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

Phase 1

• Conditions: lcerative Colitis; MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2019-003780-21-NL
• Lead Sponsor: Alimentiv Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-21
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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.
Hematology laboratory results
(e.g. absolute lymphocyte count, absolute neutrophil count
4. 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: Interventional clinical trial of medicinal product
• Study Design: Not specified