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

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ClinicalTrials.gov Identifier: NCT03920254
Recruitment Status : Not yet recruiting
First Posted : April 18, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma

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

Condition or disease Intervention/treatment Phase
Ulcerative Colitis (UC) Drug: TD-1473 Dose A Drug: TD-1473 Dose B Drug: TD-1473 Dose C Phase 2 Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
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
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)
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : July 2028
Estimated Study Completion Date : July 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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 (both Systolic and Diastolic reported)

  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920254


Contacts
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Contact: Theravance Biopharma Call Center 1-855-633-8479 medinfo@theravance.com

Locations
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United States, Florida
Theravance Biopharma Investigational Site Not yet recruiting
Aventura, Florida, United States, 33180
Theravance Biopharma Investigational Site Not yet recruiting
Clearwater, Florida, United States, 33756
Theravance Biopharma Investigational Site Not yet recruiting
Hialeah, Florida, United States, 33013
Theravance Biopharma Investigational Site Not yet recruiting
Largo, Florida, United States, 33777
Theravance Biopharma Investigational Site Not yet recruiting
Miami, Florida, United States, 33135
Theravance Biopharma Investigational Site Not yet recruiting
New Port Richey, Florida, United States, 34653
Theravance Biopharma Investigational Site Not yet recruiting
Pembroke Pines, Florida, United States, 33024
United States, Idaho
Theravance Biopharma Investigational Site Not yet recruiting
Idaho Falls, Idaho, United States, 83404
United States, Louisiana
Theravance Biopharma Investigational Site Not yet recruiting
Monroe, Louisiana, United States, 71201
United States, Massachusetts
Theravance Biopharma Investigational Site Not yet recruiting
Brockton, Massachusetts, United States, 02302
United States, North Carolina
Theravance Biopharma Investigational Site Not yet recruiting
Greenville, North Carolina, United States, 27834-3761
United States, Oklahoma
Theravance Biopharma Investigational Site Not yet recruiting
Tulsa, Oklahoma, United States, 74136
United States, Tennessee
Theravance Biopharma Investigational Site Not yet recruiting
Jackson, Tennessee, United States, 38305
United States, Texas
Theravance Biopharma Investigational Site Not yet recruiting
Garland, Texas, United States, 75044
Theravance Biopharma Investigational Site Not yet recruiting
Houston, Texas, United States, 77002
Theravance Biopharma Investigational Site Not yet recruiting
San Antonio, Texas, United States, 78215
Sponsors and Collaborators
Theravance Biopharma
Investigators
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Study Director: Medical Director Theravance Biopharma

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Responsible Party: Theravance Biopharma
ClinicalTrials.gov Identifier: NCT03920254     History of Changes
Other Study ID Numbers: 0164
2018-002135-19 ( EudraCT Number )
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Theravance Biopharma:
TD-1473
Janus kinase inhibitor
JAK inhibitor
Inflammatory Bowel Disease
IBD
Ulcerative colitis
UC
Intestinal restriction
Gut-selective

Additional relevant MeSH terms:
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Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases