Ianalumab + Standard Therapy for Lupus Nephritis

(SIRIUS-LN Trial)

Recruiting in Palo Alto (17 mi)

+195 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Novartis Pharmaceuticals

Must be taking: Corticosteroids, MPA

Must not be taking: Immunosuppressants, DMARDs

Disqualifiers: Severe renal impairment, Transplant history, Active infections, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial will test how well ianalumab injections work and how safe they are for adults with a type of kidney inflammation caused by lupus. The medication is given under the skin at regular intervals. It aims to reduce kidney inflammation by calming the immune system.

Will I have to stop taking my current medications?

The trial requires participants to switch from azathioprine to MPA before starting the study. Other medications like certain immunosuppressants and investigational drugs must be stopped before joining the trial. The protocol does not specify a washout period for all medications, so it's best to discuss your specific medications with the study team.

What makes the drug ianalumab unique for treating lupus nephritis?

Ianalumab is unique because it targets a specific protein involved in the immune response, potentially offering a new approach compared to existing treatments like voclosporin or anifrolumab, which have different mechanisms of action. ^{1 2 3 4 5}

Eligibility Criteria

Adults with active Lupus Nephritis (LN) who have started or are willing to start standard treatment, including high-dose corticosteroids and MPA. They must weigh at least 35 kg, have a positive ANA test, and meet specific criteria for active LN. Excluded are those with severe kidney damage, recent heavy steroid use, certain infections or immunodeficiencies, cancer history within 5 years, or women who could become pregnant not using effective contraception.

Inclusion Criteria

I am 18 years old or older.

Able to communicate well with the Investigator to understand and comply with the requirements of the study

You have a positive anti-nuclear antibody (ANA) test result with a certain level of ANA in your blood.

Exclusion Criteria

I agree to use barrier protection during sex while on the study treatment.

I have had cancer in any part of my body in the last 5 years.

I have an active TB infection.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous ianalumab every 4 weeks or every 12 weeks, or placebo, in combination with standard of care therapy

72 weeks

18 visits (in-person) for q4w group, 6 visits (in-person) for q12w group

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ianalumab (Monoclonal Antibodies)

Trial Overview The trial is testing the effectiveness of Ianalumab administered under the skin every 4 weeks or every 12 weeks versus a placebo. All treatments will be given in combination with standard-of-care therapy for LN. The goal is to see how well Ianalumab works and how safe it is compared to just receiving the usual treatment without this additional drug.

Participant Groups

Group I: Arm 2 - ianalumab s.c. q12w Experimental Treatment 1 Intervention

ianalumab s.c. q12w in addition to SoC

Group II: Arm 1 - ianalumab s.c. q4w Experimental Treatment 1 Intervention

ianalumab s.c. q4w in addition to standard of care (SoC)

Group III: Arm 3 - placebo s.c. q4w Placebo Group 1 Intervention

Placebo s.c. q4w in addition to SoC

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Texas Medical Branch . Galveston, TX

Kaiser Permanente Dpt of Research and Evaluation San Diego, CA

Northern Assoc of Northern VA Fairfax, VA

University of Kansas Medical Center CRAD001A2433 Kansas City, KS

More Trial Locations

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals Lead Sponsor

References

1. 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] To evaluate the dose-response, efficacy and safety of dapirolizumab pegol (DZP) in patients with SLE.

2. United States pubmed.ncbi.nlm.nih.gov

Update on the Efficacy and Safety Profile of Voclosporin: An Integrated Analysis of Clinical Trials in Lupus Nephritis. [2023] This integrated analysis evaluates the efficacy and safety of voclosporin, a novel calcineurin inhibitor, at 23.7 mg twice daily in combination with mycophenolate mofetil (MMF) and oral glucocorticoids in lupus nephritis (LN) using pooled data from two large phase II and phase III clinical trials. The purpose was to expand the pool of patients for safety analyses and to increase power for efficacy analyses in patient subpopulations.

3. England pubmed.ncbi.nlm.nih.gov

Anifrolumab in lupus nephritis: results from second-year extension of a randomised phase II trial. [2023] To characterise the safety and efficacy of anifrolumab in active lupus nephritis (LN) through year 2 of the phase II randomised, double-blind Treatment of Uncontrolled Lupus via the Interferon Pathway (TULIP)-LN trial (NCT02547922) of 2 anifrolumab dosing regimens versus placebo.

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

Phase II randomised trial of type I interferon inhibitor anifrolumab in patients with active lupus nephritis. [2022] To assess the efficacy and safety of the type I interferon receptor antibody, anifrolumab, in patients with active, biopsy-proven, Class III/IV lupus nephritis.

5. Turkey pubmed.ncbi.nlm.nih.gov

Multitarget therapy versus intravenous cyclophosphamide in the induction treatment of lupus nephritis: a metaanalysis of randomized controlled trials [2019] Background/aim: Multitarget therapy for lupus nephritis (LN) remains in its exploratory phrase and the recent evidence is insufficient. This study aimed to evaluate the efficacy and safety of mycophenolate mofetil (MMF), tacrolimus (TAC), and steroids (multitarget therapy) versus intravenous cyclophosphamide (IVC) and steroids in induction treatment of LN. Materials and methods: We searched for randomized controlled trials of MMF plus TAC versus IVC in LN using PubMed, EMBASE, the Cochrane Central Register of Controlled Trials, the China Biology Medicine Database, and the China National Knowledge Infrastructure Database. We assessed the retrieved citations and selected studies according to predefined inclusion and exclusion criteria. Results: In total, we identified 8 trials including 801 patients. The metaanalysis revealed that overall multitarget therapy is more effective at inducing complete renal remission compared with IVC (RR: 1.94, 95% CI: 1.61-2.33; P