Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Patients With Lupus (SIRIUS-SLE Extension).
The purpose of this study is to assess long-term safety and tolerability of ianalumab in patients with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).
Conditions:
Systemic Lupus Erythematosus
Study Start (Actual) 2024-05-21
Primary Completion (Estimated) 2029-12-25
Study Completion (Estimated) 2031-12-23
Enrollment (Estimated) 550
Study Type INTERVENTIONAL
Phase PHASE3
Locations:
📍 Clearwater, Florida, United States
📍 Maroochydore, Queensland, Australia
📍 Rimouski, Quebec, Canada
📍 Barcelona, Catalunya, Spain
📍 Santiago De Compostela, Galicia, Spain

Eligibility Criteria

Description

    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.
Ages Eligible for Study: 12 Years to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted2023-10-02
  • First Submitted that Met QC Criteria2023-11-15
  • First Posted2023-11-18

Study Record Updates

  • Last Update Submitted that Met QC Criteria2024-07-26
  • Last Update Posted2024-07-29
  • Last Verified2024-07