Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
State/province [7] 0 0
Nevada
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
North Dakota
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
Argentina
State/province [13] 0 0
Buenos Aires
Country [14] 0 0
Argentina
State/province [14] 0 0
Caba
Country [15] 0 0
Argentina
State/province [15] 0 0
Ciudad Autonoma de Buenos Aires
Country [16] 0 0
Argentina
State/province [16] 0 0
Ciudad De Buenos Aires
Country [17] 0 0
Argentina
State/province [17] 0 0
Florencio Varela
Country [18] 0 0
Argentina
State/province [18] 0 0
Rosario
Country [19] 0 0
Argentina
State/province [19] 0 0
San Miguel de Tucuman
Country [20] 0 0
Brazil
State/province [20] 0 0
Belo Horizonte
Country [21] 0 0
Brazil
State/province [21] 0 0
Botucatu
Country [22] 0 0
Brazil
State/province [22] 0 0
Goiania
Country [23] 0 0
Brazil
State/province [23] 0 0
Porto Alegre
Country [24] 0 0
Brazil
State/province [24] 0 0
Ribeirao Preto
Country [25] 0 0
Brazil
State/province [25] 0 0
Rio de Janeiro
Country [26] 0 0
Brazil
State/province [26] 0 0
Santo Andre
Country [27] 0 0
Brazil
State/province [27] 0 0
São José Do Rio Preto
Country [28] 0 0
Brazil
State/province [28] 0 0
Uberlandia
Country [29] 0 0
Germany
State/province [29] 0 0
Berlin
Country [30] 0 0
Germany
State/province [30] 0 0
Frankfurt
Country [31] 0 0
Germany
State/province [31] 0 0
Jena
Country [32] 0 0
Germany
State/province [32] 0 0
Ulm
Country [33] 0 0
Mexico
State/province [33] 0 0
Boca del Rio
Country [34] 0 0
Mexico
State/province [34] 0 0
Mexico City
Country [35] 0 0
Mexico
State/province [35] 0 0
Monterrey
Country [36] 0 0
Mexico
State/province [36] 0 0
Queretaro
Country [37] 0 0
Mexico
State/province [37] 0 0
San Pedro Garza Garcia
Country [38] 0 0
Poland
State/province [38] 0 0
Gdansk
Country [39] 0 0
Poland
State/province [39] 0 0
Krakow
Country [40] 0 0
Poland
State/province [40] 0 0
Sopot
Country [41] 0 0
Poland
State/province [41] 0 0
Warsaw
Country [42] 0 0
Poland
State/province [42] 0 0
Warszawa
Country [43] 0 0
Poland
State/province [43] 0 0
Wroclaw
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Ekaterinburg
Country [45] 0 0
Russian Federation
State/province [45] 0 0
Kazan
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Moscow
Country [47] 0 0
Russian Federation
State/province [47] 0 0
Novosibirsk
Country [48] 0 0
Russian Federation
State/province [48] 0 0
Rostov-On-Don
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Saint Petersburg
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Saint-Petersburg
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Samara
Country [52] 0 0
Russian Federation
State/province [52] 0 0
St-Petersburg
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Tver
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Ufa
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Yaroslavl
Country [56] 0 0
Ukraine
State/province [56] 0 0
Kharkiv
Country [57] 0 0
Ukraine
State/province [57] 0 0
Kherson
Country [58] 0 0
Ukraine
State/province [58] 0 0
Kyiv
Country [59] 0 0
Ukraine
State/province [59] 0 0
Lviv
Country [60] 0 0
Ukraine
State/province [60] 0 0
Odessa
Country [61] 0 0
Ukraine
State/province [61] 0 0
Sumy
Country [62] 0 0
Ukraine
State/province [62] 0 0
Ternopil
Country [63] 0 0
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
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/ct2/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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03662542