Safety and Efficacy of Oral Etrasimod in Adult Participan... | NCT04556734 | Trialant
NCT04556734
Sponsor
Pfizer
Status
Completed
Last Update Posted
Jun 26, 2024Actual
Enrollment
80Actual
Phase
Phase 2
Conditions
Alopecia Areata
Interventions
Etrasimod
Etrasimod
Placebo
Countries
United States
Canada
Protocol Section
Identification Module
NCT ID
NCT04556734
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
APD334-205
Secondary IDs
ID
Type
Description
Link
C5041008
Other Identifier
Alias Study Number
Brief Title
Safety and Efficacy of Oral Etrasimod in Adult Participants With Moderate-to-Severe Alopecia Areata
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 24-Week Study, With a 28-Week Open-Label Extension, to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Alopecia Areata
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
May 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 29, 2020Actual
Primary Completion Date
Jun 7, 2023Actual
Completion Date
Jun 7, 2023Actual
First Submitted Date
Sep 15, 2020
First Submission Date that Met QC Criteria
Sep 15, 2020
First Posted Date
Sep 21, 2020Actual
Results Waived
Not provided
Results First Submitted Date
May 30, 2024
Results First Submitted that Met QC Criteria
May 30, 2024
Results First Posted Date
Jun 26, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 30, 2024
Last Update Posted Date
Jun 26, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Name
Class
Arena is a wholly owned subsidiary of Pfizer
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of etrasimod monotherapy (2 milligrams [mg] and 3 mg) in participants with moderate-to-severe alopecia areata (AA).
Detailed Description
Not provided
Conditions Module
Conditions
Alopecia Areata
Keywords
T-cell-mediated autoimmune skin disorder
Alopecia areata
Alopecia
APD334
Etrasimod
Hair loss
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
80Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Etrasimod 2 mg
Experimental
Drug: Etrasimod
Etrasimod 3 mg
Experimental
Drug: Etrasimod
Placebo
Placebo Comparator
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Etrasimod
Drug
Etrasimod 2 mg tablet by mouth, once daily
Etrasimod 2 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline in Severity of Alopecia Tool I (SALT I) at Week 24: DB Treatment Period
SALT I is a well-validated metric used to determine the degree of hair loss based on the percentage (%) of scalp surface area involved on the top (40%), back (24%), left side (18%) and right side (18%) of the scalp for AA. Investigator determines the % scalp hair loss in a given quadrant, multiply this by the total scalp area delineated by that quadrant, and sum the resultant numbers for each quadrant to give the total % scalp hair loss with a maximum score of 100. Score range from 0% (no scalp hair loss) to 100% (complete scalp hair loss), higher scores indicated more scalp hair loss. Percent change from baseline in SALT I is reported in terms of Least square mean and standard error.
DB Treatment Period: Baseline (before dose on Day 1), Week 24
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in SALT I at Week 24: DB Treatment Period
SALT I is a well-validated metric used to determine the degree of hair loss based on the percentage (%) of scalp surface area involved on the top (40%), back (24%), left side (18%) and right side (18%) of the scalp for AA. Investigator determines the % scalp hair loss in a given quadrant, multiply this by the total scalp area delineated by that quadrant, and sum the resultant numbers for each quadrant to give the total % scalp hair loss with a maximum score of 100. Score range from 0% (no scalp hair loss) to 100% (complete scalp hair loss), higher scores indicated more scalp hair loss. Change from baseline in SALT I is reported in terms of Least square mean and standard error.
Other Outcomes
Measure
Description
Time Frame
Number of Participants With Adverse Events (AE): DB Treatment Period
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations based on medical significance or any diagnosis of progressive multifocal leukoencephalopathy (PML). AEs included serious AEs and all non-SAEs.
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Men or women between ≥18 and ≤70 years of age at the time of informed consent
Moderate-to-severe alopecia areata as assessed by a SALT score of ≥25 and <95 at Screening and Day 1/Baseline.
Current episode of hair loss for ≥6 months but <5 years
Stable disease condition (no significant growth of hair) in the last 6 months as assessed by the Investigator
Willing to keep the same hair style and color (eg, hair products, process, and timing for hair appointments) for the duration of the study
Key Exclusion Criteria:
History of male or female pattern hair loss >Hamilton stage III or >Ludwig stage II
Other types of alopecia (eg, cicatricial/scarring alopecia [including central centrifugal cicatricial alopecia], traction alopecia, or telogen effluvium) or other diseases that could cause hair loss
Active scalp inflammation, scalp infection, scalp psoriasis, or any other scalp condition that may interfere with the SALT assessment
Previous use of Janus kinase (JAK) inhibitor (oral or topical), including participation in clinical studies of JAK inhibitors
King B, Mesinkovska N, Senna M, Luo X, Minkiewicz J, Selfridge A. Efficacy and safety of etrasimod in alopecia areata: A multicentre, randomized, double-blind, placebo-controlled, Phase 2 study. J Eur Acad Dermatol Venereol. 2025 Jun;39(6):1174-1184. doi: 10.1111/jdv.20605. Epub 2025 Mar 27.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
The study consisted of a double-blind (DB) treatment period (24 weeks) followed by an open label extension (OLE) period (28 weeks). A total of 80 participants with moderate-to-severe alopecia areata (AA) were enrolled in the DB treatment period of the study. Out of 80 participants, 65 participants entered in the subsequent OLE period.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
DB Treatment Period: Etrasimod 2 mg
Participants who were randomized to receive etrasimod 2 milligram (mg) orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
FG001
DB Treatment Period: Etrasimod 3 mg
Periods
Title
Milestones
Reasons Not Completed
DB Treatment Period (24 Weeks)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
May 25, 2021
May 30, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Double-Blind, Placebo-Controlled
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantInvestigatorOutcomes Assessor
APD334
Etrasimod
Drug
Etrasimod 3 mg (1 mg and 2 mg tablets) by mouth, once daily
Etrasimod 3 mg
APD334
Placebo
Drug
Etrasimod matching placebo tablet by mouth, once daily
Placebo
DBT Period: Baseline, Week 24
Percentage of Participants Who Achieved Greater Than or Equal to (>=) 30%, >= 50% and >=75% Improvement From Baseline in SALT I at Week 24: DB Treatment Period
SALT I is a well-validated metric used to determine the degree of hair loss based on the percentage of scalp surface area involved on the top, back, and each side of the scalp for alopecia areata (AA). Investigator determine the percent scalp hair loss in a given quadrant, multiply this by the total scalp area delineated by that quadrant, and sum the resultant numbers for each quadrant to give the total percent scalp hair loss with a maximum score of 100. Score range from 0 to 100, where 0 =no scalp hair loss to 100 = complete scalp hair loss, higher scores indicated more scalp hair loss. Percentage of participants who achieved >=30%, >=50%, >=75% improvement from baseline in SALT I at Week 24 was reported in this outcome measure.
DB Treatment Period: Baseline, Week 24
DB Treatment Period: From first dosing date in DB up to (before the first dosing date in OLE) or (last dosing date + 4 weeks + 3 days), whichever is earlier (maximum up to 29 weeks)
Number of Participants With Adverse Events: OLE Period
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations based on medical significance or any diagnosis of PML. AEs included serious AEs and all non-SAEs.
OLE period: From first dosing date in OLE up to last dosing date + 4 weeks + 3 days (maximum up to 33 weeks)
Bryant
Arkansas
72022
United States
California Dermatology & Clinical Research Institute
Encinitas
California
92024
United States
First OC Dermatology
Fountain Valley
California
92708
United States
University of California,Irvine
Irvine
California
92697
United States
Prospect Optometry
Lomita
California
90717
United States
Torrance Clinical Research Institute,Inc.
Lomita
California
90717
United States
Yale Eye Center
New Haven
Connecticut
06511
United States
Yale Investigational Drug Services
New Haven
Connecticut
06511
United States
Yale Center for Clinical Investigation
New Haven
Connecticut
06519
United States
Yale New Haven Hospital Department of Respiratory Care
New Haven
Connecticut
06519
United States
Advanced Sleep & Respiratory Institute, PA
Daytona Beach
Florida
32117
United States
International Eye Associates
Ormond Beach
Florida
32174
United States
Leavitt Medical Associates of Florida d/ba Ameriderm Research
Ormond Beach
Florida
32174
United States
Advanced Clinical Research Institute
Tampa
Florida
33607
United States
Advanced Medical Research PC
Sandy Springs
Georgia
30328
United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis
Indiana
46250
United States
Eye Surgeons of Indiana
Indianapolis
Indiana
46260
United States
Magnante Eye Care (Ophthalmological Assessments)
Lafayette
Indiana
47905
United States
Physicians Research Group (Administrative Office Location)
Noblesville
Indiana
46060
United States
Physicians Research Group
West Lafayette
Indiana
47906
United States
Randall Dermatology, PC
West Lafayette
Indiana
47906
United States
Lawrence J. Green, MD LLC
Rockville
Maryland
20850
United States
Michigan Center for Skin Care Research
Clinton Township
Michigan
48038
United States
MediSearch Clinical Trials
Saint Joseph
Missouri
64506
United States
NYC Retina- Manhattan
New York
New York
10003
United States
Bobby Buka MD, PC
New York
New York
10012
United States
Rochester Ophthalmological Group
Rochester
New York
14623
United States
Skin Search of Rochester, Inc.
Rochester
New York
14623
United States
WDC Cosmetic and Research, PLLC
Wilmington
North Carolina
28405
United States
NW Dermatology Institute
Portland
Oregon
97210
United States
UPMC Department of Dermatology
Pittsburgh
Pennsylvania
15213
United States
UPMC Eye Center
Pittsburgh
Pennsylvania
15213
United States
International Clinical Research - Tennessee LLC
Murfreesboro
Tennessee
37130
United States
Progressive Clinical Research, PA
San Antonio
Texas
78213
United States
The Education & Research Foundation, Inc.
Lynchburg
Virginia
24501
United States
Dermatology Specialists of Spokane
Spokane
Washington
99202
United States
PRINCIPLE RESEARCH SOLUTIONS (pulmonary function testing)
Spokane
Washington
99204
United States
SPOKANE EYE CLINIC (OCT and optical exam
Spokane
Washington
99204
United States
Dermatology Research Institute
Calgary
Alberta
T2J 7E1
Canada
Laser Rejuvenation Clinics Edmonton D.T. Inc.
Edmonton
Alberta
T5J 3S9
Canada
Innovaderm Research
Montreal
Quebec
H2X 2V1
Canada
Dubinsky MC, Wu J, McDonnell A, Lazin K, Goetsch M, Branquinho D, Modesto I, Armuzzi A. Low Incidence of Macular Edema and Other Ocular Events in the Etrasimod Development Program. J Crohns Colitis. 2025 May 8;19(5):jjae173. doi: 10.1093/ecco-jcc/jjae173.
Participants who were randomized to receive etrasimod 2 mg orally once daily initially for Week 1 and then etrasimod 3 mg orally once daily for rest of the 23 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
FG002
DB Treatment Period: Placebo
Participants who were randomized to receive placebo matched to etrasimod orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
FG003
OLE Period: Etrasimod 2 mg [Etrasimod 2 mg in DB Treatment Period]
Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 2 mg orally once daily in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.
FG004
OLE Period: Etrasimod 2 mg [Placebo in DB Treatment Period]
Participants who received placebo matched to etrasimod in DB treatment period, received etrasimod 2 mg orally once daily in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.
FG005
OLE Period: Etrasimod 3 mg [Etrasimod 3 mg in DB Treatment Period]
Participants who received etrasimod 3 mg (also included participants whose dose was reduced from 3 mg to 2 mg due to safety issue) in DB treatment period, received etrasimod 3 mg orally once daily in OLE period either from Week 25 to Week 52 (participants who entered OLE phase on or after protocol amendment 2.0 and 2.1) or beginning after Week 25 to Week 52 in OLE period (participants who entered OLE before protocol amendment 2.0 and 2.1). Participants were followed up for up to 4 weeks after last dose of study drug.
FG006
OLE Period: Etrasimod 3 mg [Etrasimod 2 mg in DB Treatment Period]
Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 3 mg orally once daily in OLE period either from Week 25 to Week 52 (participants who entered OLE phase on or after protocol amendment 2.0 and 2.1) or beginning after Week 25 to Week 52 in OLE period (participants who entered OLE before protocol amendment 2.0 and 2.1). Participants were followed up for up to 4 weeks after last dose of study drug.
FG007
OLE Period: Etrasimod 3 mg [Placebo in DB Treatment Period]
Participants received placebo matched to etrasimod in DB treatment period, received etrasimod 3 mg orally once daily in OLE period either from Week 25 to Week 52 (participants who entered OLE phase on or after protocol amendment 2.0 and 2.1) or beginning after Week 25 to Week 52 in OLE period (participants who entered OLE before protocol amendment 2.0 and 2.1). Participants were followed up for up to 4 weeks after last dose of study drug.
FG00031 subjects
FG00125 subjects
FG00224 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Treated
FG00031 subjects
FG00125 subjects
FG00223 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
Completed Treatment
FG00024 subjects
FG00124 subjects
FG00217 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG0007 subjects
FG0011 subjects
FG0027 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0004 subjects
FG0011 subjects
FG0025 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Randomized but not treated
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
OLE Period (28 Weeks)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0034 subjectsParticipants who entered OLE period.
FG0044 subjectsParticipants who entered OLE period.
FG00524 subjectsParticipants who entered OLE period.
FG00620 subjectsParticipants who entered OLE period.
FG00713 subjectsParticipants who entered OLE period.
Treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0034 subjects
FG004
COMPLETED
Completed treatment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Not reported
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
DB Treatment Period randomized set included all randomized participants, irrespective of whether they received any study drug. OLE Safety set (SAF) included all participants who received at least 1 dose of study drug. Participants in DB treatment period and OLE period are not exclusive. Eligible participants from DB treatment period entered OLE period after completing treatment in DB treatment period.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
DB Treatment Period: Etrasimod 2 mg
Participants who were randomized to receive etrasimod 2 milligram (mg) orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
BG001
DB Treatment Period: Etrasimod 3 mg
Participants who were randomized to receive etrasimod 2 mg orally once daily initially for Week 1 and then etrasimod 3 mg orally once daily for rest of the 23 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
BG002
DB Treatment Period: Placebo
Participants who were randomized to receive placebo matched to etrasimod orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
BG003
OLE Period: Etrasimod 2 mg [Etrasimod 2 mg in DB Treatment Period]
Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 2 mg orally once daily in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.
BG004
OLE Period: Etrasimod 2 mg [Placebo in DB Treatment Period]
Participants who received placebo matched to etrasimod in DB treatment period, received etrasimod 2 mg orally once daily in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.
BG005
OLE Period: Etrasimod 3 mg [Etrasimod 3 mg in DB Treatment Period]
Participants who received etrasimod 3 mg (also included participants whose dose was reduced from 3 mg to 2 mg due to safety issue) in DB treatment period, received etrasimod 3 mg orally once daily in OLE period either from Week 25 to Week 52 (participants who entered OLE phase on or after protocol amendment 2.0 and 2.1) or beginning after Week 25 to Week 52 in OLE period (participants who entered OLE before protocol amendment 2.0 and 2.1). Participants were followed up for up to 4 weeks after last dose of study drug.
BG006
OLE Period: Etrasimod 3 mg [Etrasimod 2 mg in DB Treatment Period]
Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 3 mg orally once daily in OLE period either from Week 25 to Week 52 (participants who entered OLE phase on or after protocol amendment 2.0 and 2.1) or beginning after Week 25 to Week 52 in OLE period (participants who entered OLE before protocol amendment 2.0 and 2.1). Participants were followed up for up to 4 weeks after last dose of study drug.
BG007
OLE Period: Etrasimod 3 mg [Placebo in DB Treatment Period]
Participants received placebo matched to etrasimod in DB treatment period, received etrasimod 3 mg orally once daily in OLE period either from Week 25 to Week 52 (participants who entered OLE phase on or after protocol amendment 2.0 and 2.1) or beginning after Week 25 to Week 52 in OLE period (participants who entered OLE before protocol amendment 2.0 and 2.1). Participants were followed up for up to 4 weeks after last dose of study drug.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00031
BG00125
BG00224
BG0034
BG0044
BG00524
BG00620
BG00713
BG008145
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
Mean
Standard Deviation
Years
Title
Denominators
Categories
DB Treatment Period
ParticipantsBG00031
ParticipantsBG00125
ParticipantsBG00224
ParticipantsBG003
Sex: Female, Male
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
Count of Participants
Participants
Title
Denominators
Categories
DB Treatment Period
ParticipantsBG00031
ParticipantsBG00125
ParticipantsBG002
Ethnicity (NIH/OMB)
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
Count of Participants
Participants
Title
Denominators
Categories
DB Treatment Period
ParticipantsBG00031
ParticipantsBG00125
ParticipantsBG002
Race (NIH/OMB)
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
Count of Participants
Participants
Title
Denominators
Categories
DB Treatment Period
ParticipantsBG00031
ParticipantsBG00125
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percent Change From Baseline in Severity of Alopecia Tool I (SALT I) at Week 24: DB Treatment Period
SALT I is a well-validated metric used to determine the degree of hair loss based on the percentage (%) of scalp surface area involved on the top (40%), back (24%), left side (18%) and right side (18%) of the scalp for AA. Investigator determines the % scalp hair loss in a given quadrant, multiply this by the total scalp area delineated by that quadrant, and sum the resultant numbers for each quadrant to give the total % scalp hair loss with a maximum score of 100. Score range from 0% (no scalp hair loss) to 100% (complete scalp hair loss), higher scores indicated more scalp hair loss. Percent change from baseline in SALT I is reported in terms of Least square mean and standard error.
DB treatment period's full analysis set (FAS) included all randomized participants with a SALT I less than (<) 95 at baseline who received at least one dose of study drug in DB treatment period. Participants were analyzed according to the treatment they received. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Posted
Least Squares Mean
Standard Error
Percent change of scalp surface area
DB Treatment Period: Baseline (before dose on Day 1), Week 24
ID
Title
Description
OG000
DB Treatment Period: Etrasimod 2 mg
Participants who were randomized to receive etrasimod 2 milligram (mg) orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
OG001
DB Treatment Period: Etrasimod 3 mg
Participants who were randomized to receive etrasimod 2 mg orally once daily initially for Week 1 and then etrasimod 3 mg orally once daily for rest of the 23 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
OG002
DB Treatment Period: Placebo
Participants who were randomized to receive placebo matched to etrasimod orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
Units
Counts
Participants
OG00016
OG00124
OG00213
Title
Denominators
Categories
Title
Measurements
OG000-13.79± 8.557
OG001-21.43± 6.926
OG0020.35± 8.933
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Mixed model for repeated measurements (MMRM) was used for evaluation. The model included the treatment group, visit and treatment-by-visit interaction as fixed effects, disease duration and baseline SALT I score as covariates.
Mixed Models Analysis
0.2579
LS Mean Difference
-14.14
2-Sided
95
-38.933
10.648
Other
F-test
Secondary
Change From Baseline in SALT I at Week 24: DB Treatment Period
SALT I is a well-validated metric used to determine the degree of hair loss based on the percentage (%) of scalp surface area involved on the top (40%), back (24%), left side (18%) and right side (18%) of the scalp for AA. Investigator determines the % scalp hair loss in a given quadrant, multiply this by the total scalp area delineated by that quadrant, and sum the resultant numbers for each quadrant to give the total % scalp hair loss with a maximum score of 100. Score range from 0% (no scalp hair loss) to 100% (complete scalp hair loss), higher scores indicated more scalp hair loss. Change from baseline in SALT I is reported in terms of Least square mean and standard error.
DB treatment period's FAS included all randomized participants with a SALT I <95 at baseline who received at least one dose of study drug in DB treatment period. Participants were analyzed according to the treatment they received. Here, " Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Least Squares Mean
Standard Error
% of scalp surface area
DBT Period: Baseline, Week 24
ID
Title
Description
OG000
DB Treatment Period: Etrasimod 2 mg
Participants who were randomized to receive etrasimod 2 milligram (mg) orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
OG001
DB Treatment Period: Etrasimod 3 mg
Secondary
Percentage of Participants Who Achieved Greater Than or Equal to (>=) 30%, >= 50% and >=75% Improvement From Baseline in SALT I at Week 24: DB Treatment Period
SALT I is a well-validated metric used to determine the degree of hair loss based on the percentage of scalp surface area involved on the top, back, and each side of the scalp for alopecia areata (AA). Investigator determine the percent scalp hair loss in a given quadrant, multiply this by the total scalp area delineated by that quadrant, and sum the resultant numbers for each quadrant to give the total percent scalp hair loss with a maximum score of 100. Score range from 0 to 100, where 0 =no scalp hair loss to 100 = complete scalp hair loss, higher scores indicated more scalp hair loss. Percentage of participants who achieved >=30%, >=50%, >=75% improvement from baseline in SALT I at Week 24 was reported in this outcome measure.
DB treatment period's FAS included all randomized participants with a SALT I < 95 at baseline who received at least one dose of study drug in DB treatment period. Participants were analyzed according to the treatment they received. Missing data for any reason was imputed as per the non-responder imputation (NRI) method.
Posted
Number
95% Confidence Interval
Percentage of participants
DB Treatment Period: Baseline, Week 24
ID
Title
Description
OG000
DB Treatment Period: Etrasimod 2 mg
Participants who were randomized to receive etrasimod 2 milligram (mg) orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
OG001
Other Pre-specified
Number of Participants With Adverse Events (AE): DB Treatment Period
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations based on medical significance or any diagnosis of progressive multifocal leukoencephalopathy (PML). AEs included serious AEs and all non-SAEs.
DB treatment period's SAF included of all randomized participants who received at least 1 dose of study drug in DBT period. Participants were analyzed according to the treatment they received.
Posted
Count of Participants
Participants
DB Treatment Period: From first dosing date in DB up to (before the first dosing date in OLE) or (last dosing date + 4 weeks + 3 days), whichever is earlier (maximum up to 29 weeks)
ID
Title
Description
OG000
DB Treatment Period: Etrasimod 2 mg
Participants who were randomized to receive etrasimod 2 milligram (mg) orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
OG001
DB Treatment Period: Etrasimod 3 mg
Participants who were randomized to receive etrasimod 2 mg orally once daily initially for Week 1 and then etrasimod 3 mg orally once daily for rest of the 23 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
Other Pre-specified
Number of Participants With Adverse Events: OLE Period
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations based on medical significance or any diagnosis of PML. AEs included serious AEs and all non-SAEs.
OLE period's SAF included of all participants who received at least 1 dose of study drug in the OLE Period. Participants were analyzed according to the treatment they received.
Posted
Count of Participants
Participants
OLE period: From first dosing date in OLE up to last dosing date + 4 weeks + 3 days (maximum up to 33 weeks)
ID
Title
Description
OG000
OLE Period: Etrasimod 2 mg [Etrasimod 2 mg in DB Treatment Period]
Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 2 mg orally once daily in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.
OG001
OLE Period: Etrasimod 2 mg [Placebo in DB Treatment Period]
Participants who received placebo matched to etrasimod in DB treatment period, received etrasimod 2 mg orally once daily in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.
Time Frame
From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Description
Same event may appear as both SAE and 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 a serious and non-serious event during the study. Safety analysis set was evaluated.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
DB Treatment Period: Etrasimod 2 mg
Participants who were randomized to receive etrasimod 2 milligram (mg) orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
0
31
0
31
11
31
EG001
DB Treatment Period: Etrasimod 3 mg
Participants who were randomized to receive etrasimod 2 mg orally once daily initially for Week 1 and then etrasimod 3 mg orally once daily for rest of the 23 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
0
25
0
25
12
25
EG002
DB Treatment Period: Placebo
Participants who were randomized to receive placebo matched to etrasimod orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
0
23
0
23
11
23
EG003
OLE Period: Etrasimod 2 mg [Etrasimod 2 mg in DB Treatment Period]
Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 2 mg orally once daily in OLE period.Participants were followed up for up to 4 weeks after last dose of study drug.
0
4
1
4
3
4
EG004
OLE Period: Etrasimod 2 mg [Placebo in DB Treatment Period]
Participants who received placebo matched to etrasimod in DB treatment period, received etrasimod 2 mg orally once daily in OLE period.Participants were followed up for up to 4 weeks after last dose of study drug.
0
4
0
4
2
4
EG005
OLE Period: Etrasimod 3 mg [Etrasimod 3 mg in DB Treatment Period]
Participants who received etrasimod 3 mg in DB treatment period, received etrasimod 3 mg orally once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.
0
24
1
24
14
24
EG006
OLE Period: Etrasimod 3 mg [Etrasimod 2 mg in DB Treatment Period]
Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 3 mg orally once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period.Participants were followed up for up to 4 weeks after last dose of study drug.
0
20
0
20
11
20
EG007
OLE Period: Etrasimod 3 mg [Placebo in DB Treatment Period]
Participants received placebo matched to etrasimod in DB treatment period, received etrasimod 3 mg once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period.Participants were followed up for up to 4 weeks after last dose of study drug.
0
13
0
13
11
13
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
COVID-19 pneumonia
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG0031 affected4 at risk
EG0040 affected4 at risk
EG0050 affected24 at risk
EG0060 affected20 at risk
EG0070 affected13 at risk
Myelopathy
Nervous system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Radiculopathy
Nervous system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0002 affected31 at risk
EG0011 affected25 at risk
EG0021 affected23 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected24 at risk
EG0061 affected20 at risk
EG0071 affected13 at risk
COVID-19
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0001 affected31 at risk
EG0012 affected25 at risk
EG0023 affected23 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0001 affected31 at risk
EG0011 affected25 at risk
EG0023 affected23 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0013 affected25 at risk
EG0021 affected23 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0022 affected23 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0022 affected23 at risk
EG003
Gamma-glutamyl transferase increased
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0002 affected31 at risk
EG0012 affected25 at risk
EG0021 affected23 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0002 affected31 at risk
EG0011 affected25 at risk
EG0021 affected23 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0003 affected31 at risk
EG0011 affected25 at risk
EG0021 affected23 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0002 affected31 at risk
EG0010 affected25 at risk
EG0022 affected23 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0012 affected25 at risk
EG0020 affected23 at risk
EG003
Headache
Nervous system disorders
MedDRA 24.1
Non-systematic Assessment
EG0004 affected31 at risk
EG0012 affected25 at risk
EG0024 affected23 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0012 affected25 at risk
EG0021 affected23 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Atrioventricular block second degree
Cardiac disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Supraventricular extrasystoles
Cardiac disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Eye pain
Eye disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Fuchs' syndrome
Eye disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Fatigue
General disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Influenza like illness
General disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Malaise
General disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Nodule
General disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Blood pressure increased
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Electrocardiogram abnormal
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Tri-iodothyronine free increased
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Migraine
Nervous system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Retinal migraine
Nervous system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Menstruation irregular
Reproductive system and breast disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Postmenopausal haemorrhage
Reproductive system and breast disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Hypopnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected31 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
MMRM was used for evaluation. The model included the treatment group, visit and treatment-by-visit interaction as fixed effects, disease duration and baseline SALT I score as covariates.
Mixed Models Analysis
0.0592
LS Mean Difference
-21.79
2-Sided
95
-44.446
0.871
Other
F-test
Participants who were randomized to receive etrasimod 2 mg orally once daily initially for Week 1 and then etrasimod 3 mg orally once daily for rest of the 23 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
OG002
DB Treatment Period: Placebo
Participants who were randomized to receive placebo matched to etrasimod orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
Units
Counts
Participants
OG00016
OG00124
OG00213
Title
Denominators
Categories
Title
Measurements
OG000-8.87± 4.142
OG001-8.62± 3.351
OG0020.36± 4.314
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
MMRM was used for evaluation. The model included the treatment group, visit and treatment-by-visit interaction as fixed effects, disease duration and baseline SALT I score as covariates.
Mixed Models Analysis
0.1283
Least square (LS) Mean Difference
-9.23
2-Sided
95
-21.217
2.748
Other
F-test
OG001
OG002
MMRM was used for evaluation. The model included the treatment group, visit and treatment-by-visit interaction as fixed effects, disease duration and baseline SALT I score as covariates.
Mixed Models Analysis
0.1057
LS Mean Difference
-8.99
2-Sided
95
-19.936
1.962
Other
F-test
DB Treatment Period: Etrasimod 3 mg
Participants who were randomized to receive etrasimod 2 mg orally once daily initially for Week 1 and then etrasimod 3 mg orally once daily for rest of the 23 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
OG002
DBT Period: Placebo
Participants received placebo matching to etrasimod orally once daily for 24 weeks in DBT period.
Units
Counts
Participants
OG00017
OG00125
OG00216
Title
Denominators
Categories
>= 30% Improvement
Title
Measurements
OG00023.5(6.81 to 49.90)
OG00136.0(17.97 to 57.48)
OG00212.5(1.55 to 38.35)
>= 50% Improvement
Title
Measurements
OG00011.8(1.46 to 36.44)
OG00128.0(12.07 to 49.39)
OG00212.5(1.55 to 38.35)
>= 75% Improvement
Title
Measurements
OG0005.9(0.15 to 28.69)
OG00112.0(2.55 to 31.22)
OG0020.000(0.00 to 20.59)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
>= 30% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 2 mg and DB Treatment period: Placebo
Cochran-Mantel-Haenszel
0.4067
P-values were based on the comparison of etrasimod versus placebo.
Response rate difference
11.5
2-Sided
95
-14.22
37.31
Clopper-Pearson method
Other
OG001
OG002
>= 30% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 3 mg and DB Treatment period: Placebo
Cochran-Mantel-Haenszel
0.2171
P-values were based on the comparison of etrasimod versus placebo.
Response rate difference
17.5
2-Sided
95
-8.23
43.19
Clopper-Pearson method
Other
OG000
OG002
>= 50% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 2 mg and DB Treatment period: Placebo
Cochran-Mantel-Haenszel
0.9425
P-values were based on the comparison of etrasimod versus placebo.
Response rate difference
-0.8
2-Sided
95
-23.18
21.48
Clopper-Pearson method
Other
OG001
OG002
>= 50% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 3 mg and DB Treatment period: Placebo
Cochran-Mantel-Haenszel
0.4959
P-values were based on the comparison of etrasimod versus placebo.
Response rate difference
8.9
2-Sided
95
-15.19
32.94
Clopper-Pearson method
Other
OG000
OG002
>= 75% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 2 mg and DB Treatment period: Placebo
Cochran-Mantel-Haenszel
0.3576
P-values are based on the comparison of Etrasimod versus placebo.
Response rate difference
5.6
2-Sided
95
-5.39
16.59
Clopper-Pearson method
Other
OG001
OG002
>= 75% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 3 mg and DB Treatment period: Placebo.
Cochran-Mantel-Haenszel
0.2904
P-values were based on the comparison of etrasimod versus placebo.
Response rate difference
8.3
2-Sided
95
-3.43
20.12
Clopper-Pearson method
Other
OG002
DB Treatment Period: Placebo
Participants who were randomized to receive placebo matched to etrasimod orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
Units
Counts
Participants
OG00031
OG00125
OG00223
Title
Denominators
Categories
Title
Measurements
OG00021
OG00120
OG00218
OG002
OLE Period: Etrasimod 3 mg [Etrasimod 3 mg in DBT]
Participants who received etrasimod 3 mg in DB treatment period, received etrasimod 3 mg orally once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.
OG003
OLE Period: Etrasimod 3 mg [Etrasimod 2 mg in DB Treatment Period]
Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 3 mg orally once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.
OG004
OLE Period: Etrasimod 3 mg [Placebo in DB Treatment Period]
Participants received placebo matched to etrasimod in DB treatment period, received etrasimod 3 mg once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period.Participants were followed up for up to 4 weeks after last dose of study drug.