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

NCT06133972

RecruitingPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Systemic Lupus Erythematosus

Interventions: Placebo, Ianalumab

Countries: United States, Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China

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).

Eligibility overview

Sex: ALL

Age: 12 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
* 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.
Locations (143)
  • Anniston, Alabama, United States
  • Burbank, California, United States
  • La Palma, California, United States
  • Westlake Village, California, United States
  • Aurora, Colorado, United States
  • Clearwater, Florida, United States
  • Cooper City, Florida, United States
  • Plantation, Florida, United States
  • Tampa, Florida, United States
  • Lawrenceville, Georgia, United States
  • Skokie, Illinois, United States
  • Willowbrook, Illinois, United States
  • Lake Charles, Louisiana, United States
  • Baltimore, Maryland, United States
  • Detroit, Michigan, United States
  • Grand Blanc, Michigan, United States
  • Middleburg Heights, Ohio, United States
  • Jackson, Tennessee, United States
  • Memphis, Tennessee, United States
  • Bellaire, Texas, United States
  • League City, Texas, United States
  • Red Oak, Texas, United States
  • La Plata, Buenos Aires, Argentina
  • Quilmes, Buenos Aires, Argentina
  • San Miguel, Buenos Aires, Argentina
  • San Miguel, Tucumán Province, Argentina
  • Caba, Argentina
  • Caba, Argentina
  • San Miguel de Tucumán, Argentina
  • Maroochydore, Queensland, Australia
  • + 113 more on CT.gov