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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Colitis, Ulcerative

Treatments: Drug: Guselkumab Dose 1; Drug: Placebo; Drug: Guselkumab Dose 2; Drug: Golimumab Dose 1; Drug: Golimumab Dose 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT03662542

2018-001510-15 (EudraCT Number)

CNTO1959UCO2002 (Other Identifier)

CR108527

Details and patient eligibility

About

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).

Enrollment: 214 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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214 participants in 3 patient groups

Combination Therapy

Experimental group

Description:

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.

Treatment:

Drug: Golimumab Dose 1

Drug: Placebo

Drug: Guselkumab Dose 1

Drug: Golimumab Dose 2

Drug: Guselkumab Dose 2

Monotherapy: Guselkumab

Experimental group

Description:

Participants will receive guselkumab Dose 1 as IV infusion, Dose 2 as SC injection and placebo to maintain the blind.

Treatment:

Drug: Placebo

Drug: Guselkumab Dose 1

Drug: Guselkumab Dose 2

Monotherapy: Golimumab

Active Comparator group

Description:

Participants will receive golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.

Treatment:

Drug: Golimumab Dose 1

Drug: Placebo

Drug: Golimumab Dose 2