Back to resultsJAK Inhibition in Ulcerative Colitis
Primary Purpose
Colitis, Ulcerative
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
JAK inhibitor treatment
Sponsored by
About this trial
This is an interventional basic science trial for Colitis, Ulcerative focused on measuring Janus Kinase Inhibitors
Eligibility Criteria
Age Ulcerative colitis active disease
Sites / Locations
- Leiden University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment JAK inhibitor
Arm Description
Clinical practice is followed for all patients treated with JAK inhibitor. Additional biopsies and blood is taken.
Outcomes
Primary Outcome Measures
Multi-omics analyses of changes observed after JAK inhibition
Secondary Outcome Measures
Full Information
NCT ID
NCT05456412
First Posted
July 11, 2022
Last Updated
December 20, 2022
Sponsor
Leiden University Medical Center
Collaborators
Galapagos NV
1. Study Identification
Unique Protocol Identification Number
NCT05456412
Brief Title
JAK Inhibition in Ulcerative Colitis
Official Title
Influence of JAK Inhibitors on the Disease-associated Network of Intestinal Immune Cells in Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2022 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University Medical Center
Collaborators
Galapagos NV
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The treatment for Ulcerative Colitis (UC) aims to achieve and maintain remission and is usually lifelong and expensive. Current available medications are unable to break the cycle of chronic inflammation, and still a significant proportion of patients will fail to respond (primary non-response) or lose response over time (secondary non-response). There is now growing evidence that there is substantial interpatient variation in the composition of the inflammation associated network of immune cells. A deeper knowledge of the patient's alterations in the mucosal immune response would help identify key drivers of inflammation and select the appropriate therapy. By analyzing the changes in the composition of immune cells induced by Janus Kinase (JAK) inhibition, we aim to obtain a better insight into the mechanistic effects of JAK inhibition and the downstream effects. These mechanistic insights are needed to identifying potential responders and non-responders in the future.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative
Keywords
Janus Kinase Inhibitors
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Clinical practice protocol is followed. Additional biopsies and blood samples are taken.
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment JAK inhibitor
Arm Type
Experimental
Arm Description
Clinical practice is followed for all patients treated with JAK inhibitor. Additional biopsies and blood is taken.
Intervention Type
Other
Intervention Name(s)
JAK inhibitor treatment
Intervention Description
Standard care
Primary Outcome Measure Information:
Title
Multi-omics analyses of changes observed after JAK inhibition
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Age Ulcerative colitis active disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip W Voorneveld, MD, PhD
Phone
+31715296370
Email
p.w.voorneveld@lumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea van der Meulen, MD, PhD
Organizational Affiliation
Leiden University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leiden University Medical Center
City
Leiden
State/Province
Zuid Holland
ZIP/Postal Code
2333 ZA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Voorneveld, MD, PhD
Phone
+31715296370
Email
p.w.voorneveld@lumc.nl
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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JAK Inhibition in Ulcerative Colitis
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