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

Study Overview
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Brief Summary
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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

Detailed Description
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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).

Official Title
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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)

Conditions
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Ulcerative Colitis (UC)

Intervention / Treatment
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* Drug: TD-1473 Dose A
* Drug: TD-1473 Dose B
* Drug: TD-1473 Dose C


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Long Term Safety (LTS)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Treatment TD-1473 with Dose A<br>Oral daily dose of TD-1473 for up to 156 weeks | Drug: TD-1473 Dose A<br>* See Arm description<br>|
| Experimental: Active Treatment TD-1473 with Dose B<br>Oral daily dose of TD-1473 for up to 156 weeks | Drug: TD-1473 Dose B<br>* See Arm description<br>|
| Experimental: Active Treatment TD-1473 with Dose C<br>Oral daily dose of TD-1473 for up to 156 weeks | Drug: TD-1473 Dose C<br>* See Arm description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | 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. | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TD-1473, Janus kinase inhibitor, JAK inhibitor, Inflammatory Bowel Disease, IBD, Ulcerative colitis, UC, Intestinal restriction, Gut-selective