary outcome [8] 0 0
Improvement in FACIT-Fatigue©
Timepoint [8] 0 0
Baseline to Week 52
Secondary outcome [9] 0 0
Improvement in SF-36 PCS mean
Timepoint [9] 0 0
Baseline to Week 52
Secondary outcome [10] 0 0
Improvement in LupusQoL Physical Health mean
Timepoint [10] 0 0
Baseline to Week 52
Secondary outcome [11] 0 0
Incidence of Treatment-emergent AEs (TEAEs) / SAEs
Timepoint [11] 0 0
Baseline to Week 52
Secondary outcome [12] 0 0
Proportion of subjects with CRR at Week 104 within subjects who had achieved CRR at Week 52
Timepoint [12] 0 0
Week 52 to Week 104
Secondary outcome [13] 0 0
Proportion of subjects with improved or maintained renal response at Week 104
Timepoint [13] 0 0
Week 52 to Week 104

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/09/2023
Sample size
Target
Accrual to date
Final
275
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Novartis Investigative Site - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
Argentina
State/province [7] 0 0
Buenos Aires
Country [8] 0 0
Argentina
State/province [8] 0 0
Cordoba
Country [9] 0 0
Brazil
State/province [9] 0 0
CE
Country [10] 0 0
Brazil
State/province [10] 0 0
RS
Country [11] 0 0
Brazil
State/province [11] 0 0
Santa Catarina
Country [12] 0 0
Brazil
State/province [12] 0 0
SP
Country [13] 0 0
Brazil
State/province [13] 0 0
Sao Jose do Rio Preto
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Chile
State/province [15] 0 0
Los Rios
Country [16] 0 0
Chile
State/province [16] 0 0
RM
Country [17] 0 0
Chile
State/province [17] 0 0
Concepcion
Country [18] 0 0
Chile
State/province [18] 0 0
Santiago
Country [19] 0 0
China
State/province [19] 0 0
Guangdong
Country [20] 0 0
China
State/province [20] 0 0
Guangxi
Country [21] 0 0
China
State/province [21] 0 0
Hebei
Country [22] 0 0
China
State/province [22] 0 0
Hunan
Country [23] 0 0
China
State/province [23] 0 0
Jiangxi
Country [24] 0 0
China
State/province [24] 0 0
Shandong
Country [25] 0 0
China
State/province [25] 0 0
Sichuan
Country [26] 0 0
China
State/province [26] 0 0
Beijing
Country [27] 0 0
China
State/province [27] 0 0
Chongqing
Country [28] 0 0
China
State/province [28] 0 0
Shanghai
Country [29] 0 0
China
State/province [29] 0 0
Wuhan
Country [30] 0 0
Colombia
State/province [30] 0 0
Antioquia
Country [31] 0 0
Colombia
State/province [31] 0 0
Barranquilla
Country [32] 0 0
Colombia
State/province [32] 0 0
Cali
Country [33] 0 0
Colombia
State/province [33] 0 0
Cundinamarca
Country [34] 0 0
Croatia
State/province [34] 0 0
Zagreb
Country [35] 0 0
Czechia
State/province [35] 0 0
Prague 2
Country [36] 0 0
Czechia
State/province [36] 0 0
Praha 5
Country [37] 0 0
Czechia
State/province [37] 0 0
Praha
Country [38] 0 0
Denmark
State/province [38] 0 0
Odense
Country [39] 0 0
France
State/province [39] 0 0
Marseille
Country [40] 0 0
Germany
State/province [40] 0 0
Mainz
Country [41] 0 0
Greece
State/province [41] 0 0
Macedoni
Country [42] 0 0
Greece
State/province [42] 0 0
Athens
Country [43] 0 0
Guatemala
State/province [43] 0 0
Guatemala City
Country [44] 0 0
Guatemala
State/province [44] 0 0
Guatemala
Country [45] 0 0
Guatemala
State/province [45] 0 0
Quetzaltenango
Country [46] 0 0
India
State/province [46] 0 0
Delhi
Country [47] 0 0
Italy
State/province [47] 0 0
PD
Country [48] 0 0
Japan
State/province [48] 0 0
Aichi
Country [49] 0 0
Japan
State/province [49] 0 0
Fukuoka
Country [50] 0 0
Japan
State/province [50] 0 0
Miyagi
Country [51] 0 0
Japan
State/province [51] 0 0
Okayama
Country [52] 0 0
Japan
State/province [52] 0 0
Yamanashi
Country [53] 0 0
Korea, Republic of
State/province [53] 0 0
Seocho Gu
Country [54] 0 0
Korea, Republic of
State/province [54] 0 0
Seoul
Country [55] 0 0
Mexico
State/province [55] 0 0
Baja California Norte
Country [56] 0 0
Mexico
State/province [56] 0 0
Mexico CP
Country [57] 0 0
Mexico
State/province [57] 0 0
Yucatan
Country [58] 0 0
Mexico
State/province [58] 0 0
Mexico
Country [59] 0 0
Norway
State/province [59] 0 0
Oslo
Country [60] 0 0
Peru
State/province [60] 0 0
Lima
Country [61] 0 0
Philippines
State/province [61] 0 0
Batangas
Country [62] 0 0
Philippines
State/province [62] 0 0
Iloilo
Country [63] 0 0
Philippines
State/province [63] 0 0
Manila
Country [64] 0 0
Philippines
State/province [64] 0 0
Quezon
Country [65] 0 0
Portugal
State/province [65] 0 0
Coimbra
Country [66] 0 0
Portugal
State/province [66] 0 0
Guimaraes
Country [67] 0 0
Portugal
State/province [67] 0 0
Lisbon
Country [68] 0 0
Portugal
State/province [68] 0 0
Porto
Country [69] 0 0
Romania
State/province [69] 0 0
Jud. Bihor
Country [70] 0 0
Romania
State/province [70] 0 0
Valcea
Country [71] 0 0
Romania
State/province [71] 0 0
Bucharest
Country [72] 0 0
Romania
State/province [72] 0 0
Bucuresti
Country [73] 0 0
Russian Federation
State/province [73] 0 0
Kazan
Country [74] 0 0
Russian Federation
State/province [74] 0 0
Kemerovo
Country [75] 0 0
Russian Federation
State/province [75] 0 0
Rostov On Don
Country [76] 0 0
Russian Federation
State/province [76] 0 0
Saint Petersburg
Country [77] 0 0
Russian Federation
State/province [77] 0 0
Yaroslavl
Country [78] 0 0
Slovakia
State/province [78] 0 0
Piestany
Country [79] 0 0
Spain
State/province [79] 0 0
Catalunya
Country [80] 0 0
Spain
State/province [80] 0 0
Galicia
Country [81] 0 0
Spain
State/province [81] 0 0
Pontevedra
Country [82] 0 0
Sweden
State/province [82] 0 0
Stockholm
Country [83] 0 0
Switzerland
State/province [83] 0 0
St Gallen
Country [84] 0 0
Taiwan
State/province [84] 0 0
Kaohsiung
Country [85] 0 0
Taiwan
State/province [85] 0 0
Taichung
Country [86] 0 0
Taiwan
State/province [86] 0 0
Tao Yuan
Country [87] 0 0
Thailand
State/province [87] 0 0
Bangkok
Country [88] 0 0
Turkey
State/province [88] 0 0
Istanbul
Country [89] 0 0
Turkey
State/province [89] 0 0
Zuhuratbaba / Istanbul
Country [90] 0 0
Vietnam
State/province [90] 0 0
VNM
Country [91] 0 0
Vietnam
State/province [91] 0 0
Hanoi
Country [92] 0 0
Vietnam
State/province [92] 0 0
Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04181762