JAK Inhibition in Ulcerative Colitis

NCT05456412 | Recruiting

• 1 other identifier: 81808
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Colitis, Ulcerative

Keywords

Janus Kinase Inhibitors

Outcome Measures

Primary Outcomes (1)

• Multi-omics analyses of changes observed after JAK inhibition

  1 year

Study Arms (1)

Treatment JAK inhibitor

EXPERIMENTAL

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

Other: JAK inhibitor treatment

Interventions

JAK inhibitor treatment OTHER

Standard care

Treatment JAK inhibitor

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Age Ulcerative colitis active disease

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Galapagos NV: collaborator

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Andrea van der Meulen, MD, PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip W Voorneveld, MD, PhD

CONTACT

+31715296370; p.w.voorneveld@lumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Clinical practice protocol is followed. Additional biopsies and blood samples are taken.

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 13, 2022
• Study Start: December 20, 2022
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 22, 2022

Record last verified: 2022-12

Locations

NL (1)