Efficacy & Safety of TD-1473 in Ulcerative Colitis

Clinical Trial ID: NCT03758443


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.


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


  • Last Updated


  • Sponsor

    Theravance Biopharma

  • Condition Name

    Ulcerative Colitis (UC)

Learn about this trial.

Check the eligibility requirements, study details, and more.

Related Trials

Different trials target different symptoms, condition types, and patients. Learn more about other emergeing treatments being investigated now.