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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03662542
Registration number
NCT03662542
Ethics application status
Date submitted
6/09/2018
Date registered
7/09/2018
Date last updated
12/12/2023
Titles & IDs
Public title
A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
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Scientific 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
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Secondary ID [1]
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2018-001510-15
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Secondary ID [2]
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CR108527
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Universal Trial Number (UTN)
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Trial acronym
VEGA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colitis, Ulcerative
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Guselkumab Dose 1
Treatment: Drugs - Guselkumab Dose 2
Treatment: Drugs - Golimumab Dose 1
Treatment: Drugs - Golimumab Dose 2
Treatment: Drugs - Placebo
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.
Experimental: Monotherapy: Guselkumab - Participants will receive guselkumab Dose 1 as IV infusion, Dose 2 as SC injection and placebo to maintain the blind.
Active comparator: Monotherapy: Golimumab - Participants will receive golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
Treatment: Drugs: Guselkumab Dose 1
Guselkumab Dose 1 will be administered as IV infusion.
Treatment: Drugs: Guselkumab Dose 2
Guselkumab Dose 2 will be administered as SC injection.
Treatment: Drugs: Golimumab Dose 1
Golimumab Dose 1 will be administered as SC injection.
Treatment: Drugs: Golimumab Dose 2
Golimumab Dose 2 will be administered as SC injection.
Treatment: Drugs: Placebo
Placebo will be administered.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Combination Phase: Percentage of Participants Who Achieved Clinical Response at Week 12
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Assessment method [1]
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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.
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Timepoint [1]
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Week 12
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Secondary outcome [1]
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Combination Phase: Percentage of Participants Who Achieved Clinical Remission at Week 12
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Assessment method [1]
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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.
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Timepoint [1]
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Week 12
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Eligibility
Key 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
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Minimum age
18
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Maximum age
65
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/11/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/11/2021
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Sample size
Target
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Accrual to date
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Final
214
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Princess Alexandra Hospital - Brisbane
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St Vincent's Hospital - Melbourne - Fitzroy
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Nepean Hospital - Kingswood
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Royal Adelaide Hospital - North Terrace
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Macquarie University Hospital - NSW
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Royal Melbourne Hospital - Parkville
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Recruitment hospital [7]
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Mater Hospital Brisbane (Inflammatory Bowel Diseases) - South Brisbane
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Recruitment postcode(s) [1]
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4102 - Brisbane
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Recruitment postcode(s) [2]
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3065 - Fitzroy
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Recruitment postcode(s) [3]
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2747 - Kingswood
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Recruitment postcode(s) [4]
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5000 - North Terrace
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Recruitment postcode(s) [5]
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2109 - NSW
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Recruitment postcode(s) [6]
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3050 - Parkville
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Recruitment postcode(s) [7]
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4101 - South Brisbane
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Recruitment outside Australia
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California
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Research & Development, LLC
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Address
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT03662542
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/42/NCT03662542/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/42/NCT03662542/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03662542
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