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

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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
Van Nuys, 91405
California
United States
Australia
Novartis Investigative Site
Recruiting
Westmead, 2145
New South Wales
Australia
Czechia
Novartis Investigative Site
Recruiting
Prague 2, 128 50
-
Czechia
Novartis Investigative Site
Recruiting
Praha 5, 150 06
-
Czechia
Novartis Investigative Site
Recruiting
Praha, 12808
-
Czechia
Denmark
Novartis Investigative Site
Recruiting
Arhus N, DK-8200
-
Denmark
Germany
Novartis Investigative Site
Recruiting
Berlin, 13353
-
Germany
Novartis Investigative Site
Recruiting
Freiburg, 79106
-
Germany
Novartis Investigative Site
Recruiting
Kiel, 24105
-
Germany
Novartis Investigative Site
Recruiting
Mainz, 55131
-
Germany
Japan
Novartis Investigative Site
Recruiting
Toyoake city, 470 1192
Aichi
Japan
Novartis Investigative Site
Recruiting
Kitakyushu-city, 807-8556
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Maebashi city, 371 8511
Gunma
Japan
Novartis Investigative Site
Recruiting
Sapporo city, 060 8648
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Kanazawa-city, 920-8641
Ishikawa
Japan
Novartis Investigative Site
Recruiting
Sendai city, 980 8574
Miyagi
Japan
Novartis Investigative Site
Recruiting
Chuo ku, 104-8560
Tokyo
Japan
Novartis Investigative Site
Recruiting
Shinjuku-ku, 160 8582
Tokyo
Japan
Latvia
Novartis Investigative Site
Recruiting
Riga, LV 1002
-
Latvia
Portugal
Novartis Investigative Site
Recruiting
Guimaraes, 4835 044
-
Portugal
Russian Federation
Novartis Investigative Site
Recruiting
Petrozavodsk, 185019
-
Russian Federation
Novartis Investigative Site
Recruiting
Rostov on Don, 344022
-
Russian Federation
Slovakia
Novartis Investigative Site
Recruiting
Piestany, 92101
-
Slovakia
Spain
Novartis Investigative Site
Recruiting
Cordoba, 14004
Andalucia
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08036
Catalunya
Spain
Novartis Investigative Site
Recruiting
La Coruna, 15706
Galicia
Spain
Sweden
Novartis Investigative Site
Recruiting
Stockholm, 171 76
-
Sweden
Switzerland
Novartis Investigative Site
Recruiting
Bern, 3010
-
Switzerland
Novartis Investigative Site
Recruiting
Lausanne, 1005
-
Switzerland
Novartis Investigative Site
Recruiting
St Gallen, CH 9007
-
Switzerland
Thailand
Novartis Investigative Site
Recruiting
Bangkok, 10400
-
Thailand
Turkey
Novartis Investigative Site
Recruiting
Istanbul, 34300
-
Turkey
Novartis Investigative Site
Recruiting
Kocaeli, 41380
-
Turkey

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111

Have a question?

Call 1-999-669-6682 or email [email protected]