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Clinical Trials in Italy / NCT04033445
Active, not recruiting Phase 2/3

A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

NCT04033445 · tracked via the Priya Life Science Italy tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 2/3
Started
2019-09-26
Last updated
2026-09-28

Condition(s) studied

Ulcerative Colitis

Investigational drug(s) / intervention(s)

PlaceboGuselkumab →

Placebo: Participants will receive matching placebo IV or SC.

Guselkumab: Participants will receive guselkumab IV or SC.

Study summary

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Documented diagnosis of ulcerative colitis (UC) * Moderately to severely active UC, defined by modified Mayo score * Demonstrated inadequate response or intolerance to medical therapies specified in the protocol * Screening laboratory test results within the parameters specified in the protocol Exclusion Criteria: * Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease * UC limited to the rectum only or to less than (\<) 20 centimeter (cm) of the colon * Presence of a stoma * Presence or history of a fistula * Receiving prohibited medications and/or treatment

Primary outcome measure(s)

  • Induction Study 1: Percentage of Participants With Clinical Response at Week I-12 — At Week I-12
    Clinical response was defined as a decrease from induction baseline in the modified Mayo score by greater than or equal to (\>=) 30 percent (%) and \>=2 points, with either a \>=1 point decrease from baseline (Week 0 of IS-1) in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for specified arms only.
  • Induction Study 2: Percentage of Participants With Clinical Remission at Week I-12 — At Week I-12
    Clinical remission was based on the modified Mayo score. Clinical remission was defined as Mayo stool frequency subscore of 0 or 1 and not increased from baseline (Week 0 of IS-2), a Mayo rectal bleeding subscore of 0, and Mayo endoscopic subscore of 0 or 1 with no friability. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for specified arms only.
  • Maintenance Study: Percentage of Participants With Clinical Remission at Week M-44 — At Week M-44
    Clinical remission was based on the modified Mayo score. Clinical remission was defined as Mayo stool frequency subscore of 0 or 1 and not increased from baseline (Week 0 of IS-1 and IS-2), a Mayo rectal bleeding subscore of 0, and Mayo endoscopic subscore of 0 or 1 with no friability. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for randomized arms only.

Trial sites (392)

FacilityCityRegionStatus
Om Research LLC Lancaster California
UCLA Los Angeles California
Peak Gastroenterology Associates 1 Colorado Springs Colorado
Florida Research Network, LLC Gainesville Florida
University of Florida Health Jacksonville Gainesville Florida
Harmony Medical Research Institute, Inc. Hialeah Florida
UF Health Jacksonville Gastroenterology Emerson Jacksonville Florida
I.H.S. Health. LLC Kissimmee Florida
Columbus Clinical Services LLC Miami Florida
Vista Health Research, LLC Miami Florida
Orlando Health Orlando Florida
Care Access Research, Orlando Orlando Florida
Synexus Clinical Research US Inc 2 Pinellas Park Florida
Univ. of South Florida Med. Group Tampa Florida
Atlanta Gastroenterology Associates Atlanta Georgia
Morehouse School of Medicine Atlanta Georgia
The Emory Clinic Atlanta Georgia
Atlanta Gastroenterology Associates 1 Atlanta Georgia
Atlanta Center For Gastroenterology Decatur Georgia
Gastroenterolgy Associates of Central GA Macon Georgia
University of Chicago Chicago Illinois
Health Science Research Center Pratt Kansas
Tri-State Gastroenterology Assoc Crestview Hills Kentucky
Baystate Medical Center Springfield Massachusetts
Clinical Research Institute of Michigan, LLC Clinton Township Michigan
Revive Research Institute Farmington Hills Michigan
Infusion Associates Grand Rapids Michigan
Mid-America Gastro-Intestinal Consultants Kansas City Missouri
Barnes-jewish Hospital St Louis Missouri
Las Vegas Medical Research Las Vegas Nevada
University of North Carolina at Chapel Hill Chapel Hill North Carolina
Duke University Hospital Medical Center Raleigh North Carolina
Synexus Clinical Research US Inc Columbus Ohio
Digestive Specialists, Inc Springboro Ohio
Gastro Intestinal Research Institute of Northern Ohio LLC Westlake Ohio
Care Access Research, Poland Youngstown Ohio
Digestive Disease Specialists Inc Oklahoma City Oklahoma
US Digestive Health Wyomissing Pennsylvania
Synexus Clinical Research US Inc 1 Anderson South Carolina
Gastroenterology Associates of Orangeburg, SC Orangeburg South Carolina

+ 352 more sites — see the full list on the official registry below.

On this site

📄 Tremfya (guselkumab) drug profile →

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Other trials for the same condition

Development of Novel Imaging and Molecular Biomarkers of Fibrosis in Patient With Ulcerative Colitis Recruiting
A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis Active, not recruiting
A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis (ROSETTA) Active, not recruiting
Estimation of Cardiovascular Risk in Patients With Crohn's Disease and Ulcerative Colitis (PROVACI) Enrolling by invitation
A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04033445 on ClinicalTrials.gov ↗ ← All trials in Italy