Efficacy & Safety of TD-1473 in Ulcerative Colitis

  • STATUS
    Recruiting
  • End date
    Jul 28, 2025
  • participants needed
    880
  • sponsor
    Theravance Biopharma
Updated on 28 January 2021
Investigator
Theravance Biopharma Call Center
Primary Contact
Theravance Biopharma Investigational Site (3.0 mi away) Contact
+202 other location
corticosteroids
immunomodulators
aminosalicylates

Summary

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.

Description

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.

Details
Condition Ulcerative Colitis, Ulcerative Colitis (Pediatric)
Treatment Placebo, TD-1473 Dose A, TD-1473 Dose B, TD-1473 Dose C
Clinical Study IdentifierNCT03758443
SponsorTheravance Biopharma
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

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
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