Trial Outcomes & Findings for Open-label Extension Study of Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Lupus Nephritis (NCT NCT05232864)

Last Updated: 2025-05-16

Results Overview

Complete Renal Response (CRR) is a composite endpoint defined as: * Estimated Glomerular Filtration Rate (eGFR) \>= 60 mL/min/1.73 m\^2 or no less than 85% of core Baseline values and * 24-hour Urine-to-Protein Creatinine Ratio (UPCR) =\< 0.5mg/mg The glomerular filtration rate was estimated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation based on subject gender, age (years) and serum creatinine (mg/dL). Central laboratory serum creatinine values were used for all renal function data analysis. UPCR was determined by a central laboratory by dividing the protein concentration by the creatinine concentration as measured in the urine collected. UPCR was determined using one of the following two types of urine collection, 24-hour urine collection or first morning void urinary sample, both of which were collected in the subjects' home.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

31 participants

Primary outcome timeframe

Up to 28 weeks: from enrollment in the extension study (Week 104E1) up to Week 132 or Early termination of the Extension Study. Study day is defined with respect to the core study.

Results posted on

2025-05-16

Participant Flow

This study was conducted in 18 centers in 13 countries: Australia (1 site), Brazil (2 sites), Colombia (1 site), Czech Republic (2 sites), Guatemala (2 sites), Japan (2 sites), Korea (1 site), Republic of Philippines (1 site), Portugal (2 sites), Slovakia (Slovak Republic) (1 site), Spain (1 site), Thailand (1 site), Vietnam (1 site)

Participant milestones

Participant milestones
Measure	Secukinumab 300 mg Patients who were on Secukinumab 300 mg in the Core Study (CAIN457Q12301) and continued treatment with Secukinumab 300 mg every four weeks in the Extension Study until study termination notification (maximum treatment exposure during the extension study: 281 days)	Placebo to Secukinumab 300 mg Patients who were on Placebo in the Core Study (CAIN457Q12301) and continued treatment with Secukinumab 300 mg every four weeks in the Extension Study until study termination notification (maximum treatment exposure during the extension study: 310 days)
Overall Study STARTED	16	15
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	16	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Secukinumab 300 mg Patients who were on Secukinumab 300 mg in the Core Study (CAIN457Q12301) and continued treatment with Secukinumab 300 mg every four weeks in the Extension Study until study termination notification (maximum treatment exposure during the extension study: 281 days)	Placebo to Secukinumab 300 mg Patients who were on Placebo in the Core Study (CAIN457Q12301) and continued treatment with Secukinumab 300 mg every four weeks in the Extension Study until study termination notification (maximum treatment exposure during the extension study: 310 days)
Overall Study Adverse Event	0	1
Overall Study Study terminated by sponsor	16	14

Baseline Characteristics

Open-label Extension Study of Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Lupus Nephritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Secukinumab 300 mg n=16 Participants Patients who were on Secukinumab 300 mg in the Core Study (CAIN457Q12301) and continued treatment with Secukinumab 300 mg every four weeks in the Extension Study until study termination notification (maximum treatment exposure during the extension study: 281 days)	Placebo to Secukinumab 300 mg n=15 Participants Patients who were on Placebo in the Core Study (CAIN457Q12301) and continued treatment with Secukinumab 300 mg every four weeks in the Extension Study until study termination notification (maximum treatment exposure during the extension study: 310 days)	Total n=31 Participants Total of all reporting groups
Age, Continuous	35.6 Years STANDARD_DEVIATION 8.26 • n=99 Participants	30.6 Years STANDARD_DEVIATION 9.83 • n=107 Participants	33.2 Years STANDARD_DEVIATION 9.26 • n=206 Participants
Age, Customized < 30 years	4 Participants n=99 Participants	7 Participants n=107 Participants	11 Participants n=206 Participants
Age, Customized >= 30 years	12 Participants n=99 Participants	8 Participants n=107 Participants	20 Participants n=206 Participants
Sex: Female, Male Female	14 Participants n=99 Participants	14 Participants n=107 Participants	28 Participants n=206 Participants
Sex: Female, Male Male	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	6 Participants n=99 Participants	0 Participants n=107 Participants	6 Participants n=206 Participants
Race (NIH/OMB) Asian	8 Participants n=99 Participants	8 Participants n=107 Participants	16 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) White	2 Participants n=99 Participants	6 Participants n=107 Participants	8 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants

PRIMARY outcome

Timeframe: Up to 28 weeks: from enrollment in the extension study (Week 104E1) up to Week 132 or Early termination of the Extension Study. Study day is defined with respect to the core study.

Population: Full Analysis Set. Percentages were calculated based on the number of participants with an assessment at the specified time point independently if subject was still on treatment or discontinued from treatment before that timepoint.

Outcome measures

Outcome measures
Measure	Secukinumab 300 mg n=9 Participants Patients who were on Secukinumab 300 mg in the Core Study (CAIN457Q12301) and continued treatment with Secukinumab 300 mg every four weeks in the Extension Study until study termination notification (maximum treatment exposure during the extension study: 281 days)	Placebo to Secukinumab 300 mg n=9 Participants Patients who were on Placebo in the Core Study (CAIN457Q12301) and continued treatment with Secukinumab 300 mg every four weeks in the Extension Study until study termination notification (maximum treatment exposure during the extension study: 310 days)
Percentage of Participants Achieving Complete Renal Response (CRR) Week 104E1 (Baseline Extension Study) (n = 9, 9)	4 Participants	5 Participants
Percentage of Participants Achieving Complete Renal Response (CRR) Week 132 (n = 6, 5)	3 Participants	5 Participants

Adverse Events

Secukinumab 300 mg

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

Placebo to Secukinumab 300 mg

Serious events: 8 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Secukinumab 300 mg n=16 participants at risk Patients who were on Secukinumab 300 mg in the Core Study (CAIN457Q12301) and continued treatment with Secukinumab 300 mg every four weeks in the Extension Study until study termination notification (maximum treatment exposure during the extension study: 281 days)	Placebo to Secukinumab 300 mg n=15 participants at risk Patients who were on Placebo in the Core Study (CAIN457Q12301) and continued treatment with Secukinumab 300 mg every four weeks in the Extension Study until study termination notification (maximum treatment exposure during the extension study: 310 days)
Eye disorders Cataract	6.2% 1/16 • On-treatment adverse events and deaths were reported from first dose of study treatment in the Core Study up to 84 days after last dose of study medication in the Extension Study, assessed up to approximately 3 year. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the extension trial.	0.00% 0/15 • On-treatment adverse events and deaths were reported from first dose of study treatment in the Core Study up to 84 days after last dose of study medication in the Extension Study, assessed up to approximately 3 year. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the extension trial.
Gastrointestinal disorders Dyspepsia	6.2% 1/16 • On-treatment adverse events and deaths were reported from first dose of study treatment in the Core Study up to 84 days after last dose of study medication in the Extension Study, assessed up to approximately 3 year. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the extension trial.	6.7% 1/15 • On-treatment adverse events and deaths were reported from first dose of study treatment in the Core Study up to 84 days after last dose of study medication in the Extension Study, assessed up to approximately 3 year. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the extension trial.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/16 • On-treatment adverse events and deaths were reported from first dose of study treatment in the Core Study up to 84 days after last dose of study medication in the Extension Study, assessed up to approximately 3 year. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the extension trial.	6.7% 1/15 • On-treatment adverse events and deaths were reported from first dose of study treatment in the Core Study up to 84 days after last dose of study medication in the Extension Study, assessed up to approximately 3 year. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the extension trial.
Infections and infestations COVID-19	0.00% 0/16 • On-treatment adverse events and deaths were reported from first dose of study treatment in the Core Study up to 84 days after last dose of study medication in the Extension Study, assessed up to approximately 3 year. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the extension trial.	13.3% 2/15 • On-treatment adverse events and deaths were reported from first dose of study treatment in the Core Study up to 84 days after last dose of study medication in the Extension Study, assessed up to approximately 3 year. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the extension trial.
Infections and infestations Dengue fever	0.00% 0/16 • On-treatment adverse events and deaths were reported from first dose of study treatment in the Core Study up to 84 days after last dose of study medication in the Extension Study, assessed up to approximately 3 year. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the extension trial.	6.7% 1/15 • On-treatment adverse events and deaths were reported from first dose of study treatment in the Core Study up to 84 days after last dose of study medication in the Extension Study, assessed up to approximately 3 year. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the extension trial.
Infections and infestations Diarrhoea infectious	6.2% 1/16 • On-treatment adverse events and deaths were reported from first dose of study treatment in the Core Study up to 84 days after last dose of study medication in the Extension Study, assessed up to approximately 3 year. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the extension trial.	0.00% 0/15 • On-treatment adverse events and deaths were reported from first dose of study treatment in the Core Study up to 84 days after last dose of study medication in the Extension Study, assessed up to approximately 3 year. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the extension trial.
Infections and infestations Endometritis	0.00% 0/16 • On-treatment adverse events and deaths were reported from first dose of study treatment in the Core Study up to 84 days after last dose of study medication in the Extension Study, assessed up to approximately 3 year. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the extension trial.	6.7% 1/15 • On-treatment adverse events and deaths were reported from first dose of study treatment in the Core Study up to 84 days after last dose of study medication in the Extension Study, assessed up to approximately 3 year. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the extension trial.
Infections and infestations Pyelonephritis acute	6.2% 1/16 • On-treatment adverse events and deaths were reported from first dose of study treatment in the Core Study up to 84 days after last dose of study medication in the Extension Study, assessed up to approximately 3 year. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the extension trial.	6.7% 1/15 • On-treatment adverse events and deaths were reported from first dose of study treatment in the Core Study up to 84 days after last dose of study medication in the Extension Study, assessed up to approximately 3 year. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the extension trial.
Infections and infestations Urinary tract infection	0.00% 0/16 • On-treatment adverse events and deaths were reported from first dose of study treatment in the Core Study up to 84 days after last dose of study medication in the Extension Study, assessed up to approximately 3 year. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the extension trial.	13.3% 2/15 • On-treatment adverse events and deaths were reported from first dose of study treatment in the Core Study up to 84 days after last dose of study medication in the Extension Study, assessed up to approximately 3 year. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the extension trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/16 • On-treatment adverse events and deaths were reported from first dose of study treatment in the Core Study up to 84 days after last dose of study medication in the Extension Study, assessed up to approximately 3 year. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the extension trial.	13.3% 2/15 • On-treatment adverse events and deaths were reported from first dose of study treatment in the Core Study up to 84 days after last dose of study medication in the Extension Study, assessed up to approximately 3 year. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the extension trial.
Psychiatric disorders Bipolar disorder	0.00% 0/16 • On-treatment adverse events and deaths were reported from first dose of study treatment in the Core Study up to 84 days after last dose of study medication in the Extension Study, assessed up to approximately 3 year. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the extension trial.	6.7% 1/15 • On-treatment adverse events and deaths were reported from first dose of study treatment in the Core Study up to 84 days after last dose of study medication in the Extension Study, assessed up to approximately 3 year. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the extension trial.
Renal and urinary disorders Lupus nephritis	0.00% 0/16 • On-treatment adverse events and deaths were reported from first dose of study treatment in the Core Study up to 84 days after last dose of study medication in the Extension Study, assessed up to approximately 3 year. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the extension trial.	6.7% 1/15 • On-treatment adverse events and deaths were reported from first dose of study treatment in the Core Study up to 84 days after last dose of study medication in the Extension Study, assessed up to approximately 3 year. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the extension trial.
Reproductive system and breast disorders Endometriosis	0.00% 0/16 • On-treatment adverse events and deaths were reported from first dose of study treatment in the Core Study up to 84 days after last dose of study medication in the Extension Study, assessed up to approximately 3 year. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the extension trial.	6.7% 1/15 • On-treatment adverse events and deaths were reported from first dose of study treatment in the Core Study up to 84 days after last dose of study medication in the Extension Study, assessed up to approximately 3 year. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the extension trial.

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: +1 862 778 8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER