Ianalumab for Lupus
(SIRIUS-SLE 2 Trial)

Recruiting in Palo Alto (17 mi)

+108 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Novartis Pharmaceuticals

Must be taking: CS, Anti-malarials, DMARDs

Must not be taking: Calcineurin inhibitors, JAK inhibitors

Disqualifiers: Active infections, Hepatitis, Tuberculosis, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial will test if ianalumab, an injection given regularly, is safe and effective for people with active systemic lupus erythematosus (SLE). The medication aims to calm down their overactive immune system to reduce inflammation and damage.

Will I have to stop taking my current medications?

The trial allows participants to continue their current standard-of-care treatments, such as corticosteroids (CS), anti-malarial drugs, or other disease-modifying antirheumatic drugs (DMARDs). However, if you are taking certain other medications like high-dose CS, specific kinase inhibitors, or biologics, you may need to stop them before joining the trial.

Eligibility Criteria

This trial is for people aged 12+ (or 18+ in certain countries) with active systemic lupus erythematosus diagnosed at least 6 months ago. They must have specific antibodies, be on current treatments like steroids or DMARDs, and meet disease activity criteria. Exclusions include prior ianalumab use, recent other treatments, infections including hepatitis and HIV, severe organ dysfunction or life-threatening diseases.

Inclusion Criteria

I weigh at least 35 kg.

I was diagnosed with lupus at least 6 months ago, according to EULAR/ACR criteria.

SLEDAI-2K criteria at screening: SLEDAI-2K score ≥ 6 points, excluding points attributed to 'fever', 'lupus headache', 'alopecia', and 'organic brain syndrome'.

+4 more

Exclusion Criteria

Presence of abnormal laboratory values prior to randomization.

History of primary or secondary immunodeficiency, including a positive human immunodeficiency virus (HIV) test result at screening.

I do not have any health issues that could affect my participation in the study.

+13 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive monthly subcutaneous injections of ianalumab or placebo on top of standard-of-care treatment

60 weeks

Monthly visits (in-person)

Follow-up

Participants are monitored for safety, efficacy, and immunogenicity after treatment

104 weeks

Participant Groups

The study tests the effectiveness of Ianalumab versus a placebo when given monthly as an injection alongside standard lupus care. It aims to see if Ianalumab can better manage symptoms compared to usual treatment alone.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ianalumab s.c. monthlyExperimental Treatment1 Intervention

ianalumab s.c. monthly

Group II: placebo s.c. monthlyPlacebo Group1 Intervention

placebo s.c. monthly