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Clinical trial to evaluate the efficacy, safety and tolerability of ianalumab in combination with standard therapy in participants with active lupus nephritis (SIRIUS-LN)

THE PURPOSE OF THIS STUDY IS TO DETERMINE HOW IANALUMAB WORKS IN PARTICIPANTS WITH NL. - TO DETERMINE IF IANALUMAB CAN HELP TREAT NL. - TO DETERMINE IF IT IS SAFE FOR PARTICIPANTS WITH NL TO TAKE IANALUMAB. - TO COMPARE DIFFERENT IANALUMAB REGIMENS AND SEE WHICH WORKS BEST - TO SEE IF GIVING IANALUMAB WITH STANDARD TREATMENT (SOC) IS BETTER THAN USING SOC ALONE WITH NO ACTIVE TREATMENT (PLACEBO). A PLACEBO IS A DRUG WITH NO ACTIVE INGREDIENTS INSIDE.

Status
In recruitment
headquarters
Pamplona/Madrid

Technical Summary

  • PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED, RANDOMIZED TRIAL TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF IANALUMAB IN COMBINATION WITH STANDARD THERAPY IN PARTICIPANTS WITH ACTIVE LUPUS NEPHRITIS (SIRIUS-LN).
  • Code EudraCT: 2020-005830-14
  • Protocol number: CVAY736K12301
  • Promoter: Novartis Farmaceutica
  • Molecule/Drug: ianalumab

* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.

More information about this clinical trial

Information offered by the Spanish Registry of Clinical Studies

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