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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
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
Combination Phase: Percentage of Participants Who Achieved Clinical Response at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Combination Phase: Percentage of Participants Who Achieved Clinical Remission at Week 12
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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/11/2021
Sample size
Target
Accrual to date
Final
214
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [2] 0 0
St Vincent's Hospital - Melbourne - Fitzroy
Recruitment hospital [3] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - North Terrace
Recruitment hospital [5] 0 0
Macquarie University Hospital - NSW
Recruitment hospital [6] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [7] 0 0
Mater Hospital Brisbane (Inflammatory Bowel Diseases) - South Brisbane
Recruitment postcode(s) [1] 0 0
4102 - Brisbane
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
2747 - Kingswood
Recruitment postcode(s) [4] 0 0
5000 - North Terrace
Recruitment postcode(s) [5] 0 0
2109 - NSW
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment postcode(s) [7] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
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Nevada
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United States of America
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North Carolina
Country [9] 0 0
United States of America
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North Dakota
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United States of America
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Texas
Country [11] 0 0
United States of America
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Virginia
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United States of America
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Washington
Country [13] 0 0
Argentina
State/province [13] 0 0
Buenos Aires
Country [14] 0 0
Argentina
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Caba
Country [15] 0 0
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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Argentina
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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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Belo Horizonte
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Brazil
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Botucatu
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Brazil
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Goiania
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Brazil
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Porto Alegre
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Brazil
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Ribeirao Preto
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Brazil
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Rio de Janeiro
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Brazil
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Santo Andre
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Brazil
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São José Do Rio Preto
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Brazil
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Uberlandia
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Germany
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Berlin
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Germany
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Frankfurt
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Germany
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Jena
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Germany
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Ulm
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Mexico
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Boca del Rio
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Mexico
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Mexico City
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Mexico
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Monterrey
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Mexico
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Queretaro
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Mexico
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San Pedro Garza Garcia
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Poland
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Gdansk
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Poland
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Krakow
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Poland
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Sopot
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Poland
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Warsaw
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Warszawa
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Poland
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Wroclaw
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Russian Federation
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Ekaterinburg
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Rostov-On-Don
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Samara
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Russian Federation
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St-Petersburg
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Russian Federation
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Tver
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Russian Federation
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Ufa
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Russian Federation
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Yaroslavl
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Ukraine
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Kharkiv
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Kherson
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Kyiv
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Lviv
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Odessa
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Sumy
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Ukraine
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Ternopil
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Ukraine
State/province [63] 0 0
Vinnytsya

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03662542