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

November 17, 2023 updated by: Janssen Research & Development, LLC

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

214

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1431
        • CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
      • Caba, Argentina, C1426ABP
        • Centro Médico Dra. De Salvo
      • Caba, Argentina, C1128AAF
        • Expertia S.A
      • Ciudad Autonoma de Buenos Aires, Argentina, C1280AEB
        • Hospital Britanico de Buenos Aires
      • Ciudad De Buenos Aires, Argentina, C1430EGF
        • Clínica Adventista Belgrano
      • Florencio Varela, Argentina, 1888
        • Hospital de Alta Complejidad en Red 'El Cruce'
      • Rosario, Argentina, 2000
        • Fundacion de Estudios Clinicos
      • San Miguel de Tucuman, Argentina, 4000
        • Sanatorio 9 de Julio
  • Australia
      • Brisbane, Australia, 4102
        • Princess Alexandra Hospital
      • Fitzroy, Australia, 3065
        • St Vincent's Hospital - Melbourne
      • Kingswood, Australia, 2747
        • Nepean Hospital
      • NSW, Australia, 2109
        • Macquarie University Hospital
      • North Terrace, Australia, 5000
        • Royal Adelaide Hospital
      • Parkville, Australia, 3050
        • Royal Melbourne Hospital
      • South Brisbane, Australia, 4101
        • Mater Hospital Brisbane (Inflammatory Bowel Diseases)
  • Brazil
      • Belo Horizonte, Brazil, 30130-100
        • Hospital Das Clinicas Da Ufmg
      • Botucatu, Brazil, 18618-970
        • Universidade Estadual Paulista 'Julio De Mesquita Filho'
      • Goiania, Brazil, 74535-170
        • Inst Goiano Gastroenterologia e Endoscopia Digest Ltda - Clinica de Gastro
      • Porto Alegre, Brazil, 90035-903
        • Hospital das Clinicas de Porto Alegre
      • Ribeirao Preto, Brazil, 14098-900
        • Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP
      • Rio de Janeiro, Brazil, 20241-180
        • Instituto Brasil de Pesquisa Clinica
      • Rio de Janeiro, Brazil, 20050-902
        • Universidade Federal do Rio de Janeiro - Faculdade de Medicina
      • Santo Andre, Brazil, 09060-870
        • Fundacao do ABC - Centro Universitario FMABC
      • São José Do Rio Preto, Brazil, 15015-110
        • Kaiser Hospta
      • Uberlandia, Brazil, 38400-368
        • Eurolatino Pesquisas Medicas Ltda
  • Germany
      • Berlin, Germany, 12203
        • Charite Berlin
      • Frankfurt, Germany, 60590
        • Universitatsklinikum Frankfurt/ Medizinische Klinik 1
      • Jena, Germany, 07740
        • Universitätsklinikum Jena
      • Ulm, Germany, 89081
        • Universitaetsklinikum Ulm
  • Mexico
      • Boca del Rio, Mexico, 94229
        • Clínica Saluz
      • Mexico City, Mexico, 03300
        • Clinicos Asociados BOCM, SC
      • Monterrey, Mexico, 64610
        • Centro Regiomontano de Estudios Clínicos Roma S.C.
      • Queretaro, Mexico, 76000
        • Capital Humano para la Investigacion clinica
      • San Pedro Garza Garcia, Mexico, 66278
        • Centro Medico Zambrano Hellion
  • Poland
      • Gdansk, Poland, 80-382
        • Synexus Polska Sp. z o.o. Oddzial w Gdansku
      • Krakow, Poland, 30-510
        • Pratia MCM Krakow
      • Sopot, Poland, 81-756
        • Endoskopia Sp. z o.o. z siedzibą w Sopocie
      • Warsaw, Poland, 02-507
        • Centralny Szpital Kliniczny MSWiA w Warszawie
      • Warszawa, Poland, 00-728
        • WIP Warsaw IBD Point Profesor Kierkus
      • Warszawa, Poland, 00-635
        • Centrum Zdrowia MDM
      • Warszawa, Poland, 03 580
        • Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz
      • Wroclaw, Poland, 50-449
        • Melita Medical Sp. z o.o.
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620109
        • Medical Association 'New Hospital'
      • Kazan, Russian Federation, 420012
        • Kazan State Medical University
      • Moscow, Russian Federation, 127015
        • City Clinical Hospital # 24
      • Novosibirsk, Russian Federation, 630005
        • Medical Center SibNovoMed LLC
      • Rostov-On-Don, Russian Federation, 344022
        • Rostov State Medical University
      • Saint Petersburg, Russian Federation, 195257
        • Elizavetinskaya hospital
      • Saint Petersburg, Russian Federation, 197110
        • City Clinical Hospital #31
      • Saint-Petersburg, Russian Federation, 196143
        • Eco-safety Ltd
      • Samara, Russian Federation, 443001
        • Medical University Reaviz
      • St-Petersburg, Russian Federation, 191186
        • International Medical Centre SOGAZ
      • Tver, Russian Federation, 170036
        • Tver Regional Clinical Hospital
      • Ufa, Russian Federation, 450005
        • GBUZ Respublican Clinical Hospital n.a. GG Kuvatova
      • Yaroslavl, Russian Federation, 150062
        • Regional Clinical Hospital
      • Yaroslavl, Russian Federation, 150010
        • City Clinical Hospital #2
  • Ukraine
      • Kharkiv, Ukraine, 61037
        • Communal Nonprofit Enterprise 'City Clinical Hospital # 2 N.A. Prof. O.O. Shalimov'
      • Kharkiv, Ukraine, 61039
        • SI 'L.T. Maloyi National Institute of Therapy of National Academy of Medical Sciences of Ukraine
      • Kherson, Ukraine, 73003
        • Municipal Institution 'Kherson City Clinical Hospital n.a. Y.Y.Karabelesh'
      • Kyiv, Ukraine, 01030
        • Kyiv City Clinical Hospital #18
      • Kyiv, Ukraine, 02091
        • Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'
      • Lviv, Ukraine, 79007
        • Lviv Clinical Hospital on Railway Transport of Affiliate Healthcare center of JSC Ukrainian Railway
      • Lviv, Ukraine, 79010
        • Communal Nonprofit Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
      • Odessa, Ukraine, 65025
        • Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
      • Sumy, Ukraine, 40022
        • Sumy State University, Sumy Regional Clinical Hospital
      • Ternopil, Ukraine, 46002
        • Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
      • Vinnytsya, Ukraine, 21009
        • Medical Center Ltd 'Health Clinic', Department Of General Therapy
      • Vinnytsya, Ukraine, 21018
        • Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov
  • United States
    • California
      • San Diego, California, United States, 92114
        • Precision Research Institute
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Peak Gastroenterology Associates
    • Florida
      • Tampa, Florida, United States, 33609
        • GCP Clinical Research
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Gastrointestinal Specialists of Georgia
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Chevy Chase Clinical Research
      • Glen Burnie, Maryland, United States, 21061
        • Woodholme Gastroenterology
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Sierra Clinical Research
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • The University of North Carolina at Chapel Hill
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Fargo Gastroenterology Clinic, PC
    • Texas
      • Southlake, Texas, United States, 76092
        • Texas Digestive Disease Consultants
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Gastroenterology Associates of Tidewater
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason
      • Tacoma, Washington, United States, 98405
        • Washington Gastroenterology, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Placebo
Placebo will be administered.
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.
Experimental: Monotherapy: Guselkumab
Participants will receive guselkumab Dose 1 as IV infusion, Dose 2 as SC injection and placebo to maintain the blind.
Drug: Placebo
Placebo will be administered.
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.
Active Comparator: Monotherapy: Golimumab
Participants will receive golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
Drug: Placebo
Placebo will be administered.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Combination Phase: Percentage of Participants Who Achieved Clinical Response at Week 12
Time Frame: 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.
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Combination Phase: Percentage of Participants Who Achieved Clinical Remission at Week 12
Time Frame: 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.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Investigators

  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2018

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

November 15, 2021

Study Registration Dates

First Submitted

September 6, 2018

First Submitted That Met QC Criteria

September 6, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Estimated)

December 12, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR108527
  • 2018-001510-15 (EudraCT Number)
  • CNTO1959UCO2002 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colitis, Ulcerative

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe