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 4 countries around the world.

    • Australia
    • Czech Republic
    • Poland
    • United States of America

Enter your city or postal code to find a location near you.

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

    miles

  • 3.

    LKH-Universitätsklinikum Klinikum Graz

    Graz, Steiermark
    Austria

    +43031638514388

    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

    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@fhshealth.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

    Webster, Texas
    United States of America

    (281) 557-2527

    miles

  • 25.

    Digestive Health Center PA

    Ocean Springs, Mississippi
    United States of America

    (228) 872-7612

    lbrowndhc@yahoo.com

    miles

  • 26.

    Advanced Gastro

    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 Osijek

    Osijek,
    Croatia

    +0038531511511

    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@tasmc.health.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

    Box Hill, Victoria
    Australia

    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

    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

    miles

  • 52.

    Nazareth EMMS Hospital

    Jerusalem,
    Israel

    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

    Saint Augustine, Florida
    United States of America

    904-824-1776

    draahmadi3@gmail.com

    miles

  • 56.

    Omega Research Consultants LLC

    Orlando, Florida
    United States of America

    407-271-8030

    kayesu@omegarcllc.com

    miles

  • 57.

    Ospedale Casa Sollievo Della Sofferenza IRCCS

    San Giovanni Rotondo,
    Italy

    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

    penate@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@aol.com

    miles

  • 74.

    Hepato-Gastroenterologie HK, s. r. o.

    Hradec Kralove,
    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

    +61870742200

    jane.andrews@sa.gov.au

    miles

  • 80.

    Concord Repatriation General Hospital

    Concord, NSW
    Australia

    +61297676111

    rupert.leong@health.nsw.gov.au

    miles

  • 81.

    St Vincents Hospital Melbourne

    Melbourne, 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

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