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

  • STATUS
    Recruiting
  • End date
    Sep 28, 2028
  • participants needed
    500
  • sponsor
    Theravance Biopharma
Updated on 28 January 2021
Investigator
Theravance Biopharma Call Center
Primary Contact
Theravance Biopharma Investigational Site (3.8 mi away) Contact
+158 other location
remission

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

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).

Details
Condition Ulcerative Colitis, Ulcerative Colitis (Pediatric)
Treatment TD-1473 Dose A, TD-1473 Dose B, TD-1473 Dose C
Clinical Study IdentifierNCT03920254
SponsorTheravance Biopharma
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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