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Clinical Trials in South Korea / NCT05528510
Active, not recruiting Phase 3

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

NCT05528510 · tracked via the Priya Life Science South Korea tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2022-09-13
Last updated
2026-09-28

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
No
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)

FacilityCityRegionStatus
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 South Korea

A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer Recruiting
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease Recruiting
A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Recruiting
A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease Recruiting
A Study of Pasritamig With or Without JNJ-87189401 Versus Placebo for Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC) Recruiting

Other trials for the same condition

A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC Active, not recruiting
Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD Enrolling by invitation
A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis Recruiting
A Study of Jyseleca Tablet (Filgotinib Maleate) in Korean Participants Recruiting
A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe 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 South Korea