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

NCT05528510 · tracked via the Priya Life Science Canada tracker

Sponsor

Janssen Research & Development, LLC

Phase

Phase 3

Started

2022-09-13

Last updated

2026-08-28

Condition(s) studied

Colitis, Ulcerative

Investigational drug(s) / intervention(s)

Guselkumab Dose 1 →Guselkumab Dose 2 →Guselkumab Dose 3 →Placebo

Guselkumab Dose 1: Guselkumab (Dose 1) will be administered as SC injection.

Guselkumab Dose 2: Guselkumab (Dose 2) will be administered as SC injection.

Guselkumab Dose 3: Guselkumab (Dose 3) will be administered as SC injection.

Placebo: Placebo will be administered as SC injection.

Study summary

The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Signed informed consent form * 18 years of age or older * Documented diagnosis of ulcerative colitis (UC) at least 12 weeks prior to screening * Moderately to severely active UC as per the modified Mayo score * Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol Exclusion Criteria: * Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease * Surgery within 8 weeks before screening or planned surgery during the study that may confound the evaluation of benefit from study intervention * Receiving prohibited medications and treatments * UC limited to the rectum only * Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) corona virus disease (COVID-19) infection

Primary outcome measure(s)

Percentage of Participants in Clinical Remission at Week 12 — Week 12
Percentage of participants in clinical remission at Week 12 was reported. Clinical remission is defined as a Mayo stool frequency subscore of 0 or 1 and not increased from baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity.

Trial sites (236)

Facility	City	Region
Research Solutions of Arizona	Litchfield Park	Arizona
Om Research LLC 1	Apple Valley	California
Om Research LLC	Lancaster	California
Medical Associates Research Group, Inc.	San Diego	California
Peak Gastroenterology Associates	Colorado Springs	Colorado
Gastro Florida	Clearwater	Florida
I.H.S. Health. LLC	Kissimmee	Florida
Columbus Clinical Services LLC	Miami	Florida
Vista Health Research, LLC	Miami	Florida
Orlando Health	Orlando	Florida
Theia Clincial Research, LLC	Temple Terrace	Florida
Digestive Healthcare of Georgia, P.C	Atlanta	Georgia
Atlanta Gastroenterology Associates	Atlanta	Georgia
Gastroenterology Associates of Central GA	Macon	Georgia
Cotton O'Neil Digestive Health Center	Topeka	Kansas
Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan
Detroit Clinical Research Center	Farmington Hills	Michigan
Smart Medical Research	Hollis	New York
University of North Carolina	Chapel Hill	North Carolina
Peters Medical Research	High Point	North Carolina
Dayton Gastroenterology, Inc	Dayton	Ohio
Gastro Intestinal Research Institute of Northern Ohio LLC	Westlake	Ohio
Allegheny General Hospital of Research	Pittsburgh	Pennsylvania
Frontier Clinical Research	Uniontown	Pennsylvania
Gastroenterology Associates of Orangeburg, SC	Orangeburg	South Carolina
Southern Star Research Institute, LLC	San Antonio	Texas
UT Health Science Center at San Antonio	San Antonio	Texas
Tyler Research Institute, LLC	Tyler	Texas
Victoria Gastroenterology	Victoria	Texas
Care Access Research, Ogden	Ogden	Utah
Gastroenterology Associates	Salt Lake City	Utah
Gastroenterology Associates of Tidewater	Chesapeake	Virginia
Cer Instituto Medico	Buenos Aires	Argentina
Hospital General de Agudos José Maria Ramos Mejía	Buenos Aires	Argentina
Clinica Adventista Belgrano	Ciudad de Buenos Aires	Argentina
Sanatorio Duarte Quiroz	Córdoba	Argentina
Hospital Privado Universitario De Cordoba	Córdoba	Argentina
Hospital Italiano de La Plata	La Plata	Argentina
Centro de Investigaciones Medicas Mar Del Plata	Mar del Plata	Argentina
Hospital Provincial del Centenario	Rosario	Argentina

+ 196 more sites — see the full list on the official registry below.

More Janssen Research & Development, LLC trials in Canada

A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis Recruiting

A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies Active, not recruiting

A Study of Pasritamig With or Without JNJ-87189401 Versus Placebo for Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC) Recruiting

A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy Active, not recruiting

Nipocalimab in Moderate to Severe Sjogren's Disease Active, not recruiting

Other trials for the same condition

A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis Recruiting

A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis Recruiting

Diet Intervention Treatment for Active Ulcerative Colitis Recruiting

Comparison of Medical RESCUE Strategies for Patients With Steroid-refractory Acute Severe Ulcerative Colitis Recruiting

A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis 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 NCT05528510 on ClinicalTrials.gov ↗ ← All trials in Canada