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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 weeks
Treatment ~ Varies
Follow Up ~from first dose to 30 days post last dose (up to 110 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose to 30 days post last dose (up to 110 weeks) for reporting.

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 more

Side effects data

From 2023 Phase 2 trial • 67 Patients • NCT04877990
25%
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

Deucravacitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04877990 — Phase 2
Crohn's Disease Research Study Groups: Long-Term Extension Rollover Study: Deucravacitinib
Crohn's Disease Clinical Trial 2023: Deucravacitinib Highlights & Side Effects. Trial Name: NCT04877990 — Phase 2
Deucravacitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04877990 — Phase 2
~15 spots leftby Dec 2025