406 Participants Needed

Ianalumab for Lupus

(SIRIUS-SLE 1 Trial)

Recruiting at 173 trial locations
NP
Overseen ByNovartis Pharmaceuticals
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: Novartis Pharmaceuticals
Must be taking: CS, Anti-malarials, DMARDs
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

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.

Research Team

NP

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

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'.
See 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.
See 11 more

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

Treatment Details

Interventions

  • Ianalumab
  • Placebo
Trial Overview 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.
Participant Groups
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

Find a Clinic Near You

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 profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD