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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

A Phase 2 study to evaluate the efficacy, safety and tolerability of TD-1473 in subjects with moderately-to-severely active Crohn's Disease with up to 48 weeks of treatment.

Key facts

Study ID

NCT03635112

Run by

Theravance Biopharma

People needed

167

Starts

2018-11-19

Expected to finish

2021-12-30

Last updated by the study team

2023-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 ≥ 3 with ulceration (corresponding to a score of 1) in at least 1 of the 5 ileocolonic segments on the Ulcerated Surface 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

You may not qualify if…

• 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
• Prior exposure or potential exposure to a JAK inhibitor that was stopped due to intolerance or lack of efficacy
• 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

Where it is running

• Theravance Biopharma Investigational Site — Mobile, Alabama, United States
• Theravance Biopharma Investigational Site — Scottsdale, Arizona, United States
• Theravance Biopharma Investigational Site — La Jolla, California, United States
• Theravance Biopharma Investigational Site — Los Angeles, California, United States
• Theravance Biopharma Investigational Site — Oakland, California, United States
• Theravance Biopharma Investigational Site — Santa Monica, California, United States
• Theravance Biopharma Investigational Site — Aventura, Florida, United States
• Theravance Biopharma Investigational Site — Clearwater, Florida, United States
• Theravance Biopharma Investigational Site — Hialeah, Florida, United States
• Theravance Biopharma Investigational Site — Hollywood, Florida, United States
• Theravance Biopharma Investigational Site — Largo, Florida, United States
• Theravance Biopharma Investigational Site — Miami, Florida, United States
• Theravance Biopharma Investigational Site — New Port Richey, Florida, United States
• Theravance Biopharma Investigational Site — St. Petersburg, Florida, United States
• Theravance Biopharma Investigational Site — Tampa, Florida, United States
• Theravance Biopharma Investigational Site — Tampa, Florida, United States
• Theravance Biopharma Investigational Site — New Lenox, Illinois, United States
• Theravance Biopharma Investigational Site — Kansas City, Kansas, United States
• Theravance Biopharma Investigational Site — Louisville, Kentucky, United States
• Theravance Biopharma Investigational Site — Rockville, Maryland, United States
• Theravance Biopharma Investigational Site — Brockton, Massachusetts, United States
• Theravance Biopharma Investigational Site — Wyoming, Michigan, United States
• Theravance Biopharma Investigational Site — St Louis, Missouri, United States
• Theravance Biopharma Investigational Site — Las Vegas, Nevada, United States
• Theravance Biopharma Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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