Last updated on July 2019

Efficacy and Safety of TD-1473 in Crohn's Disease

Are you eligible to participate in this study?

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

  • Conditions: Crohn's Disease
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Is at least 18 years of age at screening
  • Males and females with clinical evidence of Crohn's disease for at least 3 months duration at screening
  • Moderately-to-severely active Crohn's Disease at baseline, as defined by a Crohn's Disease Activity Index (CDAI) score of 220-450 inclusive
  • SES-CD score of 6 ( 4 if isolated ileal disease) with ulceration (corresponding to a score of 1) in at least 1 of the 5 ileocolonic segments on the Presence of Ulcers subscore of the SES-CD]
  • Is corticosteroid-dependent or has demonstrated inadequate response, or intolerance to conventional therapy (aminosalicylates, corticosteroids and immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate) or biologics (e.g., anti-TNF therapy, anti-IL-12/23 (anti-interleukin), anti-integrin).
  • Additional inclusion criteria apply

Exclusion Criteria:

  • Is currently receiving biologic (anti-TNF, anti-integrin, or anti-IL12/23) therapy
  • Has a current bacterial, parasitic, fungal, or viral infection
  • Has clinically significant abnormalities in laboratory evaluations
  • Any prior exposure to an approved JAK inhibitor or potential exposure to an investigational JAK inhibitor
  • Subject has participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to Screening or 5x the half-life of the investigational drug, whichever is longer, or is currently participating in another trial of an investigational drug (or medical device)
  • Subject has failed 3 biologic agents of 3 different mechanisms of action (i.e., anti-TNF, anti-integrin, and anti-IL12/23)
  • Additional exclusion criteria apply

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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