RightFit
RecruitingPhase 3

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

A Randomized, Double-blind, Placebo-controlled Extension Study, Followed by a Study Treatment Withdrawal or Open-label Period, to Assess the Long-term Safety and Tolerability of Ianalumab in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE Extension)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 100 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study checks the long-term safety of ianalumab and how well people can tolerate it. It is for people with systemic lupus erythematosus (lupus) who finished treatment in one of the two main SIRIUS-SLE studies.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign a form agreeing to join the study. For those under 18, a parent or legal guardian must sign, and the child must agree when appropriate.
  • If you reach the legal age to give consent during the study, sign your own consent form at the next visit.
  • Have finished treatment through Week 60 in study CVAY736F12301 or CVAY736F12302 without stopping treatment.
  • The study doctor expects that continuing study treatment will help you.

Who can't join

  • Use treatments that are not allowed in this study.
  • Have an active infection that needs treatment through a vein or into a muscle and that the study doctor thinks makes joining unsafe.
  • Plan to get live vaccines during the study.
  • Are pregnant or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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. Other protocol-defined inclusion/exclusion criteria may apply.

Study sites (25)

AL

CA

CO

FL

GA

IL

LA

MD

MI

OH

PA

TN

TX