A study to investigate the efficacy and safety of anifrolumab in adults with chronic and/or subacute cutaneous lupus erythematosus - LAVENDER

Study identifier:D346BC00001

ClinicalTrials.gov identifier:NCT06015737

EudraCT identifier:2021-003698-70

CTIS identifier:2023-503692-24-00

Will Be Recruiting

Official Title

A Multicenter, Randomized, Double blind, Placebo controlled, Phase III Study to Evaluate the Efficacy and Safety of Anifrolumab in Adults with Chronic and/or Subacute Cutaneous Lupus Erythematosus who are Refractory and/or Intolerant to Antimalarial Therapy

Medical condition

Cutaneous lupus erythematosus

Phase

Phase 3

Healthy volunteers

No

Study drug

-

Sex

All

Estimated Enrollment

460

Study type

Interventional

Age

18 Years - 70 Years

Date

Study Start Date: 25 Oct 2023
Estimated Primary Completion Date: 25 Mar 2026
Estimated Study Completion Date: 16 Dec 2026

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2023 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria