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

Alimentiv B.V.0 个研究点目标入组 13 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•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.

•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
•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.

发起方

Alimentiv B.V.