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Completed

NCT Number: NCT03662542

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

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).

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Key information

Conditions

Colitis, Ulcerative Colitis Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CEMIC (Centro de Educación Médica e Investigaciones Clínicas), Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Guselkumab dose 1

Drug

Guselkumab Dose 1 will be administered as IV infusion.

Guselkumab dose 2

Drug

Guselkumab Dose 2 will be administered as SC injection.

Golimumab Dose 1

Drug

Golimumab Dose 1 will be administered as SC injection.

Golimumab Dose 2

Drug

Golimumab Dose 2 will be administered as SC injection.

Placebo

Drug

Placebo will be administered.

Primary outcomes

  1. 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

  1. Combination Phase: Percentage of Participants Who Achieved Clinical Remission at Week 12

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study 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

Acronym: VEGA

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Sep 7, 2018
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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