A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus (Tulip SC)

  • STATUS
    Recruiting
  • End date
    Dec 23, 2024
  • participants needed
    360
  • sponsor
    AstraZeneca
Updated on 11 October 2022
lupus
anifrolumab

Summary

The purpose of this study is evaluating the efficacy and safety of SC antifrolumab in adult patients with moderate -to-severe SLE despite receiving standard therapy

Description

This is a Phase 3, multicentre, multinational, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of a subcutaneous treatment regimen of anifrolumab versus placebo in participants with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE) while receiving standard of care (SOC) treatment. Participants must be taking either 1 or any combination of the following: oral glucocorticoids, antimalarial, and/or immunosuppressants. The study will be performed in adult participants of 18 to 70 years of age.

Approximately 360 participants receiving SOC treatment will be randomised in a 1:1 ratio to receive a fixed subcutaneous dose of anifrolumab or placebo administered once weekly via an accessorized prefilled syringe and with the primary endpoint evaluated at Week 52.

Details
Condition Systemic Lupus Erythematosus
Treatment Placebo, MEDI-546
Clinical Study IdentifierNCT04877691
SponsorAstraZeneca
Last Modified on11 October 2022

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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