Trial Outcomes & Findings for TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study (NCT NCT03920254)
NCT ID: NCT03920254
Last Updated: 2022-11-02
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
46 participants
Primary outcome timeframe
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)
Results posted on
2022-11-02
Participant Flow
46 out of the planned 500 participants were enrolled and received study drug between 23 July 2020 and 27 October 2021.
Participant milestones
| Measure |
TD-1473 20mg
Participants received TD-1473 orally at a dose of 20mg once daily.
|
TD-1473 80mg
Participants received TD-1473 orally at a dose of 80mg once daily.
|
TD-1473 200mg
Participants received TD-1473 orally at a dose of 200mg once daily.
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
18
|
15
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
13
|
18
|
15
|
Reasons for withdrawal
| Measure |
TD-1473 20mg
Participants received TD-1473 orally at a dose of 20mg once daily.
|
TD-1473 80mg
Participants received TD-1473 orally at a dose of 80mg once daily.
|
TD-1473 200mg
Participants received TD-1473 orally at a dose of 200mg once daily.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
2
|
|
Overall Study
Study Terminated By Sponsor
|
12
|
17
|
12
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study
Baseline characteristics by cohort
| Measure |
TD-1473 20mg
n=13 Participants
Participants received TD-1473 orally at a dose of 20mg once daily.
|
TD-1473 80mg
n=18 Participants
Participants received TD-1473 orally at a dose of 80mg once daily.
|
TD-1473 200mg
n=15 Participants
Participants received TD-1473 orally at a dose of 200mg once daily.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.31 years
STANDARD_DEVIATION 17.375 • n=99 Participants
|
43.22 years
STANDARD_DEVIATION 15.869 • n=107 Participants
|
46.13 years
STANDARD_DEVIATION 13.432 • n=206 Participants
|
45.04 years
STANDARD_DEVIATION 15.296 • n=7 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
44 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
40 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 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)Population: Includes all participants from the Safety Analysis Set.
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.
Outcome measures
| Measure |
TD-1473 20mg
n=13 Participants
Participants received TD-1473 orally at a dose of 20mg once daily.
|
TD-1473 80mg
n=18 Participants
Participants received TD-1473 orally at a dose of 80mg once daily.
|
TD-1473 200mg
n=15 Participants
Participants received TD-1473 orally at a dose of 200mg once daily.
|
|---|---|---|---|
|
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
|
4 Participants
|
5 Participants
|
6 Participants
|
Adverse Events
TD-1473 20mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
TD-1473 80mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
TD-1473 200mg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TD-1473 20mg
n=13 participants at risk
Participants received TD-1473 orally at a dose of 20mg once daily.
|
TD-1473 80mg
n=18 participants at risk
Participants received TD-1473 orally at a dose of 80mg once daily.
|
TD-1473 200mg
n=15 participants at risk
Participants received TD-1473 orally at a dose of 200mg once daily.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.00%
0/13 • 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)
Includes all participants from the Safety Analysis Set.
|
0.00%
0/18 • 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)
Includes all participants from the Safety Analysis Set.
|
6.7%
1/15 • 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)
Includes all participants from the Safety Analysis Set.
|
Other adverse events
| Measure |
TD-1473 20mg
n=13 participants at risk
Participants received TD-1473 orally at a dose of 20mg once daily.
|
TD-1473 80mg
n=18 participants at risk
Participants received TD-1473 orally at a dose of 80mg once daily.
|
TD-1473 200mg
n=15 participants at risk
Participants received TD-1473 orally at a dose of 200mg once daily.
|
|---|---|---|---|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/13 • 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)
Includes all participants from the Safety Analysis Set.
|
0.00%
0/18 • 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)
Includes all participants from the Safety Analysis Set.
|
6.7%
1/15 • 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)
Includes all participants from the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
1/13 • 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)
Includes all participants from the Safety Analysis Set.
|
0.00%
0/18 • 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)
Includes all participants from the Safety Analysis Set.
|
0.00%
0/15 • 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)
Includes all participants from the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.7%
1/13 • 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)
Includes all participants from the Safety Analysis Set.
|
0.00%
0/18 • 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)
Includes all participants from the Safety Analysis Set.
|
0.00%
0/15 • 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)
Includes all participants from the Safety Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/13 • 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)
Includes all participants from the Safety Analysis Set.
|
5.6%
1/18 • 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)
Includes all participants from the Safety Analysis Set.
|
0.00%
0/15 • 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)
Includes all participants from the Safety Analysis Set.
|
|
Psychiatric disorders
Depression
|
0.00%
0/13 • 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)
Includes all participants from the Safety Analysis Set.
|
5.6%
1/18 • 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)
Includes all participants from the Safety Analysis Set.
|
0.00%
0/15 • 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)
Includes all participants from the Safety Analysis Set.
|
|
Infections and infestations
COVID-19
|
0.00%
0/13 • 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)
Includes all participants from the Safety Analysis Set.
|
0.00%
0/18 • 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)
Includes all participants from the Safety Analysis Set.
|
6.7%
1/15 • 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)
Includes all participants from the Safety Analysis Set.
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/13 • 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)
Includes all participants from the Safety Analysis Set.
|
0.00%
0/18 • 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)
Includes all participants from the Safety Analysis Set.
|
6.7%
1/15 • 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)
Includes all participants from the Safety Analysis Set.
|
|
Infections and infestations
Clostridium difficile infection
|
7.7%
1/13 • 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)
Includes all participants from the Safety Analysis Set.
|
0.00%
0/18 • 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)
Includes all participants from the Safety Analysis Set.
|
0.00%
0/15 • 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)
Includes all participants from the Safety Analysis Set.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/13 • 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)
Includes all participants from the Safety Analysis Set.
|
5.6%
1/18 • 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)
Includes all participants from the Safety Analysis Set.
|
0.00%
0/15 • 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)
Includes all participants from the Safety Analysis Set.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/13 • 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)
Includes all participants from the Safety Analysis Set.
|
5.6%
1/18 • 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)
Includes all participants from the Safety Analysis Set.
|
0.00%
0/15 • 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)
Includes all participants from the Safety Analysis Set.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/13 • 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)
Includes all participants from the Safety Analysis Set.
|
0.00%
0/18 • 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)
Includes all participants from the Safety Analysis Set.
|
6.7%
1/15 • 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)
Includes all participants from the Safety Analysis Set.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
7.7%
1/13 • 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)
Includes all participants from the Safety Analysis Set.
|
16.7%
3/18 • 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)
Includes all participants from the Safety Analysis Set.
|
6.7%
1/15 • 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)
Includes all participants from the Safety Analysis Set.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
1/13 • 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)
Includes all participants from the Safety Analysis Set.
|
0.00%
0/18 • 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)
Includes all participants from the Safety Analysis Set.
|
0.00%
0/15 • 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)
Includes all participants from the Safety Analysis Set.
|
|
General disorders
Pyrexia
|
15.4%
2/13 • 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)
Includes all participants from the Safety Analysis Set.
|
0.00%
0/18 • 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)
Includes all participants from the Safety Analysis Set.
|
0.00%
0/15 • 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)
Includes all participants from the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/13 • 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)
Includes all participants from the Safety Analysis Set.
|
0.00%
0/18 • 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)
Includes all participants from the Safety Analysis Set.
|
6.7%
1/15 • 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)
Includes all participants from the Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
1/13 • 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)
Includes all participants from the Safety Analysis Set.
|
0.00%
0/18 • 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)
Includes all participants from the Safety Analysis Set.
|
0.00%
0/15 • 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)
Includes all participants from the Safety Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/13 • 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)
Includes all participants from the Safety Analysis Set.
|
5.6%
1/18 • 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)
Includes all participants from the Safety Analysis Set.
|
0.00%
0/15 • 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)
Includes all participants from the Safety Analysis Set.
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • 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)
Includes all participants from the Safety Analysis Set.
|
0.00%
0/18 • 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)
Includes all participants from the Safety Analysis Set.
|
0.00%
0/15 • 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)
Includes all participants from the Safety Analysis Set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place