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

Phase 2

Completed

• Conditions: Colitis, Ulcerative
• Interventions: Drug: Guselkumab Dose 1; Drug: Guselkumab Dose 2; Drug: Golimumab Dose 1; Drug: Placebo; Drug: Golimumab Dose 2

• Registration Number: NCT03662542
• Lead Sponsor: Janssen Research & Development, LLC

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-06
• Study First Submitted QC: 2018-09-06
• Study First Posted: 2018-09-07
• Study Start: 2018-11-20
• Primary Completion: 2020-12-01
• Study Completion: 2021-11-15
• Disposition First Submitted: 2021-11-26
• Disposition First Submitted QC: 2021-11-26
• Disposition First Posted: 2021-11-30
• Status Verified: 2023-11
• Results First Submitted: 2023-11-17
• Results First Submitted QC: 2023-11-17
• Last Update Submitted: 2023-11-17
• Results First Posted: 2023-12-12
• Last Update Posted: 2023-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination Therapy	Golimumab Dose 1	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.
Combination Therapy	Golimumab Dose 2	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.
Monotherapy: Guselkumab	Guselkumab Dose 1	Participants will receive guselkumab Dose 1 as IV infusion, Dose 2 as SC injection and placebo to maintain the blind.
Monotherapy: Golimumab	Placebo	Participants will receive golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
Monotherapy: Golimumab	Golimumab Dose 2	Participants will receive golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
Combination Therapy	Guselkumab Dose 1	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.
Combination Therapy	Guselkumab Dose 2	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.
Combination Therapy	Placebo	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.
Monotherapy: Guselkumab	Guselkumab Dose 2	Participants will receive guselkumab Dose 1 as IV infusion, Dose 2 as SC injection and placebo to maintain the blind.
Monotherapy: Guselkumab	Placebo	Participants will receive guselkumab Dose 1 as IV infusion, Dose 2 as SC injection and placebo to maintain the blind.
Monotherapy: Golimumab	Golimumab Dose 1	Participants will receive golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.

Primary Outcome Measures

Name	Time	Method
Combination Phase: Percentage of Participants Who Achieved Clinical Response at Week 12	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 Outcome Measures

Name	Time	Method
Combination Phase: Percentage of Participants Who Achieved Clinical Remission at Week 12	Week 12	Clinical remission was defined as the Mayo score less than or equal to (\<=) 2 with no individual subscore greater than (\>) 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.

Trial Locations

Locations (82)

Precision Research Institute; 🇺🇸 San Diego, California, United States

Peak Gastroenterology Associates; 🇺🇸 Colorado Springs, Colorado, United States

GCP Clinical Research; 🇺🇸 Tampa, Florida, United States

Gastrointestinal Specialists of Georgia; 🇺🇸 Marietta, Georgia, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

Chevy Chase Clinical Research; 🇺🇸 Chevy Chase, Maryland, United States

Woodholme Gastroenterology; 🇺🇸 Glen Burnie, Maryland, United States

Sierra Clinical Research; 🇺🇸 Las Vegas, Nevada, United States

The University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Fargo Gastroenterology Clinic, PC; 🇺🇸 Fargo, North Dakota, United States

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