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

Systemic Lupus Erythematosus Clinical Trial

— SIRIUS-SLE LTE  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06133972
• Other study ID #: CVAY736F12301E1
• Secondary ID: 2023-505929-14
• Status: Recruiting
• Phase: Phase 3
• Start date: May 21, 2024
• Est. completion date: December 23, 2031

Study information

• Verified date: June 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: 1-888-669-6682
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: December 23, 2031
• Est. primary completion date: December 25, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Other protocol-defined inclusion/exclusion criteria may apply.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• Placebo
Placebo s.c. monthly
• Ianalumab
Ianalumab s.c. monthly Ianalumab s.c. quarterly

Locations

Country	Name	City	State
Spain	Novartis Investigative Site	Barcelona	Catalunya

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Average daily dose of oral corticosteroids administered	Evaluating the effect of ianalumab on corticosteroids intake	up to Week 216
Secondary	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