Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).
- Registration Number
- NCT06133972
- Lead Sponsor
- Novartis Pharmaceuticals
- 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).
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 550
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ianalumab quarterly Ianalumab Ianalumab s.c. quarterly Placebo monthly Placebo Placebo s.c. monthly Ianalumab monthly Ianalumab Ianalumab s.c. monthly
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 scaleChange 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
Trial Locations
- Locations (10)
Pinnacle Research Group Llc
🇺🇸Anniston, Alabama, United States
Advanced Medical Research
🇺🇸La Palma, California, United States
Millennium Clinical Trials
🇺🇸Westlake Village, California, United States
Clinical Res Of W Florida
🇺🇸Clearwater, Florida, United States
Accurate Clinical Research
🇺🇸Lake Charles, Louisiana, United States
Ahmed Arif Medical Research Center
🇺🇸Grand Blanc, Michigan, United States
West Tennessee Research Institute
🇺🇸Jackson, Tennessee, United States
Shelby Research LLC
🇺🇸Memphis, Tennessee, United States
Novel Research LLC
🇺🇸Bellaire, Texas, United States
Novartis Investigative Site
🇹🇭Bangkok, Thailand