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JAK Inhibition in Ulcerative Colitis

NCT ID: NCT05456412

Last Updated: 2022-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-20

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colitis, Ulcerative

Keywords

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Janus Kinase Inhibitors

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Clinical practice protocol is followed. Additional biopsies and blood samples are taken.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment JAK inhibitor

Clinical practice is followed for all patients treated with JAK inhibitor. Additional biopsies and blood is taken.

Group Type EXPERIMENTAL

JAK inhibitor treatment

Intervention Type OTHER

Standard care

Interventions

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JAK inhibitor treatment

Standard care

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Age Ulcerative colitis active disease
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Galapagos NV

INDUSTRY

Sponsor Role collaborator

Leiden University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Andrea E. van der Meulen - de Jong, MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea van der Meulen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

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Leiden University Medical Center

Leiden, South Holland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Philip W Voorneveld, MD, PhD

Role: CONTACT

Phone: +31715296370

Email: [email protected]

Facility Contacts

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Philip Voorneveld, MD, PhD

Role: primary

Other Identifiers

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81808

Identifier Type: -

Identifier Source: org_study_id