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 21, 2023

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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
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
University of Alabama
Recruiting
Birmingham, 35294 - Alabama
Contact: Walter W Chatham (205-934-9843)
United States
Medvin Clinical Research
Recruiting
Covina, 91722 - California
Contact: Samy Metyas (626-869-5730) - [email protected] -
United States
Kaiser Permanente Fontana
Recruiting
Fontana, 92335 - California
Contact: Steve Lee (909-427-5595)
United States
Purushotham & Akther Kotha, MD
Recruiting
La Mesa, 91942 - California
Contact: Roshan Kotha (619-229-1995 ext: 208)
United States
Loma Linda University
Recruiting
Loma Linda, 92354 - California
Contact: Karina Torralba (909-558-6091)
United States
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Recruiting
Los Angeles, 90095
California
United States
Novartis Investigative Site
Recruiting
S. Gate, 90280
California
United States
Center for Innovative Therapy
Recruiting
San Diego, 92037 - California
Contact: Kenneth C Kalunian (858-246-2386)
United States
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Recruiting
Thousand Oaks, 91360
California
United States
Inland Rheumatology Clinical Trials
Recruiting
Upland, 91786 - California
Contact: Eric Lee (909-296-8746)
United States
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Recruiting
Van Nuys, 91405
California
United States
Hartford Healthcare
Recruiting
Hartford, 06106 - Connecticut
Contact: John Magaldi Magaldi (860-972-5978)
United States
Novartis Investigative Site
Recruiting
Aventura, 33180
Florida
United States
Arthritis and Rheum Ctr of S. Florida
Recruiting
Margate, 33063 - Florida
Contact: Jigar Shah (786-674-8868) - [email protected] -
United States
Center for Arthritis and Rheumatic Diseases
Recruiting
Miami, 33173 - Florida
Contact: Joseph LaConti (305-661-2299 ext: 120)
United States
IRIS Research and Development, LLC
Recruiting
Plantation, 33324 - Florida
Contact: Guillermo Valenzuela (954-476-2338 ext: 218)
United States
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Atlanta, 30309
Georgia
United States
Piedmont Healthcare
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Atlanta, 30318 - Georgia
Contact: Machua Machua (404-367-3350 ext: 3362) - [email protected] -
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Qualmedica Research dba Pedia Research
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Evansville, 47715 - Indiana
Contact: Moges Sisay (812-205-2475)
United States
Tufts Medical Center
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Boston, 02111 - Massachusetts
Contact: Steven Vlad (617-636-7438)
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Beth Israel Deaconess Medical Center
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Boston, 02215 - Massachusetts
Contact: Vasileios Kyttaris (617-632-9691)
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Ahmed Arif Medical Research Center (AAMRC)
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Grand Blanc, 48439 - Michigan
Contact: Ali Karrar (810-694-0082)
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NYU Langone Ambulatory Care Brooklyn Heights
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Brooklyn, 11201 - New York
Contact: David Goddard (929-455-2585)
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Feinstein Institute for Medical Research-Northwell Health
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Manhasset, 11030 - New York
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United States
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New York, 10021
New York
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Syracuse, 13210 - New York
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Oklahoma Medical Research Foundation Rheumatology Center of Excellence
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Oklahoma City, 73104 - Oklahoma
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Temple University Hospital
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Philadelphia, 19140 - Pennsylvania
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Amarillo Center for Clinical Research
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Amarillo, 79016 - Texas
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Colleyville, 76034 - Texas
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