Summary

Eligibility
for people ages 2-17 (full criteria)
Location
at Oakland, California and other locations
Dates
study started
completion around

Description

Summary

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.

Official Title

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

Keywords

Colitis, Ulcerative, Colitis, Ulcerative Colitis, Ulcer, Monoclonal Antibodies, Guselkumab Subcutaneous, Guselkumab Intravenous

Eligibility

You can join if…

Open to people ages 2-17

  • 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

You CAN'T join if...

  • 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)

Locations

  • Children's Hospital Oakland accepting new patients
    Oakland California 94609 United States
  • Riley Hospital for Children accepting new patients
    Indianapolis Indiana 46202 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT06260163
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated