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A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus

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Trial Profile

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Feb 2026

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At a glance

  • Drugs Anifrolumab (Primary)
  • Indications Systemic lupus erythematosus
  • Focus Registrational; Therapeutic Use
  • Acronyms TULIP 1
  • Sponsors AstraZeneca; AstraZeneca AB

Most Recent Events

  • 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.
  • 03 Jun 2023 Results (n=369) assessing the long-term impact of anifrolumab compared with placebo on Lupus Low Disease Activity State attainment over the 1 year TULIP-1/TULIP-2 (NCT02446912, NCT02446899) and 3 year long-term extension (NCT02794285) study periods, presented at the 24th Annual Congress of the European League Against Rheumatism.
  • 23 Jan 2023 Results of post-hoc pooled analysis of two studies (NCT02446912 and NCT02446899) assessing lupus low disease activity state (LLDAS) attainment in anifrolumab-treated patients were published in the Annals of the Rheumatic Diseases.

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