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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001633-27 | EudraCT Number |
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This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TD-1473 in subjects with moderately-to-severely active UC over 28 days. This exploratory study will also serve as a signal seeking endeavor to demonstrate biologic effect associated with TD-1473 through biomarker analysis and clinical, endoscopic, and histologic assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TD-1473 low dose | Experimental | 10 subjects will be randomized to receive low-dose TD-1473 orally daily for 28 days |
|
| TD-1473 mid dose | Experimental | 10 subjects will be randomized to receive mid-dose TD-1473 orally daily for 28 days |
|
| TD-1473 high dose | Experimental | 10 subjects will be randomized to receive high-dose TD-1473 orally daily for 28 days |
|
| Placebo | Placebo Comparator | 10 subjects will be randomized to receive placebo orally daily for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TD-1473 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent Adverse Events (TEAE) | Number of participants who experience one or more treatment-emergent Adverse Events (TEAE) | Baseline to end of follow-up (a maximum of 42 days) |
| Moderate or Severe Treatment-emergent Adverse Events (TEAE) | Number of participants who experience one or more moderate or severe treatment-emergent Adverse Events (TEAE) | Baseline to end of follow-up (a maximum of 42 days) |
| Serious Treatment-emergent Adverse Events (TEAE) | Number of participants who experience one or more serious treatment-emergent Adverse Events (TEAE) | Baseline to end of follow-up (a maximum of 42 days) |
| Clinical Laboratory Measurements | Number of participants who experienced a Clinically Significant Clinical Laboratory Measurements | Baseline to end of follow-up (a maximum of 42 days) |
| Electrocardiogram | Number of participants who experienced a Clinically Significant Electrocardiogram (ECG) Result | Baseline to Day 14 |
| Vital Signs | Number of participants who experienced a Clinically Significant Vital Sign Measurement | Baseline to end of follow-up (a maximum of 42 days) |
| Cmax in plasma | Maximum Observed Plasma Concentration of TD-1473 |
| Measure | Description | Time Frame |
|---|---|---|
| C-reactive protein (CRP) | Mean Change in Serum C-reactive Protein (CRP) | Baseline, Day 14 and Day 28 |
| Fecal Calprotectin | Mean Change in Fecal Calprotectin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Theravance Biopharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Theravance Biopharma Investigational Site | Scottsdale | Arizona | 85259 | United States | ||
| Theravance Biopharma Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32161949 | Derived | Sandborn WJ, Nguyen DD, Beattie DT, Brassil P, Krey W, Woo J, Situ E, Sana R, Sandvik E, Pulido-Rios MT, Bhandari R, Leighton JA, Ganeshappa R, Boyle DL, Abhyankar B, Kleinschek MA, Graham RA, Panes J. Development of Gut-Selective Pan-Janus Kinase Inhibitor TD-1473 for Ulcerative Colitis: A Translational Medicine Programme. J Crohns Colitis. 2020 Sep 16;14(9):1202-1213. doi: 10.1093/ecco-jcc/jjaa049. |
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Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000718529 | izencitinib |
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| Drug |
|
| Day 1 and Day 14 |
| Tmax in plasma | Time to Reach Maximum Observed Plasma Concentration (Cmax) of TD-1473 | Day 1 and Day 14 |
| Tlast in plasma | Time to Last Quantifiable Concentration of TD-1473 | Day 1 and Day 14 |
| Ctrough in plasma | Trough Concentration of TD-1473 | Day 14 (Pre-dose) |
| AUC0-4 in plasma | Area Under the Concentration-time Curve from Time Zero to 4 hours Post-Dose of TD-1473 | Day 1 and Day 14 |
| Ctissue in plasma | Tissue Concentration of TD-1473 | Day 28 |
| Baseline and Day 28 |
| Partial Mayo score | Mean Change in Partial Mayo Score | Baseline, Day 14 and Day 28 |
| Monroe |
| Louisiana |
| 71201 |
| United States |
| Theravance Biopharma Investigational Site | Hermitage | Tennessee | 37076 | United States |
| Theravance Biopharma Investigational Site | Houston | Texas | 77004 | United States |
| Theravance Biopharma Investigational Site | San Antonio | Texas | 78215 | United States |
| Theravance Biopharma Investigational Site | Tbilisi | 0141 | Georgia |
| Theravance Biopharma Investigational Site | Chisinau | MD-2025 | Moldova |
| Theravance Biopharma Investigational Site | Bucharest | 50152 | Romania |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |