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

Clinical Trial ID: NCT03635112

Description

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 36 weeks of treatment.

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 TD˗1473 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 24 additional weeks.


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 ≥ 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

  • Start Date

    2018-11-19

  • Last Updated

    2019-04-15

  • Sponsor

    Theravance Biopharma

  • Condition Name

    Crohn's Disease

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