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

PHASE3RECRUITING

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).

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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.

Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, refusing or unable to use highly effective methods of contraception while on study treatment and for 6 months after stopping of study drug (or longer if required by concomitant medications).

United States (and other countries, if locally required): sexually active males, unless they agree to use barrier protection during intercourse with women of child-bearing potential while taking study treatment.

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Eligibility

Age eligible for study : 12 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-05-21

Primary completion: 2029-12-25

Study completion finish: 2031-12-23

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT06133972

Intervention or treatment

DRUG: Placebo

DRUG: Ianalumab

Conditions

• Systemic Lupus Erythematosus

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Condition: Systemic Lupus Erythematosus
DRUG: Placebo and other drugs
Maroochydore, Queensland, Australia
Sponsor: Novartis Pharmaceuticals

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Find a site

Closest Location:

Novartis Investigative Site

Research sites nearby

Select from list below to view details:

Novartis Investigative Site
Maroochydore, Queensland, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Ianalumab monthly Ianalumab s.c. monthly	DRUG: Ianalumab Ianalumab s.c. monthly Ianalumab s.c. quarterly
EXPERIMENTAL: Ianalumab quarterly Ianalumab s.c. quarterly	DRUG: Ianalumab Ianalumab s.c. monthly Ianalumab s.c. quarterly
PLACEBO_COMPARATOR: Placebo monthly Placebo s.c. monthly	DRUG: Placebo Placebo s.c. monthly

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Number of treatment-emergent Adverse events/Serious Adverse events	Assessment of long-term safety and tolerability of ianalumab	through study completion, up to approximately 91 months

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
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	up to Week 216
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	up to Week 216
Average daily dose of oral corticosteroids administered	Evaluating the effect of ianalumab on corticosteroids intake	up to Week 216
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	up to Week 216

Frequently Asked Questions

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References

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