A Randomized, Double-blind, Placebo-controlled Multicenter Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)

Conditions

Systemic Lupus Erythematosus

Brief summary

Proportion of participants achieving SRI-4 at Week 60

Detailed description

Proportion of participants with no moderate or severe British Isles Lupus Assessment Group flare up to Week 60, Proportion of participants maintaining between Week 36 and Week 60 a reduced corticosteroid dose of predniso(lo)ne ≤5 mg/day or ≤baseline dose, whichever is lower, Proportion of participants achieving British Isles Lupus Assessment Group-based Composite Lupus Assessment at Week 60, Proportion of participants achieving Lupus Low Disease Activity State at Week 60, Time to first occurrence of SRI-4 from baseline to Week 60, Proportion of participants achieving SRI-4 at Week 60 while maintaining between Week 36 and Week 60 a reduced corticosteroid dose of predniso(lo)ne ≤5 mg/day or ≤baseline dose, whichever is lower, Proportion of participants achieving SRI-6 at Week 60, Proportion of participants achieving SF-36 Bodily Pain response at Week 60, Proportion of participants with AEs and SAEs, Clinical laboratory measurements, Vital Signs, Incidence and titer of anti-ianalumab antibodies in serum (ADA assay) over time, Ianalumab concentration in serum during the treatment and followup (up to the end of study)

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGTENOFOVIR ALAFENAMIDE

DRUG-

DRUGVAY736

DRUGTENOFOVIR DISOPROXIL

DRUGENTECAVIR

DRUGPlacebo to VAY736

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of participants achieving SRI-4 at Week 60	—

Secondary

Measure	Time frame
Proportion of participants with no moderate or severe British Isles Lupus Assessment Group flare up to Week 60, Proportion of participants maintaining between Week 36 and Week 60 a reduced corticosteroid dose of predniso(lo)ne ≤5 mg/day or ≤baseline dose, whichever is lower, Proportion of participants achieving British Isles Lupus Assessment Group-based Composite Lupus Assessment at Week 60, Proportion of participants achieving Lupus Low Disease Activity State at Week 60, Time to first occurrence of SRI-4 from baseline to Week 60, Proportion of participants achieving SRI-4 at Week 60 while maintaining between Week 36 and Week 60 a reduced corticosteroid dose of predniso(lo)ne ≤5 mg/day or ≤baseline dose, whichever is lower, Proportion of participants achieving SRI-6 at Week 60, Proportion of participants achieving SF-36 Bodily Pain response at Week 60, Proportion of participants with AEs and SAEs, Clinical laboratory measurements, Vital Signs, Incidence and titer of anti-ianalumab anti	—

Measure

Time frame

Proportion of participants with no moderate or severe British Isles Lupus Assessment Group flare up to Week 60, Proportion of participants maintaining between Week 36 and Week 60 a reduced corticosteroid dose of predniso(lo)ne ≤5 mg/day or ≤baseline dose, whichever is lower, Proportion of participants achieving British Isles Lupus Assessment Group-based Composite Lupus Assessment at Week 60, Proportion of participants achieving Lupus Low Disease Activity State at Week 60, Time to first occurrence of SRI-4 from baseline to Week 60, Proportion of participants achieving SRI-4 at Week 60 while maintaining between Week 36 and Week 60 a reduced corticosteroid dose of predniso(lo)ne ≤5 mg/day or ≤baseline dose, whichever is lower, Proportion of participants achieving SRI-6 at Week 60, Proportion of participants achieving SF-36 Bodily Pain response at Week 60, Proportion of participants with AEs and SAEs, Clinical laboratory measurements, Vital Signs, Incidence and titer of anti-ianalumab anti

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Countries

France, Germany, Italy, Romania

Outcome results

None listed