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, 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.

Precision Research Institute, San Diego, California

Status

Recruiting

Address

Precision Research Institute

San Diego, California, 92114

Site Contact

844-434-4210

Peak Gastroenterology Associates, Colorado Springs, Colorado

Status

Not yet recruiting

Address

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907

Site Contact

844-434-4210

GCP Clinical Research, Tampa, Florida

Status

Not yet recruiting

Address

GCP Clinical Research

Tampa, Florida, 33609

Site Contact

844-434-4210

Gastrointestinal Specialists of Georgia, Marietta, Georgia

Status

Not yet recruiting

Address

Gastrointestinal Specialists of Georgia

Marietta, Georgia, 30060

Site Contact

844-434-4210

Tandem Clinical Research, Marrero, Louisiana

Status

Withdrawn

Address

Tandem Clinical Research

Marrero, Louisiana, 70072

Site Contact

844-434-4210

Chevy Chase Clinical Research, Chevy Chase, Maryland

Status

Not yet recruiting

Address

Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815

Site Contact

844-434-4210

Sierra Clinical Research, Las Vegas, Nevada

Status

Not yet recruiting

Address

Sierra Clinical Research

Las Vegas, Nevada, 89106

Site Contact

844-434-4210

Chapel Hill, North Carolina

Status

Not yet recruiting

Address

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599

Site Contact

844-434-4210

Mentor, Ohio

Status

Withdrawn

Address

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, 44060

Site Contact

844-434-4210

Baylor College of Medicine, Houston, Texas

Status

Not yet recruiting

Address

Baylor College of Medicine

Houston, Texas, 77030

Site Contact

844-434-4210

Gastroenterology Associates of Tidewater, Chesapeake, Virginia

Status

Not yet recruiting

Address

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, 23320

Site Contact

844-434-4210

Washington Gastroenterology, PLLC, Tacoma, Washington

Status

Recruiting

Address

Washington Gastroenterology, PLLC

Tacoma, Washington, 98405

Site Contact

844-434-4210

International Sites

Buenos Aires, Argentina

Status

Not yet recruiting

Address

CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

Buenos Aires, , 1431

Site Contact

844-434-4210

Hospital Aleman, Buenos Aires, Argentina

Status

Not yet recruiting

Address

Hospital Aleman

Buenos Aires, , C1118AAT

Site Contact

844-434-4210

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

Site Contact

844-434-4210

Fundación de Estudios Clínicos, Rosario, Argentina

Status

Not yet recruiting

Address

Fundación de Estudios Clínicos

Rosario, , 2000

Site Contact

844-434-4210

Sanatorio 9 de Julio, San Miguel De Tucuman, Argentina

Status

Not yet recruiting

Address

Sanatorio 9 de Julio

San Miguel De Tucuman, , 4000

Site Contact

844-434-4210

Princess Alexandra Hospital, Brisbane, Australia

Status

Not yet recruiting

Address

Princess Alexandra Hospital

Brisbane, , 4102

Site Contact

844-434-4210

St Vincent's hospital, Darlinghurst, Australia

Status

Withdrawn

Address

St Vincent's hospital

Darlinghurst, , 2010

Site Contact

844-434-4210

Saint Vincent's Hospital - Melbourne, Fitzroy, Australia

Status

Not yet recruiting

Address

Saint Vincent's Hospital - Melbourne

Fitzroy, , 3065

Site Contact

844-434-4210

Nepean Hospital, Kingswood, Australia

Status

Not yet recruiting

Address

Nepean Hospital

Kingswood, , 2747

Site Contact

844-434-4210

Royal Melbourne Hospital, Parkville, Australia

Status

Not yet recruiting

Address

Royal Melbourne Hospital

Parkville, , 3050

Site Contact

844-434-4210

Mater Hospital Brisbane, South Brisbane, Australia

Status

Not yet recruiting

Address

Mater Hospital Brisbane

South Brisbane, , 4101

Site Contact

844-434-4210

The Queen Elizabeth Hospital, Woodville South, Australia

Status

Not yet recruiting

Address

The Queen Elizabeth Hospital

Woodville South, , 5011

Site Contact

844-434-4210

Hospital Das Clinicas Da Ufmg, Belo Horizonte, Brazil

Status

Not yet recruiting

Address

Hospital Das Clinicas Da Ufmg

Belo Horizonte, , 30130-100

Site Contact

844-434-4210

Botucatu, Brazil

Status

Not yet recruiting

Address

Universidade Estadual Paulista 'Julio De Mesquita Filho'

Botucatu, , 18618-970

Site Contact

844-434-4210

Hospital Nossa Senhora Das Gracas, Curitiba, Brazil

Status

Not yet recruiting

Address

Hospital Nossa Senhora Das Gracas

Curitiba, , 80810-040

Site Contact

844-434-4210

Clinica De Gastroenterologia, Goiania, Brazil

Status

Not yet recruiting

Address

Clinica De Gastroenterologia

Goiania, , 74535-170

Site Contact

844-434-4210

Porto Alegre, Brazil

Status

Not yet recruiting

Address

Hospital de Clínicas de Porto Alegre/ HCPA / UFRGS

Porto Alegre, , 90035-903

Site Contact

844-434-4210

Rio De Janeiro, Brazil

Status

Not yet recruiting

Address

UFRJ-Hospital Universitário Clementino Fraga Filho

Rio De Janeiro, , 20050-902

Site Contact

844-434-4210

Bioclinica, Rio De Janeiro, Brazil

Status

Not yet recruiting

Address

Bioclinica

Rio De Janeiro, , 22271-100

Site Contact

844-434-4210

Faculdade de Medicina Do Abc, Santo Andre, Brazil

Status

Not yet recruiting

Address

Faculdade de Medicina Do Abc

Santo Andre, , 09060-870

Site Contact

844-434-4210

Kaiser Hospta, São José Do Rio Preto, Brazil

Status

Not yet recruiting

Address

Kaiser Hospta

São José Do Rio Preto, , 15015-110

Site Contact

844-434-4210

Hospital Sirio Libanes, São Paulo, Brazil

Status

Not yet recruiting

Address

Hospital Sirio Libanes

São Paulo, , 13080-060

Site Contact

844-434-4210

Eurolatino Pesquisas Médicas, Uberlândia, Brazil

Status

Not yet recruiting

Address

Eurolatino Pesquisas Médicas

Uberlândia, , 38400-368

Site Contact

844-434-4210

Charite Berlin, Berlin, Germany

Status

Not yet recruiting

Address

Charite Berlin

Berlin, , 12203

Site Contact

844-434-4210

DRK Kliniken Westend, Berlin, Germany

Status

Not yet recruiting

Address

DRK Kliniken Westend

Berlin, , 14050

Site Contact

844-434-4210

Frankfurt, Germany

Status

Not yet recruiting

Address

Universitätsklinikum Frankfurt/ Medizinische Klinik 1

Frankfurt, , 60590

Site Contact

844-434-4210

Universitätsklinikum Jena, Jena, Germany

Status

Not yet recruiting

Address

Universitätsklinikum Jena

Jena, , 07740

Site Contact

844-434-4210

Universitaetsklinikum Ulm, Ulm, Germany

Status

Not yet recruiting

Address

Universitaetsklinikum Ulm

Ulm, , 89081

Site Contact

844-434-4210

Centrum Medyczne Synexus, Gdansk, Poland

Status

Not yet recruiting

Address

Centrum Medyczne Synexus

Gdansk, , 80 - 382

Site Contact

844-434-4210

Malopolskie Centrum Medyczne, Krakow, Poland

Status

Not yet recruiting

Address

Malopolskie Centrum Medyczne

Krakow, , 30-510

Site Contact

844-434-4210

Centrum Medyczne Med-Gastr, Lodz, Poland

Status

Not yet recruiting

Address

Centrum Medyczne Med-Gastr

Lodz, , 91-034

Site Contact

844-434-4210

Endoskopia Sp z o.o., Sopot, Poland

Status

Not yet recruiting

Address

Endoskopia Sp z o.o.

Sopot, , 81-756

Site Contact

844-434-4210

Warsaw, Poland

Status

Not yet recruiting

Address

Centralny Szpital Kliniczny MSWiA w Warszawie

Warsaw, , 02-507

Site Contact

844-434-4210

Centrum Zdrowia MDM, Warszawa, Poland

Status

Not yet recruiting

Address

Centrum Zdrowia MDM

Warszawa, , 00-635

Site Contact

844-434-4210

NZOZ Vivamed Zespol Lekarzy Specjalistow, Warszawa, Poland

Status

Not yet recruiting

Address

NZOZ Vivamed Zespol Lekarzy Specjalistow

Warszawa, , 03-580

Site Contact

844-434-4210

Melita Medical, Wroclaw, Poland

Status

Not yet recruiting

Address

Melita Medical

Wroclaw, , 11-400

Site Contact

844-434-4210

Medical Association 'New Hospital', Ekaterinburg, Russian Federation

Status

Not yet recruiting

Address

Medical Association 'New Hospital'

Ekaterinburg, , 620109

Site Contact

844-434-4210

Kazan State Medical University, Kazan, Russian Federation

Status

Not yet recruiting

Address

Kazan State Medical University

Kazan, , 420012

Site Contact

844-434-4210

LEC City Clinical Hospital # 24, Moscow, Russian Federation

Status

Not yet recruiting

Address

LEC City Clinical Hospital # 24

Moscow, , 127015

Site Contact

844-434-4210

Medical Center 'SibNovoMed' LLC, Novosibirsk, Russian Federation

Status

Not yet recruiting

Address

Medical Center 'SibNovoMed' LLC

Novosibirsk, , 630005

Site Contact

844-434-4210

Novosibirsk, Russian Federation

Status

Not yet recruiting

Address

Federal State Budgetary Institution 'Scientific Research Institute'

Novosibirsk, , 630117

Site Contact

844-434-4210

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

Status

Not yet recruiting

Address

Rostov State Medical University

Rostov-On-Don, , 344022

Site Contact

844-434-4210

Saint Petersburg, Russian Federation

Status

Withdrawn

Address

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

Saint Petersburg, , 194291

Site Contact

844-434-4210

Leningrad Regional Clinical Hospital, Saint Petersburg, Russian Federation

Status

Withdrawn

Address

Leningrad Regional Clinical Hospital

Saint Petersburg, , 194291

Site Contact

844-434-4210

Elizavetinskaya hospital, Saint Petersburg, Russian Federation

Status

Not yet recruiting

Address

Elizavetinskaya hospital

Saint Petersburg, , 195257

Site Contact

844-434-4210

City Clinical Hospital #31, Saint Petersburg, Russian Federation

Status

Not yet recruiting

Address

City Clinical Hospital #31

Saint Petersburg, , 197110

Site Contact

844-434-4210

City Hospital #9, Saint Petersburg, Russian Federation

Status

Withdrawn

Address

City Hospital #9

Saint Petersburg, , 197110

Site Contact

844-434-4210

Saint-Petersburg, Russian Federation

Status

Withdrawn

Address

City Hospital named after St. Martyr Elizabeth

Saint-Petersburg, , 195257

Site Contact

844-434-4210

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

Status

Not yet recruiting

Address

City Clinical Hospital # 26

Saint-Petersburg, , 196247

Site Contact

844-434-4210

International Medical Centre SOGAZ, St-Petersburg, Russian Federation

Status

Not yet recruiting

Address

International Medical Centre SOGAZ

St-Petersburg, , 191186

Site Contact

844-434-4210

Ufa, Russian Federation

Status

Not yet recruiting

Address

GBUZ Respublican Clinical Hospital n.a. GG Kuvatova

Ufa, , 450005

Site Contact

844-434-4210

City Clinical Hospital # 21, Ufa, Russian Federation

Status

Withdrawn

Address

City Clinical Hospital # 21

Ufa, , 450071

Site Contact

844-434-4210

City Clinical Hospital #2, Yaroslavl, Russian Federation

Status

Not yet recruiting

Address

City Clinical Hospital #2

Yaroslavl, , 150010

Site Contact

844-434-4210

Regional Clinical Hospital, Yaroslavl, Russian Federation

Status

Not yet recruiting

Address

Regional Clinical Hospital

Yaroslavl, , 150062

Site Contact

844-434-4210

Chernivtsi Regional Clinical Hospital, Chernivtsi, Ukraine

Status

Not yet recruiting

Address

Chernivtsi Regional Clinical Hospital

Chernivtsi, , 58001

Site Contact

844-434-4210

Kharkiv City Clinical Hospital, Kharkiv, Ukraine

Status

Not yet recruiting

Address

Kharkiv City Clinical Hospital

Kharkiv, , 61037

Site Contact

844-434-4210

Kharkiv, Ukraine

Status

Not yet recruiting

Address

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

Kharkiv, , 61039

Site Contact

844-434-4210

Kherson, Ukraine

Status

Not yet recruiting

Address

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

Kherson, , 73000

Site Contact

844-434-4210

Kyivska miska klinichna likarnia 18, Kyiv, Ukraine

Status

Not yet recruiting

Address

Kyivska miska klinichna likarnia 18

Kyiv, , 01030

Site Contact

844-434-4210

Private Clinic OK Clinic, Kyiv, Ukraine

Status

Not yet recruiting

Address

Private Clinic OK Clinic

Kyiv, , 02091

Site Contact

844-434-4210

Lviv, Ukraine

Status

Not yet recruiting

Address

Danylo Halytsky Lviv National Medical University

Lviv, , 79010

Site Contact

844-434-4210

Odessa, Ukraine

Status

Not yet recruiting

Address

State Institution Odesa Regional Clinical Hospital

Odessa, ,

Site Contact

844-434-4210

Ternopil University Hospital, Ternopil, Ukraine

Status

Not yet recruiting

Address

Ternopil University Hospital

Ternopil, , 46002

Site Contact

844-434-4210

Vinnytsya, Ukraine

Status

Not yet recruiting

Address

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

Vinnytsya, , 21009

Site Contact

844-434-4210

Vinnytsya, Ukraine

Status

Not yet recruiting

Address

Vinnytsya regional clinical hospital n.a.Pyrogov, VNMU

Vinnytsya, , 21018

Site Contact

844-434-4210

Miska likarnia №7, Zaporizhzhia, Ukraine

Status

Not yet recruiting

Address

Miska likarnia №7

Zaporizhzhia, , 69118

Site Contact

844-434-4210

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