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Investigate the efficacy and safety of anifrolumab in adults with chronic and/or subacute cutaneous

UCI Specialty Area: Rheumatology
Principal Investigator: Michelle Min
Official Title: Clinical Study in Cutaneous Lupus Erythematosus with Anifrolumab
A Study On:
Lupus Erythematosus
Skin - Dermatologic

Study Description

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

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

Key inclusion criteria:

  1. Participants must have a confirmed diagnosis of CLE. Diagnosis must be clinically and histologically confirmed with the following:
  • CLASI-A total score greater than or equal to 10 points at Screening and confirmed at randomization.
  • CLA-IGA-R erythema score of greater than or equal to 3 and CLA-IGA-R-OMC score of greater than or equal to 1 at Screening and confirmed at randomization.
  • Inadequate response or intolerant to antimalarial therapy.
  1. 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.
  2. Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  3. Participants should have a coronavirus disease 2019 (COVID-19) negative PCR or antigen test result as per local policies at Screening.

Key exclusion criteria:

  1. History or evidence of suicidal ideation.
  2. Severe or life-threatening Systemic lupus erythematosus (SLE).
  3. Active SLE or Sjögren's Syndrome.
  4. Any active skin conditions other than CLE that may interfere with the study.
  5. History of recurrent infection requiring hospitalization and IV antibiotics.
  6. COVID-19 infection
  7. Any history of an anaphylactic reaction to human proteins, or monoclonal antibodies.
  8. 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

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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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