ClinicalTrials.gov

History of Changes for Study: NCT03920254
TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study
Latest version (submitted November 16, 2021) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 April 15, 2019 None (earliest Version on record)
2 May 17, 2019 Study Status, Contacts/Locations and Outcome Measures
3 June 13, 2019 Study Status, IPDSharing and Contacts/Locations
4 June 25, 2019 Contacts/Locations and Study Status
5 July 24, 2019 Study Status and Contacts/Locations
6 August 13, 2019 Study Status and Contacts/Locations
7 October 22, 2019 Outcome Measures, Study Status and Contacts/Locations
8 November 22, 2019 Study Status and Contacts/Locations
9 December 10, 2019 Study Status and Contacts/Locations
10 March 19, 2020 Study Status and Contacts/Locations
11 May 11, 2020 Study Status and Contacts/Locations
12 September 1, 2020 Recruitment Status, Study Status, Contacts/Locations and Oversight
13 September 9, 2020 Contacts/Locations and Study Status
14 January 5, 2021 Contacts/Locations and Study Status
15 September 29, 2021 Recruitment Status, Contacts/Locations, Study Status and Study Design
16 November 16, 2021 Recruitment Status and Study Status
Comparison Format:

Scroll up to access the controls

Study NCT03920254
Submitted Date:  April 15, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: 0164
Brief Title: TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study
Official Title: A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects With Ulcerative Colitis (UC)
Secondary IDs: 2018-002135-19 [EudraCT Number]
Open or close this module Study Status
Record Verification: April 2019
Overall Status: Not yet recruiting
Study Start: July 2019
Primary Completion: July 2028 [Anticipated]
Study Completion: July 2028 [Anticipated]
First Submitted: March 28, 2019
First Submitted that
Met QC Criteria:
April 15, 2019
First Posted: April 18, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
April 15, 2019
Last Update Posted: April 18, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Theravance Biopharma
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: A 3-Year Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis who have participated in the Maintenance Study of Protocol 0157
Detailed Description: This is a multi-center, long-term safety study to evaluate the safety and tolerability of TD-1473 for up to 156 weeks (3 years) + 4 week follow-up in subjects with moderate to severe UC exiting the preceding Maintenance Study of Protocol 0157 (NCT03758443).
Open or close this module Conditions
Conditions: Ulcerative Colitis (UC)
Keywords: TD-1473
Janus kinase inhibitor
JAK inhibitor
Inflammatory Bowel Disease
IBD
Ulcerative colitis
UC
Intestinal restriction
Gut-selective
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2/Phase 3
Interventional Study Model: Parallel Assignment
Long Term Safety (LTS)
Number of Arms: 3
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Non-Randomized
Enrollment: 500 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Active Treatment TD-1473 with Dose A
Oral daily dose of TD-1473 for up to 156 weeks
Drug: TD-1473 Dose A
See Arm description
Experimental: Active Treatment TD-1473 with Dose B
Oral daily dose of TD-1473 for up to 156 weeks
Drug: TD-1473 Dose B
See Arm description
Experimental: Active Treatment TD-1473 with Dose C
Oral daily dose of TD-1473 for up to 156 weeks
Drug: TD-1473 Dose C
See Arm description
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Adverse Events
[ Time Frame: Day 1 to a maximum of Week 160 (156 weeks treatment + 4 week follow-up) ]

Incidence and severity of treatment-emergent adverse events
2. Laboratory Safety tests: Chemistry - Sodium
[ Time Frame: Day 1 to a maximum of Week 160 (156 weeks treatment + 4 week follow-up) ]

Changes in laboratory safety tests: Chemistry - Sodium
3. Laboratory Safety tests: Chemistry - Potassium
[ Time Frame: Day 1 to a maximum of Week 160 (156 weeks treatment + 4 week follow-up) ]

Changes in laboratory safety tests: Chemistry - Potassium
4. Laboratory Safety tests: Chemistry - Calcium
[ Time Frame: Day 1 to a maximum of Week 160 (156 weeks treatment + 4 week follow-up) ]

Changes in laboratory safety tests: Chemistry - Calcium
5. Laboratory Safety tests: Chemistry - Magnesium
[ Time Frame: Day 1 to a maximum of Week 160 (156 weeks treatment + 4 week follow-up) ]

Changes in laboratory safety tests: Chemistry - Magnesium
6. Laboratory Safety tests: Hematology - Hematocrit
[ Time Frame: Day 1 to a maximum of Week 160 (156 weeks treatment + 4 week follow-up) ]

Changes in laboratory safety tests: Hematology - Hematocrit
7. Laboratory Safety tests: Hematology - Hemoglobin
[ Time Frame: Day 1 to a maximum of Week 160 (156 weeks treatment + 4 week follow-up) ]

Changes in laboratory safety tests: Hematology - Hemoglobin
8. Laboratory Safety tests: Hematology - White Blood Cell Count
[ Time Frame: Day 1 to a maximum of Week 160 (156 weeks treatment + 4 week follow-up) ]

Changes in laboratory safety tests: Hematology - White Blood Cell Count
9. Laboratory Safety tests: Hematology - Eosinophils
[ Time Frame: Day 1 to a maximum of Week 160 (156 weeks treatment + 4 week follow-up) ]

Changes in laboratory safety tests: Hematology - Eosinophils
10. ECGs: QT Interval
[ Time Frame: Day 1 to a maximum of Week 160 (156 weeks treatment + 4 week follow-up) ]

Changes in ECG: QT Interval
11. Vital Signs: Heart Rate
[ Time Frame: Day 1 to a maximum of Week 160 (156 weeks treatment + 4 week follow-up) ]

Changes in Heart Rate
12. Vital Signs: Blood Pressure
[ Time Frame: Day 1 to a maximum of Week 160 (156 weeks treatment + 4 week follow-up) ]

Changes in Blood Pressure
13. Vital Signs: Temperature
[ Time Frame: Day 1 to a maximum of Week 160 (156 weeks treatment + 4 week follow-up) ]

Changes in Temperature
14. Vital Signs: Respirations
[ Time Frame: Day 1 to a maximum of Week 160 (156 weeks treatment + 4 week follow-up) ]

Changes in Respirations
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based: Yes
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

To be eligible for the study, subjects are required to enter the LTS Study within 14 days of exiting the Maintenance Study of Protocol 0157 and must meet all the following criteria:

  • Capable of providing informed consent, which must be obtained prior to any study related procedures.
  • One of the following:
    • Those who demonstrated persistent loss of response (no improvement 8 weeks after meeting loss of response criteria) OR
    • Two Clinical Flares after an episode of loss of response during the Maintenance Study OR
    • Those who have completed the Maintenance Study and confirmation of clinical remission status results are available
  • During the study and for 7 days after receiving the last dose of the study drug, females of childbearing potential or men capable of fathering children must agree to use highly effective birth control measures (failure rate <1% when used consistently and correctly)) or agree to abstain from sexual intercourse. Females of childbearing potential must test negative for pregnancy at Day 1
  • All male subjects must agree to refrain from semen donation during the study and for 7 days after the last dose of study drug.
  • Must be able and willing to adhere to the study visit schedule and comply with other study requirements.

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
  • Has been diagnosed during Protocol 0157 with Crohn's disease, other colitis conditions or the subject has a current or past diagnosis of a fistula or abdominal abscess
  • Has endoscopic findings during Protocol 0157 of colitis-associated colonic dysplasia (with the exception of subjects with non-colitis associated spontaneous adenomas that have been completely resected)
  • Has clinically significant abnormalities in laboratory evaluations
  • Additional exclusion criteria apply
Open or close this module Contacts/Locations
Central Contact Person: Theravance Biopharma Call Center
Telephone: 1-855-633-8479
Email: medinfo@theravance.com
Study Officials: Medical Director
Study Director
Theravance Biopharma
Locations: United States, Florida
Theravance Biopharma Investigational Site
Aventura, Florida, United States, 33180
Theravance Biopharma Investigational Site
Clearwater, Florida, United States, 33756
Theravance Biopharma Investigational Site
Hialeah, Florida, United States, 33013
Theravance Biopharma Investigational Site
Largo, Florida, United States, 33777
Theravance Biopharma Investigational Site
Miami, Florida, United States, 33135
Theravance Biopharma Investigational Site
New Port Richey, Florida, United States, 34653
Theravance Biopharma Investigational Site
Pembroke Pines, Florida, United States, 33024
United States, Louisiana
Theravance Biopharma Investigational Site
Monroe, Louisiana, United States, 71201
United States, Massachusetts
Theravance Biopharma Investigational Site
Brockton, Massachusetts, United States, 02302
United States, North Carolina
Theravance Biopharma Investigational Site
Greenville, North Carolina, United States, 27834-3761
United States, Oklahoma
Theravance Biopharma Investigational Site
Tulsa, Oklahoma, United States, 74136
United States, Tennessee
Theravance Biopharma Investigational Site
Jackson, Tennessee, United States, 38305
United States, Texas
Theravance Biopharma Investigational Site
Houston, Texas, United States, 77002
Theravance Biopharma Investigational Site
San Antonio, Texas, United States, 78215
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services