NCT03920254|TerminatedPhase 2ResultsDMCFDA Drug

Study Stopped

Stopped early due to company decision. Company decision based on interim analysis results in TD-1473-0157.

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

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)

Theravance Biopharma ClinicalTrials.gov

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2 other identifiers

01642018-002135-19

Study Type

interventional

Target

Locations

22 countries

Sites

184

Timeline

RegisteredApr 2019

StartedJul 2020

CompletionOct 2021

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

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Jul 2020

Shorter than P25 for phase_2

Geographic Reach

22 countries

184 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

First Submitted

Initial submission to the registry

March 28, 2019

Completed

21 days until next milestone

First Posted

Study publicly available on registry

April 18, 2019

Completed

1.3 years until next milestone

Study Start

First participant enrolled

July 23, 2020

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2021

Completed

1 year until next milestone

Results Posted

Study results publicly available

November 2, 2022

Completed

Last Updated

November 2, 2022

Status Verified

October 1, 2022

Enrollment Period

1.3 years

First QC Date

March 28, 2019

Results QC Date

October 10, 2022

Last Update Submit

October 10, 2022

Conditions

Ulcerative Colitis (UC)

Keywords

TD-1473Janus kinase inhibitorJAK inhibitorInflammatory Bowel DiseaseIBDUlcerative colitisUCIntestinal restrictionGut-selective

Outcome Measures

Primary Outcomes (1)

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)

Study Arms (3)

Active Treatment TD-1473 with Dose A

EXPERIMENTAL

Oral daily dose of TD-1473 for up to 156 weeks

Drug: TD-1473 Dose A

Active Treatment TD-1473 with Dose B

EXPERIMENTAL

Oral daily dose of TD-1473 for up to 156 weeks

Drug: TD-1473 Dose B

Active Treatment TD-1473 with Dose C

EXPERIMENTAL

Oral daily dose of TD-1473 for up to 156 weeks

Drug: TD-1473 Dose C

Interventions

TD-1473 Dose ADRUG

See Arm description

Active Treatment TD-1473 with Dose A

TD-1473 Dose BDRUG

See Arm description

Active Treatment TD-1473 with Dose B

TD-1473 Dose CDRUG

See Arm description

Active Treatment TD-1473 with Dose C

Eligibility Criteria

Age18 Years+

Sexall(Gender-based eligibility)

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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

Contact the study team to confirm eligibility.