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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03920254

Recruitment Status Recruiting

First Posted April 18, 2019

Last update posted September 11, 2020

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:Ulcerative Colitis (UC)
  • Intervention/Treatment: Drug: TD-1473 Dose A
    Drug: TD-1473 Dose B
    Drug: TD-1473 Dose C
  • Phase: 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
  • Study Type: Interventional
  • 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 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
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • 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

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

Locations
Show 173 Study Locations
Sponsors and Collaborators

Theravance Biopharma

Investigators

Study Director: Medical Director Theravance Biopharma

More Information
  • Responsible Party: Theravance Biopharma
  • ClinicalTrials.gov Identifier: NCT03920254 History of Changes
  • Other Study ID Numbers: 0164, 2018-002135-19
  • First Posted: April 18, 2019 Key Record Dates
  • Last Update Posted: September 11, 2020
  • Last Verified: September 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Plan Description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Theravance Biopharma: IBD
    Inflammatory Bowel Disease
    Ulcerative colitis
    UC
    Intestinal restriction
    Gut-selective
    TD-1473
    Janus kinase inhibitor
    JAK inhibitor
  • Additional relevant MeSH terms: Colitis
    Colitis, Ulcerative
    Ulcer