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Colitis, UlcerativePhase 2VEGANCT03662542

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

A Phase 2 study testing Guselkumab Dose 1, Guselkumab Dose 2 and Golimumab Dose 1 in people with Colitis, Ulcerative, run by Janssen Research & Development, LLC at 82 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Colitis, Ulcerative
What is being tested?
Guselkumab Dose 1, Guselkumab Dose 2 and Golimumab Dose 1
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
214 participants
Where
82 sitesin 9 countries
Study dates
20 Nov 2018to 15 Nov 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

82 sites in 9 countries.

82 sites in 9 countries

United States14 sites

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia, 23320

  • Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907

  • Fargo Gastroenterology Clinic, PC

    Fargo, North Dakota, 58103

  • Woodholme Gastroenterology

    Glen Burnie, Maryland, 21061

  • Indiana University

    Indianapolis, Indiana, 46202

  • Sierra Clinical Research

    Las Vegas, Nevada, 89106

  • Gastrointestinal Specialists of Georgia

    Marietta, Georgia, 30060

  • Precision Research Institute

    San Diego, California, 92114

  • Virginia Mason

    Seattle, Washington, 98101

  • Texas Digestive Disease Consultants

    Southlake, Texas, 76092

  • Washington Gastroenterology, PLLC

    Tacoma, Washington, 98405

  • GCP Clinical Research

    Tampa, Florida, 33609

Other trials in United States

Russia14 sites

  • Kazan State Medical University

    Kazan', 420012

  • City Clinical Hospital # 24

    Moscow, 127015

  • Medical Center SibNovoMed LLC

    Novosibirsk, 630005

  • Rostov State Medical University

    Rostov-on-Don, 344022

  • International Medical Centre SOGAZ

    Saint Petersburg, 191186

  • Elizavetinskaya hospital

    Saint Petersburg, 195257

  • Eco-safety Ltd

    Saint Petersburg, 196143

  • City Clinical Hospital #31

    Saint Petersburg, 197110

  • Medical University Reaviz

    Samara, 443001

  • Tver Regional Clinical Hospital

    Tver', 170036

  • GBUZ Respublican Clinical Hospital n.a. GG Kuvatova

    Ufa, 450005

  • City Clinical Hospital #2

    Yaroslavl, 150010

  • Regional Clinical Hospital

    Yaroslavl, 150062

  • Medical Association 'New Hospital'

    Yekaterinburg, 620109

Other trials in Russia

Ukraine12 sites

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

    Kharkiv, 61037

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

    Kharkiv, 61039

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

    Kherson, 73003

  • Kyiv City Clinical Hospital #18

    Kyiv, 01030

  • Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'

    Kyiv, 02091

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

    Lviv, 79007

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

    Lviv, 79010

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

    Odesa, 65025

  • Sumy State University, Sumy Regional Clinical Hospital

    Sumy, 40022

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

    Ternopil, 46002

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

    Vinnytsia, 21009

  • Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov

    Vinnytsia, 21018

Other trials in Ukraine

Brazil10 sites

  • Hospital Das Clinicas Da Ufmg

    Belo Horizonte, 30130-100

  • Universidade Estadual Paulista 'Julio De Mesquita Filho'

    Botucatu, 18618-970

  • Inst Goiano Gastroenterologia e Endoscopia Digest Ltda - Clinica de Gastro

    Goiânia, 74535-170

  • Hospital das Clinicas de Porto Alegre

    Porto Alegre, 90035-903

  • Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP

    Ribeirão Preto, 14098-900

  • Universidade Federal do Rio de Janeiro - Faculdade de Medicina

    Rio de Janeiro, 20050-902

  • Instituto Brasil de Pesquisa Clinica

    Rio de Janeiro, 20241-180

  • Fundacao do ABC - Centro Universitario FMABC

    Santo André, 09060-870

  • Kaiser Hospta

    São José do Rio Preto, 15015-110

  • Eurolatino Pesquisas Medicas Ltda

    Uberlândia, 38400-368

Other trials in Brazil

Argentina8 sites

  • CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

    Buenos Aires, 1431

  • Hospital Britanico de Buenos Aires

    Buenos Aires, C1280AEB

  • Expertia S.A

    Caba, C1128AAF

  • Centro Médico Dra. De Salvo

    Caba, C1426ABP

  • Clínica Adventista Belgrano

    Ciudad de Buenos Aires, C1430EGF

  • Fundacion de Estudios Clinicos

    Rosario, 2000

  • Hospital de Alta Complejidad en Red 'El Cruce'

    San Juan Bautista, 1888

  • Sanatorio 9 de Julio

    San Miguel de Tucumán, 4000

Other trials in Argentina

Poland8 sites

  • Synexus Polska Sp. z o.o. Oddzial w Gdansku

    Gdansk, 80-382

  • Pratia MCM Krakow

    Krakow, 30-510

  • Endoskopia Sp. z o.o. z siedzibą w Sopocie

    Sopot, 81-756

  • Centrum Zdrowia MDM

    Warsaw, 00-635

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 00-728

  • Centralny Szpital Kliniczny MSWiA w Warszawie

    Warsaw, 02-507

  • Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz

    Warsaw, 03 580

  • Melita Medical Sp. z o.o.

    Wroclaw, 50-449

Other trials in Poland

Australia7 sites

  • Princess Alexandra Hospital

    Brisbane, 4102

  • St Vincent's Hospital - Melbourne

    Fitzroy, 3065

  • Nepean Hospital

    Kingswood, 2747

  • Royal Adelaide Hospital

    North Terrace, 5000

  • Macquarie University Hospital

    NSW, 2109

  • Royal Melbourne Hospital

    Parkville, 3050

  • Mater Hospital Brisbane (Inflammatory Bowel Diseases)

    South Brisbane, 4101

Other trials in Australia

Mexico5 sites

  • Clínica Saluz

    Boca del Rio, 94229

  • Clinicos Asociados BOCM, SC

    Mexico City, 03300

  • Centro Regiomontano de Estudios Clínicos Roma S.C.

    Monterrey, 64610

  • Capital Humano para la Investigacion clinica

    Querétaro, 76000

  • Centro Medico Zambrano Hellion

    San Pedro Garza García, 66278

Other trials in Mexico

Germany4 sites

  • Charite Berlin

    Berlin, 12203

  • Universitatsklinikum Frankfurt/ Medizinische Klinik 1

    Frankfurt, 60590

  • Universitätsklinikum Jena

    Jena, 07740

  • Universitaetsklinikum Ulm

    Ulm, 89081

Other trials in Germany

About this study

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

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).

Being tested
Guselkumab Dose 1, Guselkumab Dose 2, Golimumab Dose 1, Golimumab Dose 2, Placebo
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Guselkumab Dose 1Drug

    Guselkumab Dose 1 will be administered as IV infusion.

  • Guselkumab Dose 2Drug

    Guselkumab Dose 2 will be administered as SC injection.

  • Golimumab Dose 1Drug

    Golimumab Dose 1 will be administered as SC injection.

  • Golimumab Dose 2Drug

    Golimumab Dose 2 will be administered as SC injection.

  • PlaceboDrug

    Placebo will be administered.

Study groups in NCT03662542
Study groupRoleWhat they receive
Combination TherapyExperimentalParticipants 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.
Receives: Drug: Guselkumab Dose 1; Drug: Guselkumab Dose 2; Drug: Golimumab Dose 1; Drug: Golimumab Dose 2; Drug: Placebo
Monotherapy: GuselkumabExperimentalParticipants will receive guselkumab Dose 1 as IV infusion, Dose 2 as SC injection and placebo to maintain the blind.
Receives: Drug: Guselkumab Dose 1; Drug: Guselkumab Dose 2; Drug: Placebo
Monotherapy: GolimumabActive comparatorParticipants will receive golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
Receives: Drug: Golimumab Dose 1; Drug: Golimumab Dose 2; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Combination Phase: Percentage of Participants Who Achieved Clinical Response at 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.

    Measured: Week 12

Secondary outcomes (1)

  1. Combination Phase: Percentage of Participants Who Achieved Clinical Remission at 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.

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2018
  2. Study start20 Nov 2018
  3. Primary completion1 Dec 2020
  4. Study completion15 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
214 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03662542
Sponsor's protocol ID
CR108527
Other IDs
2018-001510-15, CNTO1959UCO2002, 2018
Acronym
VEGA
Status last verified
Nov 2023
First submitted
6 Sep 2018
Last updated
12 Dec 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Shao J, Vetter M, Vermeulen A, Feagan BG, Sands BE, Panes J, Xu Z. Combination Therapy With Guselkumab and Golimumab in Patients With Moderately to Severely Active Ulcerative Colitis: Pharmacokinetics, Immunogenicity and Drug-Drug Interactions. Clin Pharmacol Ther. 2024 Jun;115(6):1418-1427. doi: 10.1002/cpt.3235. Epub 2024 Mar 15.

    PubMed 38488354

  • Feagan BG, Sands BE, Sandborn WJ, Germinaro M, Vetter M, Shao J, Sheng S, Johanns J, Panes J; VEGA Study Group. Guselkumab plus golimumab combination therapy versus guselkumab or golimumab monotherapy in patients with ulcerative colitis (VEGA): a randomised, double-blind, controlled, phase 2, proof-of-concept trial. Lancet Gastroenterol Hepatol. 2023 Apr;8(4):307-320. doi: 10.1016/S2468-1253(22)00427-7. Epub 2023 Feb 1.

    PubMed 36738762

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Guselkumab Dose 1, Guselkumab Dose 2 and Golimumab Dose 1 in people with Colitis, Ulcerative, run by Janssen Research & Development, LLC at 82 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States, Russia, Ukraine, Brazil, Argentina and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combination Phase: Percentage of Participants Who Achieved Clinical Response at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03662542, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.

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