Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).
Purpose
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
- Systemic Lupus Erythematosus
Eligibility
- Eligible Ages
- Between 12 Years and 100 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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. Other protocol-defined inclusion/exclusion criteria may apply.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- 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.) injection
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Ianalumab monthly |
Ianalumab s.c. monthly |
|
|
Experimental Ianalumab quarterly |
Ianalumab s.c. quarterly |
|
|
Placebo Comparator Placebo monthly |
Placebo s.c. monthly |
|
Recruiting Locations
Pinnacle Research Group Llc
Anniston, Alabama 36207
Anniston, Alabama 36207
Advanced Medical Research
La Palma, California 90623
La Palma, California 90623
Millennium Clinical Trials
Westlake Village, California 91361
Westlake Village, California 91361
Clinical Res Of W Florida
Clearwater, Florida 33765
Clearwater, Florida 33765
Accurate Clinical Research
Lake Charles, Louisiana 70601
Lake Charles, Louisiana 70601
Ahmed Arif Medical Research Center
Grand Blanc, Michigan 48439
Grand Blanc, Michigan 48439
West Tennessee Research Institute
Jackson, Tennessee 38305
Jackson, Tennessee 38305
Shelby Research LLC
Memphis, Tennessee 38119
Memphis, Tennessee 38119
More Details
- NCT ID
- NCT06133972
- Status
- Recruiting
- Sponsor
- Novartis Pharmaceuticals
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.