Atopic Dermatitis, Atopic Dermatitis, Unspecified, Eczema, Eczema, Atopic
Conditions
Keywords
Systemic Failure, Oral
Brief summary
The purpose of this study is to learn about the safety and effects of the study medicine called etrasimod for the possible treatment of atopic dermatitis (AD), also called eczema, in adults who have already tried AD treatments taken by mouth or by injection that work all over the body. These adults can have moderate to severe AD. This study is seeking participants who: * have AD for at least 1 year * have moderate-to-severe AD * have tried treatments that work all over the body and saw no effects * are willing to apply a moisturizer at least once daily during the study This is a 2-part study that is only selecting about 60 participants for Part 1 as of now. In Part 1, half of the participants will receive etrasimod, a pill to be taken by mouth once daily. The other half will receive a placebo, a pill that looks like etrasimod but has no medicine also taken by mouth once daily. No one will know what treatment the participant is taking. The Sponsor will compare participant experiences of those taking etrasimod to those taking placebo for 16 weeks. This will help determine if the study medicine is safe and effective. After the first 16 weeks, some participants may continue the study knowing they are taking etrasimod for an additional 52 weeks. Those participating for just the first 16-weeks, will need to visit the study clinic at least 6 times during the study (about every 4 weeks), and will have to come for 2 safety follow up visits at 2nd and 4th week after the last dose of study medicine. People who want to and can continue for an additional 52 weeks will need to visit the study clinic for at least 6 more visits making 12 total visits over 68 weeks followed by 2 safety follow up visits at the 2nd and 4th week after the last dose of study medicine. In Part 2 of the study, around 340 more participants will be participating. Everyone will receive etrasimod pills once daily for 52 weeks. Participants will need to go to the study clinic at least 9 times after which they will have to go for 2 more safety follow up visits at the 2nd and 4th weeks after the last dose of study medicine. At every study visit in Part 1 and Part 2, the focus will be on signs and symptoms of AD (like lesions, itch, and pain) as well as general health and overall side effects. Blood samples and vital signs will be taken at every visit. Due to the way the study medicine works, the in-study clinic visit will last at least 4 hours on Day 1 (Part 1 and Part 2) and Week 16 (Part 1).
Interventions
DRUGetrasimod
PART 1 Double Blind one 2 mg tablet once daily for up to 16 weeks PART 1 Open Label Extension one 2 mg tablet once daily for an additional 52 weeks PART 2 Open Label one 2 mg tablet once daily for up 52 weeks
DRUGPlacebo
PART 1 DOUBLE BLIND Placebo - one table daily for up to 16 weeks
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
PART 1 Double Blind portion (Day 1 through Week 16): all parties are blinded to treatment. PART 1 Open Label Extension portion: All parties will be aware participant is taking etrasimod for up to an additional 52 weeks. PART 2 Open Label All parties will be aware participant is taking etrasimod for 52 weeks.
Intervention model description
Part 1: Approximately 60 participants with moderate-to-severe AD with a history of prior systemic treatment failure will be randomized (1:1 ratio) in a double blind (DB) manner to receive etrasimod 2 mg or placebo orally, once daily, for 16 weeks. Randomization will be stratified by disease severity as measured by IGA score (3 \[moderate AD\], 4 \[severe AD\]) at baseline. After DB period, participants may be given the option to continue in an open label extension (OLE) phase whereby they will receive etrasimod 2 mg (tablet) for up to an additional 52 weeks. Part 2: Approximately 340 additional participants will be enrolled to receive etrasimod 2 mg orally, once daily, for 52 weeks in an open-label manner.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Participants must meet the following key inclusion criteria to be eligible for enrollment into the study: 1\. Age 18-80 at screening (or minimum age of consent according to local regulations). 2 Chronic AD (also known as atopic eczema) that was diagnosed at least 1 year prior to Screening and meets Hanifin and Rajka criteria at screening).1 3. Moderate to severe AD: 1. IGA score ≥3 (on the 0 to 4 IGA scale, in which 3 = moderate and 4 = severe) at screening and baseline (Day 1) 2. BSA ≥10% of AD involvement at screening and baseline (Day 1) 3. Eczema Area and Severity Index (EASI) ≥16 at screening and baseline (Day 1) 4. A participant who has failed a prior systemic therapy for AD, ie, refractory, moderate-to-severe AD that is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. 5\. Willing to apply a topical emollient/moisturizer at least once daily for ≥1 week prior to baseline (Day 1) and willing to maintain consistent (ie, no change in type, frequency, or application) daily application over the course of the study.
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply: Medical Conditions: 1. Presence of confounding factors: * Skin conditions (eg, psoriasis, seborrheic dermatitis) that may interfere with evaluation of AD or assessment of treatment response as deemed by the investigator. * Current significant active infection or requiring a treatment for infection that may interfere with the assessment of AD. 2. Hypersensitivity to etrasimod or any of the excipients. 3. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | OLE Period: Day 141/Week 20; Day 169/Week 24; Day 281/Week 40; Follow Up 1; Follow Up 2 | Vital signs evaluation included SBP, DBP, pulse rate. Number of participants with non-zero vital signs abnormalities are reported in this outcome measure. |
| Part 1, OLE Period: Number of Participants With Laboratory Test Abnormalities | 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) | Laboratory assessments included hematology, clinical chemistry, urinalysis, other parameters and reflex tests. Number of participants with abnormalities in any of laboratory parameters is reported. |
| Part 1, OLE Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV Blocks | OLE Period: Day 169/Week 24 | 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. |
| Part 1, DB Period: Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response at Week 16 | DB Period: Week 16 | 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. |
| Part 1, DB Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (All Causality) | DB Period: From first dose of study drug up to 16 Weeks of treatment | 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. |
| Part 1, DB Period: Number of Participants With TEAEs (All Causality) Leading to Study Treatment Discontinuation | DB Period: From first dose of study drug up to 16 Weeks of treatment | 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. |
| Part 1, DB Period: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) (All Causality) | DB Period: From first dose of study drug up to 16 Weeks of treatment | 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. |
| Part 1, DB Period: Number of Participants With Treatment Emergent AEs of Special Interest (AESIs) (All Causality) | DB Period: From first dose of study drug up to 16 Weeks of treatment | 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. |
| Part 1, DB Period: Number of Participants With Laboratory Test Abnormalities | DB Period: From first dose of study drug up to 16 Weeks of treatment | Laboratory assessments included hematology, clinical chemistry, urinalysis, other parameters and reflex tests. Number of participants with abnormalities in any of laboratory parameters is reported. |
| Part 1, DB Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV Blocks | 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 16 | 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. |
| Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 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 16 | 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. |
| Part 1, OLE Period: Number of Participants With TEAEs (All Causality) | 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) | 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. |
| Part 1, OLE Period: Number of Participants With Treatment Emergent AEs (All Causality) Leading to Study Treatment Discontinuation | 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) | 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. |
| Part 1, OLE Period: Number of Participants With Treatment Emergent SAEs (All Causality) | 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) | 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. |
| Part 1, OLE Period: Number of Participants With Treatment Emergent AESIs (All Causality) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1, DB Period: Percent Change From Baseline in EASI Score at Week 16 | DB Period: Baseline, 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. |
| 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 | DB Period: Week 16 | 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. |
Countries
Canada, Czechia, Poland, United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 28 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 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: DB Period | Withdrawal by Subject | 1 | 2 |
| Part 1: OLE Period | Adverse Event | 0 | 1 |
| Part 1: OLE Period | Lack of Efficacy | 0 | 1 |
| Part 1: OLE Period | Study Terminated by Sponsor | 25 | 19 |
| Part 1: OLE Period | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | DB Placebo Then OLE Etrasimod 2 mg | Total | DB Etrasimod 2 mg Then OLE Etrasimod 2 mg |
|---|---|---|---|
| Age, Continuous | 43.4 Years STANDARD_DEVIATION 18.18 | 41.6 Years STANDARD_DEVIATION 16.45 | 40.0 Years STANDARD_DEVIATION 14.78 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 10 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 48 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 27 Participants | 51 Participants | 24 Participants |
| Sex: Female, Male Female | 9 Participants | 30 Participants | 21 Participants |
| Sex: Female, Male Male | 19 Participants | 28 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 28 | 0 / 30 | 0 / 28 | 0 / 30 | 0 / 28 |
| other Total, other adverse events | 6 / 30 | 4 / 28 | 4 / 30 | 1 / 28 | 9 / 30 | 5 / 28 |
| serious Total, serious adverse events | 0 / 30 | 0 / 28 | 1 / 30 | 0 / 28 | 1 / 30 | 0 / 28 |
Outcome results
Primary
Part 1, DB Period: Number of Participants With Laboratory Test Abnormalities
Laboratory assessments included hematology, clinical chemistry, urinalysis, other parameters and reflex tests. Number of participants with abnormalities in any of laboratory parameters is reported.
Time frame: DB Period: From first dose of study drug up to 16 Weeks of treatment
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Laboratory Test Abnormalities | 22 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Laboratory Test Abnormalities | 13 Participants |
Primary
Part 1, DB Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV Blocks
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.
Time frame: 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 16
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DB Period: Etrasimod 2 mg | 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 |
| DB Period: Etrasimod 2 mg | 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 |
| DB Period: Etrasimod 2 mg | 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 |
| DB Period: Etrasimod 2 mg | 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 |
| DB Period: Etrasimod 2 mg | 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 |
| DB Period: Etrasimod 2 mg | 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 |
| DB Period: Etrasimod 2 mg | 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 |
| DB Period: Etrasimod 2 mg | 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 |
| DB Period: Etrasimod 2 mg | 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 |
| DB Period: Etrasimod 2 mg | 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 |
| DB Period: Placebo | 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 | 0 Participants |
| DB Period: Placebo | 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 | 0 Participants |
| DB Period: Placebo | 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 | 0 Participants |
| DB Period: Placebo | 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) | 0 Participants |
| DB Period: Placebo | 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 | 0 Participants |
| DB Period: Placebo | 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 | 0 Participants |
| DB Period: Placebo | 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 | 0 Participants |
| DB Period: Placebo | 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 | 0 Participants |
| DB Period: Placebo | 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 | 0 Participants |
| DB Period: Placebo | 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 | 0 Participants |
Primary
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
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.
Time frame: 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 16
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Week 12: Pulse rate: <60 bpm | 1 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 3 hrs post-dose/Day 1: Pulse rate: <60 bpm | 11 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Week 12: Pulse rate: >100 bpm | 0 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 1 hr post-dose/Day 1: DBP >90 mmHg | 2 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Pre-dose/Week 16: SBP: >150 mmHg | 0 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 4 hrs post-dose/Day 1: DBP: >90 mmHg | 1 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Pre-dose/Week 16: DBP: >90 mmHg | 2 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 2 hrs post-dose/Day 1: DBP >90 mmHg | 0 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Pre-dose/Week 16: Pulse rate: <60 bpm | 2 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 4 hrs post-dose/Day 1: Pulse rate: <60 bpm | 10 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 1 hr post dose/Week 16: SBP: >150 mmHg | 0 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Pre-dose/Day 1: Pulse rate: <60 bpm | 1 Participants |
| DB Period: Etrasimod 2 mg | 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 |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 4 hrs post-dose/Day 1: Pulse rate: >100 bpm | 1 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 1 hr post dose/Week 16: DBP: >90 mmHg | 2 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 2 hrs post-dose/Day 1: Pulse rate: <60 bpm | 12 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 1 hr post dose/Week 16: Pulse rate: <50 bpm | 1 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Week 4: DBP:>90 mmHg | 2 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 1 hr post dose/Week 16: Pulse rate: <60 bpm | 3 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 1 hr post-dose/Day 1: Pulse rate: <50 bpm | 1 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 2 hrs post dose/Week 16: SBP: >150 mmHg | 0 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Week 4: Pulse rate: <60 bpm | 2 Participants |
| DB Period: Etrasimod 2 mg | 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 |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 3 hrs post-dose/Day 1:SBP >150 mmHg | 0 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 2 hrs post dose/Week 16: DBP: >90 mmHg | 2 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Week 4: Pulse rate: >100 bpm | 1 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 2 hrs post dose/Week 16: Pulse rate: <50 bpm | 0 Participants |
| DB Period: Etrasimod 2 mg | 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 |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 2 hrs post dose/Week 16: Pulse rate: <60 bpm | 3 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Week 8: SBP: >150 mmHg | 0 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 3 hrs post dose/Week 16:DBP: >90 mmHg | 2 Participants |
| DB Period: Etrasimod 2 mg | 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 |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 3 hrs post dose/Week 16: Pulse rate: <50 bpm | 0 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Week 8: DBP:>90 mmHg | 3 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 3 hrs post dose/Week 16: Pulse rate: <60 bpm | 3 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 1 hr post-dose/Day 1: Pulse rate: <60 bpm | 7 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 4 hrs post dose/Week 16: SBP: >150 mmHg | 0 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Week 8: DBP: Change >=20 mmHg decrease | 0 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 4 hrs post dose/Week 16: DBP:>90 mmHg | 2 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 3 hrs post-dose/Day 1: DBP:>90 mmHg | 0 Participants |
| DB Period: Etrasimod 2 mg | 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 |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Week 8: Pulse rate: <60 bpm | 3 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 4 hrs post dose/Week 16: Pulse rate: <50 bpm | 0 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Pre-dose/Day 1: Pulse rate >100 bpm | 1 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 4 hrs post dose/Week 16: Pulse rate:<60 bpm | 1 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Week 12: SBP: >150 mmHg | 0 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 5 hrs post dose/Week 16:Pulse rate:<50 bpm | 0 Participants |
| DB Period: Etrasimod 2 mg | 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 |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 5 hrs post dose/Week 16:Pulse rate:<60 bpm | 0 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Week 12: DBP:>90 mmHg | 1 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 6 hrs post dose/Week 16:Pulse rate:<50 bpm | 0 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 2 hrs post-dose/Day 1: SBP: >150 mmHg | 0 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 6 hrs post dose/Week 16: Pulse rate:<60 bpm | 0 Participants |
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Pre-dose/Day 1: DBP >90 mmHg | 0 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 6 hrs post dose/Week 16: Pulse rate:<60 bpm | 1 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Pre-dose/Day 1: DBP >90 mmHg | 1 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Pre-dose/Day 1: Pulse rate: <60 bpm | 3 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Pre-dose/Day 1: Pulse rate >100 bpm | 0 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 1 hr post-dose/Day 1: SBP: Change >=30 mmHg decrease | 1 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 1 hr post-dose/Day 1: DBP >90 mmHg | 2 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 1 hr post-dose/Day 1: Pulse rate: <50 bpm | 0 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 1 hr post-dose/Day 1: Pulse rate: <60 bpm | 3 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 2 hrs post-dose/Day 1: SBP: >150 mmHg | 2 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 2 hrs post-dose/Day 1: DBP >90 mmHg | 1 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 2 hrs post-dose/Day 1: Pulse rate: <60 bpm | 5 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 3 hrs post-dose/Day 1:SBP >150 mmHg | 1 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 3 hrs post-dose/Day 1: SBP: Change>=30 mmHg decrease | 0 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 3 hrs post-dose/Day 1: DBP:>90 mmHg | 1 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 3 hrs post-dose/Day 1: DBP: Change>=20 mmHg decrease | 0 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 3 hrs post-dose/Day 1: Pulse rate: <60 bpm | 6 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 4 hrs post-dose/Day 1: DBP: >90 mmHg | 1 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 4 hrs post-dose/Day 1: Pulse rate: <60 bpm | 5 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 4 hrs post-dose/Day 1: Pulse rate: >100 bpm | 0 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Week 4: DBP:>90 mmHg | 3 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Week 4: Pulse rate: <60 bpm | 1 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Week 4: Pulse rate: >100 bpm | 0 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Week 8: SBP: >150 mmHg | 1 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Week 8: DBP:>90 mmHg | 3 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Week 8: DBP: Change >=20 mmHg decrease | 1 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Week 8: Pulse rate: <60 bpm | 1 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Week 12: SBP: >150 mmHg | 1 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Week 12: DBP:>90 mmHg | 3 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Week 12: Pulse rate: <60 bpm | 0 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Week 12: Pulse rate: >100 bpm | 2 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Pre-dose/Week 16: SBP: >150 mmHg | 1 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Pre-dose/Week 16: DBP: >90 mmHg | 0 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | Pre-dose/Week 16: Pulse rate: <60 bpm | 2 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 1 hr post dose/Week 16: SBP: >150 mmHg | 1 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 1 hr post-dose/Week 16: SBP: Change >=30 mmHg decrease | 1 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 1 hr post dose/Week 16: DBP: >90 mmHg | 1 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 1 hr post dose/Week 16: Pulse rate: <50 bpm | 1 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 1 hr post dose/Week 16: Pulse rate: <60 bpm | 4 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 2 hrs post dose/Week 16: SBP: >150 mmHg | 1 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 2 hrs post-dose/Week 16: SBP: Change >=30 mmHg decrease | 2 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 2 hrs post dose/Week 16: DBP: >90 mmHg | 2 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 2 hrs post dose/Week 16: Pulse rate: <50 bpm | 1 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 2 hrs post dose/Week 16: Pulse rate: <60 bpm | 10 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 3 hrs post dose/Week 16:DBP: >90 mmHg | 0 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 3 hrs post dose/Week 16: Pulse rate: <50 bpm | 1 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 3 hrs post dose/Week 16: Pulse rate: <60 bpm | 9 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 4 hrs post dose/Week 16: SBP: >150 mmHg | 1 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 4 hrs post dose/Week 16: DBP:>90 mmHg | 0 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 4 hrs post-dose/Week 16: DBP: Change >=20 mmHg decrease | 1 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 4 hrs post dose/Week 16: Pulse rate: <50 bpm | 1 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 4 hrs post dose/Week 16: Pulse rate:<60 bpm | 6 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 5 hrs post dose/Week 16:Pulse rate:<50 bpm | 1 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 5 hrs post dose/Week 16:Pulse rate:<60 bpm | 1 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 6 hrs post dose/Week 16:Pulse rate:<50 bpm | 1 Participants |
Primary
Part 1, DB Period: Number of Participants With TEAEs (All Causality) Leading to Study Treatment Discontinuation
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.
Time frame: DB Period: From first dose of study drug up to 16 Weeks of treatment
Population: DB period: Safety analysis set included of all participants who were randomized and received at least 1 dose of study drug in DB period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With TEAEs (All Causality) Leading to Study Treatment Discontinuation | 1 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With TEAEs (All Causality) Leading to Study Treatment Discontinuation | 0 Participants |
Primary
Part 1, DB Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (All Causality)
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.
Time frame: DB Period: From first dose of study drug up to 16 Weeks of treatment
Population: DB period: Safety analysis set included of all participants who were randomized and received at least 1 dose of study drug in DB period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (All Causality) | 16 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (All Causality) | 8 Participants |
Primary
Part 1, DB Period: Number of Participants With Treatment Emergent AEs of Special Interest (AESIs) (All Causality)
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.
Time frame: DB Period: From first dose of study drug up to 16 Weeks of treatment
Population: DB period: Safety analysis set included of all participants who were randomized and received at least 1 dose of study drug in DB period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Treatment Emergent AEs of Special Interest (AESIs) (All Causality) | 2 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Treatment Emergent AEs of Special Interest (AESIs) (All Causality) | 1 Participants |
Primary
Part 1, DB Period: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) (All Causality)
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.
Time frame: DB Period: From first dose of study drug up to 16 Weeks of treatment
Population: DB period: Safety analysis set included of all participants who were randomized and received at least 1 dose of study drug in DB period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) (All Causality) | 0 Participants |
| DB Period: Placebo | Part 1, DB Period: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) (All Causality) | 0 Participants |
Primary
Part 1, DB Period: Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response at Week 16
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.
Time frame: DB Period: Week 16
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response at Week 16 | 3.3 Percentage of Participants |
| DB Period: Placebo | Part 1, DB Period: Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response at Week 16 | 7.1 Percentage of Participants |
Comparison: Normal approximation adjusting for the stratification factor (disease severity as measured by baseline IGA score 3 \[moderate\], 4 \[severe\]) derived from clinical database via Cochran-Mantel-Haenszel (CMH) approach was used.p-value: =0.55895% CI: [-16.36, 8.83]Cochran-Mantel-Haenszel
Primary
Part 1, OLE Period: Number of Participants With Laboratory Test Abnormalities
Laboratory assessments included hematology, clinical chemistry, urinalysis, other parameters and reflex tests. Number of participants with abnormalities in any of laboratory parameters is reported.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DB Period: Etrasimod 2 mg | Part 1, OLE Period: Number of Participants With Laboratory Test Abnormalities | 20 Participants |
| DB Period: Placebo | Part 1, OLE Period: Number of Participants With Laboratory Test Abnormalities | 18 Participants |
Primary
Part 1, OLE Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV Blocks
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.
Time frame: OLE Period: Day 169/Week 24
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, Overall Number of Participants Analyzed signifies number of participants evaluable for the specified outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DB Period: Etrasimod 2 mg | 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 |
| DB Period: Etrasimod 2 mg | 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 |
| DB Period: Etrasimod 2 mg | 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 |
| DB Period: Etrasimod 2 mg | 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 |
| DB Period: Placebo | 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 | 0 Participants |
| DB Period: Placebo | 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) | 0 Participants |
| DB Period: Placebo | 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 | 0 Participants |
| DB Period: Placebo | 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 | 0 Participants |
Primary
Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign
Vital signs evaluation included SBP, DBP, pulse rate. Number of participants with non-zero vital signs abnormalities are reported in this outcome measure.
Time frame: OLE Period: Day 141/Week 20; Day 169/Week 24; Day 281/Week 40; Follow Up 1; Follow Up 2
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. Number Analyzed=participants evaluable for specified timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DB Period: Etrasimod 2 mg | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Week 20: SBP: Change:>=30 mmHg decrease | 0 Participants |
| DB Period: Etrasimod 2 mg | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Week 24: Pulse rate: <60 bpm | 1 Participants |
| DB Period: Etrasimod 2 mg | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Week 20: Pulse rate: <60 bpm | 1 Participants |
| DB Period: Etrasimod 2 mg | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Week 32: DBP: >90 mmHg | 1 Participants |
| DB Period: Etrasimod 2 mg | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Week 20: SBP: >150 mmHg | 1 Participants |
| DB Period: Etrasimod 2 mg | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Week 40: DBP: >90 mmHg | 1 Participants |
| DB Period: Etrasimod 2 mg | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Week 24: SBP: >150 mmHg | 0 Participants |
| DB Period: Etrasimod 2 mg | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Follow-up 1: DBP: >90 mmHg | 2 Participants |
| DB Period: Etrasimod 2 mg | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Week 20: DBP: >90 mmHg | 2 Participants |
| DB Period: Etrasimod 2 mg | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Follow-up 1: Pulse rate: <60 bpm | 1 Participants |
| DB Period: Etrasimod 2 mg | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Week 24: SBP: Change:>=30 mmHg decrease | 0 Participants |
| DB Period: Etrasimod 2 mg | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Follow-up 2: DBP: >90 mmHg | 2 Participants |
| DB Period: Etrasimod 2 mg | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Week 24: DBP: >90 mmHg | 1 Participants |
| DB Period: Etrasimod 2 mg | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Follow-up 2: Pulse rate: <60 bpm | 1 Participants |
| DB Period: Etrasimod 2 mg | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Week 24: DBP: Change>=20 mmHg decrease | 0 Participants |
| DB Period: Placebo | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Follow-up 2: Pulse rate: <60 bpm | 2 Participants |
| DB Period: Placebo | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Week 24: DBP: >90 mmHg | 1 Participants |
| DB Period: Placebo | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Week 20: SBP: >150 mmHg | 1 Participants |
| DB Period: Placebo | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Week 20: SBP: Change:>=30 mmHg decrease | 1 Participants |
| DB Period: Placebo | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Week 20: DBP: >90 mmHg | 1 Participants |
| DB Period: Placebo | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Week 20: Pulse rate: <60 bpm | 0 Participants |
| DB Period: Placebo | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Week 24: SBP: >150 mmHg | 1 Participants |
| DB Period: Placebo | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Week 24: DBP: Change>=20 mmHg decrease | 1 Participants |
| DB Period: Placebo | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Week 24: Pulse rate: <60 bpm | 1 Participants |
| DB Period: Placebo | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Week 32: DBP: >90 mmHg | 0 Participants |
| DB Period: Placebo | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Week 40: DBP: >90 mmHg | 0 Participants |
| DB Period: Placebo | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Follow-up 1: DBP: >90 mmHg | 0 Participants |
| DB Period: Placebo | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Follow-up 1: Pulse rate: <60 bpm | 2 Participants |
| DB Period: Placebo | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Follow-up 2: DBP: >90 mmHg | 0 Participants |
| DB Period: Placebo | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Week 24: SBP: Change:>=30 mmHg decrease | 1 Participants |
Primary
Part 1, OLE Period: Number of Participants With TEAEs (All Causality)
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DB Period: Etrasimod 2 mg | Part 1, OLE Period: Number of Participants With TEAEs (All Causality) | 9 Participants |
| DB Period: Placebo | Part 1, OLE Period: Number of Participants With TEAEs (All Causality) | 5 Participants |
Primary
Part 1, OLE Period: Number of Participants With Treatment Emergent AEs (All Causality) Leading to Study Treatment Discontinuation
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DB Period: Etrasimod 2 mg | Part 1, OLE Period: Number of Participants With Treatment Emergent AEs (All Causality) Leading to Study Treatment Discontinuation | 0 Participants |
| DB Period: Placebo | Part 1, OLE Period: Number of Participants With Treatment Emergent AEs (All Causality) Leading to Study Treatment Discontinuation | 1 Participants |
Primary
Part 1, OLE Period: Number of Participants With Treatment Emergent AESIs (All Causality)
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DB Period: Etrasimod 2 mg | Part 1, OLE Period: Number of Participants With Treatment Emergent AESIs (All Causality) | 1 Participants |
| DB Period: Placebo | Part 1, OLE Period: Number of Participants With Treatment Emergent AESIs (All Causality) | 0 Participants |
Primary
Part 1, OLE Period: Number of Participants With Treatment Emergent SAEs (All Causality)
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DB Period: Etrasimod 2 mg | Part 1, OLE Period: Number of Participants With Treatment Emergent SAEs (All Causality) | 1 Participants |
| DB Period: Placebo | Part 1, OLE Period: Number of Participants With Treatment Emergent SAEs (All Causality) | 0 Participants |
Secondary
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
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.
Time frame: DB Period: Week 16
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Period: Etrasimod 2 mg | 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 |
| DB Period: Placebo | 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 | 14.3 Percentage of Participants |
Comparison: Normal approximation adjusting for the stratification factor (disease severity as measured by baseline IGA score 3 \[moderate\], 4 \[severe\]) derived from clinical database via Cochran-Mantel-Haenszel (CMH) approach was used.p-value: =0.368595% CI: [-10.7, 28.85]Cochran-Mantel-Haenszel
Secondary
Part 1, DB Period: Percent Change From Baseline in EASI Score at 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.
Time frame: DB Period: Baseline, Week 16
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DB Period: Etrasimod 2 mg | Part 1, DB Period: Percent Change From Baseline in EASI Score at Week 16 | -53.87 Percent change | Standard Error 9.007 |
| DB Period: Placebo | Part 1, DB Period: Percent Change From Baseline in EASI Score at Week 16 | -24.65 Percent change | Standard Error 9.533 |
Comparison: Jump-to-Control (JTC) method was used for evaluation. A complete imputed dataset was analyzed using analysis of covariance model including effects of treatment group, actual stratification factor, and baseline value. Multiple results of the treatment comparison were combined using Rubin's rules, reporting the combined treatment difference, its standard error, 95% CI and 2-sided p-value, across the visits.p-value: =0.030395% CI: [-55.53, -2.9]Rubin's rule