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Phase 3RecruitingInterventionalNCT06133972

Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension). (SIRIUS-SLE LTE)

A Randomized, Double-blind, Placebo-controlled Extension Study, Followed by a Study Treatment Withdrawal or Open-label Period, to Assess the Long-term Safety and Tolerability of Ianalumab in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE Extension)

  • Systemic Lupus Erythematosus
I want to take partRefer a patient11 sites in India · 162 worldwide

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
Novartis Pharmaceuticals
Enrolment target
550
Started
21 May 2024
Main results due (estimated)
3 April 2034
Study ends (estimated)
2 October 2034
Allocation
Randomized
Design
Parallel
Purpose
Treatment
Masking
Quadruple (participant, care provider, investigator, outcomes assessor)
Sites
162 · 11 in India
First posted
18 November 2023
Registry updated
1 October 2026

The trial is designed to evaluate long-term safety, tolerability and efficacy of two regimen of ianalumab versus placebo, given as monthly or quarterly subcutaneous (s.c.) injection. After the 3 year randomized, placebo-controlled period the study will continue as open-label to evaluate long term safety and efficacy of ianalumab, on or off-treatment, for an additional two years, followed by further monitoring of longer-term safety for up to two additional years

Can you take part?

  • Ages 12 years to 100 years.
  • Open to any sex.
  • You need the condition being studied. Healthy volunteers are not accepted.

Age groups: child, adult, older adult.

These are the headline rules. Every study has a longer list, and whether you are eligible is decided by the research team at the site, never by this page.

Read the full eligibility criteria
Key Inclusion Criteria:

* Signed informed consent prior to participation in the extension study. Parent or legal guardian's signed informed consent and child's assent, if appropriate, are required before any assessment is performed for participants \<18 years of age. Of note, if the participant reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.
* Participants must have participated in either one of the two SIRIUS-SLE core studies, CVAY736F12301 or CVAY736F12302, and have completed the treatment period through Week 60 without treatment discontinuation.
* In the judgement of the investigator, participants must be expected to clinically benefit from continued study treatment.

Key Exclusion Criteria:

* Use of prohibited therapies.
* Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection which in the opinion of the investigator will place the participant at risk for participation.
* Plans for administration of live vaccines during the study period.
* Pregnant or nursing (lactating) women.

Other protocol-defined inclusion/exclusion criteria may apply.

What this study is about

In the sponsor’s own words, from the registry.

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).

Read the detailed description

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:

* a 3-year double-blind, randomized, placebo-controlled treatment period, evaluating the safety and efficacy of ianalumab or placebo (Period 1); * followed by a 2-year treatment period evaluating safety and efficacy of treatment withdrawal and open-label ianalumab administered s.c. monthly. * and an up to 2-year open-label, safety monitoring period (Period 3).

Keywords: Systemic Lupus Erythematosus · SLE · B cell depletion · SLEDAI-2K · BILAG-2004 · SRI-4, ANA · ianalumab · VAY736

What participants receive

  • Experimental

    Ianalumab monthly

    Ianalumab s.c. monthly

    Drug: Ianalumab

  • Experimental

    Ianalumab quarterly

    Ianalumab s.c. quarterly

    Drug: Ianalumab

  • Placebo comparator

    Placebo monthly

    Placebo s.c. monthly

    Drug: Placebo

Interventions

  • PlaceboDrug

    Placebo s.c. monthly

  • IanalumabDrug

    Also known as VAY736

    Ianalumab s.c. monthly Ianalumab s.c. quarterly

What the study measures

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Average daily dose of corticosteroids administered

    Evaluating the effect of ianalumab on corticosteroids intake

    Time frame: up to Week 324

  5. 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

  6. Ianalumab serum concentrations during treatment and follow-up after last dose

    To characterize the Pharmacokinetics (PK) of ianalumab

    Time frame: up to Week 324

  7. 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

Who is running it

Lead sponsor
Novartis Pharmaceuticals
Sponsor type
Industry
Responsible party
The sponsor
Organisation
Novartis
Data monitoring committee
Yes
US FDA-regulated drug
Yes
US FDA-regulated device
No
Sponsor's study ID
CVAY736F12301E1
Other IDs
2023-505929-14-00, 2023

  • Novartis Pharmaceuticals

    Study director

    Novartis Pharmaceuticals

Study sites(162)

Showing 40 of 162 sites, filter to narrow it down. 126 of 162 on this study are recruiting right now, and 11 are in India. A site can stop enrolling while the study as a whole is still open.

References and data sharing

Participant data shared
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

Source: ClinicalTrials.gov record NCT06133972, status verified September 2026. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythema | Trialion