Status:
TERMINATED
Efficacy & Safety of TD-1473 in Ulcerative Colitis
Lead Sponsor:
Theravance Biopharma
Conditions:
Ulcerative Colitis (UC)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 ...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2021
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT03758443
Start Date
March 11 2019
End Date
October 20 2021
Last Update
November 15 2022
Active Locations (188)
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1
Theravance Biopharma Investigational Site
Chula Vista, California, United States, 91911
2
Theravance Biopharma Investigational Site
La Jolla, California, United States, 92037
3
Theravance Biopharma Investigational Site
Lancaster, California, United States, 93534
4
Theravance Biopharma Investigational Site
Orange, California, United States, 92866