Ianalumab for Lupus

(SIRIUS-SLE 2 Trial)

Recruiting at 144 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness and safety of ianalumab for treating active systemic lupus erythematosus (SLE), a condition where the immune system attacks the body's own tissues. Participants will receive monthly injections of either ianalumab or a placebo, alongside their usual lupus treatments. Suitable candidates for this trial have had an SLE diagnosis for at least six months and are currently experiencing active symptoms despite ongoing treatment. As a Phase 3 trial, this study serves as the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that ianalumab is likely to be safe for humans?

Research has shown that ianalumab has promising safety results. In one study, people with systemic lupus erythematosus (SLE) handled ianalumab well during treatment. Another study found it was safe to use ianalumab for up to 68 weeks without major safety issues. Patients responded well to the treatment, meeting important health goals and reducing their need for steroids. Overall, these studies suggest that ianalumab is generally safe and well-tolerated for people with SLE. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lupus?

Unlike the standard treatments for lupus, which often include corticosteroids and immunosuppressants, ianalumab offers a novel approach by targeting the BAFF receptor on B cells. This mechanism of action is different because it directly modulates the activity of B cells, which play a significant role in lupus. Researchers are excited about ianalumab because it has the potential to offer a more targeted treatment option, potentially leading to fewer side effects and improved disease management. Additionally, ianalumab is administered as a monthly subcutaneous injection, which could enhance patient convenience compared to more frequent dosing schedules of some current therapies.

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

Research has shown that ianalumab, which participants in this trial may receive, may help treat systemic lupus erythematosus (SLE). One study found that patients who took ianalumab experienced a significant reduction in B cells, which contribute to lupus symptoms. Another study reported that after a year of using ianalumab, patients showed noticeable improvements in their symptoms and lab results. Additionally, patients have generally tolerated ianalumab well, indicating it is likely safe. These findings suggest that ianalumab could effectively manage SLE. ^{1 2 5 6 7}

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. 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 ...

2. 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.

3. 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 ...

4. 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.

5. 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 ...

6. 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.

7. 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 ...