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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03662542




Registration number
NCT03662542
Ethics application status
Date submitted
6/09/2018
Date registered
7/09/2018
Date last updated
11/06/2020

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
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
Secondary ID [1] 0 0
2018-001510-15
Secondary ID [2] 0 0
CR108527
Universal Trial Number (UTN)
Trial acronym
VEGA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colitis, Ulcerative 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical Response at Week 12 - Clinical response as defined by Mayo score. The Mayo score is 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.
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Clinical Remission at Week 12 - Clinical remission as defined by Mayo score. The Mayo score is 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.
Timepoint [1] 0 0
Week 12

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
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [2] 0 0
St Vincent's hospital - Darlinghurst
Recruitment hospital [3] 0 0
Saint Vincent's Hospital - Melbourne - Fitzroy
Recruitment hospital [4] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [5] 0 0
Macquarie University Hospital - New South Wales
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - North Terrace
Recruitment hospital [7] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [8] 0 0
Mater Hospital Brisbane (Inflammatory Bowel Diseases) - South Brisbane
Recruitment hospital [9] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment postcode(s) [1] 0 0
4102 - Brisbane
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
2747 - Kingswood
Recruitment postcode(s) [5] 0 0
2109 - New South Wales
Recruitment postcode(s) [6] 0 0
5000 - North Terrace
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment postcode(s) [8] 0 0
4101 - South Brisbane
Recruitment postcode(s) [9] 0 0
5011 - Woodville South
Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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Indiana
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Louisiana
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Maryland
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Michigan
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Virginia
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Washington
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Argentina
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Buenos Aires
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Argentina
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Caba
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Argentina
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Ciudad Autonoma de Buenos Aires
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Argentina
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Ciudad De Buenos Aires
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Argentina
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Florencio Varela
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Rosario
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Argentina
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San Miguel de Tucuman
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Brazil
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Botucatu
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Curitiba
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Goiania
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Porto Alegre
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Ribeirão Preto
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Rio de Janeiro
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Santo Andre
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Rostov-On-Don
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Saint Petersburg
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Saint-Petersburg
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Samara
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Tver
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Ufa
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Yaroslavl
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Ukraine
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Chernivtsi
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Kharkiv
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Kherson
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Lviv
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Odessa
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Sumy
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Ternopil
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Vinnytsya
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Ukraine
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Zaporizhzhya

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/show/NCT03662542
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
JNJ.CT@sylogent.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03662542