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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04181762




Registration number
NCT04181762
Ethics application status
Date submitted
27/11/2019
Date registered
29/11/2019
Date last updated
30/03/2021

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) - Proportion of subjects achieving protocol-defined CRR
Timepoint [1] 0 0
Week 52
Secondary outcome [1] 0 0
Change in 24-hour Urine Protein-to Creatinine Ratio (UPCR) - Change from Baseline in 24-hour UPCR
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Proportion of subjects achieving Partial Renal Response (PRR) - Proportion of subjects achieving protocol-defined PRR
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Average daily dose of oral corticosteroids - Average daily dose of oral corticosteroids compared to placebo
Timepoint [3] 0 0
Week 16 to Week 52
Secondary outcome [4] 0 0
Proportion of subjects achieving PRR - Proportion of subjects achieving PRR
Timepoint [4] 0 0
Week 24
Secondary outcome [5] 0 0
Time to achieve CRR - Time to achieve CRR
Timepoint [5] 0 0
Baseline to Week 52
Secondary outcome [6] 0 0
Time to achieve PRR - 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 - Time to achieve first morning void UPCR = 0.5 mg/mg
Timepoint [7] 0 0
Baseline to Week 52
Secondary outcome [8] 0 0
Improvement in FACIT-Fatigue© - Improvement in FACIT-Fatigue© mean change of score compared to placebo
Timepoint [8] 0 0
Baseline to Week 52
Secondary outcome [9] 0 0
Improvement in SF-36 PCS mean - Improvement in SF-36 PCS mean change compared to placebo
Timepoint [9] 0 0
Baseline to Week 52
Secondary outcome [10] 0 0
Improvement in LupusQoL Physical Health mean - Improvement in LupusQoL Physical Health mean change of score compared to placebo
Timepoint [10] 0 0
Baseline to Week 52
Secondary outcome [11] 0 0
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
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 - Estimate the proportion of subjects with CRR at Week 104 within subjects who had achieved CRR at Week 52 in the secukinumab group
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 - 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
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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Westmead
Recruitment hospital [2] 0 0
Novartis Investigative Site - Woolloongabba
Recruitment hospital [3] 0 0
Novartis Investigative Site - Murdoch
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
6150 - Murdoch
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
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Brazil
State/province [8] 0 0
CE
Country [9] 0 0
Brazil
State/province [9] 0 0
RS
Country [10] 0 0
Brazil
State/province [10] 0 0
SP
Country [11] 0 0
Brazil
State/province [11] 0 0
Sao Jose do Rio Preto
Country [12] 0 0
China
State/province [12] 0 0
Beijing
Country [13] 0 0
China
State/province [13] 0 0
Tianjin
Country [14] 0 0
Colombia
State/province [14] 0 0
Antioquia
Country [15] 0 0
Colombia
State/province [15] 0 0
Barranquilla
Country [16] 0 0
Colombia
State/province [16] 0 0
Cundinamarca
Country [17] 0 0
Croatia
State/province [17] 0 0
Zagreb
Country [18] 0 0
Czechia
State/province [18] 0 0
Prague 2
Country [19] 0 0
Czechia
State/province [19] 0 0
Praha 5
Country [20] 0 0
Czechia
State/province [20] 0 0
Praha
Country [21] 0 0
Denmark
State/province [21] 0 0
Aalborg
Country [22] 0 0
Denmark
State/province [22] 0 0
Arhus N
Country [23] 0 0
Denmark
State/province [23] 0 0
Odense
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
Country [25] 0 0
Germany
State/province [25] 0 0
Freiburg
Country [26] 0 0
Germany
State/province [26] 0 0
Kiel
Country [27] 0 0
Germany
State/province [27] 0 0
Mainz
Country [28] 0 0
Greece
State/province [28] 0 0
Athens
Country [29] 0 0
Greece
State/province [29] 0 0
Heraklion Crete
Country [30] 0 0
Guatemala
State/province [30] 0 0
Guatemala City
Country [31] 0 0
Guatemala
State/province [31] 0 0
Guatemala
Country [32] 0 0
India
State/province [32] 0 0
Delhi
Country [33] 0 0
India
State/province [33] 0 0
Gujarat
Country [34] 0 0
India
State/province [34] 0 0
Maharashtra
Country [35] 0 0
Italy
State/province [35] 0 0
BS
Country [36] 0 0
Japan
State/province [36] 0 0
Aichi
Country [37] 0 0
Japan
State/province [37] 0 0
Fukuoka
Country [38] 0 0
Japan
State/province [38] 0 0
Gunma
Country [39] 0 0
Japan
State/province [39] 0 0
Hokkaido
Country [40] 0 0
Japan
State/province [40] 0 0
Ishikawa
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Japan
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Miyagi
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Japan
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Tokyo
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Japan
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Niigata
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Korea, Republic of
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Seocho Gu
Country [45] 0 0
Korea, Republic of
State/province [45] 0 0
Seoul
Country [46] 0 0
Latvia
State/province [46] 0 0
Riga
Country [47] 0 0
Norway
State/province [47] 0 0
Oslo
Country [48] 0 0
Philippines
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Batangas
Country [49] 0 0
Philippines
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Quezon City
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Portugal
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Coimbra
Country [51] 0 0
Portugal
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Guimaraes
Country [52] 0 0
Portugal
State/province [52] 0 0
Lisbon
Country [53] 0 0
Portugal
State/province [53] 0 0
Porto
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Kazan
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Russian Federation
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Petrozavodsk
Country [56] 0 0
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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Tyumen
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Slovakia
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Piestany
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South Africa
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Western Cape
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Spain
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Andalucia
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Spain
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Catalunya
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Spain
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Galicia
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Spain
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Pontevedra
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Sweden
State/province [65] 0 0
Linkoping
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Sweden
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Stockholm
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Sweden
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Uppsala
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Switzerland
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Bern
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Switzerland
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Lausanne
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Switzerland
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St Gallen
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Switzerland
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Zuerich
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Taiwan
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Taichung
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Thailand
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Bangkok
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Turkey
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Istanbul
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Turkey
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Kocaeli
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Turkey
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Zuhuratbaba / Istanbul
Country [77] 0 0
Vietnam
State/province [77] 0 0
VNM
Country [78] 0 0
Vietnam
State/province [78] 0 0
Hanoi

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

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT04181762
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
novartis.email@novartis.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04181762