Ianalumab for Lupus
(SIRIUS-SLE LTE Trial)
Recruiting in Palo Alto (17 mi)
+47 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Novartis Pharmaceuticals
Disqualifiers: Infections, Live vaccines, Pregnancy, others
Pivotal Trial (Near Approval)
Prior Safety Data
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.
12345Eligibility 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.
+3 more
Trial 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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Ianalumab quarterlyExperimental Treatment1 Intervention
Ianalumab s.c. quarterly
Group II: Ianalumab monthlyExperimental Treatment1 Intervention
Ianalumab s.c. monthly
Group III: Placebo monthlyPlacebo Group1 Intervention
Placebo s.c. monthly
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Shelby Research LLCMemphis, TN
Novartis Investigative SiteRimouski, Canada
Pinnacle Research Group Llc .Anniston, AL
Clinical Res Of W FloridaClearwater, FL
More Trial Locations
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Who Is Running the Clinical Trial?
Novartis PharmaceuticalsLead Sponsor
References
Characterisation of anifrolumab, a fully human anti-interferon receptor antagonist antibody for the treatment of systemic lupus erythematosus. [2022]We investigated the mechanistic and pharmacological properties of anifrolumab, a fully human, effector-null, anti-type I interferon (IFN) alpha receptor 1 (IFNAR1) monoclonal antibody in development for SLE.
[Allergo-immunology. Clinical immunology]. [2016]The past year has been characterized by significant novelties from the point of view of the clinical immunologist. With the BLISS 52 study showing that belimumab has the ability to decrease the activity of systemic lupus erythematosus (SLE) resistant to conventional therapy an important step towards the control of this difficult disease has been carried forward. In addition, the long-term results of the ALMS study have demonstrated that mycophenolate mofetil is superior to azathioprine in maintaining the remission in patients with severe lupus nephritis. Furthermore, the results of the RAVE and RITUXVASC studies have documented that rituximab is a valid alternative to cyclophosphamide in the control of ANCA associated vasculitis.
The efficacy of novel B cell biologics as the future of SLE treatment: a review. [2018]Systemic lupus erythematosus (SLE) is a chronic autoimmune inflammatory disease with wide ranging multi-systemic effects. Current understanding centralises B cells in SLE pathogenesis with clinical features resulting from autoantibody formation, immune complex deposition, antigen presentation and cytokine activation. Existing standard of care therapies generates adverse side effects; secondary to corticosteroid use and untargeted immunosuppression. The inability to uphold remission and abolish the disease process, in addition to the increasing numbers of patients seen with refractory disease with these therapies, has provoked the development of novel B cell biologics targeting specific pathogenic pathways fundamental to the SLE disease process. Current evidence highlighting the efficacy of Rituximab, Ocrelizumab and Epratuzumab in inducing B cell depletion and achieving disease amelioration through specific B cell surface receptor antagonism is discussed. We review the efficacy of Atacicept, Briobacept and Belimumab in antagonising B lymphocyte stimulator (BLyS) and A proliferation inducing ligand (APRIL), two stimulatory cytokines crucial to B cell survival, growth and function. Two large multicentre randomised controlled trials, BLISS-52 and BLISS-76, have led to FDA approval of Belimumab. Following this breakthrough, other anti-BLyS therapies, Blisibimod and Tabalumab, are currently under Phase III evaluation. Similarly, murine models and Phase I/II trials have demonstrated significant efficacy of Rituximab, Epratuzumab, Briobacept and Atacicept as potential future therapies and we now eagerly await results from Phase III trials. Future research must compare the efficacy of different biologics amongst different patient subpopulations and SLE manifestations, in order to develop clinically and cost effective therapies.
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.
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]We aim to investigate the association between serum B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL) levels with disease activity and clinical findings in SLE patients.