Promising lupus drug anifrolumab now tested in kids

NCT ID NCT05835310

Recruiting now Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This phase 3 study tests anifrolumab, a biologic drug given by IV, in 100 children aged 5 to 18 with moderate to severe systemic lupus erythematosus (SLE). Participants continue their standard care and are randomly assigned to receive anifrolumab or a placebo. The goal is to see if the drug can reduce lupus activity and improve symptoms, while also checking safety and proper dosing in children.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Anifrolumab (a biologic drug given by IV infusion)
What this could lead to: If successful, this could provide a new treatment option to better control lupus in children, reducing disease flares and improving daily life.
What could go wrong: This is still an experimental treatment. It may not work better than placebo, and side effects like infections or allergic reactions are possible. The study is relatively small (100 participants).

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Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SYSTEMIC LUPUS ERYTHEMATOSUS

Contacts and locations

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Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••

Locations

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Phoenix, Arizona, 85016, United States
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Los Angeles, California, 90027, United States
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Washington D.C., District of Columbia, 20010, United States
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Chicago, Illinois, 60611, United States
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Chicago, Illinois, 60637, United States
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New Orleans, Louisiana, 70118, United States
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Bethesda, Maryland, 20889, United States
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Saint Paul, Minnesota, 55125, United States
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New Hyde Park, New York, 11042, United States
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New York, New York, 10032, United States
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The Bronx, New York, 10467, United States
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Valhalla, New York, 10595, United States
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Durham, North Carolina, 27710, United States
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Cincinnati, Ohio, 45229, United States
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Cleveland, Ohio, 44109, United States
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Columbus, Ohio, 43203, United States
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Portland, Oregon, 97227, United States
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Philadelphia, Pennsylvania, 19104, United States
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Greenville, South Carolina, 29605, United States
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El Paso, Texas, 79902, United States
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Houston, Texas, 77030, United States
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Salt Lake City, Utah, 84108, United States
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Buenos Aires, C1270, Argentina
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Córdoba, 5000, Argentina
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Rosario, S2000PBJ, Argentina
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San Miguel de Tucumán, T4000AXL, Argentina
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Belo Horizonte, 30130-100, Brazil
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Porto Alegre, 90035-903, Brazil
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Ribeirão Preto, 14048-900, Brazil
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São Paulo, 04024-002, Brazil
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São Paulo, 05403 000, Brazil
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Calgary, British Columbia, T2N 4N1, Canada
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Vancouver, British Columbia, V6H 3N1, Canada
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Toronto, Ontario, M5G 1X8, Canada
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Beijing, 100020, China
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Beijing, 100032, China
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Beijing, 100730, China
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Changchun, 130021, China
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Changsha, 410007, China
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Nanjing, 210008, China
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Shanghai, 201102, China
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Suzhou, 215002, China
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Wenzhou, 325027, China
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Zhengzhou, 450018, China
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Barranquilla, 01800, Colombia
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Medellín, 050034, Colombia
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Bordeaux, 33076, France
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Bron, 69677, France
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Le Kremlin-Bicêtre, 94275, France
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Lille, 59037, France
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Toulouse, 31300, France
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Berlin, D-13353, Germany
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Freiburg im Breisgau, 79106, Germany
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Sankt Augustin, 53757, Germany
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Genova, 16148, Italy
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Milan, 20122, Italy
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Milan, 20122, Italy
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Padova, 35128, Italy
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Roma, 00165, Italy
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Bunkyō City, 113-8519, Japan
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Bunkyō City, 113-8603, Japan
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Chiba, 266-0007, Japan
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Fuchu-shi, 183-8561, Japan
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Kawasaki-shi, 216-8511, Japan
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Kobe, 650-0047, Japan
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Obu-shi, 474-8710, Japan
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Shinjuku-ku, 162-8666, Japan
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Yokohama, 232 8555, Japan
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Yokohama, 236-0004, Japan
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Atizapán de Zaragoza, 52937, Mexico
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Guadalajara, 44620, Mexico
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Mérida, 97070, Mexico
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México, 06720, Mexico
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Monterrey, 64460, Mexico
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Lodź, 91-738, Poland
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Warsaw, 02-637, Poland
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Wroclaw, 52-114, Poland
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Lisbon, 1169-045, Portugal
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Lisbon, 1649-035, Portugal
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Porto, 4200-319, Portugal
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Cape Town, 7700, South Africa
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Esplugues de Llobregat, 8950, Spain
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Madrid, 28009, Spain
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Madrid, 28034, Spain
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Madrid, 28046, Spain
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Málaga, 29011, Spain
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Santiago de Compostela, 15706, Spain
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Valencia, 46026, Spain
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Ankara, 06230, Turkey (Türkiye)
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Istanbul, 34098, Turkey (Türkiye)
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Kayseri, 38039, Turkey (Türkiye)
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Umraniye, 34760, Turkey (Türkiye)
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Birmingham, B4 6NH, United Kingdom
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Bristol, BS2 8BJ, United Kingdom
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Liverpool, L12 2AP, United Kingdom
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London, NW1 2PG, United Kingdom
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London, WC1N 3JH, United Kingdom
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Manchester, M13 9WL, United Kingdom
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Southampton, SO16 6YD, United Kingdom

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