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
Overview
- Phase
- Phase 2
- Intervention
- Guselkumab Dose 1
- Conditions
- Colitis, Ulcerative
- Sponsor
- Janssen Research & Development, LLC
- Enrollment
- 214
- Locations
- 82
- Primary Endpoint
- Combination Phase: Percentage of Participants Who Achieved Clinical Response at Week 12
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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).
Investigators
Eligibility 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
Arms & Interventions
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.
Intervention: Guselkumab Dose 1
Monotherapy: Golimumab
Participants will receive golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
Intervention: Placebo
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.
Intervention: Guselkumab Dose 2
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.
Intervention: Golimumab Dose 1
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.
Intervention: Golimumab Dose 2
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.
Intervention: Placebo
Monotherapy: Guselkumab
Participants will receive guselkumab Dose 1 as IV infusion, Dose 2 as SC injection and placebo to maintain the blind.
Intervention: Guselkumab Dose 1
Monotherapy: Guselkumab
Participants will receive guselkumab Dose 1 as IV infusion, Dose 2 as SC injection and placebo to maintain the blind.
Intervention: Guselkumab Dose 2
Monotherapy: Guselkumab
Participants will receive guselkumab Dose 1 as IV infusion, Dose 2 as SC injection and placebo to maintain the blind.
Intervention: Placebo
Monotherapy: Golimumab
Participants will receive golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
Intervention: Golimumab Dose 1
Monotherapy: Golimumab
Participants will receive golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
Intervention: Golimumab Dose 2
Outcomes
Primary Outcomes
Combination Phase: Percentage of Participants Who Achieved Clinical Response at Week 12
Time Frame: Week 12
Clinical response was defined as a decrease from baseline in the Mayo score greater than or equal to (\>=) 30 percent (%) and \>=3 points with either a decrease from baseline in the rectal bleeding subscore (RBS) \>=1 or a RBS of 0 or 1. The Mayo score was 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. Higher scores indicate more severity. This outcome measure was analyzed for combination phase only as preplanned in the protocol.
Secondary Outcomes
- Combination Phase: Percentage of Participants Who Achieved Clinical Remission at Week 12(Week 12)