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Promising lupus drug anifrolumab now tested in kids

NCT ID NCT05835310

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 4 times

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).

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant's parent/caregiver/legally authorized representative and participant (if required per local country regulation) capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Informed assent is to be provided by the participant per local country regulation. * Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) criteria for at least 3 months prior to signing the ICF. * At Screening, participant must have moderate to severe active SLE disease, as adjudicated by the Central Adjudication Committee, defined as: (a) SLEDAI-2K activity of: (i) ≥ 6 points with at least 4 points (≥ 4 points) coming from the following clinical components ('Clinical' SLEDAI-2K score): arthritis, myositis, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, or vasculitis and excluding points attributed to a fever, SLE headache, and organic brain syndrome (ii) Clinical SLEDAI score of ≥ 4 points verified at Day 1 (b) BILAG-2004 activity of: (i) ≥ 1 BILAG A score; or (ii) ≥ 2 BILAG B scores (c) PGA score ≥ 1.0 on a 0 to 3 VAS * Participant should meet all of following tuberculosis (TB) criteria: A. No signs or symptoms of active TB B. No medical history or past physical examinations suggestive of active TB C. No recent contact with a person with active TB or if there has been such contact, referral to a TB specialist for evaluation and initiation of treatment for latent TB, if warranted, prior to the first administration of study intervention in accordance with local SoC D. No history of latent TB without documented completion of treatment prior to initial screening visit * Female participants of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test at randomization. * Female participants of childbearing and male participants must adhere to the contraception methods. Exclusion Criteria: * Known diagnosis of an IFN-mediated autoinflammatory interferonopathy. * History of, or current diagnosis of, clinically significant non-SLE-related vasculitides. * In participants aged 11 years and above: history or evidence of suicidal ideation. * History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF. * Any positive result on screening for human immunodeficiency virus. * Active hepatitis B surface antigen OR hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody and detectable HCV ribonucleic acid (RNA) or any active or recent case of Herpes Zoster infection. * Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF. * History of severe COVID-19 infection requiring hospitalization, intensive care unit care, or assisted ventilation or any prior COVID-19 infection with unresolved sequelae. Any mild/asymptomatic COVID-19 infection (laboratory confirmed or suspected based on clinical symptoms). * Prior use of anifrolumab. * Prior treatment with directly acting cytotoxic B-cell depleting therapeutics (eg, rituximab) \< 26 weeks prior to ICF signature. * Blood transfusion or receipt of blood products except albumin within 4 weeks prior to signing the ICF.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    94 sites in 15 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • Research Site

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    Los Angeles, California, 90027, United States

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    Washington D.C., District of Columbia, 20010, United States

  • Research Site

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    Chicago, Illinois, 60611, United States

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    Chicago, Illinois, 60637, United States

  • Research Site

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    New Orleans, Louisiana, 70118, United States

  • Research Site

    WITHDRAWN

    Bethesda, Maryland, 20889, United States

  • Research Site

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    Saint Paul, Minnesota, 55125, United States

  • Research Site

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    New Hyde Park, New York, 11042, United States

  • Research Site

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    New York, New York, 10032, United States

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    The Bronx, New York, 10467, United States

  • Research Site

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    Valhalla, New York, 10595, United States

  • Research Site

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    Durham, North Carolina, 27710, United States

  • Research Site

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    Cincinnati, Ohio, 45229, United States

  • Research Site

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    Cleveland, Ohio, 44109, United States

  • Research Site

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    Columbus, Ohio, 43203, United States

  • Research Site

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    Portland, Oregon, 97227, United States

  • Research Site

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    Philadelphia, Pennsylvania, 19104, United States

  • Research Site

    WITHDRAWN

    Greenville, South Carolina, 29605, United States

  • Research Site

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    El Paso, Texas, 79902, United States

  • Research Site

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    Houston, Texas, 77030, United States

  • Research Site

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    Salt Lake City, Utah, 84108, United States

  • Research Site

    WITHDRAWN

    Buenos Aires, C1270, Argentina

  • Research Site

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    Córdoba, 5000, Argentina

  • Research Site

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    Rosario, S2000PBJ, Argentina

  • Research Site

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    San Miguel de Tucumán, T4000AXL, Argentina

  • Research Site

    NOT_YET_RECRUITING

    Belo Horizonte, 30130-100, Brazil

  • Research Site

    NOT_YET_RECRUITING

    Belo Horizonte, 30150-274, Brazil

  • Research Site

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    Porto Alegre, 90035-903, Brazil

  • Research Site

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    Ribeirão Preto, 14048-900, Brazil

  • Research Site

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    São Paulo, 04024-002, Brazil

  • Research Site

    RECRUITING

    São Paulo, 05403 000, Brazil

  • Research Site

    NOT_YET_RECRUITING

    Calgary, British Columbia, T2N 4N1, Canada

  • Research Site

    RECRUITING

    Vancouver, British Columbia, V6H 3N1, Canada

  • Research Site

    RECRUITING

    Toronto, Ontario, M5G 1X8, Canada

  • Research Site

    WITHDRAWN

    Beijing, 100020, China

  • Research Site

    NOT_YET_RECRUITING

    Beijing, 100032, China

  • Research Site

    RECRUITING

    Beijing, 100730, China

  • Research Site

    RECRUITING

    Changchun, 130021, China

  • Research Site

    RECRUITING

    Changsha, 410007, China

  • Research Site

    NOT_YET_RECRUITING

    Dongguan, 523059, China

  • Research Site

    NOT_YET_RECRUITING

    Nanjing, 210008, China

  • Research Site

    RECRUITING

    Shanghai, 201102, China

  • Research Site

    RECRUITING

    Suzhou, 215002, China

  • Research Site

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    Wenzhou, 325027, China

  • Research Site

    RECRUITING

    Zhengzhou, 450018, China

  • Research Site

    RECRUITING

    Barranquilla, 01800, Colombia

  • Research Site

    WITHDRAWN

    Medellín, 050034, Colombia

  • Research Site

    RECRUITING

    Bordeaux, 33076, France

  • Research Site

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    Bron, 69677, France

  • Research Site

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    Le Kremlin-Bicêtre, 94275, France

  • Research Site

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    Lille, 59037, France

  • Research Site

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    Toulouse, 31300, France

  • Research Site

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    Berlin, D-13353, Germany

  • Research Site

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    Freiburg im Breisgau, 79106, Germany

  • Research Site

    RECRUITING

    Sankt Augustin, 53757, Germany

  • Research Site

    NOT_YET_RECRUITING

    Florence, 50139, Italy

  • Research Site

    RECRUITING

    Genova, 16148, Italy

  • Research Site

    RECRUITING

    Milan, 20122, Italy

  • Research Site

    NOT_YET_RECRUITING

    Milan, 20122, Italy

  • Research Site

    RECRUITING

    Padova, 35128, Italy

  • Research Site

    RECRUITING

    Roma, 00165, Italy

  • Research Site

    RECRUITING

    Bunkyō City, 113-8519, Japan

  • Research Site

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    Bunkyō City, 113-8603, Japan

  • Research Site

    RECRUITING

    Chiba, 266-0007, Japan

  • Research Site

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    Fuchu-shi, 183-8561, Japan

  • Research Site

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    Kawasaki-shi, 216-8511, Japan

  • Research Site

    RECRUITING

    Kobe, 650-0047, Japan

  • Research Site

    NOT_YET_RECRUITING

    Nagasaki, 852-8501, Japan

  • Research Site

    RECRUITING

    Obu-shi, 474-8710, Japan

  • Research Site

    RECRUITING

    Shinjuku-ku, 162-8666, Japan

  • Research Site

    RECRUITING

    Yokohama, 232 8555, Japan

  • Research Site

    RECRUITING

    Yokohama, 236-0004, Japan

  • Research Site

    NOT_YET_RECRUITING

    Atizapán de Zaragoza, 52937, Mexico

  • Research Site

    RECRUITING

    Guadalajara, 44620, Mexico

  • Research Site

    RECRUITING

    Mérida, 97070, Mexico

  • Research Site

    RECRUITING

    México, 06720, Mexico

  • Research Site

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    Monterrey, 64460, Mexico

  • Research Site

    RECRUITING

    Lodź, 91-738, Poland

  • Research Site

    RECRUITING

    Warsaw, 02-637, Poland

  • Research Site

    RECRUITING

    Wroclaw, 52-114, Poland

  • Research Site

    WITHDRAWN

    Lisbon, 1169-045, Portugal

  • Research Site

    WITHDRAWN

    Lisbon, 1649-035, Portugal

  • Research Site

    WITHDRAWN

    Porto, 4200-319, Portugal

  • Research Site

    WITHDRAWN

    Cape Town, 7700, South Africa

  • Research Site

    RECRUITING

    Esplugues de Llobregat, 8950, Spain

  • Research Site

    RECRUITING

    Madrid, 28009, Spain

  • Research Site

    RECRUITING

    Madrid, 28034, Spain

  • Research Site

    NOT_YET_RECRUITING

    Madrid, 28046, Spain

  • Research Site

    RECRUITING

    Málaga, 29011, Spain

  • Research Site

    NOT_YET_RECRUITING

    Santiago de Compostela, 15706, Spain

  • Research Site

    RECRUITING

    Valencia, 46026, Spain

  • Research Site

    RECRUITING

    Ankara, 06230, Turkey (Türkiye)

  • Research Site

    RECRUITING

    Istanbul, 34098, Turkey (Türkiye)

  • Research Site

    RECRUITING

    Kayseri, 38039, Turkey (Türkiye)

  • Research Site

    RECRUITING

    Umraniye, 34760, Turkey (Türkiye)

  • Research Site

    RECRUITING

    Birmingham, B4 6NH, United Kingdom

  • Research Site

    RECRUITING

    Bristol, BS2 8BJ, United Kingdom

  • Research Site

    RECRUITING

    Liverpool, L12 2AP, United Kingdom

  • Research Site

    RECRUITING

    London, NW1 2PG, United Kingdom

  • Research Site

    RECRUITING

    London, WC1N 3JH, United Kingdom

  • Research Site

    RECRUITING

    Manchester, M13 9WL, United Kingdom

  • Research Site

    RECRUITING

    Southampton, SO16 6YD, United Kingdom

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