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Janus Kinase (JAK) Inhibitor
A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative Colitis
Phase 2
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose to 30 days post last dose (up to 110 weeks)
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the safety and effectiveness of Deucravacitinib in patients with moderate to severe Crohn's disease or Ulcerative Colitis who were part of an earlier study. The medication aims to reduce inflammation and improve symptoms.
Eligible Conditions
- Crohn's Disease
- Colitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose to 30 days post last dose (up to 110 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose to 30 days post last dose (up to 110 weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change From Baseline in Electrocardiogram (ECG) Parameters
Change From Baseline in Electrocardiogram (ECG) Parameters - ECG Mean Heart Rate
Change From Baseline in Laboratory Parameters
+4 moreSide effects data
From 2023 Phase 2 trial • 67 Patients • NCT0487799025%
COVID-19
13%
Pneumonia
13%
Nasopharyngitis
8%
Upper respiratory tract infection
8%
Cough
8%
Pyrexia
8%
Mouth ulceration
4%
Urinary tract infection
4%
Small intestinal obstruction
4%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
CROHN'S DISEASE
ULCERATIVE COLITIS
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Long-Term Extension Rollover Study: DeucravacitinibExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deucravacitinib
2021
Completed Phase 4
~310
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,691 Previous Clinical Trials
4,097,521 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- There are other requirements and restrictions that apply to participate in the study.You have already participated in an open-label extension study for Crohn's disease or ulcerative colitis.
Research Study Groups:
This trial has the following groups:- Group 1: Long-Term Extension Rollover Study: Deucravacitinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.