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TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03920254
Recruitment Status : Not yet recruiting
First Posted : April 18, 2019
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma

Tracking Information
First Submitted Date  ICMJE March 28, 2019
First Posted Date  ICMJE April 18, 2019
Last Update Posted Date March 23, 2020
Estimated Study Start Date  ICMJE March 2020
Estimated Primary Completion Date September 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2019)
  • 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
  • Laboratory Safety tests [ Time Frame: Day 1 to a maximum of Week 160 (156 weeks treatment + 4 week follow-up) ]
    Number of subjects with laboratory test abnormalities
  • ECGs [ Time Frame: Day 1 to a maximum of Week 160 (156 weeks treatment + 4 week follow-up) ]
    Number of subjects with clinically significant ECG findings
  • Vital Signs [ Time Frame: Day 1 to a maximum of Week 160 (156 weeks treatment + 4 week follow-up) ]
    Number of subjects with clinically significant vital sign abnormalities
Original Primary Outcome Measures  ICMJE
 (submitted: April 15, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Vital Signs: Temperature [ Time Frame: Day 1 to a maximum of Week 160 (156 weeks treatment + 4 week follow-up) ]
    Changes in Temperature
  • Vital Signs: Respirations [ Time Frame: Day 1 to a maximum of Week 160 (156 weeks treatment + 4 week follow-up) ]
    Changes in Respirations
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study
Official Title  ICMJE 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)
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Long Term Safety (LTS)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis (UC)
Intervention  ICMJE
  • Drug: TD-1473 Dose A
    See Arm description
  • Drug: TD-1473 Dose B
    See Arm description
  • Drug: TD-1473 Dose C
    See Arm description
Study Arms  ICMJE
  • Experimental: Active Treatment TD-1473 with Dose A
    Oral daily dose of TD-1473 for up to 156 weeks
    Intervention: Drug: TD-1473 Dose A
  • Experimental: Active Treatment TD-1473 with Dose B
    Oral daily dose of TD-1473 for up to 156 weeks
    Intervention: Drug: TD-1473 Dose B
  • Experimental: Active Treatment TD-1473 with Dose C
    Oral daily dose of TD-1473 for up to 156 weeks
    Intervention: Drug: TD-1473 Dose C
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 15, 2019)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2028
Estimated Primary Completion Date September 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Theravance Biopharma Call Center 1-855-633-8479 medinfo@theravance.com
Listed Location Countries  ICMJE Bulgaria,   Georgia,   Greece,   Hungary,   Israel,   Japan,   Poland,   Portugal,   Serbia,   Slovakia,   South Africa,   Spain,   Taiwan,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03920254
Other Study ID Numbers  ICMJE 0164
2018-002135-19 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
Responsible Party Theravance Biopharma
Study Sponsor  ICMJE Theravance Biopharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Theravance Biopharma
PRS Account Theravance Biopharma
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP