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

  • STATUS
    Recruiting
  • End date
    Jan 8, 2023
  • participants needed
    160
  • sponsor
    Theravance Biopharma
Updated on 8 September 2021
Investigator
Theravance Biopharma Call Center
Primary Contact
Theravance Biopharma Investigational Site (4.5 mi away) Contact
+208 other location
corticosteroids
methotrexate
tumor necrosis factor
mercaptopurine
conventional treatment
crohn's disease
azathioprine
anti-tnf therapy
ulceration
immunomodulators
aminosalicylate

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.

Description

A Phase 2 multi-center, randomized, double blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 12 weeks of induction therapy with TD1473 in subjects with moderately-to-severely active CD. This study includes 3 phases: Screening, Induction, and Active Treatment Extension (ATE). The Induction phase of the study is a randomized, double blind, placebo controlled, parallel group study evaluating 2 oral dose levels of TD-1473 compared to placebo for 12 weeks in subjects with moderately to-severely active CD. Subjects who complete Induction will continue to receive TD-1473 in the ATE, for up to 48 additional weeks.

Details
Condition Inflammatory bowel disease, Crohn's Disease, Crohn's Disease (Pediatric), crohns disease
Treatment Placebo, TD-1473
Clinical Study IdentifierNCT03635112
SponsorTheravance Biopharma
Last Modified on8 September 2021

Eligibility

Yes No Not Sure

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
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