Efficacy & Safety of TD-1473 in Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 29 November 2021
• Main ID: NCT03758443
• Date of registration: 19/11/2018
• Prospective Registration: Yes
• Primary sponsor: Theravance Biopharma
• Public title: Efficacy & Safety of TD-1473 in Ulcerative Colitis RHEA
• Scientific title: A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group 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
• Date of first enrolment: March 11, 2019
• Target sample size: 243
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03758443
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2/Phase 3

Countries of recruitment

Australia, Bulgaria, Canada, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Poland, Portugal, Romania, Serbia, Slovakia, South Africa, Spain, Taiwan, Ukraine, United States

Contacts

• Name: Medical Monitor
• Affiliation: Theravance Biopharma

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis (UC)

Intervention(s)

Drug: TD-1473 Dose A

Drug: TD-1473 Dose C

Drug: Placebo

Drug: TD-1473 Dose B

Primary Outcome(s)

Phase 3 Induction: Clinical remission by adapted Mayo score components at Week 8 [Time Frame: Week 8]

Phase 3 Maintenance: Clinical remission by adapted Mayo score components at Maintenance (m) Week 44 [Time Frame: (maintenance Week) mWeek 44]

Phase 2b Induction: Change from baseline in total Mayo score (tMS) at Week 8 [Time Frame: Baseline to Week 8]

Secondary Outcome(s)

Clinical response by Adapted Mayo score (aMS response) at Week 8 [Time Frame: Baseline to Week 8]

Endoscopic healing at mWeek 44 [Time Frame: mWeek 44]

Maintenance of clinical response at mWeek 44 [Time Frame: mWeek 44]

Mucosal healing at mWeek 44 [Time Frame: mWeek 44]

Endoscopic healing at Week 8 [Time Frame: Week 8]

Maintenance of clinical remission at mWeek 44 in those who were in remission at mWeek 0 [Time Frame: mWeek 44]

Corticosteroid-free remission at mWeek 44 [Time Frame: mWeek 44]

Symptomatic remission at mWeek 44 [Time Frame: mWeek 44]

Clinical remission by adapted Mayo Score Components at Week 8 [Time Frame: Week 8]

Mucosal healing at Week 8 [Time Frame: Week 8]

Symptomatic remission at Week 8 [Time Frame: Week 8]

Secondary ID(s)

0157

2018-002136-24

Source(s) of Monetary Support

Please refer to primary and secondary sponsors