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

Lupus Nephritis Clinical Trial

— SELUNE  

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04181762
• Other study ID #: CAIN457Q12301
• Secondary ID: 2019-003211-57PA
• Status: Terminated
• Phase: Phase 3
• Start date: July 7, 2020
• Est. completion date: September 13, 2023

Study information

• Verified date: February 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 275
• Est. completion date: September 13, 2023
• Est. primary completion date: September 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Drug:
• secukinumab
STUDY DRUG

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Ciudad Autonoma de Bs As	Buenos Aires
Argentina	Novartis Investigative Site	Cordoba
Australia	Novartis Investigative Site	Westmead	New South Wales
Brazil	Novartis Investigative Site	Fortaleza	CE
Brazil	Novartis Investigative Site	Joinville	Santa Catarina
Brazil	Novartis Investigative Site	Porto Alegre	RS
Brazil	Novartis Investigative Site	Santo Andre	SP
Brazil	Novartis Investigative Site	Sao Jose do Rio Preto
Brazil	Novartis Investigative Site	Sao Paulo	SP
Brazil	Novartis Investigative Site	São Paulo	SP
Canada	Novartis Investigative Site	Toronto	Ontario
Chile	Novartis Investigative Site	Concepcion
Chile	Novartis Investigative Site	Santiago
Chile	Novartis Investigative Site	Santiago	RM
Chile	Novartis Investigative Site	Valdivia	Los Rios
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Binzhou	Shandong
China	Novartis Investigative Site	Changsha	Hunan
China	Novartis Investigative Site	Chengdu	Sichuan
China	Novartis Investigative Site	Chongqing
China	Novartis Investigative Site	Guangzhou	Guangdong
China	Novartis Investigative Site	Nanchang	Jiangxi
China	Novartis Investigative Site	Nanning	Guangxi
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shijiazhuang	Hebei
China	Novartis Investigative Site	Wuhan
Colombia	Novartis Investigative Site	Barranquilla
Colombia	Novartis Investigative Site	Cali
Colombia	Novartis Investigative Site	Cundinamarca
Colombia	Novartis Investigative Site	Medellin	Antioquia
Croatia	Novartis Investigative Site	Zagreb
Czechia	Novartis Investigative Site	Prague 2
Czechia	Novartis Investigative Site	Praha
Czechia	Novartis Investigative Site	Praha 5
Denmark	Novartis Investigative Site	Odense
France	Novartis Investigative Site	Marseille
Germany	Novartis Investigative Site	Mainz
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Thessaloniki	Macedoni
Guatemala	Novartis Investigative Site	Guatemala
Guatemala	Novartis Investigative Site	Guatemala City
Guatemala	Novartis Investigative Site	Quetzaltenango
India	Novartis Investigative Site	New Delhi	Delhi
India	Novartis Investigative Site	New Delhi	Delhi
Italy	Novartis Investigative Site	Padova	PD
Japan	Novartis Investigative Site	Chuo-city	Yamanashi
Japan	Novartis Investigative Site	Kitakyushu-city	Fukuoka
Japan	Novartis Investigative Site	Kurashiki	Okayama
Japan	Novartis Investigative Site	Sendai city	Miyagi
Japan	Novartis Investigative Site	Toyoake city	Aichi
Korea, Republic of	Novartis Investigative Site	Seoul	Seocho Gu
Korea, Republic of	Novartis Investigative Site	Seoul
Mexico	Novartis Investigative Site	Ciudad de Mexico	Mexico CP
Mexico	Novartis Investigative Site	Merida	Yucatan
Mexico	Novartis Investigative Site	Mexicali	Baja California Norte
Mexico	Novartis Investigative Site	Mexico
Norway	Novartis Investigative Site	Oslo
Peru	Novartis Investigative Site	Santiago de Surco	Lima
Philippines	Novartis Investigative Site	Iloilo
Philippines	Novartis Investigative Site	Lipa City	Batangas
Philippines	Novartis Investigative Site	Manila
Philippines	Novartis Investigative Site	Quezon
Portugal	Novartis Investigative Site	Coimbra
Portugal	Novartis Investigative Site	Guimaraes
Portugal	Novartis Investigative Site	Lisbon
Portugal	Novartis Investigative Site	Porto
Romania	Novartis Investigative Site	Bucharest
Romania	Novartis Investigative Site	Bucuresti
Romania	Novartis Investigative Site	Bucuresti
Romania	Novartis Investigative Site	Oradea	Jud. Bihor
Romania	Novartis Investigative Site	Ramnicu Valcea	Valcea
Russian Federation	Novartis Investigative Site	Kazan
Russian Federation	Novartis Investigative Site	Kemerovo
Russian Federation	Novartis Investigative Site	Rostov On Don
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	Yaroslavl
Slovakia	Novartis Investigative Site	Piestany
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Santiago De Compostela	Galicia
Spain	Novartis Investigative Site	Vigo	Pontevedra
Sweden	Novartis Investigative Site	Stockholm
Switzerland	Novartis Investigative Site	St Gallen
Taiwan	Novartis Investigative Site	Kaohsiung
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Tao Yuan
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Bangkok
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Zuhuratbaba / Istanbul
United States	Novartis Investigative Site	Atlanta	Georgia
United States	Novartis Investigative Site	Aventura	Florida
United States	Novartis Investigative Site	Birmingham	Alabama
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Fontana	California
United States	Novartis Investigative Site	Grand Blanc	Michigan
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Plantation	Florida
Vietnam	Novartis Investigative Site	Hanoi
Vietnam	Novartis Investigative Site	Ho Chi Minh
Vietnam	Novartis Investigative Site	Ho Chi Minh	VNM

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Australia,  Brazil,  Canada,  Chile,  China,  Colombia,  Croatia,  Czechia,  Denmark,  France,  Germany,  Greece,  Guatemala,  India,  Italy,  Japan,  Korea, Republic of,  Mexico,  Norway,  Peru,  Philippines,  Portugal,  Romania,  Russian Federation,  Slovakia,  Spain,  Sweden,  Switzerland,  Taiwan,  Thailand,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects achieving Complete Renal Response (CRR)	Proportion of subjects achieving protocol-defined CRR	Week 52
Secondary	Change in 24-hour Urine Protein-to Creatinine Ratio (UPCR)	Change from Baseline in 24-hour UPCR	Week 52
Secondary	Proportion of subjects achieving Partial Renal Response (PRR)	Proportion of subjects achieving protocol-defined PRR	Week 52
Secondary	Average daily dose of oral corticosteroids	Average daily dose of oral corticosteroids compared to placebo	Week 16 to Week 52
Secondary	Proportion of subjects achieving PRR	Proportion of subjects achieving PRR	Week 24
Secondary	Time to achieve CRR	Time to achieve CRR	Baseline to Week 52
Secondary	Time to achieve PRR	Time to achieve PRR	Baseline to Week 52
Secondary	Time to achieve UPCR = 0.5 mg/mg	Time to achieve first morning void UPCR = 0.5 mg/mg	Baseline to Week 52
Secondary	Improvement in FACIT-Fatigue©	Improvement in FACIT-Fatigue© mean change of score compared to placebo; The FACIT Fatigue Scale measures an individual's level of fatigue during their usual daily activities. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued)	Baseline to Week 52
Secondary	Improvement in SF-36 PCS mean	Improvement in SF-36 PCS mean change compared to placebo	Baseline to Week 52
Secondary	Improvement in LupusQoL Physical Health mean	Improvement in LupusQoL Physical Health mean change of score compared to placebo	Baseline to Week 52
Secondary	Incidence of Treatment-emergent AEs (TEAEs) / SAEs	Incidence of Treatment-emergent AEs (TEAEs) / SAEs from Baseline to Week 52; vital signs and body measurements, standard chemistry and hematology	Baseline to Week 52
Secondary	Proportion of subjects with CRR at Week 104 within subjects who had achieved CRR at Week 52	Estimate the proportion of subjects with CRR at Week 104 within subjects who had achieved CRR at Week 52 in the secukinumab group	Week 52 to Week 104
Secondary	Proportion of subjects with improved or maintained renal response at Week 104	Estimate the proportion of subjects with improved or maintained response (PRR or CRR) in subjects who had achieved at least PRR at Week 52 in the secukinumab group	Week 52 to Week 104