Ianalumab for Lupus

(SIRIUS-SLE LTE Trial)

Recruiting at 60 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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).

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.

What data supports the effectiveness of the drug Ianalumab for treating lupus?

Research on similar treatments for lupus, like Belimumab, shows that targeting B cells can help control the disease. Other drugs that target B cells, such as Rituximab and Ocrelizumab, have also shown promise in reducing lupus symptoms. ^{1 2 3 4 5}

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

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

I plan to get live vaccines during the study.

Pregnant or nursing (lactating) women

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

Timeline

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Characterisation of anifrolumab, a fully human anti-interferon receptor antagonist antibody for the treatment of systemic lupus erythematosus. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

[Allergo-immunology. Clinical immunology]. [2016]

3. Netherlands pubmed.ncbi.nlm.nih.gov

The efficacy of novel B cell biologics as the future of SLE treatment: a review. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Phase 2, randomized, placebo-controlled trial of dapirolizumab pegol in patients with moderate-to-severe active systemic lupus erythematosus. [2022]

5. England 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. [2022]