Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)

Last updated: April 8, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

Collagen Vascular Diseases

Scleroderma

Scar Tissue

Treatment

Anifrolumab (blinded)

Anifrolumab (unblinded, open label)

Anifrolumab (blinded)

Clinical Study ID

NCT05925803
D3460C00002
2023-505976-31
  • Ages 18-70
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of treatment with subcutaneous anifrolumab versus placebo in adult participants with systemic sclerosis. The target population for this study includes patients who meet the 2013 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification for systemic sclerosis, either limited or diffuse cutaneous subsets, with a disease duration of less than 6 years from first non-Raynaud's phenomenon symptom.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Adult patients from 18 to 70 years of age inclusive

  2. Systemic sclerosis according to 2013 ACR/EULAR classification criteria

  3. Limited or diffuse cutaneous subsets

  4. Systemic sclerosis disease duration within 6 years from first non-Raynaud'sphenomenon manifestation at the time of signing the ICF

  5. Either HAQ-DI score ≥ 0.25 points or PtGA score ≥ 3 points

  6. mRSS > 10 with early disease or rapid progression as defined by the protocol

  7. mRSS ≥ 15 with disease duration ≥ 18 months and active disease as defined by theprotocol

  8. Stable background therapies can be used including hydroxychloroquine, methotrexate,azathioprine, mycophenolate mofetil, mycophenolate sodium, mycophenolic acid, oralglucocorticoids or tacrolimus

  9. Women of childbearing potential with a negative urine pregnancy test

  10. Uninvolved skin at injection sites

Exclusion

Key Exclusion Criteria:

  1. Anticentromere antibody seropositivity on central laboratory

  2. Severe cardiopulmonary disease as defined by the protocol

  3. History of systemic sclerosis renal crisis within past 12 months (estimatedglomerular filtration rate(eGFR) < 45 mL/min/1.73m2)

  4. Overlap syndromes, systemic lupus erythematosus with anti-double-strandeddeoxyribonucleic acid antibody seropositivity or anti-citrullinated proteinantibodies-positive rheumatoid arthritis, or SSc mimics (eg, scleromyxedema,eosinophilic fasciitis)

  5. History of, or current, any other inflammatory diseases, eg, inflammatory boweldisease, skin disease, that, in the opinion of the investigator, could interferewith efficacy and safety assessments or require immunomodulatory therapy

  6. Evidence of moderately severe concurrent nervous system, renal, endocrine, hepatic (eg, underlying chronic liver disease [Child Pugh A, B, C hepatic impairment]), orgastrointestinal disease (eg, clinical signs of malabsorption or needing parenteralnutrition) not related to SSc, as determined by the investigator

  7. Hematopoietic stem cell transplantation or solid organ/limb transplantation

  8. Any severe case of Herpes Zoster infection as defined by the protocol

  9. Known malignancy or a history of malignancy within 5 years, with exception ofexcised/cured local basal or squamous cell carcinoma of the skin or carcinoma insitu of the uterine cervix

  10. Major surgery within 8 weeks prior to and/or during study enrollment

  11. Known active current or history of recurrent infections

  12. Any condition that, in the opinion of the investigator or AstraZeneca, wouldinterfere with the efficacy or safety evaluation of the study intervention or putparticipant at safety risk

Study Design

Total Participants: 306
Treatment Group(s): 5
Primary Treatment: Anifrolumab (blinded)
Phase: 3
Study Start date:
November 08, 2023
Estimated Completion Date:
December 31, 2027

Study Description

This is a multicenter, randomized, double-blind, placebo-controlled, Phase III study to evaluate the efficacy and safety of anifrolumab in the treatment of adult participants with Systemic Sclerosis (SSc) who may be taking one or a combination of protocol-specified standard therapies. The use of one of the following standard immunosuppressant therapies is permitted at a stable dose, but not mandated: hydroxychloroquine, mycophenolate mofetil (MMF), mycophenolic acid or mycophenolate sodium (MPA/MPS), methotrexate, azathioprine, tacrolimus, and oral glucocorticoids. MMF or MPA/MPS, azathioprine, and methotrexate may be used in combination with hydroxychloroquine and/or low-dose oral glucocorticoids [≤ 10 mg/day].

Approximately 306 eligible participants will be randomized in a 1:1 ratio to receive either anifrolumab (or matching placebo) given subcutaneously once weekly for 52 weeks. The study will be stratified by the following factors:

  • Interstitial lung disease (ILD) (yes, no) at Week 0 (Day1);

  • MMF or MPA/MPS use (yes ,no) at Week 0 (Day 1); and

  • Disease duration, defined as the time from the first non-Raynaud's symptom attributable to SSc (<18 months, ≥ 18 months) at Week 0 (Day 1)

Study treatment will be administered subcutaneously via an accessorized prefilled syringe by study staff or by the participant or carer, either in the clinic or at home, with most doses being administered at home. The study consists of 4 periods: a 6-week screening period, a 52-week, double-blind, placebo-controlled period, a 52-week open-label active treatment period, and a 12-week safety follow-up period. There are a total of 16 study visits with most visits in the treatment period occurring every 8 to 12 weeks. The periods are described below:

  • Screening Period: This may involve one or more visits to the study site.

  • Double Blind Treatment Period: Treatment Period when participants will receive once weekly injections of anifrolumab or matching placebo. Participation will involve in-clinic study visits at Weeks 0 (Day 1), 1, 4, 8*, 16, 24, 36, 48 and 52. *The visit at Week 8 may be either by telephone or in person.

  • Open Label Treatment Period: At Week 52, all participants will be given anifrolumab (subcutaneous) once weekly for 52 weeks (last dose at Week 103). Participation will involve in-clinic study visits at Weeks 52, 53*, 56, 64, 76. 88 and 104. *The visit at Week 53 may be either by telephone or in person.

  • Safety Follow-up Period: All participants will return to the clinic for a 12-week post treatment visit. This will occur post Double Blind Treatment Period (Week 52 or Double Blind Period early discontinuation) or post Open Label Treatment Period (Week 104 or Open Label Period early discontinuation).

Connect with a study center

  • Research Site

    Graz, 8036
    Austria

    Active - Recruiting

  • Research Site

    Innsbruck, 6020
    Austria

    Active - Recruiting

  • Research Site

    Linz, 4020
    Austria

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  • Research Site

    Wien, 1090
    Austria

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    Brussels, 1070
    Belgium

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    Gent, B-9000
    Belgium

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    Leuven, 3000
    Belgium

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  • Research Site

    Calgary, Alberta T2N 4Z6
    Canada

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    Edmonton, Alberta T6G 2R7
    Canada

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    Vancouver, British Columbia 5Z 1L7
    Canada

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    Halifax, Nova Scotia B3H 2Y9
    Canada

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    Toronto, Ontario M5T 3L9
    Canada

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    Montreal, Quebec H4J 1C5
    Canada

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    Quebec, G1V 3M7
    Canada

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    Beijing, CN-100730
    China

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    Chengdu, 610041
    China

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    Guangzhou, 510530
    China

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    Hangzhou, 310014
    China

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    Lanzhou, 730000
    China

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    Shanghai, 200032
    China

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    Tianjin, 300050
    China

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    Wuhan, 430022
    China

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    Bordeaux Cedex, 33076
    France

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    Brest Cedex, 29609
    France

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    La Tronche, 38043
    France

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    Paris, 75679
    France

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    Reims, 51092
    France

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    Rennes Cedex 9, 35033
    France

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    Strasbourg, 67098
    France

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    Strasbourg Cedex, 67098
    France

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    Toulouse, 31059
    France

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    Bad Bramstedt, 24576
    Germany

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    Berlin, 10117
    Germany

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    Düsseldorf, 40225
    Germany

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    Freiburg, 79106
    Germany

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    Köln, 50937
    Germany

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    Mainz, 55131
    Germany

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    Minden, 32429
    Germany

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    München, 80336
    Germany

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    Münster, 48149
    Germany

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    Tübingen, 72076
    Germany

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    Budapest, 1138
    Hungary

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    Debrecen, 4032
    Hungary

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    Pécs, 7632
    Hungary

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    Szeged, 6725
    Hungary

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    Ahmedabad, 382421
    India

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    Delhi, 110060
    India

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    Gurugram, 122001
    India

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    Hyderabad, 500082
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    Kolkata, 700020
    India

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    Mumbai, 400053
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    Mysuru, 570004
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    New Delhi, 11029
    India

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    Pune, 411001
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    Secunderabad, 500003
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    Visakhapatnam,
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    Afula, 18101
    Israel

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    Hadera, 38100
    Israel

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    Haifa, 31048
    Israel

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    Jerusalem, 00000
    Israel

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    Kfar-Saba, 4428164
    Israel

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    Ramat Gan, 52621
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    Ancona, 60126
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    Brescia, 25123
    Italy

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    Cona, 44124
    Italy

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    Firenze, 50134
    Italy

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    Milano, 20132
    Italy

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    Monserrato, 09042
    Italy

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    Napoli, 80131
    Italy

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    Padova, 35128
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    Roma, 00168
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    Bunkyo-ku, 113-8603
    Japan

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    Fukuoka-shi, 812-8582
    Japan

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    Iruma-Gun, 350-0495
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    Kanazawa-shi, 920-8641
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    Maebashi-shi, 371-8511
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    Nagasaki-shi, 852-8501
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    Nagoya-shi, 457-0866
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    Sapporo-shi, 060-8638
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    Sendai-shi, 980-8574
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    Shinjuku-ku, 160-8582
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    Suita-shi, 565-0871
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    Takatsuki-shi, 569-8686
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    Toyoake-shi, 470-1192
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    Yokohama-shi, 236-0004
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    Busan, 49241
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    Kuala Lumpur, 59100
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    Kuching, 93586
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    Seremban, 70300
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    Cdmx, 06700
    Mexico

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    Chihuahua, 31000
    Mexico

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    Ciudad de Mexico, 06700
    Mexico

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    Guadalajara, 44158
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    Mexico City, 03310
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    México, 14000
    Mexico

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    San Luis Potosi, 78213
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    San Luis Potosí, 78250
    Mexico

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    Amsterdam, 1105 AZ
    Netherlands

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    Groningen, 9713 GZ
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    Leiden, 2300 RC
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    Białystok, 15-276
    Poland

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    Bydgoszcz, 85-168
    Poland

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    Krakow, 31-637
    Poland

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    Kraków, 30-721
    Poland

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    Poznań, 60-218
    Poland

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    Sosnowiec, 41-200
    Poland

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    Warszawa, 00-874
    Poland

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    Łódź, 90-549
    Poland

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    Bucuresti, 011172
    Romania

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    Cluj Napoca, 400006
    Romania

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    Iasi, 700661
    Romania

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    Parktown, 2193
    South Africa

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    Pretoria,
    South Africa

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    Barcelona, 08041
    Spain

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    La Coruna, 15006
    Spain

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    La Coruña, 15006
    Spain

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    Madrid, 28041
    Spain

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    Malaga, 29009
    Spain

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    Valencia, 46026
    Spain

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    Vigo, 36214
    Spain

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    Ankara, 06100
    Turkey

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    Antalya, 07059
    Turkey

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    Başakşehir, 34480
    Turkey

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    Kazımkarabekir, 01230
    Turkey

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    Kocaeli, 41380
    Turkey

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    Merkez, 23200
    Turkey

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    Cannock, WS11 2XY
    United Kingdom

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    Leeds, LS7 4SA
    United Kingdom

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  • Research Site

    London, NW3 2QG
    United Kingdom

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    Manchester, M13 9WL
    United Kingdom

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    Sheffield, S10 2JF
    United Kingdom

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    Birmingham, Alabama 35205
    United States

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  • Research Site

    Scottsdale, Arizona 85259
    United States

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  • Research Site

    Chula Vista, California 91910
    United States

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  • Research Site

    Inglewood, California 90301
    United States

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  • Research Site

    Los Angeles, California 90095
    United States

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  • Research Site

    Orange, California 92868
    United States

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    San Diego, California 92108
    United States

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    Aurora, Colorado 80045
    United States

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    New Haven, Connecticut 06519
    United States

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    North Haven, Connecticut 06473
    United States

    Site Not Available

  • Research Site

    Washington, District of Columbia 20007
    United States

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  • Research Site

    Boca Raton, Florida 33486
    United States

    Active - Recruiting

  • Research Site

    Fort Lauderdale, Florida 33309
    United States

    Active - Recruiting

  • Research Site

    Gainesville, Florida 32603
    United States

    Active - Recruiting

  • Research Site

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Research Site

    Miami, Florida 33126
    United States

    Site Not Available

  • Research Site

    Tamarac, Florida 33321
    United States

    Active - Recruiting

  • Research Site

    Atlanta, Georgia 30322
    United States

    Site Not Available

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    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Research Site

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Research Site

    New Orleans, Louisiana 70121
    United States

    Active - Recruiting

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    Shreveport, Louisiana 71103
    United States

    Site Not Available

  • Research Site

    Baltimore, Maryland 21224
    United States

    Active - Recruiting

  • Research Site

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Research Site

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • Research Site

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Research Site

    Babylon, New York 11702
    United States

    Active - Recruiting

  • Research Site

    Brooklyn, New York 11201
    United States

    Active - Recruiting

  • Research Site

    New York, New York 10032
    United States

    Active - Recruiting

  • Research Site

    Charlotte, North Carolina 28207
    United States

    Site Not Available

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    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

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    Pittsburgh, Pennsylvania 15213
    United States

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    Allen, Texas 75013
    United States

    Active - Recruiting

  • Research Site

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Research Site

    Ha Noi, 100000
    Vietnam

    Active - Recruiting

  • Research Site

    Hanoi City, 10000
    Vietnam

    Active - Recruiting

  • Research Site

    Ho Chi Minh, 70000
    Vietnam

    Active - Recruiting

  • Research Site

    Hochiminh, 70000
    Vietnam

    Active - Recruiting

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