Trial Outcomes & Findings for Efficacy and Safety of TD-1473 in Crohn's Disease (NCT NCT03635112)
NCT ID: NCT03635112
Last Updated: 2023-03-13
Results Overview
The CDAI score was generated using regression coefficients for eight different predictors of disease activity: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Benchmarks for disease activity as measured by the CDAI were: \<150, clinical remission; 150 to 219, mildly active disease; 220-450, moderately active disease; and \>450, very severe disease.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
167 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2023-03-13
Participant Flow
A total of 167 participants were randomized, of which 159 were eligible for analysis at sites in Australia, Asia/Pacific, Israel, Russia, the United States and South Africa between 19 November 2018 and 30 December 2021.
Participant milestones
| Measure |
Placebo
Participants were randomized to receive once-daily oral administrations of placebo for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 80 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
TD-1473 80 mg
Participants were randomized to receive once-daily oral administrations of TD-1473 80 mg for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 80 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
TD-1473 200 mg
Participants were randomized to receive once-daily oral administrations of TD-1473 200 mg for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 200 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
38
|
58
|
63
|
|
Overall Study
Completed Week 12 Visit
|
33
|
48
|
49
|
|
Overall Study
Switched From Placebo to TD-1473 80 mg
|
33
|
0
|
0
|
|
Overall Study
COMPLETED
|
12
|
16
|
13
|
|
Overall Study
NOT COMPLETED
|
26
|
42
|
50
|
Reasons for withdrawal
| Measure |
Placebo
Participants were randomized to receive once-daily oral administrations of placebo for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 80 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
TD-1473 80 mg
Participants were randomized to receive once-daily oral administrations of TD-1473 80 mg for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 80 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
TD-1473 200 mg
Participants were randomized to receive once-daily oral administrations of TD-1473 200 mg for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 200 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
9
|
14
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
|
Overall Study
Physician Decision
|
5
|
7
|
5
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
|
Overall Study
Study Terminated by Sponsor
|
11
|
17
|
21
|
|
Overall Study
Withdrawal by Subject
|
4
|
9
|
7
|
|
Overall Study
Miscellaneous
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of TD-1473 in Crohn's Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=38 Participants
Participants were randomized to receive once-daily oral administrations of placebo for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 80 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
TD-1473 80 mg
n=58 Participants
Participants were randomized to receive once-daily oral administrations of TD-1473 80 mg for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 80 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
TD-1473 200 mg
n=63 Participants
Participants were randomized to receive once-daily oral administrations of TD-1473 200 mg for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 200 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
Total
n=159 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.5 years
STANDARD_DEVIATION 14.85 • n=5 Participants
|
37.1 years
STANDARD_DEVIATION 12.45 • n=7 Participants
|
40.0 years
STANDARD_DEVIATION 13.64 • n=5 Participants
|
38.8 years
STANDARD_DEVIATION 13.50 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
153 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Modified Intent-to-Treat Analysis Set: Comprised all randomized evaluable participants who received at least 1 dose of study drug, had at least one postbaseline CDAI score and had non-missing values at both baseline and postbaseline visit.
The CDAI score was generated using regression coefficients for eight different predictors of disease activity: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Benchmarks for disease activity as measured by the CDAI were: \<150, clinical remission; 150 to 219, mildly active disease; 220-450, moderately active disease; and \>450, very severe disease.
Outcome measures
| Measure |
Placebo
n=33 Participants
Participants were randomized to receive once-daily oral administrations of placebo for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 80 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
TD-1473 80 mg
n=47 Participants
Participants were randomized to receive once-daily oral administrations of TD-1473 80 mg for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 80 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
TD-1473 200 mg
n=50 Participants
Participants were randomized to receive once-daily oral administrations of TD-1473 200 mg for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 200 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
|---|---|---|---|
|
Change From Baseline in Crohn's Disease Activity Index (CDAI) Score
|
-104.86 score on a scale
Standard Error 15.496
|
-105.62 score on a scale
Standard Error 12.713
|
-117.99 score on a scale
Standard Error 12.423
|
SECONDARY outcome
Timeframe: Week 12Population: Modified Intent-to-Treat Analysis Set: Comprised all randomized evaluable participants who received at least 1 dose of study drug and had at least one postbaseline CDAI score.
The CDAI score was generated using regression coefficients for eight different predictors of disease activity: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Benchmarks for disease activity as measured by the CDAI were: \<150, clinical remission; 150 to 219, mildly active disease; 220-450, moderately active disease; and \>450, very severe disease. Clinical response was defined as a reduction from baseline of ≥100 points or CDAI \<150
Outcome measures
| Measure |
Placebo
n=35 Participants
Participants were randomized to receive once-daily oral administrations of placebo for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 80 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
TD-1473 80 mg
n=54 Participants
Participants were randomized to receive once-daily oral administrations of TD-1473 80 mg for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 80 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
TD-1473 200 mg
n=56 Participants
Participants were randomized to receive once-daily oral administrations of TD-1473 200 mg for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 200 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
|---|---|---|---|
|
Number of Participants Who Demonstrated a Clinical Response as Measured by CDAI
|
19 Participants
|
28 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Modified Intent-to-Treat Analysis Set: Comprised all randomized evaluable participants who received at least 1 dose of study drug and had at least one postbaseline CDAI score.
The CDAI score was generated using regression coefficients for eight different predictors of disease activity: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Benchmarks for disease activity as measured by the CDAI were: \<150, clinical remission; 150 to 219, mildly active disease; 220-450, moderately active disease; and \>450, very severe disease. CDAI clinical remission was defined as a CDAI score less than 150 at Week 12.
Outcome measures
| Measure |
Placebo
n=35 Participants
Participants were randomized to receive once-daily oral administrations of placebo for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 80 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
TD-1473 80 mg
n=54 Participants
Participants were randomized to receive once-daily oral administrations of TD-1473 80 mg for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 80 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
TD-1473 200 mg
n=56 Participants
Participants were randomized to receive once-daily oral administrations of TD-1473 200 mg for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 200 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
|---|---|---|---|
|
Number of Participants Who Demonstrated CDAI Clinical Remission
|
13 Participants
|
13 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Modified Intent-to-Treat Analysis Set: Comprised all randomized evaluable participants who received at least 1 dose of study drug, had at least one postbaseline CDAI score and had non-missing values at both baseline and postbaseline visit.
The SES-CD incorporated 4 descriptors: the ulcer size, the proportion of surface covered by ulcer, the proportion of surface covered by other lesions, and the presence of stenosis. Each descriptor was scored in 5 segments (ileum, right colon, transverse colon, left colon, and rectum). The total score ranged from 0 to 56, with higher scores indicating a worse outcome.
Outcome measures
| Measure |
Placebo
n=20 Participants
Participants were randomized to receive once-daily oral administrations of placebo for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 80 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
TD-1473 80 mg
n=35 Participants
Participants were randomized to receive once-daily oral administrations of TD-1473 80 mg for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 80 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
TD-1473 200 mg
n=37 Participants
Participants were randomized to receive once-daily oral administrations of TD-1473 200 mg for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 200 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
|---|---|---|---|
|
Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12
|
-1.9 score on a scale
Standard Error 1.27
|
-0.2 score on a scale
Standard Error 0.96
|
-1.9 score on a scale
Standard Error 0.95
|
SECONDARY outcome
Timeframe: Week 12Population: Modified Intent-to-Treat Analysis Set: Comprised all randomized evaluable participants who received at least 1 dose of study drug and had at least one postbaseline CDAI score.
Endoscopic Response was defined as a reduction of SES-CD score or Endoscopic Remission (defined as SES-CD ≤ 2) at Week 12.
Outcome measures
| Measure |
Placebo
n=31 Participants
Participants were randomized to receive once-daily oral administrations of placebo for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 80 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
TD-1473 80 mg
n=53 Participants
Participants were randomized to receive once-daily oral administrations of TD-1473 80 mg for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 80 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
TD-1473 200 mg
n=54 Participants
Participants were randomized to receive once-daily oral administrations of TD-1473 200 mg for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 200 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
|---|---|---|---|
|
Number of Participants With Endoscopic Response at Week 12
|
6 Participants
|
5 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Modified Intent-to-Treat Analysis Set: Comprised all randomized evaluable participants who received at least 1 dose of study drug and had at least one postbaseline CDAI score.
SFAP clinical remission was defined as an abdominal pain score ≤1 (on a scale of 0-3 with 0 representing 'no pain' and 3 representing 'severe pain'), stool frequency ≤2.8, and both not worse than baseline at Week 12.
Outcome measures
| Measure |
Placebo
n=35 Participants
Participants were randomized to receive once-daily oral administrations of placebo for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 80 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
TD-1473 80 mg
n=54 Participants
Participants were randomized to receive once-daily oral administrations of TD-1473 80 mg for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 80 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
TD-1473 200 mg
n=56 Participants
Participants were randomized to receive once-daily oral administrations of TD-1473 200 mg for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 200 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
|---|---|---|---|
|
Number of Participants With Stool Frequency and Abdominal Pain (SFAP) Clinical Remission
|
6 Participants
|
6 Participants
|
10 Participants
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 11 other events
Deaths: 1 deaths
TD-1473 80 mg
Serious events: 9 serious events
Other events: 23 other events
Deaths: 0 deaths
TD-1473 80mg Post-Placebo
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
TD-1473 200 mg
Serious events: 10 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=38 participants at risk
Participants were randomized to receive once-daily oral administrations of placebo for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 80 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
TD-1473 80 mg
n=58 participants at risk
Participants were randomized to receive once-daily oral administrations of TD-1473 80 mg for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 80 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
TD-1473 80mg Post-Placebo
n=33 participants at risk
Participants who were treated with placebo in Induction Period and switched to TD-1473 80mg in Active Treatment Extension period.
|
TD-1473 200 mg
n=63 participants at risk
Participants were randomized to receive once-daily oral administrations of TD-1473 200 mg for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 200 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Crohn's Disease
|
0.00%
0/38 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
10.3%
6/58 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
3.0%
1/33 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
12.7%
8/63 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/38 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
1.7%
1/58 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/33 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/63 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/38 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/58 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
3.0%
1/33 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/63 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
2.6%
1/38 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/58 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/33 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/63 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
COVID-19 pneumonia
|
2.6%
1/38 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/58 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/33 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/63 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/38 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/58 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/33 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
1.6%
1/63 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
|
General disorders
Granuloma
|
2.6%
1/38 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/58 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/33 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/63 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/38 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/58 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
3.0%
1/33 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/63 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/38 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/58 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/33 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
1.6%
1/63 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
|
Investigations
Transaminases increased
|
2.6%
1/38 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/58 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/33 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/63 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/38 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
1.7%
1/58 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/33 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/63 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/38 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
1.7%
1/58 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/33 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/63 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/38 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
1.7%
1/58 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/33 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/63 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Placebo
n=38 participants at risk
Participants were randomized to receive once-daily oral administrations of placebo for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 80 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
TD-1473 80 mg
n=58 participants at risk
Participants were randomized to receive once-daily oral administrations of TD-1473 80 mg for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 80 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
TD-1473 80mg Post-Placebo
n=33 participants at risk
Participants who were treated with placebo in Induction Period and switched to TD-1473 80mg in Active Treatment Extension period.
|
TD-1473 200 mg
n=63 participants at risk
Participants were randomized to receive once-daily oral administrations of TD-1473 200 mg for 12 weeks during the Induction Period. Participants who completed the Induction Period received once-daily oral administrations of TD-1473 200 mg in the Active Treatment Extension period for up to 48 additional weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/38 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
5.2%
3/58 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/33 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
1.6%
1/63 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
7.9%
3/38 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
5.2%
3/58 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
3.0%
1/33 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
7.9%
5/63 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/38 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/58 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
3.0%
1/33 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
7.9%
5/63 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
2.6%
1/38 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
1.7%
1/58 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
6.1%
2/33 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
6.3%
4/63 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.3%
2/38 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
6.9%
4/58 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/33 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
1.6%
1/63 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/38 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
1.7%
1/58 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/33 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
6.3%
4/63 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
2.6%
1/38 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
6.9%
4/58 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/33 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
1.6%
1/63 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/38 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
1.7%
1/58 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
6.1%
2/33 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
1.6%
1/63 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
1/38 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
1.7%
1/58 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
3.0%
1/33 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
6.3%
4/63 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/38 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
6.9%
4/58 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/33 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
1.6%
1/63 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
5.3%
2/38 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
1.7%
1/58 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
3.0%
1/33 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
1.6%
1/63 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/38 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
5.2%
3/58 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/33 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
1.6%
1/63 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
2/38 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
1.7%
1/58 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/33 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
4.8%
3/63 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Crohn's disease
|
7.9%
3/38 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
13.8%
8/58 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
6.1%
2/33 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
11.1%
7/63 • From Day 1 up to 28 days after the last dose (up to 64 weeks)
The safety analysis set comprised all participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place