Efficacy & Safety of TD-1473 in Ulcerative Colitis

• Status: Active, not recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Theravance Biopharma

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