Long-term safety evaluation of ianalumab for systemic lupus erythematosus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This extension study aims to assess the long-term safety and tolerability of ianalumab, administered either monthly or quarterly, in participants with systemic lupus erythematosus (SLE) who have previously completed core studies. Participants will receive either ianalumab or a placebo, and the study will focus on those with moderate-to-severe disease activity who are anti-nuclear antibody (ANA)-positive. The study will monitor participants for safety outcomes over an extended period following their initial treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Pinnacle Research Group Llc
  Anniston, Alabama, United States Recruiting
• Providence Medical Center
  Burbank, California, United States Recruiting
• Advanced Medical Research
  La Palma, California, United States Recruiting
• University of Colorado Denver
  Aurora, Colorado, United States Recruiting
• Clinical Res Of W Florida
  Clearwater, Florida, United States Recruiting
• GNP Research
  Cooper City, Florida, United States Recruiting

+117 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.