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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03920254




Registration number
NCT03920254
Ethics application status
Date submitted
28/03/2019
Date registered
18/04/2019
Date last updated
11/09/2020

Titles & IDs
Public title
TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study
Scientific 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)
Secondary ID [1] 0 0
2018-002135-19
Secondary ID [2] 0 0
0164
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis (UC) 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TD-1473 Dose A
Treatment: Drugs - TD-1473 Dose B
Treatment: Drugs - TD-1473 Dose C

Experimental: Active Treatment TD-1473 with Dose A - Oral daily dose of TD-1473 for up to 156 weeks

Experimental: Active Treatment TD-1473 with Dose B - Oral daily dose of TD-1473 for up to 156 weeks

Experimental: Active Treatment TD-1473 with Dose C - Oral daily dose of TD-1473 for up to 156 weeks


Treatment: Drugs: TD-1473 Dose A
See Arm description

Treatment: Drugs: TD-1473 Dose B
See Arm description

Treatment: Drugs: TD-1473 Dose C
See Arm description

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse Events - Incidence and severity of treatment-emergent adverse events
Timepoint [1] 0 0
Day 1 to a maximum of Week 160 (156 weeks treatment + 4 week follow-up)
Primary outcome [2] 0 0
Laboratory Safety tests - Number of subjects with laboratory test abnormalities
Timepoint [2] 0 0
Day 1 to a maximum of Week 160 (156 weeks treatment + 4 week follow-up)
Primary outcome [3] 0 0
ECGs - Number of subjects with clinically significant ECG findings
Timepoint [3] 0 0
Day 1 to a maximum of Week 160 (156 weeks treatment + 4 week follow-up)
Primary outcome [4] 0 0
Vital Signs - Number of subjects with clinically significant vital sign abnormalities
Timepoint [4] 0 0
Day 1 to a maximum of Week 160 (156 weeks treatment + 4 week follow-up)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Theravance Biopharma Investigational Site - South Brisbane
Recruitment hospital [2] 0 0
Theravance Biopharma Investigational Site - Woolloongabba
Recruitment hospital [3] 0 0
Theravance Biopharma Investigational Site - Malvern
Recruitment hospital [4] 0 0
Theravance Biopharma Investigational Site - Murdoch
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3144 - Malvern
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
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California
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Florida
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Tokyo
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Ukraine
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Zaporizhzhya

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Theravance Biopharma
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT03920254
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Theravance Biopharma
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Theravance Biopharma Call Center
Address 0 0
Country 0 0
Phone 0 0
1-855-633-8479
Fax 0 0
Email 0 0
medinfo@theravance.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03920254