Clinical trial NCT03662542: A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
Official title: A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colitis, Ulcerative
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2018-09-07
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Combination Phase: Percentage of Participants Who Achieved Clinical Response at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Combination Phase: Percentage of Participants Who Achieved Clinical Remission at Week 12
timeFrame: Week 12
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Precision Research Institute
state: California
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Tampa
country: United States
facility: GCP Clinical Research
state: Florida
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Chevy Chase
country: United States
facility: Chevy Chase Clinical Research
state: Maryland
city: Glen Burnie
country: United States
facility: Woodholme Gastroenterology
state: Maryland
city: Las Vegas
country: United States
facility: Sierra Clinical Research
state: Nevada
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: Fargo
country: United States
facility: Fargo Gastroenterology Clinic, PC
state: North Dakota
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants
state: Texas
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason
state: Washington
city: Tacoma
country: United States
facility: Washington Gastroenterology, PLLC
state: Washington
city: Buenos Aires
country: Argentina
facility: CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
city: Caba
country: Argentina
facility: Expertia S.A
city: Caba
country: Argentina
facility: Centro Médico Dra. De Salvo
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires
city: Ciudad De Buenos Aires
country: Argentina
facility: Clínica Adventista Belgrano
city: Florencio Varela
country: Argentina
facility: Hospital de Alta Complejidad en Red 'El Cruce'
city: Rosario
country: Argentina
facility: Fundacion de Estudios Clinicos
city: San Miguel de Tucuman
country: Argentina
facility: Sanatorio 9 de Julio
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
city: Fitzroy
country: Australia
facility: St Vincent's Hospital - Melbourne
city: Kingswood
country: Australia
facility: Nepean Hospital
city: North Terrace
country: Australia
facility: Royal Adelaide Hospital
city: NSW
country: Australia
facility: Macquarie University Hospital
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
city: South Brisbane
country: Australia
facility: Mater Hospital Brisbane (Inflammatory Bowel Diseases)
city: Belo Horizonte
country: Brazil
facility: Hospital Das Clinicas Da Ufmg
city: Botucatu
country: Brazil
facility: Universidade Estadual Paulista 'Julio De Mesquita Filho'
city: Goiania
country: Brazil
facility: Inst Goiano Gastroenterologia e Endoscopia Digest Ltda - Clinica de Gastro
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas de Porto Alegre
city: Ribeirao Preto
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP
city: Rio de Janeiro
country: Brazil
facility: Universidade Federal do Rio de Janeiro - Faculdade de Medicina
city: Rio de Janeiro
country: Brazil
facility: Instituto Brasil de Pesquisa Clinica
city: Santo Andre
country: Brazil
facility: Fundacao do ABC - Centro Universitario FMABC
city: São José Do Rio Preto
country: Brazil
facility: Kaiser Hospta
city: Uberlandia
country: Brazil
facility: Eurolatino Pesquisas Medicas Ltda
city: Berlin
country: Germany
facility: Charite Berlin
city: Frankfurt
country: Germany
facility: Universitatsklinikum Frankfurt/ Medizinische Klinik 1
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Boca del Rio
country: Mexico
facility: Clínica Saluz
city: Mexico City
country: Mexico
facility: Clinicos Asociados BOCM, SC
city: Monterrey
country: Mexico
facility: Centro Regiomontano de Estudios Clínicos Roma S.C.
city: Queretaro
country: Mexico
facility: Capital Humano para la Investigacion clinica
city: San Pedro Garza Garcia
country: Mexico
facility: Centro Medico Zambrano Hellion
city: Gdansk
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Gdansku
city: Krakow
country: Poland
facility: Pratia MCM Krakow
city: Sopot
country: Poland
facility: Endoskopia Sp. z o.o. z siedzibą w Sopocie
city: Warsaw
country: Poland
facility: Centralny Szpital Kliniczny MSWiA w Warszawie
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM
city: Warszawa
country: Poland
facility: WIP Warsaw IBD Point Profesor Kierkus
city: Warszawa
country: Poland
facility: Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz
city: Wroclaw
country: Poland
facility: Melita Medical Sp. z o.o.
city: Ekaterinburg
country: Russian Federation
facility: Medical Association 'New Hospital'
city: Kazan
country: Russian Federation
facility: Kazan State Medical University
city: Moscow
country: Russian Federation
facility: City Clinical Hospital # 24
city: Novosibirsk
country: Russian Federation
facility: Medical Center SibNovoMed LLC
city: Rostov-On-Don
country: Russian Federation
facility: Rostov State Medical University
city: Saint Petersburg
country: Russian Federation
facility: Elizavetinskaya hospital
city: Saint Petersburg
country: Russian Federation
facility: City Clinical Hospital #31
city: Saint-Petersburg
country: Russian Federation
facility: Eco-safety Ltd
city: Samara
country: Russian Federation
facility: Medical University Reaviz
city: St-Petersburg
country: Russian Federation
facility: International Medical Centre SOGAZ
city: Tver
country: Russian Federation
facility: Tver Regional Clinical Hospital
city: Ufa
country: Russian Federation
facility: GBUZ Respublican Clinical Hospital n.a. GG Kuvatova
city: Yaroslavl
country: Russian Federation
facility: City Clinical Hospital #2
city: Yaroslavl
country: Russian Federation
facility: Regional Clinical Hospital
city: Kharkiv
country: Ukraine
facility: Communal Nonprofit Enterprise 'City Clinical Hospital # 2 N.A. Prof. O.O. Shalimov'
city: Kharkiv
country: Ukraine
facility: SI 'L.T. Maloyi National Institute of Therapy of National Academy of Medical Sciences of Ukraine
city: Kherson
country: Ukraine
facility: Municipal Institution 'Kherson City Clinical Hospital n.a. Y.Y.Karabelesh'
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #18
city: Kyiv
country: Ukraine
facility: Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'
city: Lviv
country: Ukraine
facility: Lviv Clinical Hospital on Railway Transport of Affiliate Healthcare center of JSC Ukrainian Railway
city: Lviv
country: Ukraine
facility: Communal Nonprofit Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
city: Odessa
country: Ukraine
facility: Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
city: Sumy
country: Ukraine
facility: Sumy State University, Sumy Regional Clinical Hospital
city: Ternopil
country: Ukraine
facility: Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
city: Vinnytsya
country: Ukraine
facility: Medical Center Ltd 'Health Clinic', Department Of General Therapy
city: Vinnytsya
country: Ukraine
facility: Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: