Last updated on December 2017

Combined Phase 2B / 3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis


Are you eligible to participate in this study?

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

  • Conditions: Inflammatory Bowel Disease | Ulcerative Colitis
  • Age: Between 18 - 75 Years
  • Gender: Male or Female

Inclusion:

• Male or Female, 18 to 75 (Either Biologic-Naïve or Biologic-Experienced)

• Documented diagnosis of UC for at least 6 months, and with a minimum disease extent of 15 cm from the anal verge

• Previously demonstrated an inadequate clinical response, loss of response to, or intolerance of at least one of the following:

a. Corticosteroids

b. Immunomodulators

c. TNFα Antagonists

d. Vedolizumab

• May be on the following meds: 5-ASA compounds (stable for 4 weeks prior to randomization), Corticosteroids (stable for 2 weeks prior to randomization), and Azathioprine / 6-MP / MTX (stable for 4 weeks prior to randomization). 

 

Exclusion:

• Has severe extensive colitis, as evidenced by ≥ 6 blood stools daily AND one or more of the following: 

---Oral temperature > 100.4 °F (or 38 °C)

---Pulse > 90 beats / minute

• Crohn’s Disease, indeterminate colitis, ischemic colitis, isolated ulcerative proctitis

• Prior surgical intervention (e.g. total colectomy, subtotal colectomy, partial or hemicolectomy)

• History of symptomatic herpes zoster or herpes simplex within 12 weeks of screening

• History of malignancy within the last 5 years (except those treated for non-melanoma skin cancer or cervical carcinoma in situ)

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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