Ianalumab for Lupus

(SIRIUS-SLE LTE Trial)

Recruiting at 121 trial locations

Overseen By Novartis Pharmaceuticals

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Novartis Pharmaceuticals

Disqualifiers: Infections, Live vaccines, Pregnancy, 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: up to 216 weeks

550 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and tolerability of ianalumab, an experimental treatment for systemic lupus erythematosus (SLE), a condition where the immune system attacks the body. Participants will receive either ianalumab or a placebo (a non-active substance) on a monthly or quarterly basis. The trial targets individuals who completed the treatment phase in previous SIRIUS-SLE studies and are expected to benefit from continued treatment. It is specifically for those who participated in earlier studies and completed the treatment without interruption. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to the validation of a promising treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions the use of prohibited therapies, so it's best to discuss your current medications with the study team.

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

Research has shown that ianalumab appears safe for people with systemic lupus erythematosus (SLE). Studies have found that patients generally tolerate ianalumab well, experiencing few significant side effects over several weeks of treatment.

One study noted that patients taking ianalumab reduced their use of steroids without major safety issues. These results suggest that ianalumab could be a safe option for those with SLE. However, like any medication, some risks exist, so discussing with a healthcare provider is important to determine if it's suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for lupus involve immunosuppressants and corticosteroids that generally suppress the immune system to reduce inflammation. However, Ianalumab is unique because it targets a specific protein called BAFF-R, which is involved in the survival of B-cells, a type of immune cell that plays a role in lupus. By targeting BAFF-R, Ianalumab has the potential to more precisely reduce the overactive immune response seen in lupus without broadly suppressing the entire immune system. Researchers are excited about this targeted approach because it could lead to fewer side effects and improve the quality of life for patients with lupus. Additionally, the subcutaneous (s.c.) delivery of Ianalumab, either monthly or quarterly, offers flexibility and convenience compared to some existing treatments.

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

This trial will evaluate Ianalumab for treating systemic lupus erythematosus (SLE), a condition where the immune system attacks the body. Research has shown that Ianalumab may help by reducing the activity of B cells, which play a key role in lupus. Participants in this trial will receive either Ianalumab monthly, Ianalumab quarterly, or a placebo. Previous studies found that patients who received Ianalumab reported feeling better, and doctors also noticed improvements. The treatment was generally safe, even with long-term use, and extended use led to more benefits. These results suggest that Ianalumab could effectively manage lupus symptoms. ^{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 with systemic lupus erythematosus who finished a previous SIRIUS-SLE study without stopping treatment. They must consent to participate and, if under 18, have guardian consent plus their own assent. Participants should be expected to benefit from continued treatment.

Inclusion Criteria

In the judgement of the investigator, participants must be expected to clinically benefit from continued study treatment.

I completed one of the SIRIUS-SLE studies without stopping the treatment.

I, or my guardian if I'm under 18, have signed the consent form.

Exclusion Criteria

Pregnant or nursing (lactating) women

I plan to get live vaccines during the study.

I do not have any serious infections needing IV or IM treatments.

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 administered subcutaneously monthly or quarterly

up to 216 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants may opt into continuation of treatment long-term

up to approximately 91 months

What Are the Treatments Tested in This Trial?

Interventions

• Ianalumab

Trial Overview The trial is testing the long-term safety of Ianalumab in individuals with lupus who completed prior SIRIUS-SLE studies. It compares ongoing Ianalumab use against a placebo to see how well patients tolerate it over an extended period.

How Is the Trial Designed?

Group I: Ianalumab quarterly Experimental Treatment 1 Intervention

Ianalumab s.c. quarterly

Group II: Ianalumab monthly Experimental Treatment 1 Intervention

Ianalumab s.c. monthly

Group III: Placebo 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

Published Research Related to This Trial

Dapirolizumab pegol (DZP) showed improvements in clinical and immunological outcomes for patients with moderately to severely active systemic lupus erythematosus (SLE) after 24 weeks, although the primary dose-response relationship was not statistically significant.

DZP was well tolerated with low incidences of serious adverse events, suggesting it is a safe option for SLE treatment, warranting further investigation into its clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 2, randomized, placebo-controlled trial of dapirolizumab pegol in patients with moderate-to-severe active systemic lupus erythematosus. Furie, RA., Bruce, IN., Dörner, T., et al.[2022]

Current treatments for systemic lupus erythematosus (SLE) often lead to adverse side effects and do not effectively maintain remission, prompting the development of novel B cell-targeted biologics.

Biologics like Rituximab, Ocrelizumab, and Belimumab have shown efficacy in depleting B cells and improving disease symptoms, with Belimumab receiving FDA approval based on results from large trials (BLISS-52 and BLISS-76).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of novel B cell biologics as the future of SLE treatment: a review. Kamal, A., Khamashta, M.[2018]

Anifrolumab effectively reduces the surface expression of the type I interferon alpha receptor (IFNAR1) on human monocytes, leading to decreased activation of the type I interferon signaling pathway, which is crucial in systemic lupus erythematosus (SLE).

The drug inhibits the production of type I interferon and its associated inflammatory responses without exhibiting cytotoxic effects, making it a promising therapeutic option for SLE and other conditions characterized by abnormal type I interferon signaling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterisation of anifrolumab, a fully human anti-interferon receptor antagonist antibody for the treatment of systemic lupus erythematosus. Riggs, JM., Hanna, RN., Rajan, B., et al.[2022]

The BLISS 52 study demonstrated that belimumab can effectively reduce the activity of systemic lupus erythematosus (SLE) that does not respond to conventional treatments, marking a significant advancement in managing this challenging disease.

Long-term results from the ALMS study indicate that mycophenolate mofetil is more effective than azathioprine in maintaining remission in patients with severe lupus nephritis, while the RAVE and RITUXVASC studies confirm that rituximab is a viable alternative to cyclophosphamide for treating ANCA-associated vasculitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Allergo-immunology. Clinical immunology]. Chizzolini, C.[2016]

In a study of 79 SLE patients and 27 healthy controls, serum levels of B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL) were significantly higher in SLE patients, indicating their involvement in the disease's pathogenesis.

While BAFF levels correlated with renal disease activity, and APRIL levels were associated with proteinuria, neither BAFF nor APRIL showed a direct correlation with overall disease activity as measured by SLEDAI scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship between serum A proliferation-inducing ligand and B-cell activating factor levels with disease activity and organ involvement in systemic lupus erythematosus. Sari, S., Cinar, S., Yalcinkaya, Y., et al.[2022]

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. novartis.com novartis.com/news/media-releases/novartis-ianalumab-first-drug-reduce-disease-activity-and-patient-burden-sjogrens-disease-phase-iii-trials

Novartis ianalumab first drug to reduce disease activity and ... Ianalumab 300 mg monthly numerically improved physician- and patient-reported outcomes1. Nominal significance was observed in NEPTUNUS-1 and the ...

4. ard.bmj.com ard.bmj.com/content/83/Suppl_1/140.2

OP0089 PHASE 2 SAFETY AND EFFICACY ... Conclusion: 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 ...