TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study
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ClinicalTrials.gov Identifier: NCT03920254 |
Recruitment Status :
Terminated
(Stopped early due to company decision. Company decision based on interim analysis results in TD-1473-0157.)
First Posted : April 18, 2019
Results First Posted : November 2, 2022
Last Update Posted : November 2, 2022
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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 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 46 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 |
Actual Primary Completion Date : | October 27, 2021 |
Actual Study Completion Date : | October 27, 2021 |

Arm | Intervention/treatment |
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Experimental: Active Treatment TD-1473 with Dose A
Oral daily dose of TD-1473 for up to 156 weeks
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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
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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
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Drug: TD-1473 Dose C
See Arm description |
- Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) [ Time Frame: Day 1 up to 4 weeks after last dose of study drug (median treatment duration was: TD-1473 20 mg - 142 days; TD-1473 80 mg - 180.0 days; TD-1473 200 mg - 158 days) ]A TEAE was defined as any AE with a recorded start date on or after the date of the first dose of study drug up through 4 weeks after the last dose of study drug. Any clinically significant changes in laboratory safety tests, electrocardiograms (ECGs) and vital signs, were also recorded as TEAEs.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | No |
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.
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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

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

Study Director: | Medical Director | Theravance Biopharma |
Documents provided by Theravance Biopharma:
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 |
Results First Posted: | November 2, 2022 |
Last Update Posted: | November 2, 2022 |
Last Verified: | October 2022 |
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 |
TD-1473 Janus kinase inhibitor JAK inhibitor Inflammatory Bowel Disease IBD |
Ulcerative colitis UC Intestinal restriction Gut-selective |
Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases |