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

Last updated: May 5, 2026
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

Lupus

Cutaneous Lupus Erythematosus

Systemic Lupus Erythematosus

Treatment

Placebo

Anifrolumab

Clinical Study ID

NCT05835310
D3461C00030
2022-502289-25-00
  • Ages 5-17
  • All Genders

Study 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 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 3 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 serum pregnancytest at screening and negative urine pregnancy test at randomization.

  • Female participants of childbearing and male participants must adhere to thecontraception methods.

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 active orrecent case of Herpes 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:
January 09, 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, double-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

    Buenos Aires 3435910, C1270
    Argentina

    Site Not Available

  • Research Site

    Córdoba, 5000
    Argentina

    Active - Recruiting

  • Research Site

    Córdoba 3860259, 5000
    Argentina

    Site Not Available

  • Research Site

    Rosario, S2000PBJ
    Argentina

    Active - Recruiting

  • Research Site

    Rosario 3838583, S2000PBJ
    Argentina

    Site Not Available

  • Research Site

    San Miguel de Tucumán, T4000AXL
    Argentina

    Site Not Available

  • Research Site

    San Miguel de Tucumán 3836873, T4000AXL
    Argentina

    Site Not Available

  • Research Site

    Botucatu, 18610-070
    Brazil

    Site Not Available

  • Research Site

    Botucatu 3469136, 18610-070
    Brazil

    Site Not Available

  • Research Site

    Curitiba, 80030-110
    Brazil

    Site Not Available

  • Research Site

    Curitiba 3464975, 80030-110
    Brazil

    Site Not Available

  • Research Site

    Porto Alegre, 90035-903
    Brazil

    Active - Recruiting

  • Research Site

    Porto Alegre 3452925, 90035-903
    Brazil

    Site Not Available

  • Research Site

    Ribeirão Preto, 14048-900
    Brazil

    Active - Recruiting

  • Research Site

    Ribeirão Preto 3451328, 14048-900
    Brazil

    Site Not Available

  • Research Site

    Sao Paulo, 04024-002
    Brazil

    Site Not Available

  • Research Site

    São Paulo, 05403 000
    Brazil

    Active - Recruiting

  • Research Site

    São Paulo 3448439, 05403 000
    Brazil

    Site Not Available

  • Research Site

    Calgary 5913490, Alberta 5883102 T3M1M4
    Canada

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  • Research Site

    Calgary, British Columbia T2N 4N1
    Canada

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  • Research Site

    Vancouver, British Columbia V6H 3N1
    Canada

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  • Research Site

    Vancouver 6173331, British Columbia 5909050 V6H 3N1
    Canada

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  • Research Site

    Toronto, Ontario M5G 1X8
    Canada

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  • Research Site

    Toronto 6167865, Ontario 6093943 M5G 1X8
    Canada

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  • Research Site

    Beijing, 100032
    China

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  • Research Site

    Beijing 1816670, 100730
    China

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  • Research Site

    Changchun, 130021
    China

    Active - Recruiting

  • Research Site

    Changchun 2038180, 130021
    China

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  • Research Site

    Changsha, 410007
    China

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  • Research Site

    Changsha 1815577, 410007
    China

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  • Research Site

    Nanjing, 210008
    China

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    Shanghai, 201102
    China

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  • Research Site

    Shanghai 1796236, 201102
    China

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    Suzhou, 215002
    China

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  • Research Site

    Suzhou 1886760, 215002
    China

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    Wenzhou, 325027
    China

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  • Research Site

    Wenzhou 1791388, 325027
    China

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    Zhengzhou, 450018
    China

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    Zhengzhou 1784658, 450018
    China

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    Barranquilla, 01800
    Colombia

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    Barranquilla 3689147, 01800
    Colombia

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    Medellin, 050034
    Colombia

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    Medellín, 050034
    Colombia

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    Medellín 3674962, 050034
    Colombia

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    Bordeaux, 33076
    France

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  • Research Site

    Bordeaux 3031582, 33076
    France

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  • Research Site

    Bordeaux Cedex, 33076
    France

    Site Not Available

  • Research Site

    Bron, 69677
    France

    Active - Recruiting

  • Research Site

    Bron 3029931, 69677
    France

    Site Not Available

  • Research Site

    LILLE Cedex, 59037
    France

    Site Not Available

  • Research Site

    Le Kremlin Bicetre, 94275
    France

    Site Not Available

  • Research Site

    Le Kremlin-Bicêtre, 94275
    France

    Active - Recruiting

  • Research Site

    Le Kremlin-Bicêtre 3003737, 94275
    France

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  • Research Site

    Lille, 59037
    France

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  • Research Site

    Lille 2998324, 59037
    France

    Site Not Available

  • Research Site

    Toulouse, 31300
    France

    Active - Recruiting

  • Research Site

    Toulouse 2972315, 31300
    France

    Site Not Available

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    Berlin, D-13353
    Germany

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  • Research Site

    Berlin 2950159, D-13353
    Germany

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    Freiburg, 79106
    Germany

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    Freiburg im Breisgau, 79106
    Germany

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    Freiburg im Breisgau 2925177, 79106
    Germany

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    Sankt Augustin, 53757
    Germany

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  • Research Site

    Sankt Augustin 2841648, 53757
    Germany

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    Genova, 16148
    Italy

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  • Research Site

    Genova 8969657, 16148
    Italy

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    Milan, 20122
    Italy

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  • Research Site

    Milan 6951411, 20122
    Italy

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    Milano, 20122
    Italy

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    Padova, 35128
    Italy

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    Padua 3171728, 35128
    Italy

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    Roma, 00165
    Italy

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    Roma 8957247, 00165
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    Bunkyo-ku, 113-8519
    Japan

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    Bunkyō City, 113-8519
    Japan

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  • Research Site

    Bunkyō City 11790632, 113-8603
    Japan

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    Chiba, 266-0007
    Japan

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    Chiba 2113015, 266-0007
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    Fuchu-shi, 183-8561
    Japan

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  • Research Site

    Kawasaki-shi, 216-8511
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    Kobe, 650-0047
    Japan

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    Kobe 1859171, 650-0047
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    Kobe-shi, 650-0047
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    Obu-shi, 474-8710
    Japan

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    Shinjuku-ku, 162-8666
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    Yokohama, 236-0004
    Japan

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  • Research Site

    Yokohama 1848354, 232 8555
    Japan

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    Yokohama-shi, 236-0004
    Japan

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    Atizapán de Zaragoza, 52937
    Mexico

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  • Research Site

    Atizapán de Zaragoza 3482970, 52937
    Mexico

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  • Research Site

    Guadalajara, 44620
    Mexico

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  • Research Site

    Guadalajara 4005539, 44620
    Mexico

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  • Research Site

    Merida, 97070
    Mexico

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  • Research Site

    Mexico, 06720
    Mexico

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  • Research Site

    Mexico 11095662, 06720
    Mexico

    Site Not Available

  • Research Site

    Monterrey, 64460
    Mexico

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  • Research Site

    Monterrey 3995465, 64460
    Mexico

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  • Research Site

    Mérida, 97070
    Mexico

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  • Research Site

    Mérida 3523349, 97070
    Mexico

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  • Research Site

    México, 06720
    Mexico

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  • Research Site

    México 10248874, 06720
    Mexico

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  • Research Site

    Toluca, 50170
    Mexico

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  • Research Site

    Toluca 3515302, 50170
    Mexico

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  • Research Site

    Lodź, 91-738
    Poland

    Active - Recruiting

  • Research Site

    Warsaw, 02-637
    Poland

    Active - Recruiting

  • Research Site

    Warsaw 756135, 02-637
    Poland

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  • Research Site

    Warszawa, 02-637
    Poland

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  • Research Site

    Wroclaw, 52-114
    Poland

    Active - Recruiting

  • Research Site

    Wroclaw 3081368, 52-114
    Poland

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  • Research Site

    Lisboa, 1649-035
    Portugal

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  • Research Site

    Lisbon, 1649-035
    Portugal

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  • Research Site

    Lisbon 2267057, 1169-045
    Portugal

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  • Research Site

    Porto, 4200-319
    Portugal

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  • Research Site

    Porto 2735943, 4200-319
    Portugal

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  • Research Site

    Cape Town, 7700
    South Africa

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    Cape Town 3369157, 7700
    South Africa

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    Esplugues de Llobregat, 8950
    Spain

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  • Research Site

    Esplugues de Llobregat 3122826, 8950
    Spain

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  • Research Site

    Madrid, 28046
    Spain

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  • Research Site

    Madrid 3117735, 28009
    Spain

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    Málaga, 29011
    Spain

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  • Research Site

    Málaga 2514256, 29011
    Spain

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    Santiago de Compostela, 15706
    Spain

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  • Research Site

    Valencia, 46026
    Spain

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  • Research Site

    Valencia 2509954, 46026
    Spain

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    Ankara, 06230
    Turkey

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  • Research Site

    Istanbul, 34098
    Turkey

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    Kayseri, 38039
    Turkey

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  • Research Site

    Umraniye, 34760
    Turkey

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  • Research Site

    Ankara, 06230
    Turkey (Türkiye)

    Active - Recruiting

  • Research Site

    Ankara 323786, 06230
    Turkey (Türkiye)

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  • Research Site

    Istanbul, 34098
    Turkey (Türkiye)

    Active - Recruiting

  • Research Site

    Istanbul 745044, 34098
    Turkey (Türkiye)

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  • Research Site

    Kayseri, 38039
    Turkey (Türkiye)

    Active - Recruiting

  • Research Site

    Kayseri 308464, 38039
    Turkey (Türkiye)

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  • Research Site

    Umraniye, 34760
    Turkey (Türkiye)

    Active - Recruiting

  • Research Site

    Umraniye 738377, 34760
    Turkey (Türkiye)

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  • Research Site

    Birmingham, B4 6NH
    United Kingdom

    Active - Recruiting

  • Research Site

    Birmingham 2655603, B4 6NH
    United Kingdom

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  • Research Site

    Bristol, BS2 8BJ
    United Kingdom

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  • Research Site

    Bristol 2654675, BS2 8BJ
    United Kingdom

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  • Research Site

    Liverpool, L12 2AP
    United Kingdom

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  • Research Site

    Liverpool 2644210, L12 2AP
    United Kingdom

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  • Research Site

    London, WC1N 3JH
    United Kingdom

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  • Research Site

    London 2643743, NW1 2PG
    United Kingdom

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    Manchester, M13 9WL
    United Kingdom

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  • Research Site

    Manchester 2643123, M13 9WL
    United Kingdom

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  • Research Site

    Southampton, SO16 6YD
    United Kingdom

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  • Research Site

    Southampton 2637487, SO16 6YD
    United Kingdom

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    Phoenix, Arizona 85016
    United States

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  • Research Site

    Phoenix 5308655, Arizona 5551752 85016
    United States

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    Los Angeles, California 90027
    United States

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    Los Angeles 5368361, California 5332921 90027
    United States

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    Washington, District of Columbia 20010
    United States

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  • Research Site

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

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  • Research Site

    Washington D.C. 4140963, District of Columbia 4138106 20010
    United States

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    Chicago, Illinois 60611
    United States

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    Chicago 4887398, Illinois 4896861 60637
    United States

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    New Orleans, Louisiana 70118
    United States

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  • Research Site

    New Orleans 4335045, Louisiana 4331987 70118
    United States

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    Bethesda, Maryland 20889
    United States

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  • Research Site

    Bethesda 4348599, Maryland 4361885 20889
    United States

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  • Research Site

    Saint Paul, Minnesota 55125
    United States

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  • Research Site

    Saint Paul 5045360, Minnesota 5037779 55125
    United States

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    Bronx, New York 10467
    United States

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  • 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

    The Bronx, New York 10467
    United States

    Active - Recruiting

  • Research Site

    Valhalla, New York 10595
    United States

    Active - Recruiting

  • Research Site

    New Hyde Park 5128514, New York 5128638 11042
    United States

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  • Research Site

    New York 5128581, New York 5128638 10032
    United States

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  • Research Site

    The Bronx 5110266, New York 5128638 10467
    United States

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  • Research Site

    Valhalla 5142090, New York 5128638 10595
    United States

    Site Not Available

  • Research Site

    Durham, North Carolina 27710
    United States

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  • Research Site

    Durham 4464368, North Carolina 4482348 27710
    United States

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  • Research Site

    Cincinnati, Ohio 45229
    United States

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  • Research Site

    Cleveland, Ohio 44109
    United States

    Active - Recruiting

  • Research Site

    Columbus, Ohio 43203
    United States

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  • Research Site

    Cincinnati 4508722, Ohio 5165418 45229
    United States

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  • Research Site

    Cleveland 5150529, Ohio 5165418 44109
    United States

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  • Research Site

    Columbus 4509177, Ohio 5165418 43203
    United States

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  • Research Site

    Portland, Oregon 97227
    United States

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  • Research Site

    Portland 5746545, Oregon 5744337 97227
    United States

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    Philadelphia, Pennsylvania 19104
    United States

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  • Research Site

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

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    Greenville, South Carolina 29605
    United States

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  • Research Site

    Greenville 4580543, South Carolina 4597040 29605
    United States

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    El Paso, Texas 79902
    United States

    Active - Recruiting

  • Research Site

    Houston, Texas 77030
    United States

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  • Research Site

    El Paso 5520993, Texas 4736286 79902
    United States

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    Houston 4699066, Texas 4736286 77030
    United States

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    Salt Lake City, Utah 84108
    United States

    Active - Recruiting

  • Research Site

    Salt Lake City 5780993, Utah 5549030 84108
    United States

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