Ianalumab for Lupus

(SIRIUS-SLE 1 Trial)

Recruiting at 223 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 B/C, HIV, 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

406 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of a new treatment called ianalumab for individuals with active systemic lupus erythematosus (SLE), an autoimmune disease where the immune system attacks the body's own tissues. Participants will receive ianalumab injections either once a month or once every three months, while others will receive a placebo for comparison. The goal is to assess how well ianalumab reduces symptoms in addition to the usual care for SLE. The trial seeks participants diagnosed with SLE for at least six months, who have certain antibodies in their blood, and are currently on specific lupus treatments. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ianalumab is well-tolerated by people with systemic lupus erythematosus (SLE). In a previous study, ianalumab proved safe for up to 68 weeks, with most participants not experiencing serious side effects. Another study also found that ianalumab was well-tolerated and helped reduce disease symptoms, allowing for less steroid use. These findings suggest that ianalumab is generally safe for people with lupus, with no major safety concerns reported so far. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for lupus involve immunosuppressive drugs like corticosteroids or hydroxychloroquine, which broadly dampen the immune system. But Ianalumab works differently, targeting a specific protein called BAFF, which plays a crucial role in the survival and activity of B-cells, the immune cells that are often overactive in lupus. Researchers are excited about Ianalumab because it offers a more targeted approach, potentially reducing side effects associated with generalized immune suppression. Additionally, Ianalumab is administered subcutaneously, either monthly or quarterly, which could offer more convenience and better adherence compared to some current treatments.

What evidence suggests that ianalumab might be an effective treatment for lupus?

Research shows that ianalumab may help treat systemic lupus erythematosus (SLE). Earlier studies found that ianalumab reduces B cells, which play a role in SLE. In this trial, participants will receive either ianalumab subcutaneously on a monthly or quarterly basis, or a placebo. Patients who received ianalumab in previous studies showed improvements in symptoms and lab results over time. The treatment was generally safe and did not cause serious side effects. These findings suggest that ianalumab could help manage SLE symptoms. ^{1 4 6 7 8}

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

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

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

BILAG-2004 disease activity level at screening of at least 1 of the following:

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Ianalumab s.c. quarterly Experimental Treatment 1 Intervention

Ianalumab s.c. quarterly

Group II: Ianalumab s.c. monthly Experimental Treatment 1 Intervention

Ianalumab s.c. monthly

Group III: 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

Citations

1. lupushub.com lupushub.com/medical-information/ianalumab-in-patients-with-systemic-lupus-erythematosus-interim-results-of-a-phase-ii-trial

Ianalumab in patients with systemic lupus erythematosus Preliminary phase II data showed that ianalumab was well tolerated, effectively depleted B cells, achieved the primary composite endpoint, and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03656562

NCT03656562 | Study the Efficacy and Safety of VAY736 ... This study is designed to evaluate the safety, tolerability, pharmacokinetics and therapeutic efficacy of treatment with either VAY736 (ianalumab) or CFZ533 ...

3. acrabstracts.org acrabstracts.org/abstract/safety-and-efficacy-of-subcutaneous-ianalumab-vay736-for-up-to-68-weeks-in-patients-with-systemic-lupus-erythematosus-results-from-phase-2-study/

Safety and Efficacy of Subcutaneous Ianalumab (VAY736) ... Safety and efficacy of subcutaneous Ianalumab (VAY736) for up to 68 weeks in patients with systemic lupus erythematosus: results from Phase 2 study.

4. ard.bmj.com ard.bmj.com/content/83/Suppl_1/956

FINDINGS FROM A PHASE 2 CLINICAL TRIAL Conclusion: Ianalumab treatment of patients with SLE led to a profound B cell depletion, as confirmed by flow cytometry and transcriptomic assessments and a ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003496724151801

OP0089 PHASE 2 SAFETY AND EFFICACY OF ... Treatment of SLE with ianalumab up to 1 year was well tolerated, and data suggest longer exposure provides further clinical and laboratory benefits.

6. novartis.com novartis.com/clinicaltrials/study/nct06133972

Phase 3 Extension Study to Evaluate Long-term Safety ... The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05639114

NCT05639114 | Phase 3 Study to Evaluate Two Regimens ... The trial will evaluate efficacy, safety and tolerability of two regimens of ianalumab compared to placebo, given as monthly or quarterly subcutaneous ...

8. ard.bmj.com ard.bmj.com/content/82/Suppl_1/275.2

ANTI-BAFFR mAb) ADMINISTERED MONTHLY OVER 28 ... Treatment of SLE with ianalumab was well tolerated and met the composite primary endpoint of SRI-4 response with sustained steroid reduction.