Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
Conditions
Interventions
Trade Name: XELJANZ
Product Name: Janus kinase Inhibitor
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Janus kinase Inhibitor
CAS Number: 477600-75-2
Concentration unit: mg milligram(
Sponsors
Alimentiv Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Identify predictive fecal, blood, and tissue biomarkers Identify pharmacodynamic fecal, blood, and tissue biomarkers Identify a fecal, blood, and tissue biomarker signature as a surrogate measure Identify whether colonic tissue phosphorylated signal transducers and activators of transcription, correlates with change from baseline in UC-100 score. Determine the time-concentration profile of JAKi in samples. Evaluate correlation of exposure of JAKi between stool, serum, and tissue samples. Explore the exposure-response relationship of JAKi Develop an exposure-response model of JAKi Identify potential demographic and disease factors affecting the most relevant JAKi exposure-response relationships Evaluate long-term hospitalization rates, surgery rates, and corticosteroid use up to 2 years after initiation of JAKi therapy Measure adverse drug reactions, and clinical, endoscopic, and histologic response and remission rates to JAKi in a “real-world” population. ;Secondary Objective: Not Applicable;Primary end point(s): Efficacy Endpoints (Objectives 1-3): Proportion of subjects in clinical, endoscopic, and histologic response and remission and identification of biomarkers that are most reflective of disease severity. Association between disease activity as measured by changes in UC-100 and biomarkers. pSTAT (Objective 4): Association between JAKi exposure and biomarker levels in colon biopsy samples. Safety Endpoint (Objectives 5 & 6): Treatment-related adverse events and disease-related hospitalizations. ;Timepoint(s) of evaluation of this end point: Week 8 and Week 24 2 years (safety endpoint) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Belgium, Canada, Italy, Netherlands, Spain, United States
Contacts
Public ContactTanja van Viegen
Alimentiv Inc.
Outcome results
None listed