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

RecruitingPhase 3

A Randomized, Double-blind, Placebo-controlled Extension Study to Assess the Long-term Safety and Tolerability of Ianalumab in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE Extension)

Who can join

Ages 12 to 100 · All sexes

Full 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.

About the study

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).

What is being tested

Sponsor: Novartis Pharmaceuticals · Participants: 550 · Started: May 21, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06133972

Locations in the U.S.

AlabamaPinnacle Research Group Llc, Anniston
CaliforniaProvidence Medical Center, Burbank
Advanced Medical Research, La Palma
ColoradoUniversity of Colorado Denver, Aurora
FloridaClinical Res Of W Florida, Clearwater
GNP Research, Cooper City
IRIS Research and Development, Plantation
Clinical Research of West Florida Inc, Tampa
GeorgiaParris and Associates Rheumatology, Lawrenceville
IllinoisRobert A Hozman MD SC, Skokie
Willow Rheumatology Wellness, Willowbrook
LouisianaAccurate Clinical Research, Lake Charles
MichiganHenry Ford Health, Detroit
Ahmed Arif Medical Research Center, Grand Blanc
OhioParamount Med Rsrch and Consult LLC, Middleburg Heights
TennesseeWest Tennessee Research Institute, Jackson
Shelby Research LLC, Memphis
TexasAccurate Clinical Research, League City
Epic Medical Research, Red Oak

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.