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

M
Marian Pfefferkorn

Primary Investigator

Enrolling By Invitation
2 years - 17 years
All
Phase 3
4 participants needed
2 Locations

Brief description of study

What is this study about?

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.

THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

What will happen during the study?
  • If your child joins the study, your child will be in the study for up to 74 weeks (approximately 1.5 years) and will need to visit the site approximately 17 times.
  • All patients in this study will get guselkumab during the 12-week induction period. For induction, your child will have a 50% chance of being put into either group. Treatment will be given through an intravenous (IV) infusion (into a vein) or a subcutaneous (SC) injection (beneath the skin) depending on which group your child is in.
  • Your child will receive treatment a total of 3 times during induction. Treatment will be received every 4 weeks (Weeks 0, 4, and 8). The dose will be based on your child’s weight.
  • After Week 12, your child will enter the maintenance period and will receive treatment by subcutaneous injection, every 4 or 8 weeks, over a 44-week period (12 times in total).

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Ulcerative colitis, Riley
  • Age: 2 years - 17 years
  • Gender: All

Inclusion 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

Exclusion Criteria:

  • 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)
 

Updated on 17 Apr 2025. Study ID: PGI-JANSSEN-TREMFYA, 20803
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