Deucravacitinib for Crohn's Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Crohn's Disease+1 MoreDeucravacitinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will assess the long-term safety and effectiveness of the drug Deucravacitinib in people who have already taken it for Crohn's disease or Ulcerative Colitis.

Eligible Conditions
  • Crohn's Disease
  • Ulcerative Colitis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

13 Primary · 0 Secondary · Reporting Duration: Up to Week 292

Up to Week 292
Number of AEs leading to study discontinuation
Number of adverse events (AEs)
Number of clinically significant abnormalities in clinical laboratory results: Clinical Chemistry test
Number of clinically significant abnormalities in clinical laboratory results: Coagulation tests
Number of clinically significant abnormalities in clinical laboratory results: Hematology tests
Number of clinically significant abnormalities in electrocardiogram (ECG) parameters: PR interval
Number of clinically significant abnormalities in electrocardiogram (ECG) parameters: QRS interval
Number of clinically significant abnormalities in electrocardiogram (ECG) parameters: QT interval
Number of clinically significant abnormalities in electrocardiogram (ECG) parameters: QTc interval
Number of clinically significant abnormalities in vital signs: Blood pressure
Number of clinically significant abnormalities in vital signs: Heart rate
Number of clinically significant abnormalities in vital signs: Temperature
Number of serious adverse events (SAEs)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Long-Term Extension Rollover Study: BMS-986165
1 of 2
Long-Term Extension Rollover Study: Deucravacitinib
1 of 2

Experimental Treatment

300 Total Participants · 2 Treatment Groups

Primary Treatment: Deucravacitinib · No Placebo Group · Phase 2

Long-Term Extension Rollover Study: BMS-986165
Drug
Experimental Group · 1 Intervention: BMS-986165 · Intervention Types: Drug
Long-Term Extension Rollover Study: Deucravacitinib
Drug
Experimental Group · 1 Intervention: Deucravacitinib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deucravacitinib
2021
Completed Phase 1
~70
Deucravacitinib
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to week 292

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,501 Previous Clinical Trials
3,927,968 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you: