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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04181762




Registration number
NCT04181762
Ethics application status
Date submitted
27/11/2019
Date registered
29/11/2019
Date last updated
2/02/2024

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
Terminated
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
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RM
Country [17] 0 0
Chile
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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
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Jiangxi
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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
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China
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Chongqing
Country [28] 0 0
China
State/province [28] 0 0
Shanghai
Country [29] 0 0
China
State/province [29] 0 0
Wuhan
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Colombia
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Antioquia
Country [31] 0 0
Colombia
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Barranquilla
Country [32] 0 0
Colombia
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Cali
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Colombia
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Cundinamarca
Country [34] 0 0
Croatia
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Zagreb
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Czechia
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Prague 2
Country [36] 0 0
Czechia
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Praha 5
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Czechia
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Praha
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Denmark
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Odense
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France
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Marseille
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Germany
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Mainz
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Greece
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Macedoni
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Greece
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Athens
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Guatemala
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Guatemala City
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Guatemala
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Guatemala
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Guatemala
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Quetzaltenango
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India
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Delhi
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Italy
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PD
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Japan
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Aichi
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Japan
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Fukuoka
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Japan
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Miyagi
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Japan
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Okayama
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Japan
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Yamanashi
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Korea, Republic of
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Seocho Gu
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Korea, Republic of
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Seoul
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Mexico
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Baja California Norte
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Mexico
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Mexico CP
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Yucatan
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Mexico
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Mexico
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Norway
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Oslo
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Peru
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Lima
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Philippines
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Batangas
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Philippines
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Iloilo
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Manila
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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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Portugal
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Lisbon
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Portugal
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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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Slovakia
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Piestany
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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
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Stockholm
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Switzerland
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St Gallen
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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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
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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
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/ct2/show/NCT04181762
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04181762