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Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)
The trial will evaluate efficacy, safety and tolerability of ianalumab compared to placebo, given as monthly subcutaneous (s. c. ) injection on top of standard-of-care (SoC) treatment in participants with active systemic lupus erythematosus (SLE).
Study details:
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).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 12 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-04-21
Primary completion: 2027-01-26
Study completion finish: 2029-01-23
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT05624749
Intervention or treatment
DRUG: ianalumab
DRUG: placebo
Conditions
- • Systemic Lupus Erythematosus
Find a site
Closest Location:
Novartis Investigative Site
Research sites nearby
Select from list below to view details:
Novartis Investigative Site
Maroochydore, Queensland, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: ianalumab s.c. monthly
| DRUG: ianalumab
|
PLACEBO_COMPARATOR: placebo s.c. monthly
| DRUG: placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Proportion of participants achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4) | SRI-4 response is defined as: * Systemic Lupus Erythematosus Disease Activity Index - 2000 (SLEDAI-2K) reduction from baseline of ≥ 4 points * No British Isles Lupus Assessment Group-2004 (BILAG-2004) worsening, defined as ≥ 1 new A or ≥ 2 new B items compared to baseline * No worsening in Physician Global Assessment of Disease Activity (PhGA), defined as an increase of ≥ 0.3 from baseline on a 0 to 3 visual analog scale | Week 60 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Proportion of participants with no moderate or severe BILAG flare | Moderate BILAG flare is defined as 2 or more new BILAG-2004 B items compared to the previous visit; severe BILAG flare is defined as 1 or more new BILAG-2004 A items compared to the previous visit | Baseline to Week 60 |
Proportion of participants maintaining between Week 36 and Week 60 a reduced corticosteroid (CS) dose of predniso(lo)ne ≤ 5 mg/day or ≤ baseline dose, whichever is lower | Maintaining reduced CS dose from Week 36 to Week 60 | Week 36 to Week 60 |
Proportion of participants achieving BILAG-based Composite Lupus Assessment (BICLA) | BICLA response is defined as: * Reduction of all baseline BILAG-2004 A to B/C/D and baseline B to C/D and no worsening in other organ systems defined as ≥ 1 new A or ≥ 2 new B items compared to baseline * No worsening from baseline in SLEDAI-2K defined as an increase from baseline of \> 0 points * No worsening in PhGA defined as an increase of ≥ 0.3 from baseline on a 0 to 3 PhGA visual analog scale | Week 60 |
Proportion of participants achieving Lupus Low Disease Activity State (LLDAS) | LLDAS response is defined as: * SLEDAI-2K ≤ 4, with no activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever) (Golder et al 2019) * No new lupus disease activity compared with the previous assessment, defined as any new SLEDAI-2K component that was not present at the previous assessment * PhGA (scale 0-3) ≤ 1 * Current predniso(lo)ne (or equivalent) dose ≤ 7.5 mg daily * Well tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents | Week 60 |
Time to first occurrence of SRI-4 | Time to first occurrence of SRI-4 from baseline to Week 60 | Baseline to Week 60 |
Proportion of participants achieving SRI-4 at Week 60 while maintaining between Week 36 and Week 60 a reduced CS dose of predniso(lo)ne ≤ 5 mg/day or ≤ baseline dose, whichever is lower | Achieving SRI-4 at Week 60 while maintaining between Week 36 and Week 60 a reduced CS dose of predniso(lo)ne ≤ 5 mg/day or ≤ baseline dose, whichever is lower | Week 36 to Week 60 |
Proportion of participants achieving SRI-6 | SRI-6 response is defined as: * SLEDAI-2K reduction from baseline of ≥ 6 points * No BILAG-2004 worsening, defined as ≥ 1 new A or ≥ 2 new B items compared to baseline * No worsening in PhGA, defined as an increase of ≥ 0.3 from baseline on a 0 to 3 visual analog scale | Week 60 |
Proportion of participants achieving SF-36 Bodily Pain response | Achieving Short Form 36 (SF-36) Bodily Pain response | Week 60 |
Proportion of participants with Adverse Events (AEs) | To evaluate safety and tolerability of ianalumab s.c. monthly | Baseline to Week 60 |
Incidence and titer of anti-drug (ianalumab) antibodies (ADAs) in serum over time | To evaluate immunogenicity of ianalumab s.c. monthly | Baseline to Week 164 |
Ianalumab concentration in serum during the treatment and follow-up | Concentration of Ianalumab in serum | Baseline to Week 164 |
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