Trial Outcomes & Findings for A Study to Learn About the Study Medicine Etrasimod in Adults With Moderate to Severe Atopic Dermatitis (AD) Who Have Already Tried Treatments Taken by Mouth or by Injection (NCT NCT05732454)
NCT ID: NCT05732454
Last Updated: 2025-05-08
Results Overview
IGA measured AD severity, based on a 5-point scale (0-4); 0= AD is clear, 1= AD is almost clear, 2= mild AD, 3= moderate AD and 4= severe AD. IGA response was defined as participants achieving IGA 0 (clear) or 1 (almost clear) and a reduction of \>=2 points from baseline.
TERMINATED
PHASE2/PHASE3
58 participants
DB Period: Week 16
2025-05-08
Participant Flow
The study had 2 parts: Part 1 and Part 2. Part 2 was never initiated; hence no results are reported for it. All results are pertaining to Part 1 in the record. Part 1 of the study had 16-week double-blind (DB) treatment period and then 52-week part 1 open label extension (OLE) treatment period.
A total of 58 participants with moderate-to-severe atopic dermatitis (AD) were enrolled in Part 1- DB period and out of them 51 continued into the Part 1- OLE period.
Participant milestones
| Measure |
DB Etrasimod 2 mg Then OLE Etrasimod 2 mg
Participants were randomized to receive etrasimod 2 milligram (mg) orally once daily for 16 weeks in DB period of Part 1. Eligible participants per investigator's judgement then continued to receive etrasimod 2 mg orally once daily for maximum of another 52 weeks in OLE period of Part 1.
|
DB Placebo Then OLE Etrasimod 2 mg
Participants were randomized to receive placebo matched to etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1. Eligible participants per investigator's judgement then received etrasimod 2 mg orally once daily for maximum of another 52 weeks in OLE period of Part 1.
|
|---|---|---|
|
Part 1: DB Period
STARTED
|
30
|
28
|
|
Part 1: DB Period
COMPLETED
|
27
|
25
|
|
Part 1: DB Period
NOT COMPLETED
|
3
|
3
|
|
Part 1: OLE Period
STARTED
|
27
|
24
|
|
Part 1: OLE Period
COMPLETED
|
0
|
0
|
|
Part 1: OLE Period
NOT COMPLETED
|
27
|
24
|
Reasons for withdrawal
| Measure |
DB Etrasimod 2 mg Then OLE Etrasimod 2 mg
Participants were randomized to receive etrasimod 2 milligram (mg) orally once daily for 16 weeks in DB period of Part 1. Eligible participants per investigator's judgement then continued to receive etrasimod 2 mg orally once daily for maximum of another 52 weeks in OLE period of Part 1.
|
DB Placebo Then OLE Etrasimod 2 mg
Participants were randomized to receive placebo matched to etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1. Eligible participants per investigator's judgement then received etrasimod 2 mg orally once daily for maximum of another 52 weeks in OLE period of Part 1.
|
|---|---|---|
|
Part 1: DB Period
Withdrawal by Subject
|
1
|
2
|
|
Part 1: DB Period
Adverse Event
|
1
|
0
|
|
Part 1: DB Period
Lost to Follow-up
|
1
|
0
|
|
Part 1: DB Period
Protocol Violation
|
0
|
1
|
|
Part 1: OLE Period
Study Terminated by Sponsor
|
25
|
19
|
|
Part 1: OLE Period
Withdrawal by Subject
|
2
|
3
|
|
Part 1: OLE Period
Adverse Event
|
0
|
1
|
|
Part 1: OLE Period
Lack of Efficacy
|
0
|
1
|
Baseline Characteristics
A Study to Learn About the Study Medicine Etrasimod in Adults With Moderate to Severe Atopic Dermatitis (AD) Who Have Already Tried Treatments Taken by Mouth or by Injection
Baseline characteristics by cohort
| Measure |
DB Etrasimod 2 mg Then OLE Etrasimod 2 mg
n=30 Participants
Participants were randomized to receive etrasimod 2 milligram (mg) orally once daily for 16 weeks in DB period of Part 1. Eligible participants per investigator's judgement then continued to receive etrasimod 2 mg orally once daily for maximum of another 52 weeks in OLE period of Part 1.
|
DB Placebo Then OLE Etrasimod 2 mg
n=28 Participants
Participants were randomized to receive placebo matched to etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1. Eligible participants per investigator's judgement then received etrasimod 2 mg orally once daily for maximum of another 52 weeks in OLE period of Part 1.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.0 Years
STANDARD_DEVIATION 14.78 • n=5 Participants
|
43.4 Years
STANDARD_DEVIATION 18.18 • n=7 Participants
|
41.6 Years
STANDARD_DEVIATION 16.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 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
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: DB Period: Week 16Population: FAS included all participants who were randomized to the study irrespective of whether they received any dose of study intervention (i.e., etrasimod or placebo). Participants were analyzed in the treatment groups as they were randomized. Number of participants in FAS with baseline IGA\>=2 was included in this analysis.
IGA measured AD severity, based on a 5-point scale (0-4); 0= AD is clear, 1= AD is almost clear, 2= mild AD, 3= moderate AD and 4= severe AD. IGA response was defined as participants achieving IGA 0 (clear) or 1 (almost clear) and a reduction of \>=2 points from baseline.
Outcome measures
| Measure |
DB Period: Etrasimod 2 mg
n=30 Participants
Participants who received etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1.
|
DB Period: Placebo
n=28 Participants
Participants who received placebo matched to etrasimod orally once daily for 16 weeks in DB period of Part 1.
|
|---|---|---|
|
Part 1, DB Period: Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response at Week 16
|
3.3 Percentage of Participants
Interval 3.28 to
|
7.1 Percentage of Participants
Interval 4.87 to
|
PRIMARY outcome
Timeframe: DB Period: From first dose of study drug up to 16 Weeks of treatmentPopulation: DB period: Safety analysis set included of all participants who were randomized and received at least 1 dose of study drug in DB period.
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
DB Period: Etrasimod 2 mg
n=30 Participants
Participants who received etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1.
|
DB Period: Placebo
n=28 Participants
Participants who received placebo matched to etrasimod orally once daily for 16 weeks in DB period of Part 1.
|
|---|---|---|
|
Part 1, DB Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (All Causality)
|
16 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: DB Period: From first dose of study drug up to 16 Weeks of treatmentPopulation: DB period: Safety analysis set included of all participants who were randomized and received at least 1 dose of study drug in DB period.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
DB Period: Etrasimod 2 mg
n=30 Participants
Participants who received etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1.
|
DB Period: Placebo
n=28 Participants
Participants who received placebo matched to etrasimod orally once daily for 16 weeks in DB period of Part 1.
|
|---|---|---|
|
Part 1, DB Period: Number of Participants With TEAEs (All Causality) Leading to Study Treatment Discontinuation
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: DB Period: From first dose of study drug up to 16 Weeks of treatmentPopulation: DB period: Safety analysis set included of all participants who were randomized and received at least 1 dose of study drug in DB period.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of death); new or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other medical events judged by investigator.
Outcome measures
| Measure |
DB Period: Etrasimod 2 mg
n=30 Participants
Participants who received etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1.
|
DB Period: Placebo
n=28 Participants
Participants who received placebo matched to etrasimod orally once daily for 16 weeks in DB period of Part 1.
|
|---|---|---|
|
Part 1, DB Period: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) (All Causality)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: DB Period: From first dose of study drug up to 16 Weeks of treatmentPopulation: DB period: Safety analysis set included of all participants who were randomized and received at least 1 dose of study drug in DB period.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state. AESIs included here were cardiovascular events (i.e., bradycardia, Atrioventricular (AV) conduction delay, and hypertension); macular edema, pulmonary events (airflow obstruction or decreased gas exchange); infections (severe infections, opportunistic infections \[including progressive multifocal leukoencephalopathy (PML)\], Herpes simplex and Herpes zoster); liver injury (liver transaminase elevation and bilirubin elevation); posterior reversible encephalopathy syndrome (PRES) and malignancies.
Outcome measures
| Measure |
DB Period: Etrasimod 2 mg
n=30 Participants
Participants who received etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1.
|
DB Period: Placebo
n=28 Participants
Participants who received placebo matched to etrasimod orally once daily for 16 weeks in DB period of Part 1.
|
|---|---|---|
|
Part 1, DB Period: Number of Participants With Treatment Emergent AEs of Special Interest (AESIs) (All Causality)
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: DB Period: From first dose of study drug up to 16 Weeks of treatmentPopulation: DB period: Safety analysis set included of all participants who were randomized and received at least 1 dose of study drug in DB period. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Laboratory assessments included hematology, clinical chemistry, urinalysis, other parameters and reflex tests. Number of participants with abnormalities in any of laboratory parameters is reported.
Outcome measures
| Measure |
DB Period: Etrasimod 2 mg
n=29 Participants
Participants who received etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1.
|
DB Period: Placebo
n=27 Participants
Participants who received placebo matched to etrasimod orally once daily for 16 weeks in DB period of Part 1.
|
|---|---|---|
|
Part 1, DB Period: Number of Participants With Laboratory Test Abnormalities
|
22 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: DB Period: Pre-dose and 4 hours (hrs) post-dose on Day 1/Week 0; Pre-dose and 4 hrs post-dose on Day 113/Week 16Population: DB period: Safety analysis set included of all participants who were randomized and received at least 1 dose of study drug in DB period. Here, "Number Analyzed"= number of participants evaluable for specified timepoints.
Standard 12-lead ECGs utilizing limb leads were used to measure PR interval, QT interval, QTc corrected using Fridericia's formula (QTcF), and QRS complex. Number of participants with non-zero ECG abnormalities and AV blocks are reported in this outcome measure.
Outcome measures
| Measure |
DB Period: Etrasimod 2 mg
n=30 Participants
Participants who received etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1.
|
DB Period: Placebo
n=28 Participants
Participants who received placebo matched to etrasimod orally once daily for 16 weeks in DB period of Part 1.
|
|---|---|---|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV Blocks
Pre-dose/Day 1: AV conduction: First-degree AV Block
|
1 Participants
|
0 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV Blocks
4 hrs post-dose/Day 1: QTCF (msec), single beat:>= 450 (male) or >= 470 (female)
|
1 Participants
|
0 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV Blocks
4 hrs post-dose/Day 1: Change From Baseline (CFB) in QT: >30 msec increase
|
9 Participants
|
0 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV Blocks
4 hrs post-dose/Day 1: AV conduction: First degree AV Block
|
3 Participants
|
0 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV Blocks
Pre-dose/Week 16: CFB in QT: >30 msec increase
|
1 Participants
|
0 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV Blocks
Pre-dose/Week 16: CFB in QT: >60 msec increase
|
1 Participants
|
0 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV Blocks
Pre-dose/Week 16: CFB in QTcF: >30 msec increase
|
2 Participants
|
0 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV Blocks
4 hrs post-dose/Week 16: CFB in QTcF: >30 msec increase
|
2 Participants
|
0 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV Blocks
4 hrs post-dose/Week 16: CFB in QT: >30 msec increase
|
2 Participants
|
0 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV Blocks
4 hrs post-dose/Week 16: AV conduction: First degree AV Block
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: DB Period: Pre-dose and 1, 2, 3, 4 hours (hrs) post-dose on Day 1/Week 0; Day 29/Week 4; Day 57/Week 8; Day 85/Week 12; Pre-dose and 1, 2, 3, 4, 5 and 6 hrs post-dose on Day 113/Week 16Population: DB period: Safety analysis set included of all participants who were randomized and received at least 1 dose of study drug in DB period. Here, "Number Analyzed"= number of participants evaluable for specified timepoints.
Vital signs evaluation included systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse rate. Number of participants with non-zero vital signs abnormalities are reported in this outcome measure.
Outcome measures
| Measure |
DB Period: Etrasimod 2 mg
n=30 Participants
Participants who received etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1.
|
DB Period: Placebo
n=28 Participants
Participants who received placebo matched to etrasimod orally once daily for 16 weeks in DB period of Part 1.
|
|---|---|---|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
6 hrs post dose/Week 16:Pulse rate:<50 bpm
|
0 Participants
|
1 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
Pre-dose/Day 1: DBP >90 mmHg
|
0 Participants
|
1 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
Pre-dose/Day 1: Pulse rate: <60 bpm
|
1 Participants
|
3 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
Pre-dose/Day 1: Pulse rate >100 bpm
|
1 Participants
|
0 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
1 hr post-dose/Day 1: SBP: Change >=30 mmHg decrease
|
0 Participants
|
1 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
1 hr post-dose/Day 1: DBP >90 mmHg
|
2 Participants
|
2 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
1 hr post-dose/Day 1: Pulse rate: <50 bpm
|
1 Participants
|
0 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
1 hr post-dose/Day 1: Pulse rate: <60 bpm
|
7 Participants
|
3 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
2 hrs post-dose/Day 1: SBP: >150 mmHg
|
0 Participants
|
2 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
2 hrs post-dose/Day 1: DBP >90 mmHg
|
0 Participants
|
1 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
2 hrs post-dose/Day 1: Pulse rate: <60 bpm
|
12 Participants
|
5 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
3 hrs post-dose/Day 1:SBP >150 mmHg
|
0 Participants
|
1 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
3 hrs post-dose/Day 1: SBP: Change>=30 mmHg decrease
|
1 Participants
|
0 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
3 hrs post-dose/Day 1: DBP:>90 mmHg
|
0 Participants
|
1 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
3 hrs post-dose/Day 1: DBP: Change>=20 mmHg decrease
|
2 Participants
|
0 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
3 hrs post-dose/Day 1: Pulse rate: <60 bpm
|
11 Participants
|
6 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
4 hrs post-dose/Day 1: DBP: >90 mmHg
|
1 Participants
|
1 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
4 hrs post-dose/Day 1: Pulse rate: <60 bpm
|
10 Participants
|
5 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
4 hrs post-dose/Day 1: Pulse rate: >100 bpm
|
1 Participants
|
0 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
Week 4: DBP:>90 mmHg
|
2 Participants
|
3 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
Week 4: Pulse rate: <60 bpm
|
2 Participants
|
1 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
Week 4: Pulse rate: >100 bpm
|
1 Participants
|
0 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
Week 8: SBP: >150 mmHg
|
0 Participants
|
1 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
Week 8: DBP:>90 mmHg
|
3 Participants
|
3 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
Week 8: DBP: Change >=20 mmHg decrease
|
0 Participants
|
1 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
Week 8: Pulse rate: <60 bpm
|
3 Participants
|
1 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
Week 12: SBP: >150 mmHg
|
0 Participants
|
1 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
Week 12: DBP:>90 mmHg
|
1 Participants
|
3 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
Week 12: Pulse rate: <60 bpm
|
1 Participants
|
0 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
Week 12: Pulse rate: >100 bpm
|
0 Participants
|
2 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
Pre-dose/Week 16: SBP: >150 mmHg
|
0 Participants
|
1 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
Pre-dose/Week 16: DBP: >90 mmHg
|
2 Participants
|
0 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
Pre-dose/Week 16: Pulse rate: <60 bpm
|
2 Participants
|
2 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
1 hr post dose/Week 16: SBP: >150 mmHg
|
0 Participants
|
1 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
1 hr post-dose/Week 16: SBP: Change >=30 mmHg decrease
|
0 Participants
|
1 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
1 hr post dose/Week 16: DBP: >90 mmHg
|
2 Participants
|
1 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
1 hr post dose/Week 16: Pulse rate: <50 bpm
|
1 Participants
|
1 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
1 hr post dose/Week 16: Pulse rate: <60 bpm
|
3 Participants
|
4 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
2 hrs post dose/Week 16: SBP: >150 mmHg
|
0 Participants
|
1 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
2 hrs post-dose/Week 16: SBP: Change >=30 mmHg decrease
|
0 Participants
|
2 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
2 hrs post dose/Week 16: DBP: >90 mmHg
|
2 Participants
|
2 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
2 hrs post dose/Week 16: Pulse rate: <50 bpm
|
0 Participants
|
1 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
2 hrs post dose/Week 16: Pulse rate: <60 bpm
|
3 Participants
|
10 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
3 hrs post dose/Week 16:DBP: >90 mmHg
|
2 Participants
|
0 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
3 hrs post dose/Week 16: Pulse rate: <50 bpm
|
0 Participants
|
1 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
3 hrs post dose/Week 16: Pulse rate: <60 bpm
|
3 Participants
|
9 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
4 hrs post dose/Week 16: SBP: >150 mmHg
|
0 Participants
|
1 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
4 hrs post dose/Week 16: DBP:>90 mmHg
|
2 Participants
|
0 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
4 hrs post-dose/Week 16: DBP: Change >=20 mmHg decrease
|
0 Participants
|
1 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
4 hrs post dose/Week 16: Pulse rate: <50 bpm
|
0 Participants
|
1 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
4 hrs post dose/Week 16: Pulse rate:<60 bpm
|
1 Participants
|
6 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
5 hrs post dose/Week 16:Pulse rate:<50 bpm
|
0 Participants
|
1 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
5 hrs post dose/Week 16:Pulse rate:<60 bpm
|
0 Participants
|
1 Participants
|
|
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
6 hrs post dose/Week 16: Pulse rate:<60 bpm
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: OLE Period: First dose of study drug in OLE period up to 4 weeks after last dose in OLE period (up to maximum of 56 Weeks)Population: Safety analysis set included all participants who received at least 1 dose of study intervention (i.e., Etrasimod or placebo). Participants were analyzed in the treatment groups as they were randomized.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
DB Period: Etrasimod 2 mg
n=30 Participants
Participants who received etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1.
|
DB Period: Placebo
n=28 Participants
Participants who received placebo matched to etrasimod orally once daily for 16 weeks in DB period of Part 1.
|
|---|---|---|
|
Part 1, OLE Period: Number of Participants With TEAEs (All Causality)
|
9 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: OLE Period: First dose of study drug in OLE period up to 4 weeks after last dose in OLE period (up to maximum of 56 Weeks)Population: Safety analysis set included all participants who received at least 1 dose of study intervention (i.e., Etrasimod or placebo). Participants were analyzed in the treatment groups as they were randomized.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
DB Period: Etrasimod 2 mg
n=30 Participants
Participants who received etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1.
|
DB Period: Placebo
n=28 Participants
Participants who received placebo matched to etrasimod orally once daily for 16 weeks in DB period of Part 1.
|
|---|---|---|
|
Part 1, OLE Period: Number of Participants With Treatment Emergent AEs (All Causality) Leading to Study Treatment Discontinuation
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: OLE Period: First dose of study drug in OLE period up to 4 weeks after last dose in OLE period (up to maximum of 56 Weeks)Population: Safety analysis set included all participants who received at least 1 dose of study intervention (i.e., Etrasimod or placebo). Participants were analyzed in the treatment groups as they were randomized.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of death); new or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other medical events judged by investigator.
Outcome measures
| Measure |
DB Period: Etrasimod 2 mg
n=30 Participants
Participants who received etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1.
|
DB Period: Placebo
n=28 Participants
Participants who received placebo matched to etrasimod orally once daily for 16 weeks in DB period of Part 1.
|
|---|---|---|
|
Part 1, OLE Period: Number of Participants With Treatment Emergent SAEs (All Causality)
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: OLE Period: First dose of study drug in OLE period up to 4 weeks after last dose in OLE period (up to maximum of 56 Weeks)Population: Safety analysis set included all participants who received at least 1 dose of study intervention (i.e., Etrasimod or placebo). Participants were analyzed in the treatment groups as they were randomized.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state. AESIs included here were cardiovascular events (i.e., bradycardia, AV conduction delay, and hypertension); macular edema, pulmonary events (airflow obstruction or decreased gas exchange); infections (severe infections, opportunistic infections \[including PML\], Herpes simplex and Herpes zoster); liver injury (liver transaminase elevation and/or bilirubin elevation); PRES and malignancies.
Outcome measures
| Measure |
DB Period: Etrasimod 2 mg
n=30 Participants
Participants who received etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1.
|
DB Period: Placebo
n=28 Participants
Participants who received placebo matched to etrasimod orally once daily for 16 weeks in DB period of Part 1.
|
|---|---|---|
|
Part 1, OLE Period: Number of Participants With Treatment Emergent AESIs (All Causality)
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: OLE Period: First dose of study drug in OLE period up to 4 weeks after last dose in OLE period (up to maximum of 56 Weeks)Population: Safety analysis set included all participants who received at least 1 dose of study intervention (i.e., Etrasimod or placebo). Participants were analyzed in the treatment groups as they were randomized. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Laboratory assessments included hematology, clinical chemistry, urinalysis, other parameters and reflex tests. Number of participants with abnormalities in any of laboratory parameters is reported.
Outcome measures
| Measure |
DB Period: Etrasimod 2 mg
n=28 Participants
Participants who received etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1.
|
DB Period: Placebo
n=25 Participants
Participants who received placebo matched to etrasimod orally once daily for 16 weeks in DB period of Part 1.
|
|---|---|---|
|
Part 1, OLE Period: Number of Participants With Laboratory Test Abnormalities
|
20 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: OLE Period: Day 169/Week 24Population: Safety analysis set included all participants who received at least 1 dose of study intervention (i.e., Etrasimod or placebo). Participants were analyzed in the treatment groups as they were randomized. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for the specified outcome measure.
Standard 12-lead ECGs utilizing limb leads were used to measure PR interval, QT interval, QTcF, and QRS complex. Number of participants with non-zero ECG abnormalities and AV blocks are reported in this outcome measure.
Outcome measures
| Measure |
DB Period: Etrasimod 2 mg
n=14 Participants
Participants who received etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1.
|
DB Period: Placebo
n=11 Participants
Participants who received placebo matched to etrasimod orally once daily for 16 weeks in DB period of Part 1.
|
|---|---|---|
|
Part 1, OLE Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV Blocks
Week 24: QTCF (msec), single beat:>= 450 (male) or >= 470 (female)
|
1 Participants
|
0 Participants
|
|
Part 1, OLE Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV Blocks
Week 24: CFB in QTcF: >30 sec increase
|
1 Participants
|
0 Participants
|
|
Part 1, OLE Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV Blocks
Week 24: CFB in QT: >30 msec increase
|
2 Participants
|
0 Participants
|
|
Part 1, OLE Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV Blocks
Week 24: CFB in QT: >60 msec increase
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: OLE Period: Day 141/Week 20; Day 169/Week 24; Day 281/Week 40; Follow Up 1; Follow Up 2Population: Safety analysis set included all participants who received at least 1 dose of study intervention (i.e., Etrasimod or placebo). Participants were analyzed in the treatment groups as they were randomized. "Number Analyzed"=participants evaluable for specified timepoints.
Vital signs evaluation included SBP, DBP, pulse rate. Number of participants with non-zero vital signs abnormalities are reported in this outcome measure.
Outcome measures
| Measure |
DB Period: Etrasimod 2 mg
n=26 Participants
Participants who received etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1.
|
DB Period: Placebo
n=23 Participants
Participants who received placebo matched to etrasimod orally once daily for 16 weeks in DB period of Part 1.
|
|---|---|---|
|
Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign
Follow-up 2: DBP: >90 mmHg
|
2 Participants
|
0 Participants
|
|
Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign
Week 20: SBP: >150 mmHg
|
1 Participants
|
1 Participants
|
|
Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign
Week 20: SBP: Change:>=30 mmHg decrease
|
0 Participants
|
1 Participants
|
|
Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign
Week 20: DBP: >90 mmHg
|
2 Participants
|
1 Participants
|
|
Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign
Week 20: Pulse rate: <60 bpm
|
1 Participants
|
0 Participants
|
|
Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign
Week 24: SBP: >150 mmHg
|
0 Participants
|
1 Participants
|
|
Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign
Week 24: SBP: Change:>=30 mmHg decrease
|
0 Participants
|
1 Participants
|
|
Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign
Week 24: DBP: >90 mmHg
|
1 Participants
|
1 Participants
|
|
Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign
Week 24: DBP: Change>=20 mmHg decrease
|
0 Participants
|
1 Participants
|
|
Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign
Week 24: Pulse rate: <60 bpm
|
1 Participants
|
1 Participants
|
|
Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign
Week 32: DBP: >90 mmHg
|
1 Participants
|
0 Participants
|
|
Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign
Week 40: DBP: >90 mmHg
|
1 Participants
|
0 Participants
|
|
Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign
Follow-up 1: DBP: >90 mmHg
|
2 Participants
|
0 Participants
|
|
Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign
Follow-up 1: Pulse rate: <60 bpm
|
1 Participants
|
2 Participants
|
|
Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign
Follow-up 2: Pulse rate: <60 bpm
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: DB Period: Week 16Population: FAS included all participants who were randomized to the study irrespective of whether they received any dose of study intervention (i.e., etrasimod or placebo). Participants were analyzed in the treatment groups as they were randomized.
EASI-75 response was defined as a 75% reduction or greater in EASI score from Baseline to Week 16. EASI quantified severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema \[E\], induration/papulation \[I\], excoriation \[Ex\] and lichenification \[L\]) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; h = head and neck; u = upper limbs; t = trunk; l = lower limbs.
Outcome measures
| Measure |
DB Period: Etrasimod 2 mg
n=30 Participants
Participants who received etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1.
|
DB Period: Placebo
n=28 Participants
Participants who received placebo matched to etrasimod orally once daily for 16 weeks in DB period of Part 1.
|
|---|---|---|
|
Part 1, DB Period: Percentage of Participants Who Achieved >=75% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-75) at Week 16
|
23.3 Percentage of Participants
Interval 7.72 to
|
14.3 Percentage of Participants
Interval 6.61 to
|
SECONDARY outcome
Timeframe: DB Period: Baseline, Week 16Population: FAS included all participants who were randomized to the study irrespective of whether they received any dose of study intervention (i.e., etrasimod or placebo). Participants were analyzed in the treatment groups as they were randomized.
EASI quantified severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema \[E\], induration/papulation \[I\], excoriation \[Ex\] and lichenification \[L\]) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; h = head and neck; u = upper limbs; t = trunk; l = lower limbs.
Outcome measures
| Measure |
DB Period: Etrasimod 2 mg
n=30 Participants
Participants who received etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1.
|
DB Period: Placebo
n=28 Participants
Participants who received placebo matched to etrasimod orally once daily for 16 weeks in DB period of Part 1.
|
|---|---|---|
|
Part 1, DB Period: Percent Change From Baseline in EASI Score at Week 16
|
-53.87 Percent change
Standard Error 9.007
|
-24.65 Percent change
Standard Error 9.533
|
Adverse Events
DB Period: Etrasimod 2 mg
DB Period: Placebo
OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period)
OLE Period: Etrasimod 2 mg (Placebo in DB Period)
DB Etrasimod 2 mg Then OLE Etrasimod 2 mg
DB Placebo Then OLE Etrasimod 2 mg
Serious adverse events
| Measure |
DB Period: Etrasimod 2 mg
n=30 participants at risk
Participants who received etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1.
|
DB Period: Placebo
n=28 participants at risk
Participants who received placebo matched to etrasimod orally once daily for 16 weeks in DB period of Part 1.
|
OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period)
n=30 participants at risk
Participants who received etrasimod 2 mg in DB period, received etrasimod 2 mg orally once daily in OLE period for maximum of another 52 weeks.
|
OLE Period: Etrasimod 2 mg (Placebo in DB Period)
n=28 participants at risk
Participants who received placebo matched to etrasimod in DB period, received etrasimod 2 mg orally once daily in OLE period for maximum of another 52 weeks.
|
DB Etrasimod 2 mg Then OLE Etrasimod 2 mg
n=30 participants at risk
Participants were randomized to receive etrasimod 2 milligram (mg) orally once daily for 16 weeks in DB period of Part 1. Eligible participants per investigator's judgement then continued to receive etrasimod 2 mg orally once daily for maximum of another 52 weeks in OLE period of Part 1.
|
DB Placebo Then OLE Etrasimod 2 mg
n=28 participants at risk
Participants were randomized to receive placebo matched to etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1. Eligible participants per investigator's judgement then received etrasimod 2 mg orally once daily for maximum of another 52 weeks in OLE period of Part 1.
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/30 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
0.00%
0/28 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
3.3%
1/30 • Number of events 1 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
0.00%
0/28 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
3.3%
1/30 • Number of events 1 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
0.00%
0/28 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
Other adverse events
| Measure |
DB Period: Etrasimod 2 mg
n=30 participants at risk
Participants who received etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1.
|
DB Period: Placebo
n=28 participants at risk
Participants who received placebo matched to etrasimod orally once daily for 16 weeks in DB period of Part 1.
|
OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period)
n=30 participants at risk
Participants who received etrasimod 2 mg in DB period, received etrasimod 2 mg orally once daily in OLE period for maximum of another 52 weeks.
|
OLE Period: Etrasimod 2 mg (Placebo in DB Period)
n=28 participants at risk
Participants who received placebo matched to etrasimod in DB period, received etrasimod 2 mg orally once daily in OLE period for maximum of another 52 weeks.
|
DB Etrasimod 2 mg Then OLE Etrasimod 2 mg
n=30 participants at risk
Participants were randomized to receive etrasimod 2 milligram (mg) orally once daily for 16 weeks in DB period of Part 1. Eligible participants per investigator's judgement then continued to receive etrasimod 2 mg orally once daily for maximum of another 52 weeks in OLE period of Part 1.
|
DB Placebo Then OLE Etrasimod 2 mg
n=28 participants at risk
Participants were randomized to receive placebo matched to etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1. Eligible participants per investigator's judgement then received etrasimod 2 mg orally once daily for maximum of another 52 weeks in OLE period of Part 1.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
6.7%
2/30 • Number of events 2 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
0.00%
0/28 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
0.00%
0/30 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
0.00%
0/28 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
6.7%
2/30 • Number of events 2 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
0.00%
0/28 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
2/30 • Number of events 2 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
3.6%
1/28 • Number of events 1 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
0.00%
0/30 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
0.00%
0/28 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
6.7%
2/30 • Number of events 2 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
3.6%
1/28 • Number of events 1 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
6.7%
2/30 • Number of events 2 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
3.6%
1/28 • Number of events 2 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
0.00%
0/30 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
3.6%
1/28 • Number of events 1 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
6.7%
2/30 • Number of events 2 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
7.1%
2/28 • Number of events 3 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
|
Vascular disorders
Hypertension
|
3.3%
1/30 • Number of events 1 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
7.1%
2/28 • Number of events 2 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
6.7%
2/30 • Number of events 2 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
0.00%
0/28 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
10.0%
3/30 • Number of events 5 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
7.1%
2/28 • Number of events 2 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/30 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
0.00%
0/28 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
6.7%
2/30 • Number of events 2 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
0.00%
0/28 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
6.7%
2/30 • Number of events 2 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
0.00%
0/28 • Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68
The same all-causality treatment-emergent event may appear as both SAE \& non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious \& non-serious event during study. Safety analysis set was evaluated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER