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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

Study Description
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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)
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : September 2028
Estimated Study Completion Date : September 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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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
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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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Sponsors and Collaborators
Theravance Biopharma
Investigators
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Study Director: Medical Director Theravance Biopharma
More Information
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Responsible Party: Theravance Biopharma
ClinicalTrials.gov Identifier: NCT03920254    
Other Study ID Numbers: 0164
2018-002135-19 ( EudraCT Number )
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 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.

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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
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases