Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Ulcerative Colitis
• Age: Between 18 Year(s) - 150 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Participant must be over 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the informed consent.
  2. A diagnosis of UC, with signs and symptoms consistent with UC for at least 3 months prior to the first study intervention administration.
  3. Moderate to severely active UC disease activity
  4. In order to participate in Cohort 1 (advanced therapy-naïve cohort), a participant must meet the eligibility criteria outlined in this inclusion criterion (IC) and must not meet the eligibility criteria for Cohort 2.
     • Participants must be naïve to 6-mercaptopurine/azathioprine (AZA) and any biologics for any other medical indication, as well as UC.
  5. In order to participate in Cohort 2 (advanced therapy-exposed cohort), a participant must have failed only one mechanism of action of biologics.
     • Documentation of an inadequate response, loss of response, or intolerance to a treatment course of one class of approved biologics and should not have been treated with additional classes of approved biologics.
     • 6-mercaptopurine/AZA or methotrexate:
       • Participant may have been previously treated with 6-mercaptopurine/AZA, but or methotrexate.
       • Participant may not take these agents concomitantly over the course of the study, and not for at least 30 days.
       • These agents must be discontinued prior to the first day of starting study intervention administration.

  
  

You may not be eligible for this study if the following are true:

• 1. Medical conditions, including the following:
     • Recent (within 6 months of screening) myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III/IV heart failure.
     • Presence of Mobitz type II second- or third-degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless the participant has a functioning pacemaker.
     • Severe untreated sleep apnea.
     • Current macular edema. (Note: Participants with diabetes, or a history of uveitis or, retinal disease, or previous macular edema must have an ophthalmic evaluation of the fundus, including the macula, prior to the first study intervention administration.)
     • Current active infection, and/or any infection requiring oral antibiotics within 14 days of screening, or intravenous (IV) antibiotics within 30 days of screening.
     • Any major infection that required hospitalization.
     • Immunodeficient state (not including previously mentioned immunosuppressants) leading to increased risk of opportunistic infections.
     • A history of cancer within 5 years, including solid tumors and hematological malignancies (except basal cell carcinoma or squamous cell carcinoma of the skin that have been fully treated, or cervical dysplasia or carcinoma in situ that have been fully treated).
     • Severe hepatic impairment (Child-Pugh Class C).
  2. Participant has a current diagnosis of Crohn’s disease (CD), indeterminate colitis, radiation colitis or ischemic colitis, a monogenic cause of UC-like intestinal inflammation, colonic diverticulitis, or an alternative diagnosis that explains their colonic inflammation.
  3. Current or recent (within 3 months of screening) evidence of fulminant colitis, toxic megacolon, or bowel perforation.
  4. Current need for, or anticipated need for, surgical intervention for UC during the course of the study.
  5. Extensive colonic resection or current stoma.
  6. Colonic dysplasia that has not been removed.
  7. Previous or current use of Janus kinase (JAK) inhibitors (eg, tofacitinib, filgotinib).