Ianalumab for Lupus
(SIRIUS-SLE 1 Trial)

Recruiting in Palo Alto (17 mi)

+163 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 B/C, HIV, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?The trial will evaluate efficacy, safety and tolerability of two regimens of ianalumab compared to placebo, given as monthly or quarterly subcutaneous (s.c.) injection on top of standard-of-care (SoC) treatment in participants with active systemic lupus erythematosus (SLE).

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 certain disease-modifying antirheumatic drugs (DMARDs). However, if you are taking other specific medications like high-dose CS, certain biologics, or traditional Chinese medicines, you may need to stop them before joining the trial.

Eligibility Criteria

Adults and children aged 12+ (18+ in some regions) diagnosed with systemic lupus erythematosus for at least 6 months, meeting specific disease activity criteria. Participants must weigh over 35 kg and be on stable lupus medications. Excluded are those with certain other health conditions, women who could get pregnant not using effective contraception, recent recipients of live vaccines or certain treatments, and individuals with severe organ dysfunction or infections.

Inclusion Criteria

My blood test shows high levels of specific antibodies related to an autoimmune condition.

I am 12 years or older, or 18 and older in certain countries.

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

+6 more

Exclusion Criteria

I don't have any serious health issues that could affect my participation.

Women of child-bearing potential (WOCBP) not using highly effective contraception

I have had specific treatments within certain time frames before screening.

+11 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

60 weeks

Monthly or quarterly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

104 weeks

Participant Groups

The trial is testing the effectiveness of Ianalumab against a placebo when given monthly or quarterly as an injection alongside standard lupus treatments. It aims to see if Ianalumab can better control lupus symptoms compared to the usual treatment alone.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Ianalumab s.c. quarterlyExperimental Treatment1 Intervention

Ianalumab s.c. quarterly

Group II: Ianalumab s.c. monthlyExperimental Treatment1 Intervention

Ianalumab s.c. monthly

Group III: Placebo s.c. monthlyPlacebo Group1 Intervention

placebo s.c. monthly