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

Last updated: June 18, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

Cutaneous Lupus Erythematosus

Lupus

Systemic Lupus Erythematosus

Treatment

Placebo

Anifrolumab

Clinical Study ID

NCT05835310
D3461C00030
  • Ages 5-17
  • All Genders

Study Summary

A Study to evaluate the PK, PD, efficacy, and safety of Anifrolumab in children with moderate to severe active SLE

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant's parent/caregiver/legally authorized representative and participant (ifrequired per local country regulation) capable of giving signed informed consent,which includes compliance with the requirements and restrictions listed in the ICFand in this protocol. Informed assent is to be provided by the participant per localcountry regulation.

  • Diagnosis of SLE according to the 2019 European League Against Rheumatism/AmericanCollege of Rheumatology (EULAR/ACR) criteria.for at least 6 months prior to signingthe ICF.

  • 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 pregnancy test atScreening.

  • Female participants of childbearing and non-childbearing potential and maleparticipants must adhere to the contraception methods.

  • At screening, negative SARS-CoV-2 RT-PCR or rapid antigen test result and no knownor suspected COVID-19 infection or exposure between screening and randomizationvisits.

Exclusion

Exclusion Criteria:

  • Known diagnosis of an IFN-mediated autoinflammatory interferonopathy.

  • History of, or current diagnosis of, clinically significant non-SLE-relatedvasculitides.

  • 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 parenteralcorticosteroids for more than a total of 2 weeks within the last 24 weeks prior tosigning the ICF.

  • Any positive result on Screening for human immunodeficiency virus.

  • Active hepatitis B surface antigen OR hepatitis B core antibody (HBcAb), hepatitis Cvirus (HCV) antibody and detectable HCV ribonucleic acid (RNA) or any severe case ofHerpes Zoster infection.

  • Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completelyresolved within 12 weeks prior to signing the ICF.

  • History of severe COVID-19 infection requiring hospitalization, intensive care unitcare, or assisted ventilation or any prior COVID-19 infection with unresolvedsequelae. Any mild/asymptomatic COVID-19 infection (laboratory confirmed orsuspected 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 priorto signing the ICF.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
March 14, 2024
Estimated Completion Date:
March 12, 2030

Study Description

This study aims to characterize the pharmacokinetics, pharmacodynamics, efficacy, and safety of Anifrolumab solution for infusion compared with placebo solution for infusion in pediatric participants with severe active systemic lupus erythematosus who are on background standard of care therapy.

The study duration for a participant will be approximately 116 weeks, which includes:

  • Screening period of up to 30 days.

  • Part A consists of a four-week, single-blind, placebo-controlled, randomised, pharmacokinetic period.

  • Part B is a double-blind, placebo-controlled, randomised, safety/efficacy period lasting 48 weeks (for rollover participants from Part A) or 52 weeks (for de novo participants).

  • Part C is a 52-week open-label extension period.

  • Part D is a safety follow-up period. One safety visit at 12 weeks post last dose.

Connect with a study center

  • Research Site

    Buenos Aires, C1270
    Argentina

    Site Not Available

  • Research Site

    Córdoba, 5000
    Argentina

    Site Not Available

  • Research Site

    Rosario, S2000PBJ
    Argentina

    Site Not Available

  • Research Site

    Botucatu, 18610-070
    Brazil

    Active - Recruiting

  • Research Site

    Curitiba, 80030-110
    Brazil

    Active - Recruiting

  • Research Site

    Porto Alegre, 90035-903
    Brazil

    Active - Recruiting

  • Research Site

    Ribeirão Preto, 14048-900
    Brazil

    Active - Recruiting

  • Research Site

    Sao Paulo, 04024-002
    Brazil

    Active - Recruiting

  • Research Site

    São Paulo, 04037-002
    Brazil

    Site Not Available

  • Research Site

    Vancouver, British Columbia V6H 3N1
    Canada

    Active - Recruiting

  • Research Site

    Toronto, Ontario M5G 1X8
    Canada

    Active - Recruiting

  • Research Site

    Beijing, 100020
    China

    Site Not Available

  • Research Site

    Changchun, 130021
    China

    Active - Recruiting

  • Research Site

    Changsha, 410007
    China

    Active - Recruiting

  • Research Site

    Shanghai, 201102
    China

    Active - Recruiting

  • Research Site

    Suzhou, 215002
    China

    Active - Recruiting

  • Research Site

    Wenzhou, 325027
    China

    Active - Recruiting

  • Research Site

    Zhengzhou, 450018
    China

    Active - Recruiting

  • Research Site

    Barranquilla, 01800
    Colombia

    Site Not Available

  • Research Site

    Medellin, 050034
    Colombia

    Site Not Available

  • Research Site

    Bordeaux, 33076
    France

    Active - Recruiting

  • Research Site

    Bordeaux Cedex, 33076
    France

    Site Not Available

  • Research Site

    Bron, 69677
    France

    Active - Recruiting

  • Research Site

    LILLE Cedex, 59037
    France

    Active - Recruiting

  • Research Site

    Le Kremlin Bicetre, 94275
    France

    Site Not Available

  • Research Site

    Le Kremlin-Bicêtre, 94275
    France

    Active - Recruiting

  • Research Site

    Toulouse, 31300
    France

    Active - Recruiting

  • Research Site

    Berlin, D-13353
    Germany

    Active - Recruiting

  • Research Site

    Freiburg, 79106
    Germany

    Active - Recruiting

  • Research Site

    Sankt Augustin, 53757
    Germany

    Active - Recruiting

  • Research Site

    Genova, 16148
    Italy

    Active - Recruiting

  • Research Site

    Milano, 20122
    Italy

    Active - Recruiting

  • Research Site

    Padova, 35128
    Italy

    Site Not Available

  • Research Site

    Roma, 00165
    Italy

    Active - Recruiting

  • Research Site

    Bunkyo-ku, 113-8519
    Japan

    Active - Recruiting

  • Research Site

    Chiba, 266-0007
    Japan

    Active - Recruiting

  • Research Site

    Fuchu-shi, 183-8561
    Japan

    Active - Recruiting

  • Research Site

    Kawasaki-shi, 216-8511
    Japan

    Active - Recruiting

  • Research Site

    Kobe-shi, 650-0047
    Japan

    Active - Recruiting

  • Research Site

    Obu-shi, 474-8710
    Japan

    Active - Recruiting

  • Research Site

    Shinjuku-ku, 162-8666
    Japan

    Active - Recruiting

  • Research Site

    Yokohama-shi, 236-0004
    Japan

    Active - Recruiting

  • Research Site

    Guadalajara, 44620
    Mexico

    Site Not Available

  • Research Site

    Merida, 97070
    Mexico

    Active - Recruiting

  • Research Site

    Mexico, 06720
    Mexico

    Site Not Available

  • Research Site

    Monterrey, 64460
    Mexico

    Site Not Available

  • Research Site

    Toluca, 50170
    Mexico

    Site Not Available

  • Research Site

    Lodź, 91-738
    Poland

    Active - Recruiting

  • Research Site

    Warszawa, 02-637
    Poland

    Active - Recruiting

  • Research Site

    Wroclaw, 52-114
    Poland

    Active - Recruiting

  • Research Site

    Lisboa, 1649-035
    Portugal

    Suspended

  • Research Site

    Porto, 4200-319
    Portugal

    Suspended

  • Research Site

    Cape Town, 7700
    South Africa

    Site Not Available

  • Research Site

    Esplugues de Llobregat, 8950
    Spain

    Active - Recruiting

  • Research Site

    Madrid, 28009
    Spain

    Active - Recruiting

  • Research Site

    Málaga, 29011
    Spain

    Active - Recruiting

  • Research Site

    Valencia, 46026
    Spain

    Active - Recruiting

  • Research Site

    Ankara, 06230
    Turkey

    Active - Recruiting

  • Research Site

    Istanbul, 34098
    Turkey

    Active - Recruiting

  • Research Site

    Kayseri, 38039
    Turkey

    Active - Recruiting

  • Research Site

    Umraniye, 34760
    Turkey

    Active - Recruiting

  • Research Site

    Birmingham, B4 6NH
    United Kingdom

    Site Not Available

  • Research Site

    Bristol, BS2 8BJ
    United Kingdom

    Site Not Available

  • Research Site

    Liverpool, L12 2AP
    United Kingdom

    Active - Recruiting

  • Research Site

    London, WC1N 3JH
    United Kingdom

    Active - Recruiting

  • Research Site

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • Research Site

    Southampton, SO16 6YD
    United Kingdom

    Active - Recruiting

  • Research Site

    Phoenix, Arizona 85016
    United States

    Active - Recruiting

  • Research Site

    Los Angeles, California 90027
    United States

    Active - Recruiting

  • Research Site

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Research Site

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Research Site

    Bethesda, Maryland 20889
    United States

    Site Not Available

  • Research Site

    Saint Paul, Minnesota 55125
    United States

    Active - Recruiting

  • Research Site

    Bronx, New York 10467
    United States

    Active - Recruiting

  • Research Site

    New Hyde Park, New York 11042
    United States

    Active - Recruiting

  • Research Site

    New York, New York 10032
    United States

    Active - Recruiting

  • Research Site

    Valhalla, New York 10595
    United States

    Active - Recruiting

  • Research Site

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Research Site

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • Research Site

    Cleveland, Ohio 44109
    United States

    Active - Recruiting

  • Research Site

    Columbus, Ohio 43203
    United States

    Site Not Available

  • Research Site

    Portland, Oregon 97227
    United States

    Active - Recruiting

  • Research Site

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Research Site

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • Research Site

    El Paso, Texas 79902
    United States

    Active - Recruiting

  • Research Site

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Research Site

    Salt Lake City, Utah 84108
    United States

    Active - Recruiting

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