A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease (NCT04397263) | Clinical Trial Compass
CompletedPhase 3
A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
Japan38 participantsStarted 2020-06-10
Plain-language summary
The purpose of this study is to evaluate the safety of Guselkumab in participants with Crohn's disease.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have Crohn's Disease (CD) or fistulizing CD of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
* Have moderate to severe CD as assessed by CDAI components of stool frequency (SF), and abdominal pain (AP) scores, and endoscopic evidence
* Have screening laboratory test results within the protocol specified parameters
* A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline
* Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD
Exclusion Criteria:
* Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation
* Unstable doses of concomitant Crohn's disease therapy
* Receipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted time frame as specified in the protocol
* Prior exposure to p40 inhibitors or p19 inhibitors
* Any medical contraindications preventing study participation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timeframe: From baseline (Week 0) up to Week 48
2
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Timeframe: From baseline (Week 0) up to Week 48
3
Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI)
Timeframe: From baseline (Week 0) up to Week 48
4
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Timeframe: From baseline (Week 0) up to Week 48
5
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Timeframe: From baseline (Week 0) up to Week 48
6
Number of Participants With TEAEs of Infections
Timeframe: From baseline (Week 0) up to Week 48
7
Number of Participants With TEAEs of Injection-site Reactions