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

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

ClinicalTrials.gov Identifier: NCT04181762

Novartis Reference Number: CAIN457Q12301

Last Update: Mar 30, 2021

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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).

Condition 
Lupus Nephritis
Phase 
Phase 3
Overall status 
Recruiting
Enrollment count 
460 participants
Start date 
Jul 07, 2020
Completion date 
Jan 08, 2026
Gender 
All
Age(s)
18 Years - 75 Years (Adult, Older Adult)

Interventions

Drug
secukinumab
STUDY DRUG

Eligibility Criteria

Inclusion Criteria:

Adult male and female subjects aged 18 - 75 years old at the time of Baseline.

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.

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:

Severe renal impairment and subjects requiring dialysis dialysis within the previous 12 months before Screening.
Significant medical Problems like myocarditis, pericarditis, severe manifestations of neuropsychiatric SLE (NPSLE).
Cyclophosphamide (CYC) use (i.v. or oral) or more than 3000 mg i.v. pulse methylprednisolone (cumulative dose) within the month prior to Baseline.
Active ongoing inflammatory diseases.
Previous exposure to secukinumab (AIN457) or any other biologic drug targeting IL-17 or the IL-17 receptor.
Ongoing infections or malignant process.
Pregnant or lactating women.

Other inclusion and exclusion criteria may apply.

Study Locations

United States
Novartis Investigative Site
Recruiting
Birmingham, 35294
Alabama
United States
Novartis Investigative Site
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La Mesa, 91942
California
United States
Novartis Investigative Site
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Loma Linda, 92354
California
United States
Novartis Investigative Site
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Van Nuys, 91405
California
United States
Novartis Investigative Site
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Aventura, 33180
Florida
United States
Novartis Investigative Site
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Plantation, 33324
Florida
United States
Novartis Investigative Site
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Boston, 02215
Massachusetts
United States
Novartis Investigative Site
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Brooklyn, 11201
New York
United States
Novartis Investigative Site
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Manhasset, 11030
New York
United States
Novartis Investigative Site
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Statesville, 28625
North Carolina
United States
Novartis Investigative Site
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Houston, 77054
Texas
United States
Australia
Novartis Investigative Site
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Westmead, 2145
New South Wales
Australia
Novartis Investigative Site
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Woolloongabba, 4102
Queensland
Australia
Novartis Investigative Site
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Murdoch, 6150
Western Australia
Australia
Brazil
Novartis Investigative Site
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Fortaleza, 60430 370
CE
Brazil
Novartis Investigative Site
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Porto Alegre, 90020-090
RS
Brazil
Novartis Investigative Site
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Santo Andre, 09060-870
SP
Brazil
Novartis Investigative Site
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Sao Paulo, 05403 000
SP
Brazil
Novartis Investigative Site
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São Paulo, 04038-002
SP
Brazil
Novartis Investigative Site
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Sao Jose do Rio Preto, 15090 000
-
Brazil
China
Novartis Investigative Site
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Beijing, 100034
-
China
Novartis Investigative Site
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Tianjin, 300052
-
China
Colombia
Novartis Investigative Site
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Medellin, 050001
Antioquia
Colombia
Novartis Investigative Site
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Barranquilla,
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Colombia
Novartis Investigative Site
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Cundinamarca, 111121
-
Colombia
Croatia
Novartis Investigative Site
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Zagreb, 10000
-
Croatia
Czech Republic
Novartis Investigative Site
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Prague 2, 128 50
-
Czech Republic
Novartis Investigative Site
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Praha 5, 150 06
-
Czech Republic
Novartis Investigative Site
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Praha, 12808
-
Czech Republic
Denmark
Novartis Investigative Site
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Aalborg, 9000
-
Denmark
Novartis Investigative Site
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Arhus N, DK-8200
-
Denmark
Novartis Investigative Site
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Odense, 5000
-
Denmark
Germany
Novartis Investigative Site
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Berlin, 13353
-
Germany
Novartis Investigative Site
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Freiburg, 79106
-
Germany
Novartis Investigative Site
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Kiel, 24105
-
Germany
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Mainz, 55131
-
Germany
Greece
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Athens, 115 27
-
Greece
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Athens, 12462
-
Greece
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Heraklion Crete, 711 10
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Greece
Guatemala
Novartis Investigative Site
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Guatemala City, 01011
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Guatemala
Novartis Investigative Site
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Guatemala, 01009
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Guatemala
Novartis Investigative Site
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Guatemala, 01010
-
Guatemala
India
Novartis Investigative Site
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New Delhi, 110 017
Delhi
India
Novartis Investigative Site
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New Delhi, 110 060
Delhi
India
Novartis Investigative Site
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Gandhinagar, 387001
Gujarat
India
Novartis Investigative Site
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Pune, 411013
Maharashtra
India
Italy
Novartis Investigative Site
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Brescia, 25123
BS
Italy
Japan
Novartis Investigative Site
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Toyoake city, 470 1192
Aichi
Japan
Novartis Investigative Site
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Kitakyushu-city, 807-8556
Fukuoka
Japan
Novartis Investigative Site
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Maebashi city, 371 8511
Gunma
Japan
Novartis Investigative Site
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Sapporo city, 060 8648
Hokkaido
Japan
Novartis Investigative Site
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Kanazawa-city, 920-8641
Ishikawa
Japan
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Sendai city, 980 8574
Miyagi
Japan
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Bunkyo ku, 113-8431
Tokyo
Japan
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Chuo ku, 104-8560
Tokyo
Japan
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Shinjuku-ku, 160 8582
Tokyo
Japan
Novartis Investigative Site
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Niigata, 951 8520
-
Japan
Korea, Republic of
Novartis Investigative Site
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Seoul, 06591
Seocho Gu
Korea, Republic of
Novartis Investigative Site
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Seoul, 04763
-
Korea, Republic of
Latvia
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Riga, LV 1002
-
Latvia
Norway
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Oslo, 0372
-
Norway
Philippines
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Lipa City, 4217
Batangas
Philippines
Novartis Investigative Site
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Quezon City, 1102
-
Philippines
Portugal
Novartis Investigative Site
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Coimbra, 3000-075
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Portugal
Novartis Investigative Site
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Guimaraes, 4835 044
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Portugal
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Lisbon, 1069-166
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Portugal
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Porto, 4099 001
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Portugal
Russian Federation
Novartis Investigative Site
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Kazan, 420012
-
Russian Federation
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Petrozavodsk, 185019
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Russian Federation
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Rostov on Don, 344022
-
Russian Federation
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Saint Petersburg, 197022
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Russian Federation
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Tyumen, 625023
-
Russian Federation
Slovakia
Novartis Investigative Site
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Piestany, 92101
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Slovakia
South Africa
Novartis Investigative Site
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Panorama, 7500
Western Cape
South Africa
Spain
Novartis Investigative Site
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Cordoba, 14004
Andalucia
Spain
Novartis Investigative Site
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Sevilla, 41013
Andalucia
Spain
Novartis Investigative Site
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Barcelona, 08036
Catalunya
Spain
Novartis Investigative Site
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La Coruna, 15706
Galicia
Spain
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Vigo, 36200
Pontevedra
Spain
Sweden
Novartis Investigative Site
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Linkoping, SE 581 85
-
Sweden
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Stockholm, 171 76
-
Sweden
Novartis Investigative Site
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Uppsala, 751 85
-
Sweden
Switzerland
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Bern, 3010
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Switzerland
Novartis Investigative Site
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Lausanne, 1005
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Switzerland
Novartis Investigative Site
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St Gallen, CH 9007
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Switzerland
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Zuerich, 8091
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Switzerland
Taiwan
Novartis Investigative Site
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Taichung, 40447
-
Taiwan
Novartis Investigative Site
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Taichung, 40705
-
Taiwan
Thailand
Novartis Investigative Site
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Bangkok, 10400
-
Thailand
Novartis Investigative Site
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Bangkok, 10700
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Thailand
Turkey
Novartis Investigative Site
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Istanbul, 34093
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Turkey
Novartis Investigative Site
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Istanbul, 34300
-
Turkey
Novartis Investigative Site
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Kocaeli, 41380
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Turkey
Novartis Investigative Site
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Zuhuratbaba / Istanbul, 34147
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Turkey
Vietnam
Novartis Investigative Site
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Ho Chi Minh, 700000
VNM
Vietnam
Novartis Investigative Site
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Hanoi, 100000
-
Vietnam

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

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