Trial Outcomes & Findings for Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis (NCT NCT02447302)
NCT ID: NCT02447302
Last Updated: 2021-04-05
Results Overview
The adapted MCS was used to measure disease activity of ulcerative colitis. It consisted of 3 subscores (stool frequency, rectal bleeding, and findings of endoscopy), each of which was rated on a scale from 0 to 3, indicating normal to severe. The adapted MCS was calculated as the sum of the 3 subscores, and the overall score values ranged from 0 to 9, with a higher score indicating more severe disease. Multiple imputation method was used to handle missing data.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
156 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2021-04-05
Participant Flow
The study included a screening period (up to 28 days), a double-blind induction treatment period (12 weeks), and a possible follow-up visit (2 weeks after the last study visit). The target population consisted of male or female participants aged between 18 and 80 years (inclusive), with moderately to severely active Ulcerative Colitis.
During the screening period (Days -28 to -1), participants were evaluated for study entry based on the inclusion and exclusion criteria. Screening procedures to evaluate participant eligibility for the study were to be conducted within 28 days prior to study drug administration on Day 1.
Participant milestones
| Measure |
Etrasimod 1 mg
Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
Etrasimod 2 mg
Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
Placebo
Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
|---|---|---|---|
|
Overall Study
STARTED
|
52
|
50
|
54
|
|
Overall Study
COMPLETED
|
47
|
46
|
48
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
6
|
Reasons for withdrawal
| Measure |
Etrasimod 1 mg
Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
Etrasimod 2 mg
Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
Placebo
Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
4
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
5
|
|
Overall Study
Sponsor Decision
|
0
|
0
|
1
|
Baseline Characteristics
The analysis was performed using the intent-to-treat (ITT) population that consisted of all randomized participants who received at least 1 dose of study drug. One subject had missing data at baseline.
Baseline characteristics by cohort
| Measure |
Etrasimod 1 mg
n=52 Participants
Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
Etrasimod 2 mg
n=50 Participants
Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
Placebo
n=54 Participants
Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.0 years
n=52 Participants
|
38.5 years
n=50 Participants
|
46.0 years
n=54 Participants
|
42 years
n=156 Participants
|
|
Age, Customized
Adults (18-64 years)
|
52 Subjects
n=52 Participants
|
49 Subjects
n=50 Participants
|
49 Subjects
n=54 Participants
|
150 Subjects
n=156 Participants
|
|
Age, Customized
From 65-80 years
|
0 Subjects
n=52 Participants
|
1 Subjects
n=50 Participants
|
5 Subjects
n=54 Participants
|
6 Subjects
n=156 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=52 Participants
|
23 Participants
n=50 Participants
|
22 Participants
n=54 Participants
|
67 Participants
n=156 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=52 Participants
|
27 Participants
n=50 Participants
|
32 Participants
n=54 Participants
|
89 Participants
n=156 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=52 Participants
|
1 Participants
n=50 Participants
|
3 Participants
n=54 Participants
|
7 Participants
n=156 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=52 Participants
|
49 Participants
n=50 Participants
|
51 Participants
n=54 Participants
|
149 Participants
n=156 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=52 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=156 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=52 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=54 Participants
|
1 Participants
n=156 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=52 Participants
|
1 Participants
n=50 Participants
|
2 Participants
n=54 Participants
|
5 Participants
n=156 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=52 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=156 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=52 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=54 Participants
|
1 Participants
n=156 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=52 Participants
|
49 Participants
n=50 Participants
|
51 Participants
n=54 Participants
|
147 Participants
n=156 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=52 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=54 Participants
|
1 Participants
n=156 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=52 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=54 Participants
|
1 Participants
n=156 Participants
|
|
Adapted Mayo Score (MCS)
|
6.5 score on a scale
STANDARD_DEVIATION 1.23 • n=52 Participants • The analysis was performed using the intent-to-treat (ITT) population that consisted of all randomized participants who received at least 1 dose of study drug. One subject had missing data at baseline.
|
6.6 score on a scale
STANDARD_DEVIATION 1.17 • n=50 Participants • The analysis was performed using the intent-to-treat (ITT) population that consisted of all randomized participants who received at least 1 dose of study drug. One subject had missing data at baseline.
|
6.5 score on a scale
STANDARD_DEVIATION 1.51 • n=53 Participants • The analysis was performed using the intent-to-treat (ITT) population that consisted of all randomized participants who received at least 1 dose of study drug. One subject had missing data at baseline.
|
6.5 score on a scale
STANDARD_DEVIATION 1.31 • n=155 Participants • The analysis was performed using the intent-to-treat (ITT) population that consisted of all randomized participants who received at least 1 dose of study drug. One subject had missing data at baseline.
|
|
The 2-component MCS
|
4.2 score on a scale
STANDARD_DEVIATION 0.75 • n=52 Participants • The analysis was performed using the ITT population that consisted of all randomized participants who received at least 1 dose of study drug. One subject had missing data at baseline.
|
4.2 score on a scale
STANDARD_DEVIATION 0.75 • n=50 Participants • The analysis was performed using the ITT population that consisted of all randomized participants who received at least 1 dose of study drug. One subject had missing data at baseline.
|
4.2 score on a scale
STANDARD_DEVIATION 0.91 • n=53 Participants • The analysis was performed using the ITT population that consisted of all randomized participants who received at least 1 dose of study drug. One subject had missing data at baseline.
|
4.2 score on a scale
STANDARD_DEVIATION 0.80 • n=155 Participants • The analysis was performed using the ITT population that consisted of all randomized participants who received at least 1 dose of study drug. One subject had missing data at baseline.
|
|
Total Mayo Score (TMS)
|
8.8 score on a scale
STANDARD_DEVIATION 1.43 • n=52 Participants • The analysis was performed using the ITT population that consisted of all randomized participants who received at least 1 dose of study drug. One subject had missing data at baseline.
|
8.9 score on a scale
STANDARD_DEVIATION 1.47 • n=50 Participants • The analysis was performed using the ITT population that consisted of all randomized participants who received at least 1 dose of study drug. One subject had missing data at baseline.
|
8.7 score on a scale
STANDARD_DEVIATION 1.72 • n=53 Participants • The analysis was performed using the ITT population that consisted of all randomized participants who received at least 1 dose of study drug. One subject had missing data at baseline.
|
8.8 score on a scale
STANDARD_DEVIATION 1.54 • n=155 Participants • The analysis was performed using the ITT population that consisted of all randomized participants who received at least 1 dose of study drug. One subject had missing data at baseline.
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: The analysis was performed using the intent-to-treat (ITT) population that consisted of all randomized participants who received at least 1 dose of study drug.
The adapted MCS was used to measure disease activity of ulcerative colitis. It consisted of 3 subscores (stool frequency, rectal bleeding, and findings of endoscopy), each of which was rated on a scale from 0 to 3, indicating normal to severe. The adapted MCS was calculated as the sum of the 3 subscores, and the overall score values ranged from 0 to 9, with a higher score indicating more severe disease. Multiple imputation method was used to handle missing data.
Outcome measures
| Measure |
Etrasimod 1 mg
n=52 Participants
Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
Etrasimod 2 mg
n=50 Participants
Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
Placebo
n=54 Participants
Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
|---|---|---|---|
|
Change From Baseline in Adapted Mayo Score (MCS) at Week 12
|
-1.94 score on a scale
Interval -2.45 to -1.42
|
-2.49 score on a scale
Interval -3.01 to -1.98
|
-1.50 score on a scale
Interval -2.0 to -1.01
|
SECONDARY outcome
Timeframe: Week 12Population: The analysis was performed using the ITT population that consisted of all randomized participants who received at least 1 dose of study drug.
For determination of the endoscopic subscore of the MCS, a flexible proctosigmoidoscopy, performed with a videoendoscope following a cleansing prep (oral or rectal cathartic) was performed at screening (within 10 days prior to administration of the first dose of study drug) and the Week 12 visit. This efficacy procedure assessed endoscopic mucosal appearance. The results were rated on a scale from 0 to 3, indicating normal to severe. Endoscopic improvement was defined as Mayo endoscopic subscore (using findings of flexible proctosigmoidoscopy) of ≤1 point. Multiple imputation method was used to handle missing data.
Outcome measures
| Measure |
Etrasimod 1 mg
n=52 Participants
Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
Etrasimod 2 mg
n=50 Participants
Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
Placebo
n=54 Participants
Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Endoscopic Improvement at Week 12
|
22.5 percentage of participants
|
41.8 percentage of participants
|
17.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The analysis was performed using the ITT population that consisted of all randomized participants who received at least 1 dose of study drug.
The 2-component MCS was used to measure disease activity of ulcerative colitis. It consisted of 2 subscores (rectal bleeding and findings on endoscopy), each of which was rated on a scale from 0 to 3, indicating normal to severe. The 2-component MCS was calculated as the sum of the 2 subscores, and the overall score value ranged from 0 to 6, with a higher score indicating more severe disease. Multiple imputation method was used to handle missing data.
Outcome measures
| Measure |
Etrasimod 1 mg
n=52 Participants
Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
Etrasimod 2 mg
n=50 Participants
Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
Placebo
n=54 Participants
Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
|---|---|---|---|
|
Change From Baseline in 2-component MCS at Week 12
|
-1.30 score on a scale
Interval -1.66 to -0.95
|
-1.75 score on a scale
Interval -2.11 to -1.4
|
-0.92 score on a scale
Interval -1.26 to -0.57
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The analysis was performed using the ITT population that consisted of all randomized participants who received at least 1 dose of study drug.
The TMS was used to measure disease activity of ulcerative colitis. It consisted of 4 subscores \[stool frequency, rectal bleeding, findings of endoscopy (flexible proctosigmoidoscopy), and Physician's Global Assessment (PGA) score\], each of which was rated on a scale from 0 to 3, indicating normal to severe. The TMS was calculated as the sum of the 4 subscores, and the overall score values ranged from 0 to 12, with a higher score indicating more severe disease. Multiple imputation method was used to handle missing data.
Outcome measures
| Measure |
Etrasimod 1 mg
n=52 Participants
Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
Etrasimod 2 mg
n=50 Participants
Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
Placebo
n=54 Participants
Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
|---|---|---|---|
|
Change From Baseline in Total Mayo Score (TMS) at Week 12
|
-2.69 score on a scale
Interval -3.36 to -2.02
|
-3.35 score on a scale
Interval -4.03 to -2.68
|
-2.08 score on a scale
Interval -2.73 to -1.44
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12Population: The analysis was performed using the ITT population that consisted of all randomized participants who received at least 1 dose of study drug.
The trichotomous composite score of clinical remission and clinical response at Week 12 is an ordinal categorical endpoint with 3 categories (score ranging 0 to 2: score 2 for achieving both clinical remission and clinical response; 1 for only achieving clinical response, and 0 for achieving neither). Multiple imputation method was used to handle missing data.
Outcome measures
| Measure |
Etrasimod 1 mg
n=52 Participants
Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
Etrasimod 2 mg
n=50 Participants
Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
Placebo
n=54 Participants
Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
|---|---|---|---|
|
Trichotomous Composite Score of Clinical Remission and Clinical Response at Week 12
|
0.60 score on a scale
Standard Error 0.11
|
0.84 score on a scale
Standard Error 0.13
|
0.41 score on a scale
Standard Error 0.09
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12Population: The analysis was performed using the ITT population that consisted of all randomized participants who received at least 1 dose of study drug.
A participant was considered to have achieved clinical remission if he/she had: 1) an endoscopy score using flexible proctosigmoidoscopy of 0 or 1 (excluding friability), 2) a rectal bleeding score of 0 or 1, and 3) a stool frequency score of 0 or 1 with a decrease of ≥1 point from baseline. Multiple imputation method was used to handle missing data.
Outcome measures
| Measure |
Etrasimod 1 mg
n=52 Participants
Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
Etrasimod 2 mg
n=50 Participants
Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
Placebo
n=54 Participants
Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Clinical Remission at Week 12
|
16.0 percentage of participants
|
33.0 percentage of participants
|
8.1 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12Population: The analysis was performed using the ITT population that consisted of all randomized participants who received at least 1 dose of study drug.
A participant was considered to have achieved clinical response if he/she met the criteria of clinical remission defined above, or met criteria of clinical response. Clinical response was defined as a decrease in the adapted MCS of ≥ 2 points and a decrease of ≥ 30% with either a decrease of rectal bleeding of ≥ 1 or rectal bleeding score of 0 or 1.
Outcome measures
| Measure |
Etrasimod 1 mg
n=52 Participants
Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
Etrasimod 2 mg
n=50 Participants
Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
Placebo
n=54 Participants
Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Clinical Response at Week 12
|
43.7 percentage of participants
|
50.6 percentage of participants
|
32.5 percentage of participants
|
Adverse Events
Etrasimod 1 mg
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Etrasimod 2 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Etrasimod 1 mg
n=52 participants at risk
Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
Etrasimod 2 mg
n=50 participants at risk
Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
Placebo
n=54 participants at risk
Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/52 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
0.00%
0/50 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
1.9%
1/54 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
3.8%
2/52 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
0.00%
0/50 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
5.6%
3/54 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/52 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
0.00%
0/50 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
1.9%
1/54 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/52 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
0.00%
0/50 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
1.9%
1/54 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
|
Infections and infestations
Anal abscess
|
1.9%
1/52 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
0.00%
0/50 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
0.00%
0/54 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/52 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
0.00%
0/50 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
1.9%
1/54 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
Other adverse events
| Measure |
Etrasimod 1 mg
n=52 participants at risk
Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
Etrasimod 2 mg
n=50 participants at risk
Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
Placebo
n=54 participants at risk
Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.8%
2/52 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
6.0%
3/50 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
3.7%
2/54 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
2/52 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
2.0%
1/50 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
7.4%
4/54 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
5.8%
3/52 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
4.0%
2/50 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
1.9%
1/54 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/52 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
6.0%
3/50 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
1.9%
1/54 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
4/52 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
4.0%
2/50 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
3.7%
2/54 • Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.
Treatment-Emergent Adverse Event (TEAE) were collected during the study.
|
Additional Information
Arena CT.gov Administrator
Arena Pharmaceuticals, Inc.
Phone: +1 855-218-9153
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER