Last updated on June 2020

A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis


Brief description of study

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

Detailed Study Description

UC is a chronic disease of the large intestine, in which the lining of the colon becomes inflamed and develops ulcers. Guselkumab is a fully human immunoglobulin G1 lambda monoclonal antibody (mAb) that binds to human interleukin (IL)-23 with high affinity. The study is designed to answer scientific questions pertaining to the efficacy and safety of guselkumab in the treatment of moderately to severely active UC. Overall, the study will evaluate long-term guselkumab treatment. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points.

Clinical Study Identifier: NCT04033445

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Alabama Medical Group

Mobile, AL United States
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University of Arizona

Tucson, AZ United States
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UC San Diego

La Jolla, CA United States
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Om Research LLC

Lancaster, CA United States
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UCLA

Los Angeles, CA United States
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Peak Gastroenterology Associates

Colorado Springs, CO United States
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Florida Research Network, LLC

Gainesville, FL United States
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University of Florida

Gainesville, FL United States
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River City Clinical Research

Jacksonville, FL United States
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SIH Research

Kissimmee, FL United States
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San Marcus Research Clinic, Inc.

Miami Lakes, FL United States
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GCP Clinical Research

Tampa, FL United States
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Emory University

Atlanta, GA United States
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IU Health University Hospital

Indianapolis, IN United States
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Tri-State Gastroenterology Assoc

Crestview Hills, KY United States
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CroNOLA, LLC

Houma, LA United States
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Louisiana Research Center

Shreveport, LA United States
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Chevy Chase Clinical Research

Chevy Chase, MD United States
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Capitol Research

Rockville, MD United States
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Baystate Medical Center

Springfield, MA United States
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Somnos Clinical Research

Lincoln, NE United States
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Digestive Disease Specialists Inc

Oklahoma City, OK United States
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University of Tennessee

Chattanooga, TN United States
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Inquest Clinical Research

Baytown, TX United States
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Baylor College of Medicine

Houston, TX United States
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Caprock Gastro Research

Lubbock, TX United States
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University of Washington

Seattle, WA United States
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Cer Instituto Medico

Buenos Aires, Argentina
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Expertia S.A

Caba, Argentina
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Cl nica Adventista Belgrano

Ciudad De Buenos Aires, Argentina
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HIGA San Martin

La Plata, Argentina
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Sanatorio 9 de Julio

San Miguel de Tucuman, Argentina
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Centro Medico Privado de Reumatologia

San Miguel De Tucuman, Argentina
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Emeritus Research

Camberwell, Australia
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Monash Health

Clayton, Australia
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St Vincent's hospital

Darlinghurst, Australia
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Western Health

Footscray, Australia
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Austin Health

Heidelberg, Australia
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Mater Hospital

South Brisbane, Australia
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2-nd MHAT

Sofia, Bulgaria
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MHAT Dr Stefan Cherkezov

Veliko Tarnovo, Bulgaria
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Hopital Saint Eloi

Montpellier, France
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CHU Saint-Etienne - H pital Nord

Saint-Priest en Jarez, France
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Toulouse, France
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CHRU Nancy-Brabois

Vandoeuvre-les-Nancy, France
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Ansan-si, Korea, Republic of
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Seoul, Korea, Republic of
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Samsung Medical Center

Seoul, Korea, Republic of
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Ajou University Hospital

Suwon, Korea, Republic of
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Radboudumc

Nijmegen, Netherlands
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NZOZ Vivamed

Warszawa, Poland
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ETG Zamosc

Zamosc, Poland
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MedLife Grivita

Bucuresti, Romania
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Spital Premiere

Timisoara, Romania
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LLC Evimed

Chelyabinsk, Russian Federation
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Ekaterinburg, Russian Federation
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Medical Center 'SibNovoMed' LLC

Novosibirsk, Russian Federation
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Rostov State Medical University

Rostov-On-Don, Russian Federation
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Elizavetinskaya hospital

Saint Petersburg, Russian Federation
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Eco-safety Ltd

Saint-Petersburg, Russian Federation
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Medical University Reaviz

Samara, Russian Federation
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International Medical Centre SOGAZ

St-Petersburg, Russian Federation
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Regional Clinical Hospital

Yaroslavl, Russian Federation
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Cambridge, United Kingdom
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Glasgow, United Kingdom
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Royal Free Hospital

London, United Kingdom
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London, United Kingdom
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Whiston Hospital

Prescot, United Kingdom
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Washington University

Saint Louis, MO United States
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Revive Research Institute

Farmington Hills, MI United States
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Crescent Health Clinical

DeSoto, TX United States
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Providence Medical Group

Spokane, WA United States
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CHU Reims

Reims, France
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Minnesota Gastroenterology, P.A

Minneapolis, MN United States
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Erlanger Health System

Chattanooga, TN United States
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Cl nica Adventista Belgrano

Ciudad De Buenos Aires, Argentina
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CHU Saint-Etienne - H pital Nord

Saint-Priest en Jarez, France
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Kissimmee, FL United States
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Las Vegas Medical Research

Las Vegas, NV United States
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Recruitment Status: Open


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