Trial Outcomes & Findings for Efficacy & Safety of TD-1473 in Ulcerative Colitis (NCT NCT03758443)
NCT ID: NCT03758443
Last Updated: 2022-11-15
Results Overview
Total Mayo Score (tMS) was calculated as the sum of four components: rectal bleeding (0-3), stool frequency (0-3), physician's global assessment (0-3) and Mayo endoscopic subscore (0-3). tMS was reported as a 0-12 point score with 12 reflecting the highest severity.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
239 participants
Primary outcome timeframe
Baseline to Week 8
Results posted on
2022-11-15
Participant Flow
A total of 239 participants were enrolled at sites in Europe, Asia/Pacific, the United States, Israel, Australia, and South Africa between 11 March 2019 and 20 October 2021.
Participant milestones
| Measure |
Placebo
Participants were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period.
Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive blinded placebo in the Maintenance Period. Participants who did not achieve clinical response at Week 8 received 80 mg TD-1473 for 8 weeks in the Extended Induction Period.
Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, were re-randomized to received placebo; 20 mg, 80 mg, or 200 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 8 weeks of TD-1473 induction therapy underwent study exit procedures.
|
TD-1473 20 mg
Participants were randomized to receive once-daily administrations of 20 mg TD-1473 for 8 weeks during the Induction Period.
Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 20 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 20 mg TD-1473 for 8 weeks in the Extended Induction Period.
Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 20 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.
|
TD-1473 80 mg
Participants were randomized to receive once-daily administrations of 80 mg TD-1473 for 8 weeks during the Induction Period.
Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 80 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 80 mg TD-1473 for 8 weeks in the Extended Induction Period.
Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 80 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.
|
TD-1473 200 mg
Participants were randomized to receive once-daily administrations of 200 mg TD-1473 for 8 weeks during the Induction Period.
Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 200 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 200 mg TD-1473 for 8 weeks in the Extended Induction Period.
Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 200 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.
|
|---|---|---|---|---|
|
Induction Period
STARTED
|
61
|
61
|
59
|
58
|
|
Induction Period
COMPLETED
|
55
|
54
|
52
|
50
|
|
Induction Period
NOT COMPLETED
|
6
|
7
|
7
|
8
|
|
Extended Induction Period
STARTED
|
42
|
32
|
32
|
29
|
|
Extended Induction Period
COMPLETED
|
29
|
29
|
23
|
22
|
|
Extended Induction Period
NOT COMPLETED
|
13
|
3
|
9
|
7
|
|
Maintenance Period
STARTED
|
29
|
31
|
25
|
22
|
|
Maintenance Period
COMPLETED
|
13
|
11
|
12
|
9
|
|
Maintenance Period
NOT COMPLETED
|
16
|
20
|
13
|
13
|
Reasons for withdrawal
| Measure |
Placebo
Participants were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period.
Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive blinded placebo in the Maintenance Period. Participants who did not achieve clinical response at Week 8 received 80 mg TD-1473 for 8 weeks in the Extended Induction Period.
Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, were re-randomized to received placebo; 20 mg, 80 mg, or 200 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 8 weeks of TD-1473 induction therapy underwent study exit procedures.
|
TD-1473 20 mg
Participants were randomized to receive once-daily administrations of 20 mg TD-1473 for 8 weeks during the Induction Period.
Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 20 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 20 mg TD-1473 for 8 weeks in the Extended Induction Period.
Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 20 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.
|
TD-1473 80 mg
Participants were randomized to receive once-daily administrations of 80 mg TD-1473 for 8 weeks during the Induction Period.
Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 80 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 80 mg TD-1473 for 8 weeks in the Extended Induction Period.
Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 80 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.
|
TD-1473 200 mg
Participants were randomized to receive once-daily administrations of 200 mg TD-1473 for 8 weeks during the Induction Period.
Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 200 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 200 mg TD-1473 for 8 weeks in the Extended Induction Period.
Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 200 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.
|
|---|---|---|---|---|
|
Induction Period
Adverse Event
|
2
|
4
|
2
|
3
|
|
Induction Period
Physician Decision
|
1
|
1
|
3
|
0
|
|
Induction Period
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Induction Period
Withdrawal by Subject
|
3
|
2
|
2
|
4
|
|
Extended Induction Period
Adverse Event
|
1
|
1
|
0
|
1
|
|
Extended Induction Period
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Extended Induction Period
Physician Decision
|
2
|
1
|
2
|
2
|
|
Extended Induction Period
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Extended Induction Period
Withdrawal by Subject
|
8
|
1
|
7
|
3
|
|
Extended Induction Period
Miscellaneous
|
1
|
0
|
0
|
0
|
|
Maintenance Period
Adverse Event
|
1
|
2
|
0
|
0
|
|
Maintenance Period
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
Maintenance Period
Persistent Loss of Response During Maintenance
|
3
|
1
|
2
|
0
|
|
Maintenance Period
Protocol Violation
|
0
|
1
|
0
|
0
|
|
Maintenance Period
Study Terminated by Sponsor
|
11
|
16
|
9
|
11
|
|
Maintenance Period
Withdrawal by Subject
|
1
|
0
|
1
|
1
|
|
Maintenance Period
Miscellaneous
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Efficacy & Safety of TD-1473 in Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
Placebo
n=61 Participants
Participants were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period.
Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive blinded placebo in the Maintenance Period. Participants who did not achieve clinical response at Week 8 received 80 mg TD-1473 for 8 weeks in the Extended Induction Period.
Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, were re-randomized to received placebo; 20 mg, 80 mg, or 200 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 8 weeks of TD-1473 induction therapy underwent study exit procedures.
|
TD-1473 20 mg
n=61 Participants
Participants were randomized to receive once-daily administrations of 20 mg TD-1473 for 8 weeks during the Induction Period.
Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 20 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 20 mg TD-1473 for 8 weeks in the Extended Induction Period.
Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 20 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.
|
TD-1473 80 mg
n=59 Participants
Participants were randomized to receive once-daily administrations of 80 mg TD-1473 for 8 weeks during the Induction Period.
Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 80 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 80 mg TD-1473 for 8 weeks in the Extended Induction Period.
Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 80 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.
|
TD-1473 200 mg
n=58 Participants
Participants were randomized to receive once-daily administrations of 200 mg TD-1473 for 8 weeks during the Induction Period.
Participants who achieved clinical response by adapted Mayo Score at Week 8 continued to receive 200 mg TD-1473 in the Maintenance Period. Participants who did not achieve clinical response at Week 8 continued to receive 200 mg TD-1473 for 8 weeks in the Extended Induction Period.
Participants who achieved clinical response to a total of 16 weeks of TD-1473 induction therapy continued to receive 200 mg TD-1473 for 44 weeks in the Maintenance Period. Participants who did not achieve clinical response to a total of 16 weeks of TD-1473 induction therapy underwent study exit procedures.
|
Total
n=239 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40.92 years
STANDARD_DEVIATION 15.390 • n=5 Participants
|
38.87 years
STANDARD_DEVIATION 14.576 • n=7 Participants
|
42.02 years
STANDARD_DEVIATION 15.317 • n=5 Participants
|
44.38 years
STANDARD_DEVIATION 14.122 • n=4 Participants
|
41.51 years
STANDARD_DEVIATION 14.905 • n=21 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
93 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
146 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
224 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
48 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
200 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 8Population: Modified Intent-to-Treat (mITT) Analysis Set (Induction Period): Comprised all randomized participants who received at least one dose of study drug.
Total Mayo Score (tMS) was calculated as the sum of four components: rectal bleeding (0-3), stool frequency (0-3), physician's global assessment (0-3) and Mayo endoscopic subscore (0-3). tMS was reported as a 0-12 point score with 12 reflecting the highest severity.
Outcome measures
| Measure |
Induction Period: Placebo
n=56 Participants
Participants were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period.
|
Induction Period: TD-1473 20 mg
n=54 Participants
Participants were randomized to receive once-daily administrations of 20 mg TD-1473 for 8 weeks during the Induction Period.
|
Induction Period: TD-1473 80 mg
n=53 Participants
Participants were randomized to receive once-daily administrations of 80 mg TD-1473 for 8 weeks during the Induction Period.
|
Induction Period: TD-1473 200 mg
n=55 Participants
Participants were randomized to receive once-daily administrations of 200 mg TD-1473 for 8 weeks during the Induction Period.
|
|---|---|---|---|---|
|
Change From Baseline in Total Mayo Score (tMS) at Week 8
|
-1.75 score on a scale
Standard Error 0.341
|
-2.02 score on a scale
Standard Error 0.350
|
-2.12 score on a scale
Standard Error 0.351
|
-2.40 score on a scale
Standard Error 0.346
|
PRIMARY outcome
Timeframe: mWeek 44Population: mITT Analysis Set (Maintenance Period): All participants randomized into the Phase 3 Maintenance Study who were also treated. Only participants randomized at least 44 weeks prior to database lock were included.
Clinical remission by Adapted Mayo score was defined based on Adapted Mayo score components within specific ranges: stool frequency score of 0 or 1, a rectal bleeding subscore of 0 and a Mayo endoscopy subscore of 0 or 1. The Adapted Mayo score was the sum of three components: rectal bleeding, stool frequency, and Mayo endoscopic subscore, each measured on a scale of 0-3 with higher scores reflecting higher severity. Participants with missing Week 44 values were imputed as non-responders.
Outcome measures
| Measure |
Induction Period: Placebo
n=9 Participants
Participants were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period.
|
Induction Period: TD-1473 20 mg
n=13 Participants
Participants were randomized to receive once-daily administrations of 20 mg TD-1473 for 8 weeks during the Induction Period.
|
Induction Period: TD-1473 80 mg
n=11 Participants
Participants were randomized to receive once-daily administrations of 80 mg TD-1473 for 8 weeks during the Induction Period.
|
Induction Period: TD-1473 200 mg
n=8 Participants
Participants were randomized to receive once-daily administrations of 200 mg TD-1473 for 8 weeks during the Induction Period.
|
|---|---|---|---|---|
|
Phase 3 Maintenance: Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Maintenance Week (mWeek) 44
|
4 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Week 8Population: mITT Analysis Set (Induction Period): Comprised all randomized participants who received at least one dose of study drug.
Clinical remission by Adapted Mayo score was defined based on Adapted Mayo score components within specific ranges: stool frequency score of 0 or 1, a rectal bleeding subscore of 0 and a Mayo endoscopy subscore of 0 or 1. The Adapted Mayo score was the sum of three components: rectal bleeding, stool frequency, and Mayo endoscopic subscore, each measured on a scale of 0-3 with higher scores reflecting higher severity.
Outcome measures
| Measure |
Induction Period: Placebo
n=61 Participants
Participants were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period.
|
Induction Period: TD-1473 20 mg
n=61 Participants
Participants were randomized to receive once-daily administrations of 20 mg TD-1473 for 8 weeks during the Induction Period.
|
Induction Period: TD-1473 80 mg
n=59 Participants
Participants were randomized to receive once-daily administrations of 80 mg TD-1473 for 8 weeks during the Induction Period.
|
Induction Period: TD-1473 200 mg
n=58 Participants
Participants were randomized to receive once-daily administrations of 200 mg TD-1473 for 8 weeks during the Induction Period.
|
|---|---|---|---|---|
|
Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Week 8
|
6 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline to mWeek 44Population: mITT Analysis Set (Maintenance Period): All participants randomized into the Phase 3 Maintenance Study who were also treated. Only participants randomized at least 44 weeks prior to database lock were included.
Clinical response was defined as a reduction from baseline in adapted Mayo score of ≥ 2 points and ≥ 30% relative to baseline. It also required ≥ 1 reduction in the rectal bleeding subscore or an absolute subscore ≤ 1. The Adapted Mayo score was the sum of three components: rectal bleeding, stool frequency, and Mayo endoscopic subscore, each measured on a scale of 0-3 with higher scores reflecting higher severity. Participants with missing Week 44 values were imputed as non-responders.
Outcome measures
| Measure |
Induction Period: Placebo
n=8 Participants
Participants were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period.
|
Induction Period: TD-1473 20 mg
n=13 Participants
Participants were randomized to receive once-daily administrations of 20 mg TD-1473 for 8 weeks during the Induction Period.
|
Induction Period: TD-1473 80 mg
n=11 Participants
Participants were randomized to receive once-daily administrations of 80 mg TD-1473 for 8 weeks during the Induction Period.
|
Induction Period: TD-1473 200 mg
n=8 Participants
Participants were randomized to receive once-daily administrations of 200 mg TD-1473 for 8 weeks during the Induction Period.
|
|---|---|---|---|---|
|
Phase 3 Maintenance: Number of Participants Who Demonstrated a Clinical Response by Adapted Mayo Score Components at mWeek 44
|
5 Participants
|
5 Participants
|
8 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: mWeek 44Population: mITT Analysis Set (Maintenance Period): All participants randomized into the Phase 3 Maintenance Study who were also treated. Only participants randomized at least 44 weeks prior to database lock were included.
Endoscopic remission was defined as an endoscopic subscore ≤ 1. Endoscopic subscore was measured using scale of 0-3, where higher numbers reflected greater severity.
Outcome measures
| Measure |
Induction Period: Placebo
n=9 Participants
Participants were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period.
|
Induction Period: TD-1473 20 mg
n=13 Participants
Participants were randomized to receive once-daily administrations of 20 mg TD-1473 for 8 weeks during the Induction Period.
|
Induction Period: TD-1473 80 mg
n=11 Participants
Participants were randomized to receive once-daily administrations of 80 mg TD-1473 for 8 weeks during the Induction Period.
|
Induction Period: TD-1473 200 mg
n=8 Participants
Participants were randomized to receive once-daily administrations of 200 mg TD-1473 for 8 weeks during the Induction Period.
|
|---|---|---|---|---|
|
Phase 3 Maintenance: Number of Participants Who Demonstrated Endoscopic Remission by Adapted Mayo Score Components at mWeek 44
|
3 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: mWeek 44Population: mITT Analysis Set (Maintenance Period): All participants randomized into the Phase 3 Maintenance Study who were also treated. Only participants randomized at least 44 weeks prior to database lock were included.
Symptomatic remission was defined as a stool frequency score ≤ 1 and a rectal bleeding subscore of 0. Stool frequency score and rectal bleeding score were each measured using scale of 0-3, where higher numbers reflected greater severity. Participants with missing Week 44 values were imputed as non-responders.
Outcome measures
| Measure |
Induction Period: Placebo
n=9 Participants
Participants were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period.
|
Induction Period: TD-1473 20 mg
n=13 Participants
Participants were randomized to receive once-daily administrations of 20 mg TD-1473 for 8 weeks during the Induction Period.
|
Induction Period: TD-1473 80 mg
n=11 Participants
Participants were randomized to receive once-daily administrations of 80 mg TD-1473 for 8 weeks during the Induction Period.
|
Induction Period: TD-1473 200 mg
n=8 Participants
Participants were randomized to receive once-daily administrations of 200 mg TD-1473 for 8 weeks during the Induction Period.
|
|---|---|---|---|---|
|
Phase 3 Maintenance: Number of Participants Who Demonstrated Symptomatic Remission by Adapted Mayo Score Components at mWeek 44
|
5 Participants
|
7 Participants
|
7 Participants
|
5 Participants
|
Adverse Events
Induction Period: Placebo
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Induction Period: TD-1473 20 mg
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
Induction Period: TD-1473 80 mg
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Induction Period: Placebo to TD-1473 80 mg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Induction Period: TD-1473 200 mg
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
Maintenance Period: Placebo
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Maintenance Period: TD-1473 20 mg
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Maintenance Period: TD-1473 80 mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Maintenance Period: TD-1473 200 mg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Induction Period: Placebo
n=61 participants at risk
Participants who were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period.
|
Induction Period: TD-1473 20 mg
n=61 participants at risk
Participants who were randomized to receive once-daily administrations of 20 mg TD-1473 for 8 weeks during the Induction Period.
Participants who did not achieve clinical response at Week 8 continued to receive 20 mg TD-1473 for 8 weeks in the Extended Induction Period.
|
Induction Period: TD-1473 80 mg
n=59 participants at risk
Participants who were randomized to receive once-daily administrations of 80 mg TD-1473 for 8 weeks during the Induction Period.
Participants who did not achieve clinical response at Week 8 continued to receive 80 mg TD-1473 for 8 weeks in the Extended Induction Period.
|
Induction Period: Placebo to TD-1473 80 mg
n=42 participants at risk
Participants who were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period.
Participants who did not achieve clinical response at Week 8 received 80 mg TD-1473 for 8 weeks in the Extended Induction Period.
|
Induction Period: TD-1473 200 mg
n=58 participants at risk
Participants who were randomized to receive once-daily administrations of 200 mg TD-1473 for 8 weeks during the Induction Period.
Participants who did not achieve clinical response at Week 8 continued to receive 200 mg TD-1473 for 8 weeks in the Extended Induction Period.
|
Maintenance Period: Placebo
n=29 participants at risk
Participants who were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period and achieved clinical response by adapted Mayo Score at Week 8 of the Induction Period continued to receive blinded placebo for 44 weeks in the Maintenance Period.
|
Maintenance Period: TD-1473 20 mg
n=31 participants at risk
Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, and were re-randomized to 20 mg TD-1473 for 44 weeks in the Maintenance Period.
|
Maintenance Period: TD-1473 80 mg
n=25 participants at risk
Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, and were re-randomized to 80 mg TD-1473 for 44 weeks in the Maintenance Period.
|
Maintenance Period: TD-1473 200 mg
n=22 participants at risk
Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, and were re-randomized to 200 mg TD-1473 for 44 weeks in the Maintenance Period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis ulcerative
|
3.3%
2/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
4.9%
3/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
1.7%
1/59 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
2.4%
1/42 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
3.4%
2/58 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/29 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/31 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
4.0%
1/25 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
4.5%
1/22 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/59 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
2.4%
1/42 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/58 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/29 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/31 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/25 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/22 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/59 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/42 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
1.7%
1/58 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/29 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/31 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/25 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/22 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/59 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
2.4%
1/42 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/58 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/29 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/31 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/25 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/22 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
1.6%
1/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/59 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/42 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/58 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/29 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/31 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/25 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/22 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
|
Infections and infestations
Cytomegalovirus colitis
|
1.6%
1/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/59 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/42 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/58 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/29 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/31 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/25 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/22 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
|
Infections and infestations
Liver abscess
|
0.00%
0/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
1.6%
1/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/59 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/42 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/58 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/29 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/31 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/25 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/22 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
|
Surgical and medical procedures
Large intestine operation
|
0.00%
0/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
1.7%
1/59 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/42 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/58 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/29 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/31 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/25 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/22 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/59 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/42 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
1.7%
1/58 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/29 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/31 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/25 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/22 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
1.6%
1/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/59 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/42 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/58 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/29 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/31 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/25 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/22 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/59 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/42 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/58 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/29 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
3.2%
1/31 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/25 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/22 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/59 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/42 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/58 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
3.4%
1/29 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/31 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/25 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/22 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/59 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/42 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/58 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/29 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
3.2%
1/31 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/25 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/22 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/59 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/42 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/58 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/29 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/31 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
4.0%
1/25 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/22 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
Other adverse events
| Measure |
Induction Period: Placebo
n=61 participants at risk
Participants who were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period.
|
Induction Period: TD-1473 20 mg
n=61 participants at risk
Participants who were randomized to receive once-daily administrations of 20 mg TD-1473 for 8 weeks during the Induction Period.
Participants who did not achieve clinical response at Week 8 continued to receive 20 mg TD-1473 for 8 weeks in the Extended Induction Period.
|
Induction Period: TD-1473 80 mg
n=59 participants at risk
Participants who were randomized to receive once-daily administrations of 80 mg TD-1473 for 8 weeks during the Induction Period.
Participants who did not achieve clinical response at Week 8 continued to receive 80 mg TD-1473 for 8 weeks in the Extended Induction Period.
|
Induction Period: Placebo to TD-1473 80 mg
n=42 participants at risk
Participants who were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period.
Participants who did not achieve clinical response at Week 8 received 80 mg TD-1473 for 8 weeks in the Extended Induction Period.
|
Induction Period: TD-1473 200 mg
n=58 participants at risk
Participants who were randomized to receive once-daily administrations of 200 mg TD-1473 for 8 weeks during the Induction Period.
Participants who did not achieve clinical response at Week 8 continued to receive 200 mg TD-1473 for 8 weeks in the Extended Induction Period.
|
Maintenance Period: Placebo
n=29 participants at risk
Participants who were randomized to receive once-daily administrations of placebo for 8 weeks during the Induction Period and achieved clinical response by adapted Mayo Score at Week 8 of the Induction Period continued to receive blinded placebo for 44 weeks in the Maintenance Period.
|
Maintenance Period: TD-1473 20 mg
n=31 participants at risk
Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, and were re-randomized to 20 mg TD-1473 for 44 weeks in the Maintenance Period.
|
Maintenance Period: TD-1473 80 mg
n=25 participants at risk
Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, and were re-randomized to 80 mg TD-1473 for 44 weeks in the Maintenance Period.
|
Maintenance Period: TD-1473 200 mg
n=22 participants at risk
Participants who achieved clinical response to a total of 8 weeks of TD-1473 induction therapy, either at Week 8 or Week 16, and were re-randomized to 200 mg TD-1473 for 44 weeks in the Maintenance Period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis ulcerative
|
1.6%
1/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
4.9%
3/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
8.5%
5/59 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
2.4%
1/42 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
12.1%
7/58 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
13.8%
4/29 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
19.4%
6/31 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
12.0%
3/25 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/22 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
|
Infections and infestations
Nasopharyngitis
|
1.6%
1/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
9.8%
6/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/59 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/42 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
6.9%
4/58 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/29 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/31 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
4.0%
1/25 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/22 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
1/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
3.3%
2/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
3.4%
2/59 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
2.4%
1/42 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
3.4%
2/58 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
3.4%
1/29 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
9.7%
3/31 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/25 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
4.5%
1/22 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
|
Nervous system disorders
Headache
|
3.3%
2/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
3.4%
2/59 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
2.4%
1/42 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
3.4%
2/58 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
3.4%
1/29 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
6.5%
2/31 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
4.0%
1/25 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/22 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
1.7%
1/59 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/42 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/58 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/29 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
6.5%
2/31 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/25 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/22 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
|
General disorders
Pyrexia
|
3.3%
2/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/59 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/42 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/58 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/29 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
6.5%
2/31 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/25 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/22 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
|
Infections and infestations
Upper respiratory tract infection
|
1.6%
1/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
1.6%
1/61 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
1.7%
1/59 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
4.8%
2/42 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/58 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
6.9%
2/29 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/31 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/25 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
0.00%
0/22 • Induction Period: Up to Week 20 Maintenance Period: Up to Week 48
The Safety analysis set included all participants who received at least one dose of study drug (TD-1473 or placebo).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place