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Efficacy and Safety of TD-1473 in Crohn's Disease (DIONE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03635112
Recruitment Status : Terminated (The study was terminated by the sponsor on 16 November 2021 after a planned review by the Independent Data Monitoring Committee.)
First Posted : August 17, 2018
Results First Posted : March 13, 2023
Last Update Posted : March 13, 2023
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Crohn's Disease
Interventions Drug: Placebo
Drug: TD-1473
Enrollment 167
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Placebo TD-1473 80 mg TD-1473 200 mg
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 38 58 63
Completed Week 12 Visit 33 48 49
Switched From Placebo to TD-1473 80 mg 33 0 0
Completed 12 16 13
Not Completed 26 42 50
Reason Not Completed
Adverse Event             5             9             14
Lost to Follow-up             1             0             1
Physician Decision             5             7             5
Protocol Violation             0             0             1
Study Terminated by Sponsor             11             17             21
Withdrawal by Subject             4             9             7
Miscellaneous             0             0             1
Arm/Group Title Placebo TD-1473 80 mg TD-1473 200 mg Total
Hide Arm/Group Description 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 38 58 63 159
Hide Baseline Analysis Population Description
Intent-to-Treat Analysis Set: Comprised all randomized participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 58 participants 63 participants 159 participants
39.5  (14.85) 37.1  (12.45) 40.0  (13.64) 38.8  (13.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 58 participants 63 participants 159 participants
Female
18
  47.4%
28
  48.3%
31
  49.2%
77
  48.4%
Male
20
  52.6%
30
  51.7%
32
  50.8%
82
  51.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 38 participants 58 participants 63 participants 159 participants
Hispanic or Latino
2
   5.3%
1
   1.7%
0
   0.0%
3
   1.9%
Not Hispanic or Latino
36
  94.7%
57
  98.3%
60
  95.2%
153
  96.2%
Unknown
0
   0.0%
0
   0.0%
2
   3.2%
2
   1.3%
Not Reported
0
   0.0%
0
   0.0%
1
   1.6%
1
   0.6%
1.Primary Outcome
Title Change From Baseline in Crohn's Disease Activity Index (CDAI) Score
Hide Description

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.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo TD-1473 80 mg TD-1473 200 mg
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 33 47 50
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-104.86  (15.496) -105.62  (12.713) -117.99  (12.423)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, TD-1473 80 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.970
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -0.76
Confidence Interval (2-Sided) 95%
-40.62 to 39.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, TD-1473 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.510
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -13.13
Confidence Interval (2-Sided) 95%
-52.46 to 26.19
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants Who Demonstrated a Clinical Response as Measured by CDAI
Hide Description

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
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo TD-1473 80 mg TD-1473 200 mg
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 35 54 56
Measure Type: Count of Participants
Unit of Measure: Participants
19
  54.3%
28
  51.9%
34
  60.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, TD-1473 80 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5102
Comments [Not Specified]
Method Cochran-Mantel-Haenszel Chi-square Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportion
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.277 to 0.135
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, TD-1473 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8591
Comments [Not Specified]
Method Cochran-Mantel-Haenszel Chi-square Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportion
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.181 to 0.218
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants Who Demonstrated CDAI Clinical Remission
Hide Description

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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo TD-1473 80 mg TD-1473 200 mg
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 35 54 56
Measure Type: Count of Participants
Unit of Measure: Participants
13
  37.1%
13
  24.1%
22
  39.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, TD-1473 80 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1805
Comments [Not Specified]
Method Cochran-Mantel-Haenszel Chi-square Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportion
Estimated Value -0.13
Confidence Interval (2-Sided) 95%
-0.322 to 0.061
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, TD-1473 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9215
Comments [Not Specified]
Method Cochran-Mantel-Haenszel Chi-square Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportion
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.204 to 0.184
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12
Hide Description 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.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo TD-1473 80 mg TD-1473 200 mg
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 20 35 37
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-1.9  (1.27) -0.2  (0.96) -1.9  (0.95)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, TD-1473 80 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.316
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value 1.6
Confidence Interval (2-Sided) 95%
-1.6 to 4.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, TD-1473 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.988
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -0.0
Confidence Interval (2-Sided) 95%
-3.2 to 3.2
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants With Endoscopic Response at Week 12
Hide Description Endoscopic Response was defined as a reduction of SES-CD score or Endoscopic Remission (defined as SES-CD ≤ 2) at Week 12.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo TD-1473 80 mg TD-1473 200 mg
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 31 53 54
Measure Type: Count of Participants
Unit of Measure: Participants
6
  19.4%
5
   9.4%
15
  27.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, TD-1473 80 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1828
Comments [Not Specified]
Method Cochran-Mantel-Haenszel Chi-square Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportion
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-0.270 to 0.059
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, TD-1473 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5785
Comments [Not Specified]
Method Cochran-Mantel-Haenszel Chi-square Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportion
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.133 to 0.244
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants With Stool Frequency and Abdominal Pain (SFAP) Clinical Remission
Hide Description 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo TD-1473 80 mg TD-1473 200 mg
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 35 54 56
Measure Type: Count of Participants
Unit of Measure: Participants
6
  17.1%
6
  11.1%
10
  17.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, TD-1473 80 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3776
Comments [Not Specified]
Method Cochran-Mantel-Haenszel Chi-square Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportion
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.225 to 0.095
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, TD-1473 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6063
Comments [Not Specified]
Method Cochran-Mantel-Haenszel Chi-square Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportion
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.189 to 0.111
Estimation Comments [Not Specified]
Time Frame From Day 1 up to 28 days after the last dose (up to 64 weeks)
Adverse Event Reporting Description The safety analysis set comprised all participants who received at least 1 dose of study drug.
 
Arm/Group Title Placebo TD-1473 80 mg TD-1473 80mg Post-Placebo TD-1473 200 mg
Hide Arm/Group Description 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. 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. Participants who were treated with placebo in Induction Period and switched to TD-1473 80mg in Active Treatment Extension period. 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.
All-Cause Mortality
Placebo TD-1473 80 mg TD-1473 80mg Post-Placebo TD-1473 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/38 (2.63%)   0/58 (0.00%)   0/33 (0.00%)   0/63 (0.00%) 
Hide Serious Adverse Events
Placebo TD-1473 80 mg TD-1473 80mg Post-Placebo TD-1473 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/38 (7.89%)   9/58 (15.52%)   3/33 (9.09%)   10/63 (15.87%) 
Gastrointestinal disorders         
Crohn's Disease † 1  0/38 (0.00%)  6/58 (10.34%)  1/33 (3.03%)  8/63 (12.70%) 
Intestinal perforation † 1  0/38 (0.00%)  1/58 (1.72%)  0/33 (0.00%)  0/63 (0.00%) 
Intussusception † 1  0/38 (0.00%)  0/58 (0.00%)  1/33 (3.03%)  0/63 (0.00%) 
Pancreatitis acute † 1  1/38 (2.63%)  0/58 (0.00%)  0/33 (0.00%)  0/63 (0.00%) 
General disorders         
Granuloma † 1  1/38 (2.63%)  0/58 (0.00%)  0/33 (0.00%)  0/63 (0.00%) 
Immune system disorders         
Drug hypersensitivity † 1  0/38 (0.00%)  0/58 (0.00%)  1/33 (3.03%)  0/63 (0.00%) 
Infections and infestations         
COVID-19 pneumonia † 1  1/38 (2.63%)  0/58 (0.00%)  0/33 (0.00%)  0/63 (0.00%) 
Rectal abscess † 1  0/38 (0.00%)  0/58 (0.00%)  0/33 (0.00%)  1/63 (1.59%) 
Injury, poisoning and procedural complications         
Intentional overdose † 1  0/38 (0.00%)  0/58 (0.00%)  0/33 (0.00%)  1/63 (1.59%) 
Investigations         
Transaminases increased † 1  1/38 (2.63%)  0/58 (0.00%)  0/33 (0.00%)  0/63 (0.00%) 
Psychiatric disorders         
Anxiety † 1  0/38 (0.00%)  1/58 (1.72%)  0/33 (0.00%)  0/63 (0.00%) 
Depression † 1  0/38 (0.00%)  1/58 (1.72%)  0/33 (0.00%)  0/63 (0.00%) 
Vascular disorders         
Vasculitis † 1  0/38 (0.00%)  1/58 (1.72%)  0/33 (0.00%)  0/63 (0.00%) 
1
Term from vocabulary, MedDRA 24.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo TD-1473 80 mg TD-1473 80mg Post-Placebo TD-1473 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/38 (28.95%)   23/58 (39.66%)   7/33 (21.21%)   22/63 (34.92%) 
Blood and lymphatic system disorders         
Anaemia † 1  0/38 (0.00%)  4/58 (6.90%)  0/33 (0.00%)  1/63 (1.59%) 
Gastrointestinal disorders         
Abdominal pain † 1  1/38 (2.63%)  1/58 (1.72%)  1/33 (3.03%)  4/63 (6.35%) 
Crohn's disease † 1  3/38 (7.89%)  8/58 (13.79%)  2/33 (6.06%)  7/63 (11.11%) 
Diarrhoea † 1  0/38 (0.00%)  3/58 (5.17%)  0/33 (0.00%)  1/63 (1.59%) 
Nausea † 1  1/38 (2.63%)  1/58 (1.72%)  2/33 (6.06%)  4/63 (6.35%) 
Vomiting † 1  1/38 (2.63%)  1/58 (1.72%)  2/33 (6.06%)  1/63 (1.59%) 
Infections and infestations         
Nasopharyngitis † 1  0/38 (0.00%)  0/58 (0.00%)  1/33 (3.03%)  5/63 (7.94%) 
Urinary tract infection † 1  1/38 (2.63%)  4/58 (6.90%)  0/33 (0.00%)  1/63 (1.59%) 
Investigations         
SARS-CoV-2 test positive † 1  0/38 (0.00%)  1/58 (1.72%)  0/33 (0.00%)  4/63 (6.35%) 
Musculoskeletal and connective tissue disorders         
Arthralgia † 1  0/38 (0.00%)  3/58 (5.17%)  0/33 (0.00%)  1/63 (1.59%) 
Back pain † 1  2/38 (5.26%)  1/58 (1.72%)  0/33 (0.00%)  3/63 (4.76%) 
Nervous system disorders         
Headache † 1  3/38 (7.89%)  3/58 (5.17%)  1/33 (3.03%)  5/63 (7.94%) 
Psychiatric disorders         
Anxiety † 1  2/38 (5.26%)  1/58 (1.72%)  1/33 (3.03%)  1/63 (1.59%) 
Skin and subcutaneous tissue disorders         
Rash † 1  2/38 (5.26%)  4/58 (6.90%)  0/33 (0.00%)  1/63 (1.59%) 
1
Term from vocabulary, MedDRA 24.1
†
Indicates events were collected by systematic assessment
The study was terminated by the sponsor on 16 November 2021 after a planned review by the Independent Data Monitoring Committee.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Medical Monitor
Organization: Theravance Biopharma
Phone: 1-855-633-8479
EMail: medinfo@theravance.com
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Responsible Party: Theravance Biopharma
ClinicalTrials.gov Identifier: NCT03635112    
Other Study ID Numbers: 0173
2018-001272-37 ( EudraCT Number )
First Submitted: July 31, 2018
First Posted: August 17, 2018
Results First Submitted: December 30, 2022
Results First Posted: March 13, 2023
Last Update Posted: March 13, 2023