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

a study on Lupus

Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

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

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

Details

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.

Keywords

Cutaneous Lupus Erythematosus, Lupus erythematosus, Anifrolumab, Cutaneous Lupus Erythematosus Disease Area Severity Index, Cutaneous lupus activity - Investigator's Global Assessment - Revised, Systemic Lupus Erythematosus, Monoclonal Antibodies

Eligibility

You can join if…

Open to people ages 18-70

  • 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.

You CAN'T join if...

  • 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 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

Locations

  • Research Site accepting new patients
    San Francisco California 94143 United States
  • Research Site not yet accepting patients
    Los Angeles California 90045 United States
  • Research Site accepting new patients
    Orange California 92868 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
ID
NCT06015737
Phase
Phase 3 Lupus Research Study
Study Type
Interventional
Participants
Expecting 460 study participants
Last Updated
Contact us about this trial