Trial Outcomes & Findings for Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis (NCT NCT02536404)

Last Updated: 2021-11-26

Results Overview

A TEAE was defined as any adverse event (AE) that occurred after the first dose of study drug in the APD334-005 (NCT02536404) study, including any AE that started in Study APD334-003 (NCT02447302) and was ongoing, worsened, or ended in Study APD334-005. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

118 participants

Primary outcome timeframe

Up to Week 48 (up to 30 days following discontinuation of the study drug)

Results posted on

2021-11-26

Participant Flow

Participant milestones

Participant milestones
Measure	Etrasimod 2 mg Participants received etrasimod 2 milligrams (mg) tablet by mouth, once daily for 34 weeks in fasted state.	Placebo Participants received matching placebo tablet by mouth, once daily for 34 weeks in fasted state.
Overall Study STARTED	112	6
Overall Study COMPLETED	92	5
Overall Study NOT COMPLETED	20	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Etrasimod 2 mg Participants received etrasimod 2 milligrams (mg) tablet by mouth, once daily for 34 weeks in fasted state.	Placebo Participants received matching placebo tablet by mouth, once daily for 34 weeks in fasted state.
Overall Study Adverse Event	5	0
Overall Study Withdrawal by Subject	4	1
Overall Study Physician Decision	10	0
Overall Study Sponsor decision	1	0

Baseline Characteristics

Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Etrasimod 2 mg n=112 Participants Participants received etrasimod 2 milligrams (mg) tablet by mouth, once daily for 34 weeks in fasted state.	Placebo n=6 Participants Participants received matching placebo tablet by mouth, once daily for 34 weeks in fasted state.	Total n=118 Participants Total of all reporting groups
Age, Continuous	43.7 Years STANDARD_DEVIATION 13.25 • n=5 Participants	50.2 Years STANDARD_DEVIATION 13.93 • n=7 Participants	44.0 Years STANDARD_DEVIATION 13.30 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	3 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	68 Participants n=5 Participants	3 Participants n=7 Participants	71 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	108 Participants n=5 Participants	6 Participants n=7 Participants	114 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	104 Participants n=5 Participants	6 Participants n=7 Participants	110 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Week 48 (up to 30 days following discontinuation of the study drug)

Population: Safety Population: All randomized participants who received study medication in the extension study APD334-005

Outcome measures

Outcome measures
Measure	Etrasimod 2 mg n=112 Participants Participants received etrasimod 2 mg tablet by mouth, once daily for 34 weeks in fasted state.	Placebo n=6 Participants Participants received matching placebo tablet by mouth, once daily for 34 weeks in fasted state.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs) TEAEs	67 Participants	5 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs) Treatment-emergent SAEs	7 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 46 (extension study APD334-005)

Population: Completers Population Evaluable Cohort: All participants who received at least 1 dose of etrasimod or placebo and completed the extension study APD334-005

A participant was considered to have achieved clinical response if he/she met the criteria of clinical remission or met criteria of clinical response. Clinical remission was defined as individual subscores of the 3-component Mayo Clinic score as follows: (1) an endoscopy score (using flexible proctosigmoidoscopy) of 0 or 1, (2) a rectal bleeding score of 0, and (3) a stool frequency score of 0 or 1 with a decrease of ≥ 1 point at Week 46 compared to APD334-003 baseline. Clinical response was defined as a decrease in 3-component Mayo Clinic score of ≥ 2 points and at least 30% with either a decrease of rectal bleeding of ≥ 1 or rectal bleeding score of 0 or 1 at Week 46 compared with baseline of study APD334-003. A score of 0 = normal and 1 = mild disease.

Outcome measures

Outcome measures
Measure	Etrasimod 2 mg n=84 Participants Participants received etrasimod 2 mg tablet by mouth, once daily for 34 weeks in fasted state.	Placebo n=4 Participants Participants received matching placebo tablet by mouth, once daily for 34 weeks in fasted state.
Proportion of Participants Who Achieved Clinical Response	78.6 Percentage of participants Interval 69.9 to 85.7	75.0 Percentage of participants Interval 24.9 to 98.7

SECONDARY outcome

Timeframe: Week 12 (core study APD334-003) and Week 46 (extension study APD334-005)

Population: Completers Population Evaluable Cohort

Outcome measures

Outcome measures
Measure	Etrasimod 2 mg n=84 Participants Participants received etrasimod 2 mg tablet by mouth, once daily for 34 weeks in fasted state.	Placebo n=4 Participants Participants received matching placebo tablet by mouth, once daily for 34 weeks in fasted state.
Proportion of Participants Who Achieved Clinical Response at Week 12 in APD334-003 and Maintained Clinical Response at Week 46 in APD334-005	39.3 Percentage of participants Interval 30.3 to 48.8	50.0 Percentage of participants Interval 9.8 to 90.2

SECONDARY outcome

Timeframe: Week 46 (extension study APD334-005)

Population: Completers Population Evaluable Cohort

A participant was considered to have achieved clinical remission if he/she had: (1) an endoscopy score (using flexible proctosigmoidoscopy) of 0 or 1, (2) a rectal bleeding score of 0, and (3) a stool frequency score of 0 or 1 with a decrease of ≥ 1 point at Week 46 compared with baseline of study APD334-003. A score of 0 = normal and 1 = mild disease.

Outcome measures

Outcome measures
Measure	Etrasimod 2 mg n=84 Participants Participants received etrasimod 2 mg tablet by mouth, once daily for 34 weeks in fasted state.	Placebo n=4 Participants Participants received matching placebo tablet by mouth, once daily for 34 weeks in fasted state.
Proportion of Participants Who Achieved Clinical Remission	39.3 Percentage of participants Interval 30.3 to 48.8	25.0 Percentage of participants Interval 1.3 to 75.1

SECONDARY outcome

Timeframe: Week 12 (core study APD334-003) and Week 46 (extension study APD334-005)

Population: Completers Population Evaluable Cohort

Outcome measures

Outcome measures
Measure	Etrasimod 2 mg n=84 Participants Participants received etrasimod 2 mg tablet by mouth, once daily for 34 weeks in fasted state.	Placebo n=4 Participants Participants received matching placebo tablet by mouth, once daily for 34 weeks in fasted state.
Proportion of Participants Who Achieved Clinical Remission at Week 12 in APD334-003 and Also Maintained Clinical Remission at Week 46 in APD334-005	14.3 Percentage of participants Interval 8.5 to 22.1	0 Percentage of participants Interval 0.0 to 52.7

Adverse Events

Etrasimod 2 mg

Serious events: 7 serious events

Other events: 66 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Etrasimod 2 mg n=112 participants at risk Participants received etrasimod 2 milligrams (mg) tablet by mouth, once daily for 34 weeks in fasted state.	Placebo n=6 participants at risk Participants received matching placebo tablet by mouth, once daily for 34 weeks in fasted state.
Blood and lymphatic system disorders Iron deficiency anaemia	1.8% 2/112 • Up to Week 48 (up to 30 days following discontinuation of the study drug) A TEAE was defined as any adverse event (AE) that occurred after the first dose of study drug in the APD334-005 (NCT02536404) study, including any AE that started in Study APD334-003 (NCT02447302) and was ongoing, worsened, or ended in Study APD334-005. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.	0.00% 0/6 • Up to Week 48 (up to 30 days following discontinuation of the study drug) A TEAE was defined as any adverse event (AE) that occurred after the first dose of study drug in the APD334-005 (NCT02536404) study, including any AE that started in Study APD334-003 (NCT02447302) and was ongoing, worsened, or ended in Study APD334-005. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.
Cardiac disorders Atrial fibrillation	0.89% 1/112 • Up to Week 48 (up to 30 days following discontinuation of the study drug) A TEAE was defined as any adverse event (AE) that occurred after the first dose of study drug in the APD334-005 (NCT02536404) study, including any AE that started in Study APD334-003 (NCT02447302) and was ongoing, worsened, or ended in Study APD334-005. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.	0.00% 0/6 • Up to Week 48 (up to 30 days following discontinuation of the study drug) A TEAE was defined as any adverse event (AE) that occurred after the first dose of study drug in the APD334-005 (NCT02536404) study, including any AE that started in Study APD334-003 (NCT02447302) and was ongoing, worsened, or ended in Study APD334-005. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.
Gastrointestinal disorders Colitis ulcerative	2.7% 3/112 • Up to Week 48 (up to 30 days following discontinuation of the study drug) A TEAE was defined as any adverse event (AE) that occurred after the first dose of study drug in the APD334-005 (NCT02536404) study, including any AE that started in Study APD334-003 (NCT02447302) and was ongoing, worsened, or ended in Study APD334-005. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.	0.00% 0/6 • Up to Week 48 (up to 30 days following discontinuation of the study drug) A TEAE was defined as any adverse event (AE) that occurred after the first dose of study drug in the APD334-005 (NCT02536404) study, including any AE that started in Study APD334-003 (NCT02447302) and was ongoing, worsened, or ended in Study APD334-005. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.
Gastrointestinal disorders Large intestine perforation	0.89% 1/112 • Up to Week 48 (up to 30 days following discontinuation of the study drug) A TEAE was defined as any adverse event (AE) that occurred after the first dose of study drug in the APD334-005 (NCT02536404) study, including any AE that started in Study APD334-003 (NCT02447302) and was ongoing, worsened, or ended in Study APD334-005. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.	0.00% 0/6 • Up to Week 48 (up to 30 days following discontinuation of the study drug) A TEAE was defined as any adverse event (AE) that occurred after the first dose of study drug in the APD334-005 (NCT02536404) study, including any AE that started in Study APD334-003 (NCT02447302) and was ongoing, worsened, or ended in Study APD334-005. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.
Gastrointestinal disorders Pancreatitis	0.89% 1/112 • Up to Week 48 (up to 30 days following discontinuation of the study drug) A TEAE was defined as any adverse event (AE) that occurred after the first dose of study drug in the APD334-005 (NCT02536404) study, including any AE that started in Study APD334-003 (NCT02447302) and was ongoing, worsened, or ended in Study APD334-005. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.	0.00% 0/6 • Up to Week 48 (up to 30 days following discontinuation of the study drug) A TEAE was defined as any adverse event (AE) that occurred after the first dose of study drug in the APD334-005 (NCT02536404) study, including any AE that started in Study APD334-003 (NCT02447302) and was ongoing, worsened, or ended in Study APD334-005. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.
Gastrointestinal disorders Proctitis ulcerative	0.89% 1/112 • Up to Week 48 (up to 30 days following discontinuation of the study drug) A TEAE was defined as any adverse event (AE) that occurred after the first dose of study drug in the APD334-005 (NCT02536404) study, including any AE that started in Study APD334-003 (NCT02447302) and was ongoing, worsened, or ended in Study APD334-005. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.	0.00% 0/6 • Up to Week 48 (up to 30 days following discontinuation of the study drug) A TEAE was defined as any adverse event (AE) that occurred after the first dose of study drug in the APD334-005 (NCT02536404) study, including any AE that started in Study APD334-003 (NCT02447302) and was ongoing, worsened, or ended in Study APD334-005. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.
Infections and infestations Gastroenteritis	0.89% 1/112 • Up to Week 48 (up to 30 days following discontinuation of the study drug) A TEAE was defined as any adverse event (AE) that occurred after the first dose of study drug in the APD334-005 (NCT02536404) study, including any AE that started in Study APD334-003 (NCT02447302) and was ongoing, worsened, or ended in Study APD334-005. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.	0.00% 0/6 • Up to Week 48 (up to 30 days following discontinuation of the study drug) A TEAE was defined as any adverse event (AE) that occurred after the first dose of study drug in the APD334-005 (NCT02536404) study, including any AE that started in Study APD334-003 (NCT02447302) and was ongoing, worsened, or ended in Study APD334-005. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.
Nervous system disorders Fine motor skill dysfunction	0.89% 1/112 • Up to Week 48 (up to 30 days following discontinuation of the study drug) A TEAE was defined as any adverse event (AE) that occurred after the first dose of study drug in the APD334-005 (NCT02536404) study, including any AE that started in Study APD334-003 (NCT02447302) and was ongoing, worsened, or ended in Study APD334-005. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.	0.00% 0/6 • Up to Week 48 (up to 30 days following discontinuation of the study drug) A TEAE was defined as any adverse event (AE) that occurred after the first dose of study drug in the APD334-005 (NCT02536404) study, including any AE that started in Study APD334-003 (NCT02447302) and was ongoing, worsened, or ended in Study APD334-005. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.
Nervous system disorders Transient ischaemic attack	0.89% 1/112 • Up to Week 48 (up to 30 days following discontinuation of the study drug) A TEAE was defined as any adverse event (AE) that occurred after the first dose of study drug in the APD334-005 (NCT02536404) study, including any AE that started in Study APD334-003 (NCT02447302) and was ongoing, worsened, or ended in Study APD334-005. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.	0.00% 0/6 • Up to Week 48 (up to 30 days following discontinuation of the study drug) A TEAE was defined as any adverse event (AE) that occurred after the first dose of study drug in the APD334-005 (NCT02536404) study, including any AE that started in Study APD334-003 (NCT02447302) and was ongoing, worsened, or ended in Study APD334-005. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.
Renal and urinary disorders Cystitis haemorrhagic	0.89% 1/112 • Up to Week 48 (up to 30 days following discontinuation of the study drug) A TEAE was defined as any adverse event (AE) that occurred after the first dose of study drug in the APD334-005 (NCT02536404) study, including any AE that started in Study APD334-003 (NCT02447302) and was ongoing, worsened, or ended in Study APD334-005. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.	0.00% 0/6 • Up to Week 48 (up to 30 days following discontinuation of the study drug) A TEAE was defined as any adverse event (AE) that occurred after the first dose of study drug in the APD334-005 (NCT02536404) study, including any AE that started in Study APD334-003 (NCT02447302) and was ongoing, worsened, or ended in Study APD334-005. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.

Other adverse events

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place