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ACTIVE NOT RECRUITING
NCT06015737
PHASE3

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

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).

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.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

339

Start Date

2024-06-29

Completion Date

2027-08-10

Last Updated

2026-07-29

Healthy Volunteers

No

Interventions

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 (188)

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Phoenix, Arizona, United States

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Covina, 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

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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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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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Plantation, Florida, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Bloomfield Hills, Michigan, United States

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Rochester, Minnesota, United States

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Omaha, Nebraska, United States

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New York, New York, United States

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Rochester, New York, United States

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Charlotte, North Carolina, United States

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Statesville, North Carolina, United States

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Cleveland, Ohio, United States

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Portland, Oregon, United States

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Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Dallas, Texas, United States

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Charlottesville, Virginia, United States

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Roanoke, Virginia, United States

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Ciudad de Buenos Aires, Argentina

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Córdoba, Argentina

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Córdoba, Argentina

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Quilmes, Argentina

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San Miguel, Argentina

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Kogarah, Australia

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Melbourne, Australia

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Mitcham, Australia

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Westmead, Australia

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Woolloongabba, Australia

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Graz, Austria

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Innsbruck, Austria

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Linz, Austria

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Vienna, Austria

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Belo Horizonte, Brazil

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Porto Alegre, Brazil

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Rio de Janeiro, Brazil

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Salvador, Brazil

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São Paulo, Brazil

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Sofia, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

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Vancouver, British Columbia, Canada

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Hamilton, Ontario, Canada

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Toronto, Ontario, Canada

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Osorno, Chile

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Santiago, Chile

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Santiago, Chile

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Changchun, China

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Changsha, China

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Chengdu, China

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Chongqing, China

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Dongguan, China

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Guangzhou, China

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Heilongjiang, China

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Jinan, China

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Shanghai, China

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Shanghai, China

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Shenzhen, China

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Shenzhen, China

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Shenzhen, China

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Ürümqi, China

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Zhuzhou, China

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Barranquilla, Colombia

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Bogotá, Colombia

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Aarhus, Denmark

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Copenhagen, Denmark

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Bois-Guillaume, France

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Dijon, France

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Lyon, France

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Montivilliers, France

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Nantes, France

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Paris, France

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Paris, France

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Paris, France

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Paris, France

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Poitiers, France

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Toulouse, France

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Berlin, Germany

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Bochum, Germany

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Dresden, Germany

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Erlangen, Germany

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Essen, Germany

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Freiburg im Breisgau, Germany

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Hanover, Germany

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Kiel, Germany

And 88 more locations on ClinicalTrials.gov