Clinical trial NCT06711887: Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)
Official title: An Open-label Extension Study to Assess the Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Adult Participants With Lupus Nephritis Who Have Completed Study Treatment in the CVAY736K12301 Core Study (SIRIUS-LN Extension)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Lupus Nephritis
Keywords: Lupus Nephritis (LN)
B cell depletion
ianalumab
VAY736
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-12-02
Enrollment: 316
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this 2-year extension study is the evaluation of the efficacy and safety

1. after study treatment withdrawal in patients with lupus nephritis (LN) who achieved response (complete renal response \[CRR\] or partial renal response \[PRR\]) on double-blind treatment at the end of the SIRIUS-LN core study, and
2. of open-label ianalumab 300 mg treatment in patients who, at the end of the SIRIUS-LN core study, were either already receiving ianalumab open-label treatment or did not meet CRR/PRR criteria on double-blind treatment at the end of the SIRIUS-LN core study.

Detailed description: The SIRIUS-LN extension study is a 2-year open-label extension study for participants who have completed the treatment periods (blinded Treatment Period-1 and blinded Treatment Period-2) of the SIRIUS-LN core study on double-blind or open-label study treatment.

Investigators will use their clinical judgment to decide if it is beneficial for participants to continue with the extension study. In this extension study participants who achieve CRR or PRR status at Week 140 will be withdrawn from study treatment and will maintain the SoC medication as required. These 2 additional years in the extension study will allow to measure sustained remission, flares and safety off-study treatment. However, in the event of renal flares during the extension study, these participants who withdraw study treatment will have the option to receive open-label ianalumab.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent prior to participation in the extension study.
2. Participants must have participated in the SIRIUS-LN core study and must have completed the entire treatment up to Week 144 on double-blind or open label study treatment.

Exclusion Criteria:

1. Use of prohibited therapies
2. Pregnant or nursing (lactating) women.

Primary outcomes:
measure: For cohort 1: Incidence of renal flare, escalation of immunosuppressive medication, or death
timeFrame: Between Week 144E1 and Week 248
measure: Cohort 2: Number of participants with Treatment Emergent Adverse Events (TEAE) as assessed by CTAE v4.0
timeFrame: From the start of treatment in the SIRIUS-LN core study to EOS (up to week 352) of the extension study
measure: Cohort 2: Number of participants with Serious Adverse Events (SAE) as assessed by CTCAE v4.0
timeFrame: From the start of treatment in the SIRIUS-LN core study to EOS (up to week 352) of the extension study
measure: Cohort 2: Number of participants with clinically significant abnormal vital signs
timeFrame: From the start of treatment in the SIRIUS-LN core study to EOS (up to week 352) of the extension study
measure: Cohort 2: Number of participants with clinically significant laboratory evaluations.
timeFrame: From the start of treatment in the SIRIUS-LN core study to EOS (up to week 352) of the extension study
Secondary outcomes:
measure: Cohort 1: Number of participants with Treatment Emergent Adverse Events (TEAE) as assessed by CTCAE v4.0
timeFrame: From the start of treatment in the SIRIUS-LN core study up to EOS (week 248) of the extension study
measure: Cohort 2: Incidence and titer of anti-ianalumab antibodies in serum (ADA assay)
timeFrame: from Week 144E1 up to Week 248
measure: Cohort 2: Ianalumab concentration in serum using a validated ELISA
timeFrame: from Week 144E1 up to Week 248
measure: Cohort 1: Number of participants with Serious Adverse Events (SAE) as assessed by CTAE v4.0
timeFrame: From the start of treatment in the SIRIUS-LN core study up to EOS (week 248) of the extension study
measure: Cohort 1: Number of participants with clinically significant abnormal vital signs
timeFrame: From the start of treatment in the SIRIUS-LN core study up to EOS (week 248) of the extension study
measure: Cohort 1: Number of participants with clinically significant abnormal laboratory evaluations
timeFrame: From the start of treatment in the SIRIUS-LN core study up to EOS (week 248) of the extension study
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: