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

Accepts Healthy Volunteers

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

No
Study Type

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.

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

Trial ID:

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.

NCT03662542
Phase

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 2
Lead Sponsor

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

Janssen Research & Development, LLC
Principal Investigator

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

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

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

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

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

Colitis, Ulcerative
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Combination Therapy

Participants will receive guselkumab Dose 1 as intravenous (IV) infusion and Dose 2 as subcutaneous (SC) injection; and golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.

Experimental: Monotherapy: Guselkumab

Participants will receive guselkumab Dose 1 as IV infusion, Dose 2 as SC injection and placebo to maintain the blind.

Active Comparator: Monotherapy: Golimumab

Participants will receive golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.

Interventions

Drug: - Guselkumab Dose 1

Guselkumab Dose 1 will be administered as IV infusion.

Drug: - Guselkumab Dose 2

Guselkumab Dose 2 will be administered as SC injection.

Drug: - Golimumab Dose 1

Golimumab Dose 1 will be administered as SC injection.

Drug: - Golimumab Dose 2

Golimumab Dose 2 will be administered as SC injection.

Drug: - Placebo

Placebo will be administered.

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.

Southern Arizona VA Healthcare System, Tucson, Arizona

Status

Withdrawn

Address

Southern Arizona VA Healthcare System

Tucson, Arizona, 85723

Precision Research Institute, San Diego, California

Status

Recruiting

Address

Precision Research Institute

San Diego, California, 92114

Peak Gastroenterology Associates, Colorado Springs, Colorado

Status

Recruiting

Address

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907

Advanced Medical Research Center, Port Orange, Florida

Status

Withdrawn

Address

Advanced Medical Research Center

Port Orange, Florida, 32127

GCP Clinical Research, Tampa, Florida

Status

Recruiting

Address

GCP Clinical Research

Tampa, Florida, 33609

Gastrointestinal Specialists of Georgia, Marietta, Georgia

Status

Recruiting

Address

Gastrointestinal Specialists of Georgia

Marietta, Georgia, 30060

Indiana University, Indianapolis, Indiana

Status

Recruiting

Address

Indiana University

Indianapolis, Indiana, 46202

Tandem Clinical Research, Marrero, Louisiana

Status

Withdrawn

Address

Tandem Clinical Research

Marrero, Louisiana, 70072

Chevy Chase Clinical Research, Chevy Chase, Maryland

Status

Recruiting

Address

Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815

Woodholme Gastroenterology, Glen Burnie, Maryland

Status

Recruiting

Address

Woodholme Gastroenterology

Glen Burnie, Maryland, 21061

John D. Dingell VA Medical Center, Detroit, Michigan

Status

Withdrawn

Address

John D. Dingell VA Medical Center

Detroit, Michigan, 48201

Sierra Clinical Research, Las Vegas, Nevada

Status

Recruiting

Address

Sierra Clinical Research

Las Vegas, Nevada, 89106

Chapel Hill, North Carolina

Status

Recruiting

Address

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599

Fargo Gastroenterology Clinic, PC, Fargo, North Dakota

Status

Completed

Address

Fargo Gastroenterology Clinic, PC

Fargo, North Dakota, 58103

Mentor, Ohio

Status

Withdrawn

Address

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, 44060

Baylor College of Medicine, Houston, Texas

Status

Withdrawn

Address

Baylor College of Medicine

Houston, Texas, 77030

Texas Digestive Disease Consultants, Southlake, Texas

Status

Recruiting

Address

Texas Digestive Disease Consultants

Southlake, Texas, 76092

Gastroenterology Associates of Tidewater, Chesapeake, Virginia

Status

Recruiting

Address

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, 23320

Virginia Mason, Seattle, Washington

Status

Recruiting

Address

Virginia Mason

Seattle, Washington, 98101

Washington Gastroenterology, PLLC, Tacoma, Washington

Status

Suspended

Address

Washington Gastroenterology, PLLC

Tacoma, Washington, 98405

International Sites

Buenos Aires, Argentina

Status

Recruiting

Address

CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

Buenos Aires, , 1431

Hospital Aleman, Buenos Aires, Argentina

Status

Withdrawn

Address

Hospital Aleman

Buenos Aires, , C1118AAT

Expertia S.A, Caba, Argentina

Status

Recruiting

Address

Expertia S.A

Caba, , C1128AAF

Centro Médico Dra. De Salvo, Caba, Argentina

Status

Recruiting

Address

Centro Médico Dra. De Salvo

Caba, , C1426ABP

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

Status

Recruiting

Address

Hospital Britanico de Buenos Aires

Ciudad Autonoma de Buenos Aires, , C1280AEB

Clínica Adventista Belgrano, Ciudad De Buenos Aires, Argentina

Status

Recruiting

Address

Clínica Adventista Belgrano

Ciudad De Buenos Aires, , C1430EGF

Florencio Varela, Argentina

Status

Recruiting

Address

Hospital de Alta Complejidad en Red 'El Cruce'

Florencio Varela, , 1888

Fundación de Estudios Clínicos, Rosario, Argentina

Status

Recruiting

Address

Fundación de Estudios Clínicos

Rosario, , 2000

Sanatorio 9 de Julio, San Miguel de Tucuman, Argentina

Status

Recruiting

Address

Sanatorio 9 de Julio

San Miguel de Tucuman, , 4000

Princess Alexandra Hospital, Brisbane, Australia

Status

Recruiting

Address

Princess Alexandra Hospital

Brisbane, , 4102

St Vincent's hospital, Darlinghurst, Australia

Status

Withdrawn

Address

St Vincent's hospital

Darlinghurst, , 2010

Saint Vincent's Hospital - Melbourne, Fitzroy, Australia

Status

Recruiting

Address

Saint Vincent's Hospital - Melbourne

Fitzroy, , 3065

Nepean Hospital, Kingswood, Australia

Status

Recruiting

Address

Nepean Hospital

Kingswood, , 2747

Macquarie University Hospital, New South Wales, Australia

Status

Recruiting

Address

Macquarie University Hospital

New South Wales, , 2109

Royal Adelaide Hospital, North Terrace, Australia

Status

Recruiting

Address

Royal Adelaide Hospital

North Terrace, , 5000

Royal Melbourne Hospital, Parkville, Australia

Status

Recruiting

Address

Royal Melbourne Hospital

Parkville, , 3050

South Brisbane, Australia

Status

Recruiting

Address

Mater Hospital Brisbane (Inflammatory Bowel Diseases)

South Brisbane, , 4101

The Queen Elizabeth Hospital, Woodville South, Australia

Status

Withdrawn

Address

The Queen Elizabeth Hospital

Woodville South, , 5011

Hospital Das Clinicas Da Ufmg, Belo Horizonte, Brazil

Status

Recruiting

Address

Hospital Das Clinicas Da Ufmg

Belo Horizonte, , 30130-100

Botucatu, Brazil

Status

Recruiting

Address

Universidade Estadual Paulista 'Julio De Mesquita Filho'

Botucatu, , 18618-970

Hospital Nossa Senhora Das Gracas, Curitiba, Brazil

Status

Withdrawn

Address

Hospital Nossa Senhora Das Gracas

Curitiba, , 80810-040

Clinica De Gastroenterologia, Goiania, Brazil

Status

Recruiting

Address

Clinica De Gastroenterologia

Goiania, , 74535-170

Porto Alegre, Brazil

Status

Recruiting

Address

Hospital de Clínicas de Porto Alegre/ HCPA / UFRGS

Porto Alegre, , 90035-903

Ribeirão Preto, Brazil

Status

Recruiting

Address

Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo

Ribeirão Preto, , 14098-900

Rio de Janeiro, Brazil

Status

Recruiting

Address

UFRJ-Hospital Universitário Clementino Fraga Filho

Rio de Janeiro, , 20050-902

Instituto Brasil de Pesquisa Clinica, Rio de Janeiro, Brazil

Status

Recruiting

Address

Instituto Brasil de Pesquisa Clinica

Rio de Janeiro, , 20241-180

Faculdade de Medicina Do Abc, Santo Andre, Brazil

Status

Recruiting

Address

Faculdade de Medicina Do Abc

Santo Andre, , 09060-870

Kaiser Hospta, São José Do Rio Preto, Brazil

Status

Recruiting

Address

Kaiser Hospta

São José Do Rio Preto, , 15015-110

Hospital Sirio Libanes, São Paulo, Brazil

Status

Withdrawn

Address

Hospital Sirio Libanes

São Paulo, , 13080-060

Eurolatino Pesquisas Médicas, Uberlândia, Brazil

Status

Recruiting

Address

Eurolatino Pesquisas Médicas

Uberlândia, , 38400-368

Charite Berlin, Berlin, Germany

Status

Recruiting

Address

Charite Berlin

Berlin, , 12203

DRK Kliniken Westend, Berlin, Germany

Status

Withdrawn

Address

DRK Kliniken Westend

Berlin, , 14050

Frankfurt, Germany

Status

Recruiting

Address

Universitätsklinikum Frankfurt/ Medizinische Klinik 1

Frankfurt, , 60590

Universitätsklinikum Jena, Jena, Germany

Status

Recruiting

Address

Universitätsklinikum Jena

Jena, , 07740

Universitaetsklinikum Ulm, Ulm, Germany

Status

Recruiting

Address

Universitaetsklinikum Ulm

Ulm, , 89081

Clínica Saluz, Boca del Rio, Mexico

Status

Recruiting

Address

Clínica Saluz

Boca del Rio, , 94229

Clinica Endomedix, Mexico City, Mexico

Status

Withdrawn

Address

Clinica Endomedix

Mexico City, , 03100

Clinicos Asociados BOCM, SC, Mexico City, Mexico

Status

Recruiting

Address

Clinicos Asociados BOCM, SC

Mexico City, , 03300

Mexico, Mexico

Status

Not yet recruiting

Address

Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán

Mexico, , 14080

Monterrey, Mexico

Status

Recruiting

Address

Centro Regiomontano de Estudios Clínicos Roma S.C.

Monterrey, , 64610

Queretaro, Mexico

Status

Recruiting

Address

Capital Humano para la Investigacion clinica

Queretaro, , 76000

Centro Medico Zambrano Hellion, San Pedro Garza Garcia, Mexico

Status

Recruiting

Address

Centro Medico Zambrano Hellion

San Pedro Garza Garcia, , 66278

Gdansk, Poland

Status

Recruiting

Address

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

Gdansk, , 80-382

Pratia MCM Krakow, Krakow, Poland

Status

Completed

Address

Pratia MCM Krakow

Krakow, , 30-510

Sopot, Poland

Status

Recruiting

Address

Endoskopia Sp. z o.o. z siedzibą w Sopocie

Sopot, , 81-756

Warsaw, Poland

Status

Recruiting

Address

Centralny Szpital Kliniczny MSWiA w Warszawie

Warsaw, , 02-507

Centrum Zdrowia MDM, Warszawa, Poland

Status

Recruiting

Address

Centrum Zdrowia MDM

Warszawa, , 00-635

WIP Warsaw IBD Point Profesor Kierkus, Warszawa, Poland

Status

Recruiting

Address

WIP Warsaw IBD Point Profesor Kierkus

Warszawa, , 00-728

Warszawa, Poland

Status

Recruiting

Address

Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz

Warszawa, , 03 580

Melita Medical Sp. z o.o., Wroclaw, Poland

Status

Recruiting

Address

Melita Medical Sp. z o.o.

Wroclaw, , 50-449

Medical Association 'New Hospital', Ekaterinburg, Russian Federation

Status

Recruiting

Address

Medical Association 'New Hospital'

Ekaterinburg, , 620109

Kazan State Medical University, Kazan, Russian Federation

Status

Recruiting

Address

Kazan State Medical University

Kazan, , 420012

LEC City Clinical Hospital # 24, Moscow, Russian Federation

Status

Completed

Address

LEC City Clinical Hospital # 24

Moscow, , 127015

Medical Center 'SibNovoMed' LLC, Novosibirsk, Russian Federation

Status

Recruiting

Address

Medical Center 'SibNovoMed' LLC

Novosibirsk, , 630005

Novosibirsk, Russian Federation

Status

Withdrawn

Address

Federal State Budgetary Institution 'Scientific Research Institute'

Novosibirsk, , 630117

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

Status

Recruiting

Address

Rostov State Medical University

Rostov-On-Don, , 344022

Saint Petersburg, Russian Federation

Status

Withdrawn

Address

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

Saint Petersburg, , 194291

Leningrad Regional Clinical Hospital, Saint Petersburg, Russian Federation

Status

Withdrawn

Address

Leningrad Regional Clinical Hospital

Saint Petersburg, , 194291

Elizavetinskaya hospital, Saint Petersburg, Russian Federation

Status

Recruiting

Address

Elizavetinskaya hospital

Saint Petersburg, , 195257

City Clinical Hospital #31, Saint Petersburg, Russian Federation

Status

Recruiting

Address

City Clinical Hospital #31

Saint Petersburg, , 197110

City Hospital #9, Saint Petersburg, Russian Federation

Status

Withdrawn

Address

City Hospital #9

Saint Petersburg, , 197110

Jsc Clinic Complex, Saint-Petersburg, Russian Federation

Status

Withdrawn

Address

Jsc Clinic Complex

Saint-Petersburg, , 190013

Saint-Petersburg, Russian Federation

Status

Withdrawn

Address

City Hospital named after St. Martyr Elizabeth

Saint-Petersburg, , 195257

Eco-safety Ltd, Saint-Petersburg, Russian Federation

Status

Recruiting

Address

Eco-safety Ltd

Saint-Petersburg, , 196143

Medical University Reaviz, Samara, Russian Federation

Status

Recruiting

Address

Medical University Reaviz

Samara, , 443001

International Medical Centre SOGAZ, St-Petersburg, Russian Federation

Status

Recruiting

Address

International Medical Centre SOGAZ

St-Petersburg, , 191186

Tver Regional Clinical Hospital, Tver, Russian Federation

Status

Recruiting

Address

Tver Regional Clinical Hospital

Tver, , 170036

Ufa, Russian Federation

Status

Recruiting

Address

GBUZ Respublican Clinical Hospital n.a. GG Kuvatova

Ufa, , 450005

City Clinical Hospital # 21, Ufa, Russian Federation

Status

Withdrawn

Address

City Clinical Hospital # 21

Ufa, , 450071

City Clinical Hospital #2, Yaroslavl, Russian Federation

Status

Completed

Address

City Clinical Hospital #2

Yaroslavl, , 150010

Regional Clinical Hospital, Yaroslavl, Russian Federation

Status

Recruiting

Address

Regional Clinical Hospital

Yaroslavl, , 150062

Chernivtsi Regional Clinical Hospital, Chernivtsi, Ukraine

Status

Withdrawn

Address

Chernivtsi Regional Clinical Hospital

Chernivtsi, , 58001

Kharkiv, Ukraine

Status

Recruiting

Address

Communal Nonprofit Enterprise 'City Clinical Hospital # 2 N.A. Prof. O.O. Shalimov'

Kharkiv, , 61037

Kharkiv, Ukraine

Status

Recruiting

Address

SI 'L.T. Maloyi National Institute of Therapy of National Academy of Medical Sciences of Ukraine'

Kharkiv, , 61039

Kherson, Ukraine

Status

Recruiting

Address

Municipal Institution 'Kherson City Clinical Hospital n.a. Y.Y.Karabelesh'

Kherson, , 73003

Kyiv City Clinical Hospital #18, Kyiv, Ukraine

Status

Recruiting

Address

Kyiv City Clinical Hospital #18

Kyiv, , 01030

Private Clinic OK Clinic, Kyiv, Ukraine

Status

Recruiting

Address

Private Clinic OK Clinic

Kyiv, , 02091

Lviv, Ukraine

Status

Recruiting

Address

Lviv Clinical Hospital on Railway Transport of Affiliate Healthcare center of JSC Ukrainian Railway

Lviv, , 79007

Lviv, Ukraine

Status

Recruiting

Address

Communal Nonprofit Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'

Lviv, , 79010

Odessa, Ukraine

Status

Recruiting

Address

Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council

Odessa, , 65025

Sumy, Ukraine

Status

Recruiting

Address

Sumy State University, Sumy Regional Clinical Hospital

Sumy, , 40022

Ternopil, Ukraine

Status

Recruiting

Address

Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'

Ternopil, , 46002

Vinnytsya, Ukraine

Status

Recruiting

Address

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

Vinnytsya, , 21009

Vinnytsya, Ukraine

Status

Recruiting

Address

Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov

Vinnytsya, , 21018

Zaporizhzhya, Ukraine

Status

Withdrawn

Address

Municipal Institution City Hospital Number 7

Zaporizhzhya, , 69118

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