Efficacy & Safety of TD-1473 in Ulcerative Colitis

Clinical Trial ID: NCT03758443

Description

A Phase 2b/3 set of studies to evaluate the efficacy and safety of induction and maintenance therapy with TD-1473 in subjects with moderately-to-severely active ulcerative colitis with up to 60 weeks of treatment.

This protocol consists of 3 separate studies: an 8-week Phase 2b dose-finding induction study, an 8-week dose-confirming Phase 3 induction study, and a 44-week Phase 3 maintenance study. Subjects who respond to induction will enter the maintenance study; those who do not will receive TD-1473 during extended induction. The safety and efficacy data of the Phase 2b study will be analyzed to select the induction and maintenance dose regimens for the confirmatory Phase 3 studies. Participants who have disease relapse or complete the maintenance study may be eligible to enter a separate long-term safety study. Efficacy, pharmacokinetic, biomarkers, and safety will be evaluated in all 3 studies. 240 subjects are planned for the Phase 2b and 640 subjects are planned for the Phase 3.


Criteria

Inclusion Criteria: - Is at least 18 years of age at screening - Has a history of UC for at least 3 months prior to screening - Has moderately-to-severely active UC, as defined by a Mayo endoscopic subscore of ≥2 points and an adapted Mayo score between 4 - 9 points inclusive - Is corticosteroid-dependent or has demonstrated inadequate response, or intolerance to conventional therapy (aminosalicylates, corticosteroids, immunomodulators) or biologics - Willing to use highly-effective methods of contraception during the study and for 7 days after the last dose - Additional inclusion criteria apply Exclusion Criteria: - Has symptoms suggestive of fulminant colitis, megacolon or intestinal perforation - Likely to require surgery for UC or other major surgeries - Has previously received / is currently receiving prohibited medications within specified timeframe - Is refractory to 3 biologics with ≥2 mechanisms of action - Has a current bacterial, parasitic, fungal, or viral infection - Has clinically significant abnormalities in laboratory evaluations - Has had any prior exposure to an approved Janus kinase (JAK) inhibitor or potential exposure to an investigational JAK inhibitor that was stopped due to intolerance or lack of efficacy - Additional exclusion criteria apply

  • Start Date

    2019-03-11

  • Last Updated

    2020-02-27

  • Sponsor

    Theravance Biopharma

  • Condition Name

    Ulcerative Colitis (UC)

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