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

PHASE2CompletedINTERVENTIONAL
Enrollment

214

Participants

Timeline

Start Date

November 20, 2018

Primary Completion Date

December 1, 2020

Study Completion Date

November 15, 2021

Conditions
Colitis, Ulcerative
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.

Trial Locations (82)

1431

CEMIC (Centro de Educación Médica e Investigaciones Clínicas), Buenos Aires

1888

Hospital de Alta Complejidad en Red 'El Cruce', San Juan Bautista

2000

Fundacion de Estudios Clinicos, Rosario

2109

Macquarie University Hospital, NSW

2747

Nepean Hospital, Kingswood

3050

Royal Melbourne Hospital, Parkville

3065

St Vincent's Hospital - Melbourne, Fitzroy

4000

Sanatorio 9 de Julio, San Miguel de Tucumán

4101

Mater Hospital Brisbane (Inflammatory Bowel Diseases), South Brisbane

4102

Princess Alexandra Hospital, Brisbane

5000

Royal Adelaide Hospital, North Terrace

12203

Charite Berlin, Berlin

20815

Chevy Chase Clinical Research, Chevy Chase

21009

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

21018

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

21061

Woodholme Gastroenterology, Glen Burnie

23320

Gastroenterology Associates of Tidewater, Chesapeake

27599

The University of North Carolina at Chapel Hill, Chapel Hill

30060

Gastrointestinal Specialists of Georgia, Marietta

33609

GCP Clinical Research, Tampa

40022

Sumy State University, Sumy Regional Clinical Hospital, Sumy

46002

Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital', Ternopil

46202

Indiana University, Indianapolis

58103

Fargo Gastroenterology Clinic, PC, Fargo

60590

Universitatsklinikum Frankfurt/ Medizinische Klinik 1, Frankfurt

61037

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

61039

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

64610

Centro Regiomontano de Estudios Clínicos Roma S.C., Monterrey

65025

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

66278

Centro Medico Zambrano Hellion, San Pedro Garza García

73003

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

76000

Capital Humano para la Investigacion clinica, Querétaro

76092

Texas Digestive Disease Consultants, Southlake

79007

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

79010

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

80907

Peak Gastroenterology Associates, Colorado Springs

89081

Universitaetsklinikum Ulm, Ulm

89106

Sierra Clinical Research, Las Vegas

92114

Precision Research Institute, San Diego

94229

Clínica Saluz, Boca del Rio

98101

Virginia Mason, Seattle

98405

Washington Gastroenterology, PLLC, Tacoma

127015

City Clinical Hospital # 24, Moscow

150010

City Clinical Hospital #2, Yaroslavl

150062

Regional Clinical Hospital, Yaroslavl

170036

Tver Regional Clinical Hospital, Tver'

191186

International Medical Centre SOGAZ, Saint Petersburg

195257

Elizavetinskaya hospital, Saint Petersburg

196143

Eco-safety Ltd, Saint Petersburg

197110

City Clinical Hospital #31, Saint Petersburg

344022

Rostov State Medical University, Rostov-on-Don

420012

Kazan State Medical University, Kazan'

443001

Medical University Reaviz, Samara

450005

GBUZ Respublican Clinical Hospital n.a. GG Kuvatova, Ufa

620109

Medical Association 'New Hospital', Yekaterinburg

630005

Medical Center SibNovoMed LLC, Novosibirsk

C1280AEB

Hospital Britanico de Buenos Aires, Buenos Aires

C1128AAF

Expertia S.A, Caba

C1426ABP

Centro Médico Dra. De Salvo, Caba

C1430EGF

Clínica Adventista Belgrano, Ciudad de Buenos Aires

30130-100

Hospital Das Clinicas Da Ufmg, Belo Horizonte

18618-970

Universidade Estadual Paulista 'Julio De Mesquita Filho', Botucatu

74535-170

Inst Goiano Gastroenterologia e Endoscopia Digest Ltda - Clinica de Gastro, Goiânia

90035-903

Hospital das Clinicas de Porto Alegre, Porto Alegre

14098-900

Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP, Ribeirão Preto

20050-902

Universidade Federal do Rio de Janeiro - Faculdade de Medicina, Rio de Janeiro

20241-180

Instituto Brasil de Pesquisa Clinica, Rio de Janeiro

09060-870

Fundacao do ABC - Centro Universitario FMABC, Santo André

15015-110

Kaiser Hospta, São José do Rio Preto

38400-368

Eurolatino Pesquisas Medicas Ltda, Uberlândia

07740

Universitätsklinikum Jena, Jena

03300

Clinicos Asociados BOCM, SC, Mexico City

80-382

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

30-510

Pratia MCM Krakow, Krakow

81-756

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

00-635

Centrum Zdrowia MDM, Warsaw

00-728

WIP Warsaw IBD Point Profesor Kierkus, Warsaw

02-507

Centralny Szpital Kliniczny MSWiA w Warszawie, Warsaw

03 580

Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz, Warsaw

50-449

Melita Medical Sp. z o.o., Wroclaw

01030

Kyiv City Clinical Hospital #18, Kyiv

02091

Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies', Kyiv

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT03662542 - A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | Biotech Hunter | Biotech Hunter