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

Description

The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders.

Conditions

Colitis, Ulcerative

Study Overview

Study Details

Study overview

The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders.

A Phase 3 Randomized, Open-label Induction, Double-blind Maintenance, Parallel-group, Multicenter Protocol to Evaluate the Efficacy, Safety, and Pharmacokinetics of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

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

Condition
Colitis, Ulcerative
Intervention / Treatment

-

Contacts and Locations

Indianapolis

Riley Hospital for Children, Indianapolis, Indiana, United States, 46202

Lake Success

NYU Langone Health, Lake Success, New York, United States, 11042

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Weight greater than or equal to (\>=) 10 kilogram (kg) at the time of consent for screening
  • * A pathology report to support a documented diagnosis of Ulcerative Colitis (UC) must be available in the source documents. There is no maximum duration for which a participant needs to be diagnosed with UC. If the pathology report to support a documented diagnosis of UC is not available in the source documents, the screening endoscopy with biopsies (obtained within 3 weeks before first study intervention administration) needs to support the diagnosis of UC.
  • * Moderately to severely active UC, defined by a baseline modified Mayo (without physician's global assessment) score of 5 through 9 inclusive, with a screening Mayo endoscopy subscore \>= 2 as determined by a central review of the video of the endoscopy
  • * Medically stable based on physical examination, medical history, and vital signs, performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and acknowledged by the investigator
  • * Participants must have had an inadequate response and/or intolerance to biologic therapy and/or conventional therapies or be dependent upon corticosteroids
  • * Have UC limited to the rectum only or to less than (\<) 20 centimeter of the colon
  • * Presence of a stoma
  • * Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months of baseline
  • * Have severe colitis or have evidence of Crohn's Disease (CD)

Ages Eligible for Study

2 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Janssen Research & Development, LLC,

Janssen Research & Development, LLC Clinical Trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

2028-08-14