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RECRUITINGPhase 3INTERVENTIONAL

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

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.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Key Who May Qualify: - Participants must have a confirmed diagnosis of CLE. Diagnosis must be clinically and diagnosed by tissue sample (biopsy-confirmed) with the following: - CLASI-A total score ≥ 10 points 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. Key Who Should NOT Join This Trial: - 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, or current diagnosis of, catastrophic antiphospholipid syndrome (APS). - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 ≥ 10 points 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. Key exclusion criteria: * 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, or current diagnosis of, catastrophic antiphospholipid syndrome (APS). * 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

Treatments Being Tested

COMBINATION_PRODUCT

Anifrolumab

Anifrolumab will be provided as a solution for injection in accessorized pre-filled syringe (aPFS).

OTHER

Placebo

Matching placebo solution for injection in aPFS.

Locations (20)

Research Site
Glendale, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Covina, California, United States
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Fountain Valley, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
Research Site
Orange, California, United States
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Orange, California, United States
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San Francisco, California, United States
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Aurora, Colorado, United States
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Denver, Colorado, United States
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Fort Lauderdale, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Plantation, Florida, United States
Research Site
Chicago, Illinois, United States
Research Site
Chicago, Illinois, United States