JAK Inhibition in Ulcerative Colitis

Sponsor

Leiden University Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05456412

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Analyzing Immune Composition Changes Upon JAK Inhibitor Treatment of Ulcerative Colitis Patients	Other: JAK inhibitor treatment

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Influence of JAK Inhibitors on the Disease-associated Network of Intestinal Immune Cells in Ulcerative Colitis

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Treatment JAK inhibitor	Other: JAK inhibitor treatment Standard care

Arm

Intervention/Treatment

Treatment JAK inhibitor

Other: JAK inhibitor treatment

Standard care

Outcome Measures

Primary Outcome Measures

Multi-omics analyses of changes observed after JAK inhibition [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 65 Years

Sexes Eligible for Study:

All

Age Ulcerative colitis active disease

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Leiden University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andrea E. van der Meulen - de Jong, MD, PhD, MD, PhD, Leiden University Medical Center

ClinicalTrials.gov Identifier:

NCT05456412

Other Study ID Numbers:

81808

First Posted:

Jul 13, 2022

Last Update Posted:

Jul 13, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Colitis

Colitis, Ulcerative

Ulcer

Janus Kinase Inhibitors

Study Results

No Results Posted as of Jul 13, 2022