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

Study Purpose

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).

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03662542

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Janssen Research & Development, LLC

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Janssen Research & Development, LLC Clinical Trial
Principal Investigator Affiliation Janssen Research & Development, LLC

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries Argentina, Australia, Brazil, Germany, Mexico, Poland, Russian Federation, Ukraine, United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Colitis, Ulcerative
Study Website: View Trial Website

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Washington Gastroenterology, PLLC, Tacoma, Washington

Status

Recruiting

Address

Washington Gastroenterology, PLLC

Tacoma, Washington, 98405

Gastroenterology Associates of Tidewater, Chesapeake, Virginia

Status

Recruiting

Address

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, 23320

Baylor College of Medicine, Houston, Texas

Status

Not yet recruiting

Address

Baylor College of Medicine

Houston, Texas, 77030

Mentor, Ohio

Status

Withdrawn

Address

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, 44060

Fargo Gastroenterology Clinic, PC, Fargo, North Dakota

Status

Not yet recruiting

Address

Fargo Gastroenterology Clinic, PC

Fargo, North Dakota, 58103

Chapel Hill, North Carolina

Status

Not yet recruiting

Address

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599

Sierra Clinical Research, Las Vegas, Nevada

Status

Recruiting

Address

Sierra Clinical Research

Las Vegas, Nevada, 89106

John D. Dingell VA Medical Center, Detroit, Michigan

Status

Not yet recruiting

Address

John D. Dingell VA Medical Center

Detroit, Michigan, 48201

Chevy Chase Clinical Research, Chevy Chase, Maryland

Status

Recruiting

Address

Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815

Tandem Clinical Research, Marrero, Louisiana

Status

Withdrawn

Address

Tandem Clinical Research

Marrero, Louisiana, 70072

Indiana University, Indianapolis, Indiana

Status

Not yet recruiting

Address

Indiana University

Indianapolis, Indiana, 46202

Gastrointestinal Specialists of Georgia, Marietta, Georgia

Status

Not yet recruiting

Address

Gastrointestinal Specialists of Georgia

Marietta, Georgia, 30060

GCP Clinical Research, Tampa, Florida

Status

Recruiting

Address

GCP Clinical Research

Tampa, Florida, 33609

Advanced Medical Research Center, Port Orange, Florida

Status

Not yet recruiting

Address

Advanced Medical Research Center

Port Orange, Florida, 32127

Peak Gastroenterology Associates, Colorado Springs, Colorado

Status

Not yet recruiting

Address

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907

Precision Research Institute, San Diego, California

Status

Recruiting

Address

Precision Research Institute

San Diego, California, 92114

International Sites

Miska likarnia №7, Zaporizhzhia, Ukraine

Status

Not yet recruiting

Address

Miska likarnia №7

Zaporizhzhia, , 69118

Vinnytsya, Ukraine

Status

Not yet recruiting

Address

Vinnytsya regional clinical hospital n.a.Pyrogov, VNMU

Vinnytsya, , 21018

Vinnytsya, Ukraine

Status

Not yet recruiting

Address

Medical Center Ltd 'Health Clinic', Department Of General Therapy

Vinnytsya, , 21009

Ternopil University Hospital, Ternopil, Ukraine

Status

Not yet recruiting

Address

Ternopil University Hospital

Ternopil, , 46002

Odessa, Ukraine

Status

Not yet recruiting

Address

State Institution Odesa Regional Clinical Hospital

Odessa, ,

Lviv, Ukraine

Status

Not yet recruiting

Address

Danylo Halytsky Lviv National Medical University

Lviv, , 79010

Private Clinic OK Clinic, Kyiv, Ukraine

Status

Not yet recruiting

Address

Private Clinic OK Clinic

Kyiv, , 02091

Kyivska miska klinichna likarnia 18, Kyiv, Ukraine

Status

Not yet recruiting

Address

Kyivska miska klinichna likarnia 18

Kyiv, , 01030

Kherson, Ukraine

Status

Not yet recruiting

Address

KZ Khersonska Miska Klinichna Likarnia Im. Ye.Ie.Karabelesha

Kherson, , 73000

Kharkiv, Ukraine

Status

Not yet recruiting

Address

SE 'National institute therapy named L.T. Maloi NAMS of Ukraine'

Kharkiv, , 61039

Kharkiv City Clinical Hospital, Kharkiv, Ukraine

Status

Not yet recruiting

Address

Kharkiv City Clinical Hospital

Kharkiv, , 61037

Chernivtsi Regional Clinical Hospital, Chernivtsi, Ukraine

Status

Not yet recruiting

Address

Chernivtsi Regional Clinical Hospital

Chernivtsi, , 58001

Regional Clinical Hospital, Yaroslavl, Russian Federation

Status

Recruiting

Address

Regional Clinical Hospital

Yaroslavl, , 150062

City Clinical Hospital #2, Yaroslavl, Russian Federation

Status

Recruiting

Address

City Clinical Hospital #2

Yaroslavl, , 150010

City Clinical Hospital # 21, Ufa, Russian Federation

Status

Withdrawn

Address

City Clinical Hospital # 21

Ufa, , 450071

Ufa, Russian Federation

Status

Recruiting

Address

GBUZ Respublican Clinical Hospital n.a. GG Kuvatova

Ufa, , 450005

Tver Regional Clinical Hospital, Tver, Russian Federation

Status

Not yet recruiting

Address

Tver Regional Clinical Hospital

Tver, , 170036

International Medical Centre SOGAZ, St-Petersburg, Russian Federation

Status

Recruiting

Address

International Medical Centre SOGAZ

St-Petersburg, , 191186

Medical University Reaviz, Samara, Russian Federation

Status

Not yet recruiting

Address

Medical University Reaviz

Samara, , 443001

City Clinical Hospital # 26, Saint-Petersburg, Russian Federation

Status

Recruiting

Address

City Clinical Hospital # 26

Saint-Petersburg, , 196247

Saint-Petersburg, Russian Federation

Status

Withdrawn

Address

City Hospital named after St. Martyr Elizabeth

Saint-Petersburg, , 195257

Jsc Clinic Complex, Saint-Petersburg, Russian Federation

Status

Withdrawn

Address

Jsc Clinic Complex

Saint-Petersburg, , 190013

City Hospital #9, Saint Petersburg, Russian Federation

Status

Withdrawn

Address

City Hospital #9

Saint Petersburg, , 197110

City Clinical Hospital #31, Saint Petersburg, Russian Federation

Status

Recruiting

Address

City Clinical Hospital #31

Saint Petersburg, , 197110

Elizavetinskaya hospital, Saint Petersburg, Russian Federation

Status

Not yet recruiting

Address

Elizavetinskaya hospital

Saint Petersburg, , 195257

Leningrad Regional Clinical Hospital, Saint Petersburg, Russian Federation

Status

Withdrawn

Address

Leningrad Regional Clinical Hospital

Saint Petersburg, , 194291

Saint Petersburg, Russian Federation

Status

Withdrawn

Address

Clinical Hospital #122 n.a. after L.G. Sokolov

Saint Petersburg, , 194291

Rostov State Medical University, Rostov-On-Don, Russian Federation

Status

Recruiting

Address

Rostov State Medical University

Rostov-On-Don, , 344022

Novosibirsk, Russian Federation

Status

Withdrawn

Address

Federal State Budgetary Institution 'Scientific Research Institute'

Novosibirsk, , 630117

Medical Center 'SibNovoMed' LLC, Novosibirsk, Russian Federation

Status

Not yet recruiting

Address

Medical Center 'SibNovoMed' LLC

Novosibirsk, , 630005

LEC City Clinical Hospital # 24, Moscow, Russian Federation

Status

Not yet recruiting

Address

LEC City Clinical Hospital # 24

Moscow, , 127015

Kazan State Medical University, Kazan, Russian Federation

Status

Recruiting

Address

Kazan State Medical University

Kazan, , 420012

Medical Association 'New Hospital', Ekaterinburg, Russian Federation

Status

Recruiting

Address

Medical Association 'New Hospital'

Ekaterinburg, , 620109

Melita Medical, Wroclaw, Poland

Status

Not yet recruiting

Address

Melita Medical

Wroclaw, , 50-499

Warszawa, Poland

Status

Recruiting

Address

Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz

Warszawa, , 03 580

Centrum Zdrowia MDM, Warszawa, Poland

Status

Recruiting

Address

Centrum Zdrowia MDM

Warszawa, , 00-635

Warsaw, Poland

Status

Not yet recruiting

Address

Centralny Szpital Kliniczny MSWiA w Warszawie

Warsaw, , 02-507

Endoskopia Sp z o.o., Sopot, Poland

Status

Not yet recruiting

Address

Endoskopia Sp z o.o.

Sopot, , 81-756

Pratia MCM Krakow, Krakow, Poland

Status

Not yet recruiting

Address

Pratia MCM Krakow

Krakow, , 30-510

Gdansk, Poland

Status

Not yet recruiting

Address

Synexus Polska Sp. z o.o. Oddzial w Gdansku

Gdansk, , 80-382

Centro Medico Zambrano Hellion, San Pedro Garza Garcia, Mexico

Status

Not yet recruiting

Address

Centro Medico Zambrano Hellion

San Pedro Garza Garcia, , 66278

Monterrey, Mexico

Status

Not yet recruiting

Address

Centro Regiomontano de Estudios Clínicos Roma S.C.

Monterrey, , 64610

Mexico, Mexico

Status

Not yet recruiting

Address

Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán

Mexico, , 14080

Clínica Saluz, Boca Del Rio, Mexico

Status

Not yet recruiting

Address

Clínica Saluz

Boca Del Rio, , 94229

Universitaetsklinikum Ulm, Ulm, Germany

Status

Not yet recruiting

Address

Universitaetsklinikum Ulm

Ulm, , 89081

Universitätsklinikum Jena, Jena, Germany

Status

Not yet recruiting

Address

Universitätsklinikum Jena

Jena, , 07740

Frankfurt, Germany

Status

Not yet recruiting

Address

Universitätsklinikum Frankfurt/ Medizinische Klinik 1

Frankfurt, , 60590

DRK Kliniken Westend, Berlin, Germany

Status

Withdrawn

Address

DRK Kliniken Westend

Berlin, , 14050

Charite Berlin, Berlin, Germany

Status

Not yet recruiting

Address

Charite Berlin

Berlin, , 12203

Eurolatino Pesquisas Médicas, Uberlândia, Brazil

Status

Not yet recruiting

Address

Eurolatino Pesquisas Médicas

Uberlândia, , 38400-368

Hospital Sirio Libanes, São Paulo, Brazil

Status

Not yet recruiting

Address

Hospital Sirio Libanes

São Paulo, , 13080-060

Kaiser Hospta, São José Do Rio Preto, Brazil

Status

Not yet recruiting

Address

Kaiser Hospta

São José Do Rio Preto, , 15015-110

Faculdade de Medicina Do Abc, Santo Andre, Brazil

Status

Not yet recruiting

Address

Faculdade de Medicina Do Abc

Santo Andre, , 09060-870

Bioclinica, Rio De Janeiro, Brazil

Status

Not yet recruiting

Address

Bioclinica

Rio De Janeiro, , 22271-100

Rio De Janeiro, Brazil

Status

Not yet recruiting

Address

UFRJ-Hospital Universitário Clementino Fraga Filho

Rio De Janeiro, , 20050-902

Porto Alegre, Brazil

Status

Not yet recruiting

Address

Hospital de Clínicas de Porto Alegre/ HCPA / UFRGS

Porto Alegre, , 90035-903

Clinica De Gastroenterologia, Goiania, Brazil

Status

Not yet recruiting

Address

Clinica De Gastroenterologia

Goiania, , 74535-170

Hospital Nossa Senhora Das Gracas, Curitiba, Brazil

Status

Not yet recruiting

Address

Hospital Nossa Senhora Das Gracas

Curitiba, , 80810-040

Botucatu, Brazil

Status

Not yet recruiting

Address

Universidade Estadual Paulista 'Julio De Mesquita Filho'

Botucatu, , 18618-970

Hospital Das Clinicas Da Ufmg, Belo Horizonte, Brazil

Status

Not yet recruiting

Address

Hospital Das Clinicas Da Ufmg

Belo Horizonte, , 30130-100

The Queen Elizabeth Hospital, Woodville South, Australia

Status

Withdrawn

Address

The Queen Elizabeth Hospital

Woodville South, , 5011

South Brisbane, Australia

Status

Recruiting

Address

Mater Hospital Brisbane (Inflammatory Bowel Diseases)

South Brisbane, , 4101

Royal Melbourne Hospital, Parkville, Australia

Status

Not yet recruiting

Address

Royal Melbourne Hospital

Parkville, , 3050

Royal Adelaide Hospital, North Terrace, Australia

Status

Not yet recruiting

Address

Royal Adelaide Hospital

North Terrace, , 5000

Nepean Hospital, Kingswood, Australia

Status

Not yet recruiting

Address

Nepean Hospital

Kingswood, , 2747

Saint Vincent's Hospital - Melbourne, Fitzroy, Australia

Status

Recruiting

Address

Saint Vincent's Hospital - Melbourne

Fitzroy, , 3065

St Vincent's hospital, Darlinghurst, Australia

Status

Withdrawn

Address

St Vincent's hospital

Darlinghurst, , 2010

Concord Hospital, Concord, Australia

Status

Withdrawn

Address

Concord Hospital

Concord, , 2139

Princess Alexandra Hospital, Brisbane, Australia

Status

Not yet recruiting

Address

Princess Alexandra Hospital

Brisbane, , 4102

Sanatorio 9 de Julio, San Miguel De Tucuman, Argentina

Status

Not yet recruiting

Address

Sanatorio 9 de Julio

San Miguel De Tucuman, , 4000

Fundación de Estudios Clínicos, Rosario, Argentina

Status

Not yet recruiting

Address

Fundación de Estudios Clínicos

Rosario, , 2000

Florencio Varela, Argentina

Status

Not yet recruiting

Address

Hospital de Alta Complejidad en Red 'El Cruce'

Florencio Varela, , 1888

Hospital Britanico de Buenos Aires, Ciudad Autonoma De Buenos Aires, Argentina

Status

Not yet recruiting

Address

Hospital Britanico de Buenos Aires

Ciudad Autonoma De Buenos Aires, , C1280AEB

Expertia S.A, Caba, Argentina

Status

Not yet recruiting

Address

Expertia S.A

Caba, , C1128AAF

Hospital Aleman, Buenos Aires, Argentina

Status

Not yet recruiting

Address

Hospital Aleman

Buenos Aires, , C1118AAT

Buenos Aires, Argentina

Status

Not yet recruiting

Address

CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

Buenos Aires, , 1431

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