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

• Status: Active, not recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Theravance Biopharma

Criteria

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 ≥ 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

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

• 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