A Study of Efficacy and Safety of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis

Last Updated   April 20, 2019 - 00:00

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OVERVIEW

  • Gender
    all
  • Age
    18 - 65 years
  • Phase
    phase 2
    The drug or treatment is given to a larger group of people to see if it is effective and to better understand its safety.
  • Sites
    96 sites
  • Status
    Recruiting

SUMMARY

The purpose of this study is to evaluate the clinical efficacy and safety of combination therapy with guselkumab and golimumab in participants with moderately to severely active ulcerative colitis (UC).

CONDITIONS

  • Colitis, Ulcerative

ELIGIBILITY

Inclusion Criteria:

  • • Confirmed clinical diagnosis of ulcerative colitis (UC) at least 3 months before screening
  • • Moderately to severely active UC as defined by Mayo score
  • • History of inadequate response to or failure to tolerate conventional therapy
  • • Has screening laboratory test results within the study protocol defined parameters
  • • A woman of childbearing potential must have a negative highly sensitive serum (beta human chorionic gonadotropin) pregnancy test result at screening and a negative urine pregnancy test result at Week 0

Exclusion Criteria:

  • • Has severe extensive colitis as defined in the study protocol
  • • Has UC limited to the rectum only or to less than (<) 20 centimeter (cm) of the colon
  • • Has a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, before screening
  • • Has any known malignancy or has a history of malignancy (with the exception of basal cell carcinoma; squamous cell carcinoma in situ of the skin; or cervical carcinoma in situ that has been treated with no evidence of recurrence; or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years before screening)
  • • Has known allergies, hypersensitivity, or intolerance to guselkumab or golimumab or their excipients

DETAILS

LOCATIONS

Locations in:
Ukraine, Australia, Poland, Argentina, Germany, Brazil, Mexico, United States, Russia
City or Province (96) Country (9) Status
Lviv Danylo Halytsky Lviv National Medical University Ukraine
Not yet recruiting
Kharkiv Kharkiv City Clinical Hospital Ukraine
Not yet recruiting
Kharkiv SE 'National institute therapy named L.T. Maloi NAMS of Ukraine' Ukraine
Not yet recruiting
Vinnytsya Medical Center Ltd 'Health Clinic', Department Of General Therapy Ukraine
Not yet recruiting
Ternopil Ternopil University Hospital Ukraine
Not yet recruiting
Odessa State Institution Odesa Regional Clinical Hospital Ukraine
Not yet recruiting
Kherson KZ Khersonska Miska Klinichna Likarnia Im. Ye.Ie.Karabelesha Ukraine
Not yet recruiting
Vinnytsya Vinnytsya regional clinical hospital n.a.Pyrogov, VNMU Ukraine
Not yet recruiting
Zaporizhzhia Miska likarnia №7 Ukraine
Not yet recruiting
Kyiv Kyivska miska klinichna likarnia 18 Ukraine
Not yet recruiting
Kyiv Private Clinic OK Clinic Ukraine
Not yet recruiting
Darlinghurst, NSW St Vincent's hospital Australia
Withdrawn
Kingswood, NSW Nepean Hospital Australia
Not yet recruiting
Warsaw Centralny Szpital Kliniczny MSWiA w Warszawie Poland
Not yet recruiting
Brisbane, QLD Princess Alexandra Hospital Australia
Not yet recruiting
Rosario, S Fundación de Estudios Clínicos Argentina
Not yet recruiting
Buenos Aires, B CEMIC (Centro de Educación Médica e Investigaciones Clínicas) Argentina
Not yet recruiting
Buenos Aires, B Hospital Aleman Argentina
Not yet recruiting
Berlin, BE Charite Berlin Germany
Not yet recruiting
Frankfurt Universitätsklinikum Frankfurt/ Medizinische Klinik 1 Germany
Not yet recruiting
Ulm, BW Universitaetsklinikum Ulm Germany
Not yet recruiting
Jena Universitätsklinikum Jena Germany
Not yet recruiting
Goiania Clinica De Gastroenterologia Brazil
Not yet recruiting
Porto Alegre Hospital de Clínicas de Porto Alegre/ HCPA / UFRGS Brazil
Not yet recruiting
Santo Andre, SP FACULDADE DE MEDICINA DO ABC Brazil
Not yet recruiting
Botucatu, SP Universidade Estadual Paulista 'Julio De Mesquita Filho' Brazil
Not yet recruiting
Belo Horizonte HOSPITAL DAS CLINICAS DA UFMG Brazil
Not yet recruiting
Uberlândia, MG Eurolatino Pesquisas Médicas Brazil
Not yet recruiting
São Paulo Hospital Sirio Libanes Brazil
Not yet recruiting
Woodville South, SA The Queen Elizabeth Hospital Australia
Withdrawn
Caba, B Expertia S.A Argentina
Not yet recruiting
Gdansk Synexus Polska Sp. z o.o. Oddzial w Gdansku Poland
Not yet recruiting
Krakow Pratia MCM Krakow Poland
Not yet recruiting
Berlin, BE DRK Kliniken Westend Germany
Withdrawn
San Pedro Garza Garcia Centro Medico Zambrano Hellion Mexico
Not yet recruiting
Mexico Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán Mexico
Not yet recruiting
Concord, NSW Concord Hospital Australia
Withdrawn
South Brisbane, QLD Mater Hospital Brisbane (Inflammatory Bowel Diseases) Australia
Recruiting
Fitzroy, VIC Saint Vincent's Hospital - Melbourne Australia
Recruiting
Warszawa Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz Poland
Recruiting
Warszawa Centrum Zdrowia MDM Poland
Recruiting
Monterrey Centro Regiomontano de Estudios Clínicos Roma S.C. Mexico
Not yet recruiting
Florencio Varela, B Hospital de Alta Complejidad en Red 'El Cruce' Argentina
Not yet recruiting
North Terrace, SA Royal Adelaide Hospital Australia
Not yet recruiting
Mentor, OH Great Lakes Gastroenterology Research, LLC United States
Withdrawn
Moscow LEC City Clinical Hospital # 24 Russia
Recruiting
Ekaterinburg Medical Association 'New Hospital' Russia
Recruiting
Yaroslavl Regional Clinical Hospital Russia
Recruiting
Kazan Kazan State Medical University Russia
Recruiting
Ufa GBUZ Respublican Clinical Hospital n.a. GG Kuvatova Russia
Recruiting
Saint Petersburg City Hospital #9 Russia
Withdrawn
Ufa City Clinical Hospital # 21 Russia
Withdrawn
St-Petersburg International Medical Centre SOGAZ Russia
Recruiting
Novosibirsk Medical Center 'SibNovoMed' LLC Russia
Recruiting
Saint Petersburg Elizavetinskaya hospital Russia
Recruiting
Saint Petersburg City Clinical Hospital #31 Russia
Recruiting
Saint-Petersburg City Clinical Hospital # 26 Russia
Recruiting
Rostov-On-Don Rostov State Medical University Russia
Recruiting
Novosibirsk Federal State Budgetary Institution 'Scientific Research Institute' Russia
Withdrawn
San Diego, CA Precision Research Institute United States
Recruiting
Las Vegas, NV Sierra Clinical Research United States
Recruiting
Chapel Hill, NC The University of North Carolina at Chapel Hill United States
Recruiting
Chernivtsi Chernivtsi Regional Clinical Hospital Ukraine
Withdrawn
Tacoma, WA Washington Gastroenterology, PLLC United States
Recruiting
Marietta, GA Gastrointestinal Specialists of Georgia United States
Not yet recruiting
Chesapeake, VA Gastroenterology Associates of Tidewater United States
Recruiting
Chevy Chase, MD Chevy Chase Clinical Research United States
Recruiting
Marrero, LA Tandem Clinical Research United States
Withdrawn
Parkville, VIC Royal Melbourne Hospital Australia
Recruiting
Saint Petersburg Clinical Hospital #122 n.a. after L.G. Sokolov Russia
Withdrawn
Saint-Petersburg City Hospital named after St. Martyr Elizabeth Russia
Withdrawn
Wroclaw Melita Medical Sp. z o.o. Poland
Recruiting
Sopot, PM Endoskopia Sp. z o.o. z siedzibą w Sopocie Poland
Not yet recruiting
Yaroslavl City Clinical Hospital #2 Russia
Recruiting
San Miguel de Tucuman, T Sanatorio 9 de Julio Argentina
Not yet recruiting
Ciudad Autonoma de Buenos Aires, B Hospital Britanico de Buenos Aires Argentina
Not yet recruiting
Colorado Springs, CO Peak Gastroenterology Associates United States
Not yet recruiting
Houston, TX Baylor College of Medicine United States
Not yet recruiting
Tampa, FL GCP Clinical Research United States
Recruiting
Curitiba Hospital Nossa Senhora Das Gracas Brazil
Withdrawn
Rio de Janeiro, RJ UFRJ-Hospital Universitário Clementino Fraga Filho Brazil
Not yet recruiting
Rio de Janeiro, RJ Bioclinica Brazil
Not yet recruiting
São José do Rio Preto, SP Kaiser Hospta Brazil
Not yet recruiting
Saint Petersburg Leningrad Regional Clinical Hospital Russia
Withdrawn
Samara Medical University Reaviz Russia
Recruiting
Tver Tver Regional Clinical Hospital Russia
Not yet recruiting
Saint-Petersburg JSC CLINIC COMPLEX Russia
Withdrawn
Boca del Rio, VER Clínica Saluz Mexico
Not yet recruiting
Port Orange, FL Advanced Medical Research Center United States
Not yet recruiting
Fargo, ND Fargo Gastroenterology Clinic, PC United States
Not yet recruiting
Indianapolis, IN Indiana University United States
Not yet recruiting
Detroit, MI John D. Dingell VA Medical Center United States
Not yet recruiting
New South Wales, NSW Macquarie University Hospital Australia
Not yet recruiting
Seattle, WA Virginia Mason United States
Not yet recruiting
Lviv Derzhavnyi zaklad Klinichna likarnia DTHO Lvivska zaliznytsia Ukraine
Not yet recruiting
Ciudad Autónoma de Buenos Aires, B Centro Médico Dra. De Salvo Argentina
Not yet recruiting
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