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New treatment option for Crohn's Disease
Official title A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
ClinicalTrials.gov ID: NCT05923073
What this study is testing
What is Guselkumab?
Guselkumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for crohn's disease.
Also referred to as CNTO1959, TREMFYA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical response to guselkumab at Week 12.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- Participants must have a diagnosis of Crohn's Disease (CD) or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in...
- Participants must have moderately to severely active CD (as defined by a baseline Pediatric Crohn's Disease Activity Index [PCDAI] score greater than...
- Participants must have endoscopy with evidence of active CD defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) score greater than or...
- Participants must have a history of inadequate response, loss of response, or intolerance to immunomodulators (6-MP, AZA, or MTX), oral or IV...
You likely can't join if
- Participants has complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestation that might be...
- Participants must not have an abscess
- Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Hartford, Connecticut, United States
- Atlanta, Georgia, United States
- Indianapolis, Indiana, United States
- Boston, Massachusetts, United States
- Morristown, New Jersey, United States
- New York, New York, United States
- Dayton, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Fort Worth, Texas, United States
- Colchester, Vermont, United States
- Nedlands, Australia
- South Brisbane, Australia
- Westmead, Australia
- Vienna, Austria
- Brussels, Belgium
- Ghent, Belgium
- Leuven, Belgium
- Campinas, Brazil
- Curitiba, Brazil
+ 53 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Hartford, Connecticut, United States; Atlanta, Georgia, United States; Indianapolis, Indiana, United States; Boston, Massachusetts, United States; Morristown, New Jersey, United States and 67 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.