Trial Profile

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Anifrolumab in Asian Participants With Active Systemic Lupus Erythematosus

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 24 Dec 2025

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At a glance

06 Nov 2025 According to AstraZeneca media release, based on results form TULIP-1/2, AZALEA trials the regulatory application of Saphnelo (anifrolumab) for treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) has been accepted by China's NMPA.
29 Jul 2025 Primary endpoint (Difference in proportion of participants who are responders between anifrolumab and placebo) has been met, according to AstraZeneca media release.
16 Jul 2025 Status changed from active, no longer recruiting to completed.

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