Ignite Creation Date:
2024-05-06 @ 3:16 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04576000
Status:
TERMINATED
Last Update Posted:
2022-01-04
First Post:
2020-09-17
Brief Title:
Identification of Biomarkers of Janus Kinase Inhibitor Therapy in Patients With Ulcerative Colitis
Sponsor:
Alimentiv Inc
Organization:
Alimentiv Inc
Study Overview
Official Title:
PhaRmacOkinetics and PHarmacodynamic BiomarkErs of Janus Kinase Inhibitor Therapy in PatIents With Ulcerative Colitis PROPHETIC
Status:
TERMINATED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not able to meet recruitment targets
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROPHETIC
Brief Summary:
This study aims to provide new mechanistic insights into the molecular determinants of response or nonresponse to Janus Kinase inhibitor therapy and the biological heterogeneity that exists in Ulcerative Colitis This study will include patients who are initiating Janus Kinase inhibitor therapy according to standard of care This study consists of
Part 1 8 or 10 week induction therapy followed by an 8-week maintenance therapy
Part 2 Patients who continue Janus Kinas inhibitor therapy after part 1 will be followed further for a total of 2 years or until discontinuation of Janus Kinase inhibitor therapy whichever is first
Part 1 8 or 10 week induction therapy followed by an 8-week maintenance therapy
Part 2 Patients who continue Janus Kinas inhibitor therapy after part 1 will be followed further for a total of 2 years or until discontinuation of Janus Kinase inhibitor therapy whichever is first
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None