A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Cro… (NCT04877990) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative Colitis
United States, Australia, Canada67 participantsStarted 2021-05-07
Plain-language summary
The purpose of this study is to evaluate the long-term safety and efficacy of Deucravacitinib in participants who have previously been enrolled in a Deucravacitinib Phase 2 study for moderate to severe Crohn's disease or moderate to severe Ulcerative Colitis.
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:
• Previously completed open-label extension treatment in one of the parent Crohn's disease or ulcerative colitis studies
Exclusion Criteria:
* Women who are pregnant or breastfeeding
* Current colonic adenomas or dysplasia diagnosed at the endoscopy performed at the end of treatment visit of the parent study or past confirmed colonic dysplasia in the parent study that has not been eradicated
Other protocol-defined inclusion/exclusion criteria apply
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) and Treatment Emergent Serious Adverse Events (TESAEs)
Timeframe: From first dose to 30 days post last dose (Up to 110 weeks)
2
Number of Participants With Laboratory Abnormalities
Timeframe: From first dose to 30 days post last dose (Up to 110 weeks)
3
Number of Participants With Electrocardiogram (ECG) Abnormalities
Timeframe: From first dose to 30 days post last dose (Up to 110 weeks)
4
Number of Participants With Vital Signs Abnormalities
Timeframe: From first dose to 30 days post last dose (Up to 110 weeks)
5
Change From Baseline in Laboratory Parameters
Timeframe: Baseline, Week 12, Week 108
6
Change From Baseline in Electrocardiogram (ECG) Parameters - ECG Mean Heart Rate
Timeframe: Baseline, Week 48, Week 96
7
Change From Baseline in Electrocardiogram (ECG) Parameters