A Randomized, Double-blind, Parallel Group, Placebo-controlled, Multicenter Phase 3 Trial to Evaluate Efficacy, Safety and Tolerability of Ianalumab on Top of Standard-of-care Therapy in Participants With Active Lupus Nephritis (SIRIUS-LN).

Who is this study for? Patients with active lupus nephritis
What treatments are being studied? Ianalumab
Status: Recruiting
Location: See all (186) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

∙ Participants eligible for inclusion in this study must meet all of the following criteria:

• Adult male and female participants aged 18 years or older at the time of screening

• Weigh at least 35 kg at screening

• Have a confirmed clinical diagnosis of SLE according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Systemic Lupus Erythematosus (SLE) classification criteria

• Have a positive anti-nuclear antibody (ANA) test result; ANA titer ≥ 1:80 at screening visit based on central or local laboratory result

• Active LN at screening, as defined by meeting the 3 following criteria:

• Renal biopsy within 6 months prior to screening period indicating ISN/RPS class III or IV active glomerulonephritis with or without co-existing class V features, or pure class V membranous LN. If no biopsy was performed within 6 months prior to screening period, a biopsy will need to be performed during the screening period after having met all other inclusion/exclusion criteria.

• UPCR ≥ 1.0 g/g on 24h urine collection at Screening

• eGFR ≥ 25mL/min/1.73 m2. Participants with eGFR \< 30 mL/min/1.73 m2 require renal biopsy during the screening period showing sclerosis in ≤ 50% of glomeruli

• Newly diagnosed participants as well as pre-treated LN participants (including refractory cases) can be included, as long as they are currently on, or willing to initiate SoC induction therapy for LN using MPA

‣ Induction therapy, as defined by treatment including both high dose corticosteroids and MPA, should be initiated prior to or on day of randomization

⁃ Anti-malarial treatment at stable dosing prior to randomization is strongly recommended, in the absence of contraindications

⁃ Participants on azathioprine treatment at Screening must be switched to MPA prior to randomization

• Receipt of at least one dose of pulse methylprednisolone i.v. (250 - 1000 mg per day up to 3000 mg cumulative dose) or equivalent for treatment of current episode of active LN within 60 days prior randomization. Participant who cannot take the pulse i.v. corticosteroid therapy should directly start on 0.8-1.0 mg/day (max 80mg/day) oral predniso(lo)ne.

• Able to communicate well with the Investigator to understand and comply with the requirements of the study

Locations
United States
Alabama
University Of Alabama
RECRUITING
Birmingham
California
Advanced Medical Research
RECRUITING
La Palma
University of California LA
RECRUITING
Los Angeles
Wallace Rheumatic Study Center
WITHDRAWN
Los Angeles
University of California Irvine
RECRUITING
Orange
UC Davis School of Medicine
RECRUITING
Sacramento
Kaiser Permanente
RECRUITING
San Diego
University of California San Diego
RECRUITING
San Diego
Florida
Mayo Clinic Jacksonville
RECRUITING
Jacksonville
University Of Miami
RECRUITING
Miami
Georgia
Emory University School of Medicine
RECRUITING
Atlanta
Fides Clinical Research
RECRUITING
Atlanta
Parris and Associates Rheumatology
RECRUITING
Lawrenceville
Kansas
University of Kansas Hospital
RECRUITING
Kansas City
Louisiana
Accurate Clinical Research
RECRUITING
Lake Charles
UMC New Orleans
RECRUITING
New Orleans
Michigan
Wayne State University
RECRUITING
Detroit
North Carolina
Brookview Hills Research Assoc
WITHDRAWN
Winston-salem
New Jersey
Sahni Rheumatology and Therapy
RECRUITING
West Long Branch
New Mexico
VA NM Healthcare System
RECRUITING
Albuquerque
Nevada
Univ of Nevada School of Med
RECRUITING
Las Vegas
New York
NY Nephrology
RECRUITING
Clifton Park
Hospital for Special Surgery
RECRUITING
New York
Northwell Health
RECRUITING
New York
Circuit Clinical
RECRUITING
Orchard Park
James J Peters VA Medical Center
RECRUITING
The Bronx
Ohio
University Of Cincinnati
RECRUITING
Cincinnati
Pennsylvania
Univ of Pennsylvania Medical Center
RECRUITING
Philadelphia
Texas
Arthritis and Rheumatology Ins
RECRUITING
Allen
Precision Comprehensive Research
RECRUITING
Colleyville
Liberty Research Center
RECRUITING
Dallas
Univof Texas Southwestern Med Cntr
RECRUITING
Dallas
University of Texas Medical Branch
WITHDRAWN
Galveston
Uni of Texas Health Science Center
RECRUITING
San Antonio
Baylor Scott and White Research
RECRUITING
Temple
Virginia
Northern Assoc of Northern VA
RECRUITING
Fairfax
Wisconsin
Uni Wisconsin School Med Pub Health
RECRUITING
Madison
Other Locations
Argentina
Novartis Investigative Site
RECRUITING
Buenos Aires
Novartis Investigative Site
RECRUITING
Buenos Aires
Novartis Investigative Site
WITHDRAWN
Buenos Aires
Novartis Investigative Site
RECRUITING
Caba
Novartis Investigative Site
RECRUITING
La Plata
Novartis Investigative Site
RECRUITING
San Miguel De Tucumán
Brazil
Novartis Investigative Site
RECRUITING
Belo Horizonte
Novartis Investigative Site
WITHDRAWN
Curitiba
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Juiz De Fora
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Porto Alegre
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Porto Alegre
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Recife
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Salvador
Novartis Investigative Site
RECRUITING
Salvador
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Santo André
Novartis Investigative Site
WITHDRAWN
São Luís
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Vitória
Canada
Novartis Investigative Site
RECRUITING
Calgary
Novartis Investigative Site
RECRUITING
Etobicoke
Novartis Investigative Site
RECRUITING
London
Novartis Investigative Site
RECRUITING
Montreal
Novartis Investigative Site
RECRUITING
Sherbrooke
Novartis Investigative Site
RECRUITING
Toronto
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Vancouver
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Winnipeg
Chile
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Santiago
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Temuco
China
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Beijing
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Binzhou
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Changchun
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Changsha
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Chengdu
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Chongqing
Novartis Investigative Site
COMPLETED
Guangzhou
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Guangzhou
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Guangzhou
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Guangzhou
Novartis Investigative Site
COMPLETED
Guangzhou
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Haikou
Novartis Investigative Site
WITHDRAWN
Hefei
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Linyi
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Liuzhou
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Nanchang
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Nanjing
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Shanghai
Novartis Investigative Site
COMPLETED
Shanghai
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Shanghai
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Shantou
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Shenyang
Novartis Investigative Site
WITHDRAWN
Shenzhen
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Shenzhen
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Wuhan
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Wuhan
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Xian
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Zhejiang
Colombia
Novartis Investigative Site
RECRUITING
Barranquilla
Novartis Investigative Site
RECRUITING
Barranquilla
Novartis Investigative Site
RECRUITING
Bogota
Novartis Investigative Site
RECRUITING
Medellín
Estonia
Novartis Investigative Site
RECRUITING
Tallinn
Novartis Investigative Site
RECRUITING
Tallinn
France
Novartis Investigative Site
WITHDRAWN
Angers
Novartis Investigative Site
RECRUITING
Besançon
Novartis Investigative Site
RECRUITING
Bordeaux
Novartis Investigative Site
RECRUITING
Grenoble
Novartis Investigative Site
RECRUITING
Lyon
Novartis Investigative Site
RECRUITING
Marseille
Novartis Investigative Site
RECRUITING
Poitiers
Novartis Investigative Site
RECRUITING
Toulouse
Novartis Investigative Site
RECRUITING
Vandœuvre-lès-nancy
Germany
Novartis Investigative Site
RECRUITING
Aachen
Novartis Investigative Site
RECRUITING
Bochum
Novartis Investigative Site
RECRUITING
Münster
Novartis Investigative Site
WITHDRAWN
Regensburg
Guatemala
Novartis Investigative Site
RECRUITING
Guatemala City
Novartis Investigative Site
RECRUITING
Guatemala City
Novartis Investigative Site
RECRUITING
Quetzaltenango
Hong Kong Special Administrative Region
Novartis Investigative Site
RECRUITING
Kwun Tong
Novartis Investigative Site
RECRUITING
Tuenmen
Hungary
Novartis Investigative Site
RECRUITING
Budapest
Novartis Investigative Site
RECRUITING
Budapest
Novartis Investigative Site
RECRUITING
Debrecen
Novartis Investigative Site
RECRUITING
Kaposvár
India
Novartis Investigative Site
RECRUITING
Bangalore
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Chandigarh
Novartis Investigative Site
RECRUITING
Lucknow
Novartis Investigative Site
RECRUITING
Secunderabad
Italy
Novartis Investigative Site
WITHDRAWN
Cagliari
Novartis Investigative Site
RECRUITING
Florence
Novartis Investigative Site
RECRUITING
Foggia
Novartis Investigative Site
RECRUITING
Milan
Novartis Investigative Site
WITHDRAWN
Napoli
Novartis Investigative Site
RECRUITING
Pavia
Novartis Investigative Site
RECRUITING
Roma
Novartis Investigative Site
RECRUITING
Torino
Novartis Investigative Site
RECRUITING
Udine
Lithuania
Novartis Investigative Site
RECRUITING
Kaunas
Novartis Investigative Site
RECRUITING
Vilnius
Malaysia
Novartis Investigative Site
RECRUITING
Kuala Lumpur
Novartis Investigative Site
RECRUITING
Kuala Terengganu
Novartis Investigative Site
RECRUITING
Sibu
Mexico
Novartis Investigative Site
RECRUITING
León
Novartis Investigative Site
RECRUITING
Monterrey
Novartis Investigative Site
RECRUITING
Oaxaca City
Novartis Investigative Site
WITHDRAWN
Querétaro
Novartis Investigative Site
RECRUITING
Querétaro
Republic of Korea
Novartis Investigative Site
RECRUITING
Bundang Gu
Novartis Investigative Site
RECRUITING
Busan
Novartis Investigative Site
WITHDRAWN
Daegu
Novartis Investigative Site
WITHDRAWN
Daejeon
Novartis Investigative Site
RECRUITING
Gwangju
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
WITHDRAWN
Seoul
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Suwon
Romania
Novartis Investigative Site
RECRUITING
Bucharest
Novartis Investigative Site
RECRUITING
Bucharest
Novartis Investigative Site
RECRUITING
Cluj-napoca
Novartis Investigative Site
RECRUITING
Oradea
Novartis Investigative Site
WITHDRAWN
Râmnicu Vâlcea
Novartis Investigative Site
RECRUITING
Timișoara
Singapore
Novartis Investigative Site
RECRUITING
Singapore
Novartis Investigative Site
RECRUITING
Singapore
Spain
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
WITHDRAWN
El Palmar
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Pamplona
Novartis Investigative Site
RECRUITING
San Cristóbal De La Laguna
Novartis Investigative Site
RECRUITING
Santiago De Compostela
Novartis Investigative Site
RECRUITING
Valencia
Novartis Investigative Site
RECRUITING
Vigo
Taiwan
Novartis Investigative Site
RECRUITING
Kaohsiung City
Novartis Investigative Site
RECRUITING
Taichung
Novartis Investigative Site
RECRUITING
Taichung
Novartis Investigative Site
RECRUITING
Taipei
Thailand
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Bangkok
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Bangkok
Novartis Investigative Site
RECRUITING
Bangkok
Novartis Investigative Site
RECRUITING
Chiang Mai
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Songkhla
United Kingdom
Novartis Investigative Site
RECRUITING
Bradford
Novartis Investigative Site
RECRUITING
London
Viet Nam
Novartis Investigative Site
RECRUITING
Hanoi
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Ho Chi Minh City
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: 2022-07-14
Estimated Completion Date: 2030-11-05
Participants
Target number of participants: 420
Treatments
Experimental: Arm 1 - ianalumab s.c. q4w
ianalumab s.c. q4w in addition to standard of care (SoC)
Experimental: Arm 2 - ianalumab s.c. q12w
ianalumab s.c. q12w in addition to SoC
Placebo_comparator: Arm 3 - placebo s.c. q4w
Placebo s.c. q4w in addition to SoC
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov