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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06133972

Collaborator

(none)

550

Enrollment

Arms

90.7

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus	Drug: Placebo Drug: Ianalumab	Phase 3

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

or CVAY736F12302 (SIRIUS-SLE 2) core studies.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

550 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.) injectionThe 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

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-blind, Placebo-controlled Extension Study to Assess the Long-term Safety and Tolerability of Ianalumab in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE Extension)

Anticipated Study Start Date :

May 17, 2024

Anticipated Primary Completion Date :

Dec 9, 2031

Anticipated Study Completion Date :

Dec 9, 2031

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ianalumab monthly Ianalumab s.c. monthly	Drug: Ianalumab Ianalumab s.c. monthly Ianalumab s.c. quarterly Other Names: VAY736
Experimental: Ianalumab quarterly Ianalumab s.c. quarterly	Drug: Ianalumab Ianalumab s.c. monthly Ianalumab s.c. quarterly Other Names: VAY736
Placebo Comparator: Placebo monthly Placebo s.c. monthly	Drug: Placebo Placebo s.c. monthly

Arm

Intervention/Treatment

Experimental: Ianalumab monthly

Ianalumab s.c. monthly

Drug: Ianalumab

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

Other Names:

VAY736

Experimental: Ianalumab quarterly

Ianalumab s.c. quarterly

Drug: Ianalumab

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

Other Names:

VAY736

Placebo Comparator: Placebo monthly

Placebo s.c. monthly

Drug: Placebo

Placebo s.c. monthly

Outcome Measures

Primary Outcome Measures

Number of treatment-emergent Adverse events/Serious Adverse events [through study completion, up to approximately 91 months]
Assessment of long-term safety and tolerability of ianalumab

Secondary Outcome Measures

Proportion of participants who achieved Systemic Lupus Erythematosus Responder Index -4 (SRI-4) response [up to Week 216]
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
Change in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index [up to Week 216]
SLICC/ACR Damage Index is a measure of cumulative damage due to SLE
Average daily dose of oral corticosteroids administered [up to Week 216]
Evaluating the effect of ianalumab on corticosteroids intake
Annualized BILAG moderate or severe flare rate [up to Week 216]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.
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.