Pharmacokinetics and Pharmacodynamic Biomarkers of Janus Kinase Inhibitor Therapy in Patients With Ulcerative Colitis (PROPHETIC Study)

Completed

• Conditions: inflammatory bowel disease; Ulcerative colitis; 10017943

• Registration Number: NL-OMON54935
• Lead Sponsor: Alimentiv B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 13

Inclusion Criteria

1. 18 years of age or older.
2. Male or nonpregnant, nonlactating females.
3. Diagnosis of UC for at least 3 months prior to screening.
4. Moderately to severely active UC (total MCS * 6), with objective evidence of
inflammation defined by a Mayo endoscopic subscore (MES) * 2 and disease
extending > 15 cm from the anal verge.
5. Physician plans to administer JAKi for at least 8 weeks of induction therapy
as part of SOC.
6. Documentation of a negative test result for latent tuberculosis within the
last 12 months, or according to routine clinical practice.
7. Able to participate fully in all aspects of this clinical trial, including
collection of tissue biopsies.
8. Written informed consent must be obtained and documented.

Exclusion Criteria

1. Diagnosis of CD or indeterminate colitis.
2. An active, serious infection, including localized infections.
3. Concomitant administration of biological therapies for UC or potent
immunosuppressants,
such as azathioprine and cyclosporine. Subjects with previous exposure to these
treatments
should undergo an appropriate washout period according to local practice prior
to starting
JAKi, in keeping with routine clinical practice.
4. Hematology laboratory results (e.g., absolute lymphocyte count, absolute
neutrophil count, and
hemoglobin levels) that contraindicate the product label.
5. Interval between live vaccinations and initiation of JAKi therapy should be
in accordance with
current vaccination guidelines regarding immunosuppressive agents.
6. Serious underlying disease other than UC that in the opinion of the
investigator may interfere
with the subject*s ability to participate fully in the study.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>See objectives </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable </p><br>