A randomized, double-blind, parallel group, placebo-controlled, multicenter phase 3 trial to evaluate the efficacy, safety and tolerability of ianalumab on top of standard-of-care therapy in participants with active lupus nephritis (SIRIUS-LN)

Conditions

Lupus nephritis

Brief summary

Incidence of stable CRR at Week 72; participants who discontinue treatment before Week 72 or use corticosteroids at a dose >7.5 mg/day after Week 60 will be considered non-responders

Detailed description

Time to first occurrence of stable UPCR <0.5 g/g or ≥50% reduction from baseline up to Week 72, Incidence of stable ORR at Week 48; participants who discontinue treatment before Week 48 or use corticosteroids at a dose >7.5 mg/day after Week 36 will be considered non-responders, Incidence of stable CRR at Week 72 while maintaining daily corticosteroid dose ≤5mg/day between Week 24 and Week 72. Participants who discontinue treatment before Week 72 will be considered non-responders, Incidence of renal flares related event or death through Week 72, Change from baseline in BILAG-2004 at Week 72, Change from baseline in FACIT-Fatigue at Week 72, Ianalumab concentration in serum and calculated PK parameters, Incidence and titer of anti-ianalumab antibodies in serum (ADA assay) over time, Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Vital signs, Clinical laboratory measurements

Related papers

No related papers found yet.

Interventions

DRUGVAY736

DRUGTENOFOVIR ALAFENAMIDE

DRUGPlacebo to VAY736 150 mg/1 mL Solution for injection in pre-filled syringe

DRUGPlacebo to VAY736 300 mg/2 mL Solution for injection in pre-filled syringe

DRUGENTECAVIR

DRUGMYCOPHENOLIC ACID

DRUGMYCOPHENOLATE MOFETIL

DRUGTENOFOVIR DISOPROXIL

DRUG-

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of stable CRR at Week 72; participants who discontinue treatment before Week 72 or use corticosteroids at a dose >7.5 mg/day after Week 60 will be considered non-responders	—

Secondary

Measure	Time frame
Time to first occurrence of stable UPCR <0.5 g/g or ≥50% reduction from baseline up to Week 72, Incidence of stable ORR at Week 48; participants who discontinue treatment before Week 48 or use corticosteroids at a dose >7.5 mg/day after Week 36 will be considered non-responders, Incidence of stable CRR at Week 72 while maintaining daily corticosteroid dose ≤5mg/day between Week 24 and Week 72. Participants who discontinue treatment before Week 72 will be considered non-responders, Incidence of renal flares related event or death through Week 72, Change from baseline in BILAG-2004 at Week 72, Change from baseline in FACIT-Fatigue at Week 72, Ianalumab concentration in serum and calculated PK parameters, Incidence and titer of anti-ianalumab antibodies in serum (ADA assay) over time, Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Vital signs, Clinical laboratory measurements	—

Measure

Time frame

Time to first occurrence of stable UPCR <0.5 g/g or ≥50% reduction from baseline up to Week 72, Incidence of stable ORR at Week 48; participants who discontinue treatment before Week 48 or use corticosteroids at a dose >7.5 mg/day after Week 36 will be considered non-responders, Incidence of stable CRR at Week 72 while maintaining daily corticosteroid dose ≤5mg/day between Week 24 and Week 72. Participants who discontinue treatment before Week 72 will be considered non-responders, Incidence of renal flares related event or death through Week 72, Change from baseline in BILAG-2004 at Week 72, Change from baseline in FACIT-Fatigue at Week 72, Ianalumab concentration in serum and calculated PK parameters, Incidence and titer of anti-ianalumab antibodies in serum (ADA assay) over time, Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Vital signs, Clinical laboratory measurements

—

Countries

Czechia, Estonia, France, Germany, Hungary, Italy, Lithuania, Romania, Spain

Outcome results

None listed