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出境医 / 临床实验 / TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study

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

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

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).
Study Design
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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)
Actual Study Start Date : July 23, 2020
Estimated Primary Completion Date : September 2028
Estimated Study Completion Date : September 2028
Arms and Interventions
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
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 [ Time Frame: Day 1 to a maximum of Week 160 (156 weeks treatment + 4 week follow-up) ]
    Number of subjects with laboratory test abnormalities

  3. 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

  4. 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


Eligibility Criteria
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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
Contacts and Locations

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

Locations
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