Ianalumab for Lupus

(SIRIUS-SLE 2 Trial)

Recruiting at 115 trial locations

Overseen By Novartis Pharmaceuticals

Age: Any Age

Sex: Any

Trial Phase: Phase 3

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) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 60 weeks

280 Participants Needed

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.

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

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'.

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.

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

Treatment Details

Interventions

• ianalumab
• placebo

Trial Overview 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.

Participant Groups

Group I: ianalumab s.c. monthly Experimental Treatment 1 Intervention

ianalumab s.c. monthly

Group II: placebo s.c. monthly Placebo Group 1 Intervention

placebo s.c. monthly

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD