A Phase 3 interventional study of Placebo and Ianalumab in Systemic Lupus Erythematosus, sponsored by Novartis Pharmaceuticals. Recruiting at 167 sites in 29 countries. Open to participants aged 12 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment
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).
The purpose of this extension study is to evaluate long-term safety and tolerability of ianalumab administered s.c. monthly or quarterly, compared to monthly placebo, in adolescent and adult participants with anti-nuclear antibody (ANA)-positive systemic lupus erythematosus of moderate-to-severe disease activity, who have completed either CVAY736F12301 (SIRIUS-SLE 1) or CVAY736F12302 (SIRIUS-SLE 2) core studies.
This extension study will last up to 7 years and includes the following three treatment periods:
1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.
This study's planned enrollment of 550 is above the median of 52 across 876 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 1, 2026. See what changed
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ianalumab s.c. monthly
Drug: Ianalumab
Ianalumab s.c. quarterly
Drug: Ianalumab
Placebo s.c. monthly
Drug: Placebo
Placebo s.c. monthly
Ianalumab s.c. monthly Ianalumab s.c. quarterly
Also known as: VAY736
Number of treatment-emergent Adverse events/Serious Adverse events
Assessment of long-term safety and tolerability of ianalumab
Time frame: through study completion, up to approximately 324 weeks
Proportion of participants who achieved Systemic Lupus Erythematosus Responder Index -4 (SRI-4) response
SRI-4 response is defined as: * Systemic Lupus Erythematosus Disease Activity Index - 2000 (SLEDAI-2K) reduction from baseline of ≥ 4 points * No British Isles Lupus Assessment Group-2004 (BILAG-2004) worsening, defined as ≥ 1 new A or ≥ 2 new B items compared to baseline * No worsening in Physician Global Assessment of Disease Activity (PhGA), defined as an increase of ≥ 0.3 from baseline on a 0 to 3 visual analog scale
Time frame: up to Week 324
Proportion of participants who achieved Definition of Remission in SLE (DORIS) response
DORIS is defined as: * Clinical SLEDAI (cSLEDAI) = 0 (excluding serological items, anti-dsDNA and complement) * Physician global assessment (PhGA, scale 0-3) \< 0.5 * Current CS (predniso(lo)ne or equivalent) dose ≤ 5 mg/day * Patient may be on antimalarials, low dose glucocorticoids and/or stable immune-suppressive treatment including biologics.
Time frame: up to Week 324
Change in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index
SLICC/ACR Damage Index is a measure of cumulative damage due to SLE
Time frame: up to Week 324
Average daily dose of corticosteroids administered
Evaluating the effect of ianalumab on corticosteroids intake
Time frame: up to Week 324
Annualized BILAG moderate or severe flare rate
Annualized BILAG moderate or severe flare rate where moderate BILAG flare is defined as 2 or more new BILAG-2004 B items, and severe BILAG flare is defined as 1 or more new BILAG-2004 A items, compared to the previous visit
Time frame: up to Week 324
Ianalumab serum concentrations during treatment and follow-up after last dose
To characterize the Pharmacokinetics (PK) of ianalumab
Time frame: up to Week 324
Incidence and titer of anti-ianalumab antibodies in serum (ADA assay) over time.
To characterize the immunogenicity of ianalumab
Time frame: up to Week 324
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Showing the first 100 of 167 sites across 29 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Ianalumab
Lupus Erythematosus, Systemic →