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 Sex
- 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 4830198, Alabama 4829764 36207
Anniston 4830198, Alabama 4829764 36207
Providence Medical Center
Burbank 5331835, California 5332921 91505
Burbank 5331835, California 5332921 91505
Advanced Medical Research
La Palma 5364022, California 5332921 90623
La Palma 5364022, California 5332921 90623
Millennium Clinical Trials
Westlake Village 5408395, California 5332921 91361
Westlake Village 5408395, California 5332921 91361
University of Colorado Denver
Aurora 5412347, Colorado 5417618 80045
Aurora 5412347, Colorado 5417618 80045
Clinical Res Of W Florida
Clearwater 4151316, Florida 4155751 33765
Clearwater 4151316, Florida 4155751 33765
GNP Research
Cooper City 4151824, Florida 4155751 33024
Cooper City 4151824, Florida 4155751 33024
IRIS Research and Development
Plantation 4168782, Florida 4155751 33324
Plantation 4168782, Florida 4155751 33324
Robert A Hozman MD SC
Skokie 4911600, Illinois 4896861 60076
Skokie 4911600, Illinois 4896861 60076
Willow Rheumatology Wellness
Willowbrook 4916709, Illinois 4896861 60527
Willowbrook 4916709, Illinois 4896861 60527
Accurate Clinical Research
Lake Charles 4330236, Louisiana 4331987 70601
Lake Charles 4330236, Louisiana 4331987 70601
Ahmed Arif Medical Research Center
Grand Blanc 4994320, Michigan 5001836 48439
Grand Blanc 4994320, Michigan 5001836 48439
Paramount Med Rsrch and Consult LLC
Middleburg Heights 5162851, Ohio 5165418 44130
Middleburg Heights 5162851, Ohio 5165418 44130
West Tennessee Research Institute
Jackson 4632595, Tennessee 4662168 38305
Jackson 4632595, Tennessee 4662168 38305
Shelby Research LLC
Memphis 4641239, Tennessee 4662168 38119
Memphis 4641239, Tennessee 4662168 38119
Novel Research LLC
Bellaire 4673353, Texas 4736286 77401
Bellaire 4673353, Texas 4736286 77401
Accurate Clinical Research
League City 4705692, Texas 4736286 77573
League City 4705692, Texas 4736286 77573
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.