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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 January 2022
• Main ID: NCT03662542
• Date of registration: 06/09/2018
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis VEGA
• 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
• Date of first enrolment: November 20, 2018
• Target sample size: 214
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03662542
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Argentina, Australia, Brazil, Germany, Mexico, Poland, Russian Federation, Ukraine, United States

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion criteria

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

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Colitis, Ulcerative

Intervention(s)

Drug: Golimumab Dose 1

Drug: Guselkumab Dose 1

Drug: Guselkumab Dose 2

Drug: Golimumab Dose 2

Drug: Placebo

Primary Outcome(s)

Clinical Response at Week 12 [Time Frame: Week 12]

Secondary Outcome(s)

Clinical Remission at Week 12 [Time Frame: Week 12]

Secondary ID(s)

CNTO1959UCO2002

2018-001510-15

CR108527

Source(s) of Monetary Support

Please refer to primary and secondary sponsors