CLINICAL TRIAL / NCT06015737

A 2-stage, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus

Interventional
Active
NCT06015737

Eligibility Details Visit Clinicaltrials.gov

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

This study aims to evaluate the efficacy and safety of subcutaneous (SC) anifrolumab versus placebo in adult participants with cutaneous lupus erythematosus (CLE).

Detailed Description

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.

Eligibility Details

Gender
All

Age Group
18 Years to 70 Years

Accepting Healthy Volunteers
No

Key inclusion criteria: - Participants must have a confirmed diagnosis of CLE. Diagnosis must be clinically and histologically confirmed with the following: - CLASI-A total score â‰¥ 10 points at Screening and confirmed at randomization. - CLA-IGA-R erythema score of â‰¥ 3 and CLA-IGA-R-OMC score of â‰¥ 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. Key exclusion criteria: - History or evidence of suicidal ideation. - Severe or life-threatening Systemic lupus erythematosus (SLE). - Active SLE or SjÃ¶gren'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 infection - Any 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. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply