RecruitingPhase 3NCT05835310

An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants

A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of IV Anifrolumab in Pediatric Participants 5 to < 18 Years of Age With Moderate to Severe Active Systemic Lupus Erythematosus While on Background Standard of Care Therapy


Sponsor

AstraZeneca

Enrollment

100 participants

Start Date

Mar 14, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), Efficacy, and Safety of Anifrolumab in Children with Moderate to Severe Active Systemic Lupus Erythematosus (SLE)


Eligibility

Min Age: 5 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Anifrolumab and a drug called Placebo for people with systemic lupus erythematosus. The study is currently recruiting participants at 99 locations. People eligible for this study include aged 5 Years to 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAnifrolumab

Participants will receive anifrolumab via IV infusion.

DRUGPlacebo

Participants will receive matching placebo via IV infusion


Locations(99)

Research Site

Phoenix, Arizona, United States

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Los Angeles, California, United States

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Washington D.C., District of Columbia, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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New Orleans, Louisiana, United States

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Bethesda, Maryland, United States

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Saint Paul, Minnesota, United States

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New Hyde Park, New York, United States

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New York, New York, United States

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The Bronx, New York, United States

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Valhalla, New York, United States

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Durham, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Greenville, South Carolina, United States

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El Paso, Texas, United States

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Houston, Texas, United States

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Salt Lake City, Utah, United States

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Buenos Aires, Argentina

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Córdoba, Argentina

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Rosario, Argentina

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San Miguel de Tucumán, Argentina

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Belo Horizonte, Brazil

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Porto Alegre, Brazil

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Ribeirão Preto, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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Calgary, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Toronto, Ontario, Canada

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Beijing, China

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Beijing, China

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Beijing, China

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Changchun, China

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Changsha, China

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Nanjing, China

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Shanghai, China

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Suzhou, China

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Wenzhou, China

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Zhengzhou, China

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Barranquilla, Colombia

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Medellín, Colombia

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Bordeaux, France

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Bron, France

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Le Kremlin-Bicêtre, France

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Lille, France

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Toulouse, France

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Berlin, Germany

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Freiburg im Breisgau, Germany

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Sankt Augustin, Germany

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Genova, Italy

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Milan, Italy

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Milan, Italy

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Padova, Italy

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Roma, Italy

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Bunkyō City, Japan

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Bunkyō City, Japan

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Chiba, Japan

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Fuchu-shi, Japan

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Kawasaki-shi, Japan

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Kobe, Japan

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Obu-shi, Japan

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Shinjuku-ku, Japan

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Yokohama, Japan

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Yokohama, Japan

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Atizapán de Zaragoza, Mexico

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Guadalajara, Mexico

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Mérida, Mexico

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México, Mexico

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Monterrey, Mexico

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Lodź, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Lisbon, Portugal

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Lisbon, Portugal

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Porto, Portugal

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Cape Town, South Africa

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Esplugues de Llobregat, Spain

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Madrid, Spain

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Madrid, Spain

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Madrid, Spain

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Málaga, Spain

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Santiago de Compostela, Spain

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Valencia, Spain

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Ankara, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Kayseri, Turkey (Türkiye)

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Umraniye, Turkey (Türkiye)

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Birmingham, United Kingdom

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Bristol, United Kingdom

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Liverpool, United Kingdom

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London, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom

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Southampton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05835310


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