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NCT05456412 Clinical Trial

JAK Inhibition in Ulcerative Colitis

Colitis, Ulcerative Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05456412
Other study ID # 81808
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 20, 2022
Est. completion date September 2026

Study information
Verified date December 2022
Source Leiden University Medical Center
Contact Philip W Voorneveld, MD, PhD
Phone +31715296370
Email p.w.voorneveld@lumc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date September 2026
Est. primary completion date September 2025
Accepts healthy volunteers No
Gender All
Age group 16 Years to 65 Years
Eligibility Age Ulcerative colitis active disease

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• JAK inhibitor treatment
Standard care

Locations
Country Name City State
Netherlands Leiden University Medical Center Leiden Zuid Holland

Sponsors (2)
Lead Sponsor Collaborator
Leiden University Medical Center Galapagos NV

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Multi-omics analyses of changes observed after JAK inhibition 1 year
See also
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