Last updated 20 days ago
A 2-stage, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus
460 patients around the world
Available in Spain, Colombia, Chile, Brazil, Argentina, United States
The primary objectives of the study are to evaluate the efficacy of anifrolumab compared
with placebo in reducing skin disease in participants with active chronic and/or subacute
CLE who are refractory and/or intolerant to antimalarial therapy. The secondary
objectives of the study are to evaluate additional efficacy parameters of anifrolumab,
safety, tolerability, quality of life, pharmacokinetics, pharmacodynamics, and
immunogenicity. Stage 1 and Stage 2 of the study will have broadly identical study
designs with the exception of sample size. Both Stages of the study will have a
randomized, double-blind, placebo-controlled design, followed by an open-label treatment
period.
AstraZeneca
460Patients around the world
This study is for people with
Lupus
Cutaneous lupus erythematosus
Requirements for the patient
To 70 Years
All Gender
Medical requirements
- Participants must have a confirmed diagnosis of CLE. Diagnosis must be clinically and histologically confirmed with the following:CLASI-A total score ≥ 10 points at Screening and confirmed at randomization.CLA-IGA-R erythema score of ≥ 3 and CLA-IGA-R-OMC score of ≥ 1 at Screening and confirmed at randomization.Inadequate response or intolerant to antimalarial therapy.Participants should have no medical history or signs or symptoms of active or prior tuberculosis infection (TB) and the same should reflect in chest radiograph or a chest CT scan result.Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.Participants should have a coronavirus disease 2019 (COVID-19) negative PCR or antigen test result as per local policies at Screening.
- History or evidence of suicidal ideation.Severe or life-threatening Systemic lupus erythematosus (SLE).Active SLE or Sjögren's Syndrome.Any active skin conditions other than CLE that may interfere with the study.History of recurrent infection requiring hospitalization and IV antibiotics.COVID-19 infectionAny history of an anaphylactic reaction to human proteins, or monoclonal antibodies.At screening, if participants do not meet the eligibility criteria assessed based on laboratory test results e.g tests for total bilirubin, serum creatinine etc.
StudyLAVENDER
SponsorAstraZeneca
Conditions
Cutaneous lupus erythematosus
Requirements
To 70 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06015737
