Phase 2
Completed N=67
A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative Colitis
Crohn Disease · Ulcerative Colitis
Source: ClinicalTrials.gov NCT04877990 ↗
Enrolled (actual)
67
Serious AEs
6.2%
Results posted
Sep 2024
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) — 18; 19; 2; 2 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) |
18; 19; 2; 2; 1; 1 | — |
| PRIMARY Number of Participants With Laboratory Abnormalities |
0; 0; 0; 1; 0; 0 | — |
| PRIMARY Number of Participants With Electrocardiogram (ECG) Abnormalities |
1; 0; 0; 1; 0; 0 | — |
| PRIMARY Number of Participants With Vital Signs Abnormalities |
1; 1; 1; 0; 3; 5 | — |
| PRIMARY Change From Baseline in Laboratory Parameters |
10.20; -9.17; -12.00; -0.75; -0.83; 0.00 | — |
| PRIMARY Change From Baseline in Electrocardiogram (ECG) Parameters - ECG Mean Heart Rate |
-1.4; 2.6; -1.0; -1.0 | — |
| PRIMARY Change From Baseline in Electrocardiogram (ECG) Parameters |
9.1; -2.4; 14.7; -22.0; -1.2; -0.9 | — |
| PRIMARY Change From Baseline in Vital Signs Parameters - Heart Rate |
3.6; 0.9; 1.0 | — |
| PRIMARY Change From Baseline in Vital Signs Parameters |
3.8; 3.8; 4.0; 0.3; -1.3; 9.0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04877990). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.