Now Recruiting

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis(FIGARO UC 301)

WHAT IS THE PURPOSE OF THIS STUDY?

The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in subjects with moderate to severe ulcerative colitis (UC).

TRIAL AT A GLANCE

Condition

Ulcerative Colitis

Study Intervention

SHP647; Placebo

Possibility of Active Treatment

80%

Study Type

Interventional

Phase

Phase 3

IS THIS STUDY RIGHT FOR ME?

AGE

16 to 80

Years

GENDERS

ACCEPTS HEALTHY VOLUNTEERS

No

PARTICIPATION DURATION/ REQUIREMENTS

Participation will consist of up to 9 visits to the study site. These visits will be completed over a screening period of up to 42 days, a 12-week treatment period, and a 16 week follow-up period after treatment ends.At the end of the 12-week treatment period, eligible subjects will be offered the opportunity to participate in a double-blind maintenance study or a long-term safety extension (LTS) study. Subjects who withdraw early from the 12-week treatment period or who do not wish to enter the maintenance study or LTS study will continue into a 16-week safety follow-up period. Only those subjects who complete the full course of investigational product treatment in the induction studies will be eligible to continue in the maintenance study or LTS study.

ENTRY CRITERIA

Must be between ≥16 and ≤80 years of age

Must have confirmed and documented diagnosis of UC extending proximal to the rectum (i.e., not limited to proctitis) for at least 3 months before screening

Must have moderate to severe active UC defined as a total Mayo score of ≥6, including a centrally read endoscopic subscore ≥2, rectal bleeding subscore ≥1, and stool frequency subscore ≥1 at baseline

Must have had an inadequate response to, or lost response to, at least 1 conventional treatment

Cannot have received anti-integrin/adhesion molecule treatment (e.g., natalizumab, vedolizumab, efalizumab, etrolizumab, or any other investigational anti-integrin/adhesion molecule, including SHP647)

Study Locations

We are planning* on conducting this study in 14 countries around the world.

    • Australia
    • Austria
    • Croatia
    • Czech Republic
    • Israel
    • Italy
    • Lithuania
    • Netherlands
    • Poland
    • Russian Federation
    • Serbia
    • South Africa
    • United Kingdom
    • United States of America

Enter your city or postal code to find a location near you. Click here to view FIGARO 302 Sites

RESULTS

  • 1.

    Paracelsus Medizinische Privatuniversität

    Salzburg, Salzburg
    Austria

    +435725557296

    s.gassner@salk.at

    miles

  • 2.

    A.ö. Krankenhaus der Barmherzigen Brüder

    St. Veit an der Glan, Kärnten
    Austria

    +434212499130

    hanspeter.groechenig@bbstveit.at

    miles

  • 3.

    LKH-Universitätsklinikum Klinikum Graz

    Graz, Steiermark
    Austria

    +4331638581786

    christoph.hoegenauer@medunigraz.at

    miles

  • 4.

    Arizona Digestive Health

    Sun City, Arizona
    United States of America

    (623) 237-0939

    ctrivedi@arizonadigestivehealth.com

    miles

  • 5.

    University of Chicago Medical Center

    Chicago, Illinois
    United States of America

    (773) 834-7414

    drubin@medicine.bsd.uchicago.edu

    miles

  • 6.

    Klinikum Klagenfurt Am Woerthersee

    Klagenfurt am Wörthersee,
    Austria

    +4346353831103

    markus@peck.at

    miles

  • 7.

    Medizinische Universitat Wien

    Wien,
    Austria

    +431404004741

    walter.reinisch@meduniwien.ac.at

    miles

  • 8.

    Klinikum Wels-Grieskirchen GmbH

    Wels,
    Austria

    +43072424152181

    Harald.Hofer@klinikum-wegr.at

    miles

  • 9.

    Instituto Goiano de Gastroenterologia E Endoscopia Digestiva Ltda

    Goiânia, Goiás
    Brazil

    +5562996862139

    maurobafutto@yahoo.com.br

    miles

  • 10.

    CEMEC - Centro Multidisciplinar de Estudos Clínicos

    Santo André, São Paulo
    Brazil

    ctdfb@uol.com.br

    miles

  • 11.

    Hospital Da Cidade de Passo Fundo

    Passo Fundo, Rio Grande do Sul
    Brazil

    +555491839440

    pesquisahc@bioservsmo.com.br

    miles

  • 12.

    Massachusetts General Hospital

    Boston, Massachusetts
    United States of America

    (617) 724-3238

    aananthakrishnan@partners.org

    miles

  • 13.

    Vanderbilt University Medical Center

    Nashville, Tennessee
    United States of America

    (615) 322-4643

    miles

  • 14.

    Allegheny Center For Digestive Health

    Pittsburgh, Pennsylvania
    United States of America

    (412) 359-8900

    sandra.elhachem@ahn.org

    miles

  • 15.

    Del Sol Research Management

    Tucson, Arizona
    United States of America

    (520) 257-3881

    ggottlieb@delsolresearch.com

    miles

  • 16.

    Northwestern University

    Chicago, Illinois
    United States of America

    (312) 695-4929

    shanauer@northwestern.edu

    miles

  • 17.

    Val Hansen MD

    Bountiful, Utah
    United States of America

    (801) 797-9315

    valhansen@live.com

    miles

  • 18.

    Baylor College of Medicine

    Houston, Texas
    United States of America

    (713) 798-6342

    manreet.kaur@bcm.edu

    miles

  • 19.

    Inland Empire Liver Foundation

    Rialto, California
    United States of America

    (909) 883-2999

    zkayali@ieliverfoundation.com

    miles

  • 20.

    West Virginia University Hospital

    Morgantown, West Virginia
    United States of America

    (304) 293-4123

    jkupec@hsc.wvu.edu

    miles

  • 21.

    CHI Franciscan Digestive Care Associates

    Tacoma, Washington
    United States of America

    (253) 272-8664

    stevenlarson@chifranciscan.org

    miles

  • 22.

    VA Long Beach Healthcare System

    Long Beach, California
    United States of America

    (562) 826-5628

    miles

  • 23.

    University of Washington

    Seattle, Washington
    United States of America

    (206) 598-4377

    leesd@uw.edu

    miles

  • 24.

    Inquest Clinical Research/Coastal Gastroenterology Associates, PA

    Baytown, Texas
    United States of America

    (281) 557-2527

    admalhot@yahoo.com

    miles

  • 25.

    Digestive Health Center PA

    Ocean Springs, Mississippi
    United States of America

    (228) 872-7612

    mcnairalfred@yahoo.com

    miles

  • 26.

    Advanced Gastroenterology-Union City

    Union City, Tennessee
    United States of America

    (731) 884-0600

    zeepascal@aol.com

    miles

  • 27.

    Midwest Biomedical Research Foundation - NAVREF

    Kansas City, Missouri
    United States of America

    (816) 861-4700

    tarun.rai@va.gov

    miles

  • 28.

    Friedrich, Rubin, Panella, Sapienza, and Kaplounov, LLP

    Englewood, New Jersey
    United States of America

    (201) 569-7044

    scopemd@aol.com

    miles

  • 29.

    Advanced Clinical Research Network

    Miami, Florida
    United States of America

    (305) 702-1594

    juansarol@acrntrials.com

    miles

  • 30.

    Columbus Regional Research Institute

    Columbus, Georgia
    United States of America

    (706) 321-0495

    newtrials@serrg.com

    miles

  • 31.

    Digestive Health Center at UWMC

    Seattle, Washington
    United States of America

    (206) 598-4377

    tzisman@medicine.washington.edu

    miles

  • 32.

    Clinical Hospital Centre Osijek

    Osijek,
    Croatia

    +38531511511

    vborzan@hotmail.com

    miles

  • 33.

    Institut klinicke a experimentalni mediciny

    Praha 4,
    Czech Republic

    +420603869913

    pavel.drastich@ikem.cz

    miles

  • 34.

    Charité - Universitätsmedizin Berlin

    Berlin, Berlin
    Germany

    +4930450553277

    daniel.baumgart@charite.de

    miles

  • 35.

    Royal Shrewsbury Hospital

    Shrewsbury, Shropshire
    United Kingdom

    +441743261000

    jeff.butterworth@sath.nhs.uk

    miles

  • 36.

    Tel Aviv Sourasky Medical Center

    Tel Aviv,
    Israel

    +97236974468

    sigalf@tlvmc.gov.il

    miles

  • 37.

    Complesso Integrato Columbus

    Roma, Roma
    Italy

    +39063503310

    alearmuzzi@yahoo.com

    miles

  • 38.

    Klaipeda University Hospital

    Klaipeda,
    Lithuania

    +370846396547

    viletajak@gmail.com

    miles

  • 39.

    Academisch Medisch Centrum Amsterdam

    Amsterdam,
    Netherlands

    +3215505011

    g.dhaens@amc.uva.nl

    miles

  • 40.

    Instytut Centrum Zdrowia Matki Polki

    Lódz, Lódzkie
    Poland

    +48422711341

    kpg@iczmp.edu.pl

    miles

  • 41.

    Cluj Clinical County Hospital

    Cluj-Napoca, Cluj
    Romania

    +40722756475

    dan_dumitrascu@yahoo.de

    miles

  • 42.

    Medical Company Hepatolog, LLC

    Samara,
    Russian Federation

    +78462502505

    alenamalova@mail.ru

    miles

  • 43.

    Clinical Hospital Center ''Bezanijska Kosa''

    Belgrade,
    Serbia

    +381641608353

    mikialeksa5@gmail.com

    miles

  • 44.

    The Alfred Hospital

    Melbourne, Victoria
    Australia

    +61398950369

    m.sparrow@alfred.org.au

    miles

  • 45.

    Kitasato University Kitasato Institute Hospital

    Tokyo,
    Japan

    miles

  • 46.

    University Klinichki Bolnicki Centar Zagreb

    Zagreb, Grad Zagreb
    Croatia

    miles

  • 47.

    General Hospital Virovitica

    Virovitica,
    Croatia

    +38533747291

    matkomarkotic@gmail.com

    miles

  • 48.

    Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH

    Bochum,
    Germany

    miles

  • 49.

    Gastroenterologische Gemeinschaftspraxis Mainz

    Mainz,
    Germany

    miles

  • 50.

    Uniklinik Köln

    Köln,
    Germany

    miles

  • 51.

    Shaare Zedek Medical Center

    Jerusalem,
    Israel

    +97226666064

    erang@szmc.org.il

    miles

  • 52.

    Nazareth EMMS Hospital

    Nazareth,
    Israel

    +97646028888

    mahmudmahamid@yahoo.com

    miles

  • 53.

    A.O.U. Maggiore della Carità

    Novara,
    Italy

    miles

  • 54.

    Louisiana Research Center LLC

    Shreveport, Louisiana
    United States of America

    318-525-3233

    haguilar@gis.md

    miles

  • 55.

    East Coast Institute for Research, LLC

    St Augustine, Florida
    United States of America

    (904) 824-1776

    draahmadi3@gmail.com

    miles

  • 56.

    Omega Research Consultants LLC

    Orlando, Florida
    United States of America

    (407) 988-1075

    kayesu@omegarcllc.com

    miles

  • 57.

    Ospedale Casa Sollievo Della Sofferenza IRCCS

    San Giovanni Rotondo, Puglia
    Italy

    +390882410056

    f.bossa@operapadrepio.it

    miles

  • 58.

    Atria Clinical Research

    Little Rock, Arkansas
    United States of America

    (501) 492-9175

    drMeb@atriaresearch.com

    miles

  • 59.

    Medisphere Medical Research Center LLC

    Evansville, Indiana
    United States of America

    miles

  • 60.

    DM Clinical Research

    Tomball, Texas
    United States of America

    (281) 517-0550

    drmirfan2@gmail.com

    miles

  • 61.

    Clinical Center Kragujevac

    Kragujevac, Šumadijski okrug
    Serbia

    miles

  • 62.

    VA Greater Los Angeles Healthcare

    Los Angeles, California
    United States of America

    miles

  • 63.

    Gastrointestinal Diseases, Inc

    Columbus, Georgia
    United States of America

    miles

  • 64.

    Mesa Gastrointestinal Associates

    Mesa, Arizona
    United States of America

    miles

  • 65.

    Laporte County Institute For Clinical Research

    Michigan City, Indiana
    United States of America

    (219) 879-0333

    minbeni1@yahoo.com

    miles

  • 66.

    Nuren Medical and Research Center

    Miami, Florida
    United States of America

    305-551-8493

    vaca@nurenmedical.com

    miles

  • 67.

    Gastro One

    Germantown, Tennessee
    United States of America

    (901) 820-0090

    zyounes@gastro1.com

    miles

  • 68.

    Azienda Ospedaliera Universitaria Careggi

    Firenze, Toscana
    Italy

    miles

  • 69.

    Exemplar Research, Inc.

    Elkins, West Virginia
    United States of America

    (304) 216-2411

    drratnakar@exemplarresearchinc.com

    miles

  • 70.

    Clinical Trials of SWLA LLC

    Lake Charles, Louisiana
    United States of America

    (337) 493-5310

    rmmclinicaltrials@yahoo.com

    miles

  • 71.

    Meridien Research

    Pinellas Park, Florida
    United States of America

    (727) 546-1680

    miles

  • 72.

    Pharma Research International Inc

    Naples, Florida
    United States of America

    (239) 631-2989

    miles

  • 73.

    Consultants For Clinical Research Inc

    Cincinnati, Ohio
    United States of America

    (513) 872-4549

    pbekal@ohiogi.com

    miles

  • 74.

    Hepato-Gastroenterologie HK, s. r. o.

    Hradec Kralove, Královéhradecký kraj
    Czech Republic

    +420495218475

    tomas.vanasek@hepato-gastro.com

    miles

  • 75.

    Mater Hospital Brisbane

    South Brisbane, Queensland
    Australia

    +61731638518

    jakob.begun@mater.uq.edu.au

    miles

  • 76.

    Liverpool Hospital

    Liverpool, New South Wales
    Australia

    +61287384085

    Susan.Connor1@health.nsw.gov.au

    miles

  • 77.

    Korczowski Bartosz, Gabinet Lekarski

    Rzeszow,
    Poland

    +48177404065

    korczowski@op.pl

    miles

  • 78.

    Melita Medical

    Wroclaw, Dolnoslaskie
    Poland

    +48717072111

    j.leszczyszyn@melitamedical.pl

    miles

  • 79.

    Royal Adelaide Hospital

    Adelaide, South Australia
    Australia

    +61882225827

    jane.andrews@sa.gov.au

    miles

  • 80.

    Concord Repatriation General Hospital

    Concord, New South Wales
    Australia

    +61297676111

    rupert.leong@health.nsw.gov.au

    miles

  • 81.

    St Vincents Hospital Melbourne

    Fitzroy, Victoria
    Australia

    +61392312211

    nik.ding@svha.org.au

    miles

  • 82.

    Om Research LLC

    Lancaster, California
    United States of America

    (310) 684-2494

    jpruthi@synergistresearch.com

    miles

  • 83.

    Royal Brisbane & Women's Hospital

    Herston, Queensland
    Australia

    +61736464273

    mariko.howlett@health.qld.gov.au

    miles

  • 84.

    General Hospital Zadar

    Zadar,
    Croatia

    +38523505448

    ivo.klarin@zd.t-com.hr

    miles

  • 85.

    Opca Bolnica Karlovac

    Karlovac, Karlovacka županija
    Croatia

    +385958785843

    ivana.kovacica@gmail.com

    miles

  • 86.

    Opca bolnica Bjelovar

    Bjelovar,
    Croatia

    +38543279171

    marinko.lukicm@gmail.com

    miles

  • 87.

    Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice

    Usti nad Orlici,
    Czech Republic

    +420465710223

    libor.gabalec@seznam.cz

    miles

  • 88.

    Hadassah University Hospital Ein Kerem

    Jerusalem,
    Israel

    +97226776848

    erani@hadassah.org.il

    miles

  • 89.

    Istituto Clinico Humanitas

    Rozzano (MI),
    Italy

    +39282244771

    ibdclinicaltrials@humanitas.it

    miles

  • 90.

    Ospedale Sacro Cuore Don Calabria

    Negrar, Veneto
    Italy

    +390456013949

    andrea.geccherle@sacrocuore.it

    miles

  • 91.

    Azienda Ospedaliera Mater Domini Di Catanzaro

    Catanzaro, Calabria
    Italy

    +3909613647113

    luzza@unicz.it

    miles

  • 92.

    Azienda Ospedaliera Ordine Mauriziano di Torino

    Torino,
    Italy

    +390115082534

    rrocca@mauriziano.it

    miles

  • 93.

    Hospital of Lithuanian University of Health Sciences Kaunas Clinics

    Kaunas,
    Lithuania

    +37037326264

    laimas.jonaitis@lsmuni.lt

    miles

  • 94.

    Vilnius University Hospital Santaros Klinikos

    Vilnius,
    Lithuania

    +37068825454

    edita.kazenaite@santa.lt

    miles

  • 95.

    Vilnius City Clinical Hospital

    Vilnius,
    Lithuania

    +37068691382

    surgeon@inbox.lt

    miles

  • 96.

    Clinical Research Center spółka z ograniczoną odpowiedzialnością, Medic-R Sp.k.

    Poznan,
    Poland

    +48609484605

    marcin.hanczewski@gmail.com

    miles

  • 97.

    Endoskopia Sp. z o.o.

    Sopot, Pomorskie
    Poland

    +48501011879

    badanie.kliniczne@wp.pl

    miles

  • 98.

    Centrum Innowacyjnych Terapii

    Piaseczno,
    Poland

    +48222905350

    witold.kucharski@citrials.pl

    miles

  • 99.

    Niepubliczny Zakład Opieki Zdrowotnej VIVAMED

    Warszawa, Mazowieckie
    Poland

    +48226792883

    robert@petrykamed.com

    miles

  • 100.

    Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.

    Ksawerow,
    Poland

    +48422136412

    stemii@wp.pl

    miles

  • 101.

    Sonomed Sp. z o.o.

    Szczecin,
    Poland

    +48914849903

    annamwk@wp.pl

    miles

  • 102.

    Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny

    Lódz, Lódzkie
    Poland

    +48426393046

    majkawj@bmp.net.pl

    miles

  • 103.

    Vitamed Galaj i Cichomski sp.j.

    Bydgoszcz, Kujawsko-pomorskie
    Poland

    +48665102401

    p.sikorski@vitamed.info

    miles

  • 104.

    Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj

    Torun, Kujawsko-pomorskie
    Poland

    +48501028551

    adamkopon@interia.pl

    miles

  • 105.

    Pennine Acute Hospitals Trust

    Lancashire, Bury
    United Kingdom

    +4401617782642

    jimmy.limdi@pat.nhs.uk

    miles

  • 106.

    New Cross Hospital

    Wolverhampton,
    United Kingdom

    +441902696452

    matthew.brookes@nhs.net

    miles

  • 107.

    Royal Gwent Hospital

    Newport, Newport
    United Kingdom

    +441633234234

    vivek.goel@wales.nhs.uk

    miles

  • 108.

    Northside Gastroenterology

    Cypress, Texas
    United States of America

    (281) 477-9305

    ahussain@aceclinicalresearch.com

    miles

  • 109.

    General County Hospital Vukovar and Croatian Veterans Hospital

    Vukovar,
    Croatia

    +38532452148

    petrosevic@gmail.com

    miles

  • 110.

    Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.

    Usti nad Labem,
    Czech Republic

    +420477112430

    michal.tichy@kzcr.cz

    miles

  • 111.

    Baruch Padeh Poriya Medical Center

    Tiberias,
    Israel

    +97246652688

    wnseir@poria.health.gov.il

    miles

  • 112.

    VU Medisch Centrum

    Amsterdam,
    Netherlands

    +31204440613

    h.beaumont@vumc.nl

    miles

  • 113.

    ETZ-Elisabeth

    Tilburg, Noord-Brabant
    Netherlands

    +31132216599

    researchmdl@etz.nl

    miles

  • 114.

    Miedzyleski Szpital Specjalistyczny w Warszawie

    Warszawa, Mazowieckie
    Poland

    +48609040173

    kierzkiewicz@op.pl

    miles

  • 115.

    Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II

    Zamosc,
    Poland

    +48846773600

    krzysztofmarczewski@onet.pl

    miles

  • 116.

    Twoja Przychodnia - Centrum Medyczne Nowa Sol

    Nowa Sól,
    Poland

    +48684177519

    miakisz@twojaprzychodnia.com

    miles

  • 117.

    Centralny Szpital Kliniczny MSW

    Warszawa,
    Poland

    +48225081240

    grazyna.rydzewska@cskmswia.pl

    miles

  • 118.

    LLC «Union Clinic»

    Saint-Petersburg,
    Russian Federation

    +78122351093

    baranovsky46@mail.ru

    miles

  • 119.

    Medical University Reaviz

    Samara,
    Russian Federation

    +79053034393

    bunkova27@mail.ru

    miles

  • 120.

    Moscow Clinical Scientific Center

    Moscow,
    Russian Federation

    +74953043014

    asfold@mail.ru

    miles

  • 121.

    Rostov State Medical University

    Rostov-on-Don,
    Russian Federation

    +78632719705

    tkachev@aaanet.ru

    miles

  • 122.

    Clinical Center Nis

    Nis,
    Serbia

    +38169770972

    bpetrovicnis@gmail.com

    miles

  • 123.

    General Hospital Vrsac

    Vrsac,
    Serbia

    +381641244198

    v.petrovic56@hotmail.com

    miles

  • 124.

    CLINRESCO, ARWYP Medical Suites

    Johannesburg, Gauteng
    South Africa

    +27113943400

    tf.coetzer@clinresco.co.za

    miles

  • 125.

    Dr JP Wright

    Claremont, Western Cape
    South Africa

    +27216834600

    jpwright@icon.co.za

    miles

  • 126.

    Whipps Cross University Hospital

    London, London, City of
    United Kingdom

    +4420853955226730

    sami.hoque@bartshealth.nhs.uk

    miles

  • 127.

    North Tyneside General Hospital

    North Shields, Northumberland
    United Kingdom

    +00443448118111

    anthoor.jayaprakash@northumbria-healthcare.nhs.uk

    miles

*Planning is an intent to conduct this study in the specified countries and is subject to change.