A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
- Conditions
- Colitis, Ulcerative
- Interventions
- Registration Number
- NCT03662542
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 214
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combination Therapy Golimumab Dose 1 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. Combination Therapy Golimumab Dose 2 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. Monotherapy: Guselkumab Guselkumab Dose 1 Participants will receive guselkumab Dose 1 as IV infusion, Dose 2 as SC injection and placebo to maintain the blind. Monotherapy: Golimumab Placebo Participants will receive golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind. Monotherapy: Golimumab Golimumab Dose 2 Participants will receive golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind. Combination Therapy Guselkumab Dose 1 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. Combination Therapy Guselkumab Dose 2 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. Combination Therapy Placebo 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. Monotherapy: Guselkumab Guselkumab Dose 2 Participants will receive guselkumab Dose 1 as IV infusion, Dose 2 as SC injection and placebo to maintain the blind. Monotherapy: Guselkumab Placebo Participants will receive guselkumab Dose 1 as IV infusion, Dose 2 as SC injection and placebo to maintain the blind. Monotherapy: Golimumab Golimumab Dose 1 Participants will receive golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
- Primary Outcome Measures
Name Time Method Combination Phase: Percentage of Participants Who Achieved Clinical Response at Week 12 Week 12 Clinical response was defined as a decrease from baseline in the Mayo score greater than or equal to (\>=) 30 percent (%) and \>=3 points with either a decrease from baseline in the rectal bleeding subscore (RBS) \>=1 or a RBS of 0 or 1. The Mayo score was calculated as the sum of 4 subscores (stool frequency, rectal bleeding, physician's global assessment, and endoscopy findings - each with score range of 0 (normal activity) to 3 (severe activity) and a total score range of 0 to 12 points. A score of 3 to 5 points indicates mildly active disease, a score of 6 to 10 points indicates moderately active disease, and a score of 11 to 12 points indicates severely active disease. Higher scores indicate more severity. This outcome measure was analyzed for combination phase only as preplanned in the protocol.
- Secondary Outcome Measures
Name Time Method Combination Phase: Percentage of Participants Who Achieved Clinical Remission at Week 12 Week 12 Clinical remission was defined as the Mayo score less than or equal to (\<=) 2 with no individual subscore greater than (\>) 1. The Mayo score was calculated as the sum of 4 subscores (stool frequency, rectal bleeding, physician's global assessment, and endoscopy findings) each with score range of 0 (normal activity) to 3 (severe activity) and a total score range of 0 to 12 points. A score of 3 to 5 points indicates mildly active disease, a score of 6 to 10 points indicates moderately active disease, and a score of 11 to 12 points indicates severely active disease. Higher scores indicate more severity. This outcome measure was analyzed for combination phase only as preplanned in the protocol.
Trial Locations
- Locations (82)
Nepean Hospital
🇦🇺Kingswood, Australia
Precision Research Institute
🇺🇸San Diego, California, United States
Centro Médico Dra. De Salvo
🇦🇷Caba, Argentina
Kaiser Hospta
🇧🇷São José Do Rio Preto, Brazil
CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
🇦🇷Buenos Aires, Argentina
Hospital das Clinicas de Porto Alegre
🇧🇷Porto Alegre, Brazil
Clínica Adventista Belgrano
🇦🇷Ciudad De Buenos Aires, Argentina
Gastroenterology Associates of Tidewater
🇺🇸Chesapeake, Virginia, United States
Mater Hospital Brisbane (Inflammatory Bowel Diseases)
🇦🇺South Brisbane, Australia
Pratia MCM Krakow
🇵🇱Krakow, Poland
Centralny Szpital Kliniczny MSWiA w Warszawie
🇵🇱Warsaw, Poland
Universidade Federal do Rio de Janeiro - Faculdade de Medicina
🇧🇷Rio de Janeiro, Brazil
Peak Gastroenterology Associates
🇺🇸Colorado Springs, Colorado, United States
Chevy Chase Clinical Research
🇺🇸Chevy Chase, Maryland, United States
Charite Berlin
🇩🇪Berlin, Germany
Capital Humano para la Investigacion clinica
🇲🇽Queretaro, Mexico
Macquarie University Hospital
🇦🇺NSW, Australia
Kyiv City Clinical Hospital #18
🇺🇦Kyiv, Ukraine
GCP Clinical Research
🇺🇸Tampa, Florida, United States
Melita Medical Sp. z o.o.
🇵🇱Wroclaw, Poland
Sierra Clinical Research
🇺🇸Las Vegas, Nevada, United States
City Clinical Hospital # 24
🇷🇺Moscow, Russian Federation
Hospital Das Clinicas Da Ufmg
🇧🇷Belo Horizonte, Brazil
Universidade Estadual Paulista 'Julio De Mesquita Filho'
🇧🇷Botucatu, Brazil
Expertia S.A
🇦🇷Caba, Argentina
Hospital de Alta Complejidad en Red 'El Cruce'
🇦🇷Florencio Varela, Argentina
St Vincent's Hospital - Melbourne
🇦🇺Fitzroy, Australia
Centro Regiomontano de Estudios Clínicos Roma S.C.
🇲🇽Monterrey, Mexico
Municipal Institution 'Kherson City Clinical Hospital n.a. Y.Y.Karabelesh'
🇺🇦Kherson, Ukraine
Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
🇺🇦Ternopil, Ukraine
Woodholme Gastroenterology
🇺🇸Glen Burnie, Maryland, United States
Princess Alexandra Hospital
🇦🇺Brisbane, Australia
Royal Adelaide Hospital
🇦🇺North Terrace, Australia
Universitatsklinikum Frankfurt/ Medizinische Klinik 1
🇩🇪Frankfurt, Germany
Royal Melbourne Hospital
🇦🇺Parkville, Australia
Elizavetinskaya hospital
🇷🇺Saint Petersburg, Russian Federation
Endoskopia Sp. z o.o. z siedzibą w Sopocie
🇵🇱Sopot, Poland
Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz
🇵🇱Warszawa, Poland
Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'
🇺🇦Kyiv, Ukraine
Fundacion de Estudios Clinicos
🇦🇷Rosario, Argentina
Rostov State Medical University
🇷🇺Rostov-On-Don, Russian Federation
Inst Goiano Gastroenterologia e Endoscopia Digest Ltda - Clinica de Gastro
🇧🇷Goiania, Brazil
Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP
🇧🇷Ribeirao Preto, Brazil
Universitätsklinikum Jena
🇩🇪Jena, Germany
Medical University Reaviz
🇷🇺Samara, Russian Federation
City Clinical Hospital #31
🇷🇺Saint Petersburg, Russian Federation
Clinicos Asociados BOCM, SC
🇲🇽Mexico City, Mexico
Synexus Polska Sp. z o.o. Oddzial w Gdansku
🇵🇱Gdansk, Poland
Communal Nonprofit Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
🇺🇦Lviv, Ukraine
Communal Nonprofit Enterprise 'City Clinical Hospital # 2 N.A. Prof. O.O. Shalimov'
🇺🇦Kharkiv, Ukraine
International Medical Centre SOGAZ
🇷🇺St-Petersburg, Russian Federation
Medical Center SibNovoMed LLC
🇷🇺Novosibirsk, Russian Federation
GBUZ Respublican Clinical Hospital n.a. GG Kuvatova
🇷🇺Ufa, Russian Federation
Sumy State University, Sumy Regional Clinical Hospital
🇺🇦Sumy, Ukraine
City Clinical Hospital #2
🇷🇺Yaroslavl, Russian Federation
Regional Clinical Hospital
🇷🇺Yaroslavl, Russian Federation
Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
🇺🇦Odessa, Ukraine
Gastrointestinal Specialists of Georgia
🇺🇸Marietta, Georgia, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Virginia Mason
🇺🇸Seattle, Washington, United States
Centro Medico Zambrano Hellion
🇲🇽San Pedro Garza Garcia, Mexico
Clínica Saluz
🇲🇽Boca del Rio, Mexico
Instituto Brasil de Pesquisa Clinica
🇧🇷Rio de Janeiro, Brazil
Fundacao do ABC - Centro Universitario FMABC
🇧🇷Santo Andre, Brazil
Eurolatino Pesquisas Medicas Ltda
🇧🇷Uberlandia, Brazil
Tver Regional Clinical Hospital
🇷🇺Tver, Russian Federation
The University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Hospital Britanico de Buenos Aires
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
Sanatorio 9 de Julio
🇦🇷San Miguel de Tucuman, Argentina
WIP Warsaw IBD Point Profesor Kierkus
🇵🇱Warszawa, Poland
Centrum Zdrowia MDM
🇵🇱Warszawa, Poland
Medical Center Ltd 'Health Clinic', Department Of General Therapy
🇺🇦Vinnytsya, Ukraine
Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov
🇺🇦Vinnytsya, Ukraine
Universitaetsklinikum Ulm
🇩🇪Ulm, Germany
Medical Association 'New Hospital'
🇷🇺Ekaterinburg, Russian Federation
Texas Digestive Disease Consultants
🇺🇸Southlake, Texas, United States
Kazan State Medical University
🇷🇺Kazan, Russian Federation
Eco-safety Ltd
🇷🇺Saint-Petersburg, Russian Federation
Lviv Clinical Hospital on Railway Transport of Affiliate Healthcare center of JSC Ukrainian Railway
🇺🇦Lviv, Ukraine
SI 'L.T. Maloyi National Institute of Therapy of National Academy of Medical Sciences of Ukraine
🇺🇦Kharkiv, Ukraine
Washington Gastroenterology, PLLC
🇺🇸Tacoma, Washington, United States
Fargo Gastroenterology Clinic, PC
🇺🇸Fargo, North Dakota, United States