Not Yet Recruiting

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis (AIDA)

This study is not yet recruiting. Please check back regularly for a status update.

WHAT IS THE PURPOSE OF THIS STUDY?

The purpose of this study is to evaluate the safety and tolerability of long-term treatment with SHP647 in participants with moderate to severe Ulcerative Colitis (UC).

TRIAL AT A GLANCE

Condition

Ulcerative Colitis

Study Intervention

25 mg SHP647 ; 75 mg SHP647

Possibility of Active Treatment

100%

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

For patients who are tolerating study drug and receiving clinical benefit in the judgment of the investigator, study participation (with visits every 4 weeks) may continue until SHP647 becomes available commercially, the subject withdraws from the study, or the investigator or sponsor decide to withdraw the subject, or the sponsor decides to close the study. Patients will enter a 16-week safety follow-up period following the last dose of investigational product. A patient's maximum duration of participation is expected to be approximately6 years. It is expected that the study will be completed in approximately 6 years.

ENTRY CRITERIA

Must have been enrolled previously in study SHP647-301, SHP647-302, or SHP647-303, and reached 1 of the following clinical trial milestones: 1.) Completed the Week 12 visit in induction study SHP647-301 or SHP647-302, and did not achieve a clinical response 2.) Completed the Week 52 visit in maintenance study SHP647-303 3.) Withdrew early from maintenance study SHP647-303 due to treatment failure

Patients who permanently discontinued investigational product because of an adverse event (AE), regardless of relatedness to investigational product, in study SHP647-301, SHP647-302, or SHP647-303 cannot participate

Study Locations

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

RESULTS

  • 1.

    Chicago Association for Research and Education in Science - NAVREF

    Hines, Illinois
    United States of America

    (914) 960-1653

    marmy.shah@va.gov

    miles

  • 2.

    Weill Cornell Medical College

    New York, New York
    United States of America

    (212) 746-5077

    ejs2005@med.cornell.edu

    miles

  • 3.

    Tri County Endoscopy

    Hollywood, Maryland
    United States of America

    (301) 373-7500

    kan9600@yahoo.com

    miles

  • 4.

    Dupage Medical Group

    Oakbrook Terrace, Illinois
    United States of America

    (630) 833-0653

    matthew.smith@dupagemd.com

    miles

  • 5.

    DBC Research

    Tamarac, Florida
    United States of America

    (954) 537-2100

    kbendermd@dbcresearch.com

    miles

  • 6.

    Ohio Clinical Research Partners LLC

    Willoughby, Ohio
    United States of America

    (440) 953-1899

    fvladic@gmail.com

    miles

  • 7.

    Mayo Clinic Health System

    Duluth, Minnesota
    United States of America

    (218) 786-3985

    miles

  • 8.

    Baystate Medical Center

    Springfield, Massachusetts
    United States of America

    (413) 794-7364

    rohit.singhaniamd@baystatehealth.org

    miles

  • 9.

    Gastroenterology Associates of Hazard

    Hazard, Kentucky
    United States of America

    (606) 439-3952

    shankar.gastrohep@gmail.com

    miles

  • 10.

    Atlanta Gastroenterology Specialists, PC

    Atlanta, Georgia
    United States of America

    (678) 957-0057

    bruceasalzberg@yahoo.com

    miles

  • 11.

    University of Vermont

    Burlington, Vermont
    United States of America

    (802) 847-8865

    peter.moses@vtmednet.org

    miles

  • 12.

    Veteran's Research and Education Foundation - NAVREF

    Oklahoma City, Oklahoma
    United States of America

    (405) 361-9482

    mohammad-madhoun@ouhsc.edu

    miles

  • 13.

    University of Miami Miller School of Medicine

    Miami, Florida
    United States of America

    (305) 243-2910

    miles

  • 14.

    NYU Langone Long Island Clinical Research Associates

    Great Neck, New York
    United States of America

    (516) 466-2340

    seymour.katz@nyumc.org

    miles

  • 15.

    Tri-State Gastroentrology Associates

    Florence, Kentucky
    United States of America

    (859) 594-4626

    mjones-research@tsddc.com

    miles

  • 16.

    Kindred Medical Institute for Clinical Trials, LLC

    Corona, California
    United States of America

    (951) 220-4029

    mazen.md@aol.com

    miles

  • 17.

    University of Michigan

    Ann Arbor, Michigan
    United States of America

    (734) 764-0507

    phiggins@med.umich.edu

    miles

  • 18.

    UMass Memorial Medical Center

    Worcester, Massachusetts
    United States of America

    (774) 442-4098

    anne.foley@umassmemorial.org

    miles

  • 19.

    Massachusetts General Hospital

    Boston, Massachusetts
    United States of America

    (617) 724-3238

    aananthakrishnan@partners.org

    miles

  • 20.

    Vanderbilt University Medical Center

    Nashville, Tennessee
    United States of America

    (615) 322-4643

    miles

  • 21.

    Allegheny Center For Digestive Health

    Pittsburgh, Pennsylvania
    United States of America

    (412) 359-8900

    sandra.elhachem@ahn.org

    miles

  • 22.

    Del Sol Research Management

    Tucson, Arizona
    United States of America

    (520) 547-3020

    ggottlieb@delsolresearch.com

    miles

  • 23.

    Northwestern University

    Chicago, Illinois
    United States of America

    (312) 695-4929

    shanauer@northwestern.edu

    miles

  • 24.

    Val Hansen MD

    Salt Lake City City, Utah
    United States of America

    (801) 797-9315

    valhansen@live.com

    miles

  • 25.

    Baylor College of Medicine

    Houston, Texas
    United States of America

    (713) 798-6342

    manreet.kaur@bcm.edu

    miles

  • 26.

    West Virginia University Hospital

    Morgantown, West Virginia
    United States of America

    (304) 293-4123

    jkupec@hsc.wvu.edu

    miles

  • 27.

    CHI Franciscan Digestive Care Associates

    Tacoma, Washington
    United States of America

    (253) 272-8664

    stevenlarson@fhshealth.org

    miles

  • 28.

    VA Long Beach Healthcare System

    Long Beach, California
    United States of America

    (562) 826-8000

    robert.lee@va.gov

    miles

  • 29.

    University of Washington

    Seattle, Washington
    United States of America

    (206) 598-4377

    scottl@medicine.washington.edu

    miles

  • 30.

    Inquest Clinical Research/Coastal Gastroenterology Associates, PA

    Webster, Texas
    United States of America

    (281) 557-2527

    miles

  • 31.

    Digestive Health Center PA

    Ocean Springs, Mississippi
    United States of America

    (228) 872-7612

    lbrowndhc@yahoo.com

    miles

  • 32.

    Advanced Gastro

    Union City, Tennessee
    United States of America

    md@conductclinicaltrials.com

    miles

  • 33.

    Midwest Biomedical Research Foundation - NAVREF

    Kansas City, Missouri
    United States of America

    (816) 861-4700

    tarun.rai@va.gov

    miles

  • 34.

    University of Chicago Medical Center

    Chicago, Illinois
    United States of America

    (773) 834-7414

    drubin@medicine.bsd.uchicago.edu

    miles

  • 35.

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

    Englewood, New Jersey
    United States of America

    (201) 569-7044

    scopemd@aol.com

    miles

  • 36.

    Advanced Clinical Research Network

    Sweetwater, Florida
    United States of America

    (305) 702-1594

    miles

  • 37.

    Columbus Regional Research Institute

    Columbus, Georgia
    United States of America

    (706) 321-0495

    newtrials@serrg.com

    miles

  • 38.

    Arizona Digestive Health

    Sun City, Arizona
    United States of America

    (602) 264-9100

    ctrivedi@arizonadigestivehealth.com

    miles

  • 39.

    Digestive Health Center at UWMC

    Seattle, Washington
    United States of America

    (206) 598-4377

    tzisman@medicine.washington.edu

    miles

  • 40.

    Mid Atlantic Health Specialists

    Galax, Virginia
    United States of America

    (276) 236-2947

    rvbmd@comcast.net

    miles

  • 41.

    University of California San Diego

    La Jolla, California
    United States of America

    (619) 543-2347

    bboland@ucsd.edu

    miles

  • 42.

    Washington University in St. Louis

    Saint Louis, Missouri
    United States of America

    (314) 362-9039

    mciorba@im.wustl.edu

    miles

  • 43.

    Veterans Research Foundation of Pittsburgh - NAVREF

    Pittsburgh, Pennsylvania
    United States of America

    (412) 360-3788

    fadi.francis@va.gov

    miles

  • 44.

    Kelsey Seybold Clinic

    Houston, Texas
    United States of America

    (713) 442-1223

    greg.galler@kelsey-seybold.com

    miles

  • 45.

    Alliance Medical Research LLC

    Coral Springs, Florida
    United States of America

    (954) 428-2480

    info@pioneerclinical.com

    miles

  • 46.

    Chevy Chase Clinical Research

    Chevy Chase, Maryland
    United States of America

    (301) 652-5520

    robert.hardi@capitaldigestivecare.com

    miles

  • 47.

    University of California San Francisco

    San Francisco, California
    United States of America

    (415) 476-0820

    mel.heyman@ucsf.edu

    miles

  • 48.

    Fundación Cardioinfantil Instituto Cardiológico

    Bogotá,
    Colombia

    +5716672727

    miles

  • 49.

    Hospital Universitario San Ignacio

    Bogotá, Cundinamarca
    Colombia

    +5712322118

    albis.hani@javeriana.edu.co

    miles

  • 50.

    Hospital Pablo Tobón Uribe

    Medellin,
    Colombia

    +5744459753

    miles

  • 51.

    Servimed Empresa Unipersonal

    Bucaramanga, Santander
    Colombia

    +5673163032851

    miles

  • 52.

    Fundación Clínica Shaio

    Bogota,
    Colombia

    +3102619871

    ramrs@yahoo.com

    miles

  • 53.

    UZ Gent

    Gent, Oost-Vlaanderen
    Belgium

    +3293322371

    martine.devos@ugent.be

    miles

  • 54.

    Clinical Center Banja Luka

    Banja Luka,
    Bosnia and Herzegovina

    +38751342574

    barac.tatjana@gmail.com

    miles

  • 55.

    Montreal General Hospital

    Montreal, Quebec
    Canada

    (514) 934-1934

    alain.bitton@mchc.mcgill.ca

    miles

  • 56.

    Multiprofile Hospital for Active Treatment Eurohospital

    Plovdiv,
    Bulgaria

    +359888

    akrabovap@yahoo.com

    miles

  • 57.

    Clinical Hospital Osijek

    Osijek,
    Croatia

    +38531511511

    miles

  • 58.

    Institut klinicke a experimentalni mediciny

    Praha 4,
    Czech Republic

    +420603869913

    pavel.drastich@ikem.cz

    miles

  • 59.

    CHU Estaing

    Clermont Ferrand,
    France

    miles

  • 60.

    Marienhospital Stuttgart

    Stuttgart, Baden-Württemberg
    Germany

    +4971164898873

    ewald.hommel@vinzenz.de

    miles

  • 61.

    University General Hospital of Ioannina

    Ioannina, Ioannina
    Greece

    +2651007611

    dchristodoulou@gmail.com

    miles

  • 62.

    Debreceni Egyetem Klinikai Kozpont

    Debrecen,
    Hungary

    +3652255196

    altorjay@med.unideb.hu

    miles

  • 63.

    St Vincent's University Hospital

    Dublin,
    Ireland

    +35312214711

    g.doherty@st-vincents.ie

    miles

  • 64.

    Royal Shrewsbury Hospital

    Shrewsbury, Shropshire
    United Kingdom

    +441743261000

    jeff.butterworth@sath.nhs.uk

    miles

  • 65.

    Tel Aviv Sourasky Medical Center

    Tel Aviv,
    Israel

    +97236974468

    sigalf@tasmc.health.gov.il

    miles

  • 66.

    Complesso Integrato Columbus

    Roma, Roma
    Italy

    +39063503310

    alearmuzzi@yahoo.com

    miles

  • 67.

    Severance Hospital at Yonsei University Health System - PPDS

    Seoul,
    Korea (Republic of)

    +82222281990

    geniushee@yuhs.ac

    miles

  • 68.

    Klaipeda University Hospital

    Klaipeda,
    Lithuania

    +370846396547

    viletajak@gmail.com

    miles

  • 69.

    Centro de Investigacion Clinica Acelerada, S.C.

    Distrito Federal, Distrito Federal
    Mexico

    +525557813954

    emiliobermudez14@yahoo.com.mx

    miles

  • 70.

    Academisch Medisch Centrum Amsterdam

    Amsterdam-Zuidoost,
    Netherlands

    +3215505011

    g.dhaens@amc.uva.nl

    miles

  • 71.

    Instytut Centrum Zdrowia Matki Polki

    Lódz, Lódzkie
    Poland

    +48422711341

    kpg@iczmp.edu.pl

    miles

  • 72.

    Hospital de Braga

    Braga, Braga
    Portugal

    +351253027000

    mraquel.goncalves@gmail.com

    miles

  • 73.

    Cluj Clinical County Hospital

    Cluj-Napoca, Cluj
    Romania

    +40722756475

    dan_dumitrascu@yahoo.de

    miles

  • 74.

    Medical Company Hepatolog, LLC

    Samara,
    Russian Federation

    +79033357481

    alenamalova@mail.ru

    miles

  • 75.

    Clinical Hospital Center ''Bezanijska Kosa''

    Belgrade,
    Serbia

    +381641608353

    mikialeksa5@gmail.com

    miles

  • 76.

    Fakultna nemocnica s poliklinikou F. D. Roosevelta

    Banska Bystrica,
    Slovakia

    +421915071770

    balaz@scouting.sk

    miles

  • 77.

    Hospital Universitario del Rio Hortega

    Valladolid, Valladolid
    Spain

    +34983420400

    jbarrioa95@gmail.com

    miles

  • 78.

    Universität Zürich

    Zürich, Zürich (de)
    Switzerland

    +41442551111

    luc.biedermann@usz.ch

    miles

  • 79.

    Spital Bülach AG

    Bülach, Nordrhein-Westfalen
    Switzerland

    +492217712305

    stephan.boehm@spitalbuelach.ch

    miles

  • 80.

    Kyiv Municipal Clinical Hospital #18

    Kyiv,
    Ukraine

    +380442346649

    bls@ua.fm

    miles

  • 81.

    General Hospital Virovitica

    Virovitica,
    Croatia

    miles

  • 82.

    Mater Adult Hospital

    South Brisbane, Queensland
    Australia

    miles

  • 83.

    Gastroenterologische Gemeinschaftspraxis Minden

    Minden, Nordrhein-Westfalen
    Germany

    miles

  • 84.

    Clinical Hospital Osijek

    Osijek,
    Croatia

    miles

  • 85.

    University Klinichki Bolnicki Centar Zagreb

    Zagreb, Grad Zagreb
    Croatia

    miles

  • 86.

    Dr.Carol Davila Emergency University Central Military Hospital

    Bucharest,
    Romania

    miles

  • 87.

    Gemeinschaftspraxis Dres. Zimber/Brendel/Hoesl/Maintz

    Nürnberg,
    Germany

    miles

  • 88.

    Clinical Neuroscience Solutions Inc

    Orlando, Florida
    United States of America

    miles

  • 89.

    Klinikum Wels-Grieskirchen GmbH

    Wels,
    Austria

    miles

  • 90.

    Northside Gastroenterology

    Cypress, Texas
    United States of America

    miles

  • 91.

    CHRU Lille

    Lille cedex,
    France

    miles

  • 92.

    Institut klinicke a experimentalni mediciny

    Praha 4,
    Czech Republic

    miles

  • 93.

    Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice

    Usti nad Orlici,
    Czech Republic

    miles

  • 94.

    Paracelsus Medizinische Privatuniversität

    Salzburg, Salzburg
    Austria

    miles

  • 95.

    A.ö. Krankenhaus der Barmherzigen Brüder

    St. Veit an der Glan, Kärnten
    Austria

    miles

  • 96.

    Bekes Megyei Kozponti Korhaz

    Gyula,
    Hungary

    miles

  • 97.

    LKH-Universitätsklinikum Klinikum Graz

    Graz, Steiermark
    Austria

    miles

  • 98.

    General Hospital Zadar

    Zadar,
    Croatia

    miles

  • 99.

    General Hospital Karlovac

    Karlovac, Karlovacka županija
    Croatia

    miles

  • 100.

    Northwest Med Care

    Houston, Texas
    United States of America

    miles

  • 101.

    Städtisches Klinikum Lüneburg

    Lüneburg, Niedersachsen
    Germany

    miles

  • 102.

    SI "Dept. Clin. Hospital of Zaporizhzhia-2 Railway Station" of SE "Prydniprovska Zaliznytsia"

    Zaporizhzhia, Zaporiz'ka Oblast
    Ukraine

    miles

  • 103.

    General County Hospital Vukovar

    Vukovar,
    Croatia

    miles

  • 104.

    Klinikum Klagenfurt Am Woerthersee

    Klagenfurt am Wörthersee,
    Austria

    miles

  • 105.

    Clinical Center Nis

    Nis,
    Serbia

    miles

  • 106.

    Gastro Campus Research GbR

    Münster, Nordrhein-Westfalen
    Germany

    miles

  • 107.

    Medizinische Universitat Wien

    Wien,
    Austria

    miles

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