18 and older, any sex, with Lupus Nephritis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Achieving Complete Renal Response (CRR)Primary· 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.
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
Week 104E1 (Baseline Extension Study) (n = 9, 9)
Group
Value
95% CI
Secukinumab 300 mg
4
Placebo to Secukinumab 300 mg
5
Week 132 (n = 6, 5)
Group
Value
95% CI
Secukinumab 300 mg
3
Placebo to Secukinumab 300 mg
5
Adverse events — posted to ClinicalTrials.gov
Time frame: 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..
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Secukinumab 300 mg
Serious: 4/16 (25%)
Deaths: 0/16
Placebo to Secukinumab 300 mg
Serious: 8/15 (53%)
Deaths: 0/15
Serious adverse events (13 terms)
Reaction
System
Secukinumab 300 mg
Placebo to Secukinumab 300…
COVID-19
Infections and infestations
—
—
Urinary tract infection
Infections and infestations
—
—
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Cataract
Eye disorders
—
—
Dyspepsia
Gastrointestinal disorders
—
—
Drug-induced liver injury
Hepatobiliary disorders
—
—
Dengue fever
Infections and infestations
—
—
Diarrhoea infectious
Infections and infestations
—
—
Endometritis
Infections and infestations
—
—
Pyelonephritis acute
Infections and infestations
—
—
Bipolar disorder
Psychiatric disorders
—
—
Lupus nephritis
Renal and urinary disorders
—
—
Endometriosis
Reproductive system and breast disorders
—
—
Other adverse events (154 terms — click to expand)
The purpose of this open-label extension study was to provide treatment with secukinumab for subjects who completed core study treatment in Study CAIN457Q12301 (NCT04181762), and to obtain further data on long-term efficacy, safety and tolerability of secukinunab in patients with active lupus nephritis (LN).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa
· Phase 4
· not yet recruiting
NCT07477795 — Phase II Interventional Study Evaluating Efficacy and Safety of Secukinumab in Active Severe Takayasu Patients
· Phase 2
· not yet recruiting
NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
· Phase 4
· not yet recruiting
NCT07243782 — Regulatory Post-Marketing Surveillance in Hidradenitis Suppurativa, Pediatric Plaque Psoriasis and JIA Treated With Cose
· recruiting
NCT06751238 — Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability up to 6 Years of Intravenous (i.v.) Secukinumab in
· Phase 1
· recruiting
NCT07015983 — A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite I
· Phase 2
· recruiting
NCT06711887 — Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants
· Phase 3
· recruiting
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary
· Phase 3
· not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa
· Phase 4
· not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
· not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy
· not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+
· Phase 1, PHASE2
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 16 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05232864.