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


About this study

This study seeks to identify predictive fecal, blood, and tissue biomarkers, in which biomarkers can be used to identify responders that will be reflective of disease severity or predict response to Janus Kinase Inhibitor Therapy. The benefits to the sub-study are to develop a population PK/PD model to characterize the relationships between local and systemic drug exposure and clinical, endoscopic, histologic, or biologic response to therapy.  Study also seeks to collect safety data from these subjects on Janus Kinase Inhibitor Therapy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 18 years of age or older.
  • Male or nonpregnant, nonlactating females.
  • Diagnosis of ulcerative colitis (UC) for at least 3 months prior to screening.
  • Moderately to severely active ulcerative colitis (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.
  • Physician plans to administer Janus Kinase Inhibitor Therapy for at least 8 weeks as part of standard of care (SOC).
  • Documentation of a negative test result for latent tuberculosis within the last 12 months, or according to routine clinical practice.
  • Able to participate fully in all aspects of this clinical trial, including collection of tissue biopsies.
  • Written informed consent must be obtained and documented.

Exclusion Criteria:

  • Diagnosis of Crohn’s disease or indeterminate colitis.
  • An active, serious infection, including localized infections.
  • 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 tofacitinib, in keeping with routine clinical practice.
  • Hematology laboratory results that meet the following:
    • absolute lymphocyte count < 500 cells/mm3.
    • absolute neutrophil count < 1000 cells/mm3.
    • hemoglobin < 9 g/dL.
  • Interval between live vaccinations and initiation of tofacitinib therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
  • 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.
  • Prior enrollment in the current study and having received tofacitinib.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

William Faubion, M.D.

Closed for enrollment

More information


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Additional contact information

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