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Safety and Efficacy of Oral Etrasimod in Adult Participants With Moderate-to-Severe Alopecia Areata

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04556734
Enrollment
80
Registered
2020-09-21
Start date
2020-07-29
Completion date
2023-06-07
Last updated
2024-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alopecia Areata

Keywords

T-cell-mediated autoimmune skin disorder, Alopecia areata, Alopecia, APD334, Etrasimod, Hair loss

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).

Interventions

DRUGEtrasimod

Etrasimod 2 mg tablet by mouth, once daily

DRUGPlacebo

Etrasimod matching placebo tablet by mouth, once daily

Sponsors

Arena is a wholly owned subsidiary of Pfizer
CollaboratorINDUSTRY
Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

Double-Blind, Placebo-Controlled

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Percent Change From Baseline in Severity of Alopecia Tool I (SALT I) at Week 24: DB Treatment PeriodDB Treatment Period: Baseline (before dose on Day 1), Week 24SALT 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.

Secondary

MeasureTime frameDescription
Change From Baseline in SALT I at Week 24: DB Treatment PeriodDBT Period: Baseline, Week 24SALT 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.
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 PeriodDB Treatment Period: Baseline, Week 24SALT 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.

Other

MeasureTime frameDescription
Number of Participants With Adverse Events (AE): DB Treatment PeriodDB 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)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.
Number of Participants With Adverse Events: OLE PeriodOLE period: From first dosing date in OLE up to last dosing date + 4 weeks + 3 days (maximum up to 33 weeks)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.

Countries

Canada, United States

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
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.
31
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.
25
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.
24
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.
4
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.
4
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.
24
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.
20
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.
13
Total145

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007
DB Treatment Period (24 Weeks)Adverse Event10000000
DB Treatment Period (24 Weeks)Lost to Follow-up10100000
DB Treatment Period (24 Weeks)Protocol Violation10000000
DB Treatment Period (24 Weeks)Randomized but not treated00100000
DB Treatment Period (24 Weeks)Withdrawal by Subject41500000
OLE Period (28 Weeks)Adverse Event00010002
OLE Period (28 Weeks)Lost to Follow-up00000002
OLE Period (28 Weeks)Not reported00000100
OLE Period (28 Weeks)Withdrawal by Subject00013210

Baseline characteristics

CharacteristicDB Treatment Period: Etrasimod 2 mgDB Treatment Period: Etrasimod 3 mgDB Treatment Period: PlaceboTotalOLE Period: Etrasimod 2 mg [Etrasimod 2 mg in DB Treatment Period]OLE Period: Etrasimod 2 mg [Placebo in DB Treatment Period]OLE Period: Etrasimod 3 mg [Etrasimod 3 mg in DB Treatment Period]OLE Period: Etrasimod 3 mg [Etrasimod 2 mg in DB Treatment Period]OLE Period: Etrasimod 3 mg [Placebo in DB Treatment Period]
Age, Continuous
DB Treatment Period
36.6 Years
STANDARD_DEVIATION 12.6
41.7 Years
STANDARD_DEVIATION 16.63
43.4 Years
STANDARD_DEVIATION 13.25
40.4 Years
STANDARD_DEVIATION 14.33
—————
Age, Continuous
OLE Period
———40.4 Years
STANDARD_DEVIATION 14.35
38.0 Years
STANDARD_DEVIATION 14.99
43.5 Years
STANDARD_DEVIATION 15.67
42.4 Years
STANDARD_DEVIATION 16.65
35.1 Years
STANDARD_DEVIATION 12.17
44.8 Years
STANDARD_DEVIATION 11.53
Ethnicity (NIH/OMB)
DB Treatment Period
Hispanic or Latino
4 Participants4 Participants2 Participants10 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
DB Treatment Period
Not Hispanic or Latino
25 Participants21 Participants20 Participants66 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
DB Treatment Period
Unknown or Not Reported
2 Participants0 Participants2 Participants4 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
OLE Period
Hispanic or Latino
0 Participants0 Participants0 Participants7 Participants0 Participants0 Participants3 Participants4 Participants0 Participants
Ethnicity (NIH/OMB)
OLE Period
Not Hispanic or Latino
0 Participants0 Participants0 Participants55 Participants4 Participants4 Participants21 Participants14 Participants12 Participants
Ethnicity (NIH/OMB)
OLE Period
Unknown or Not Reported
0 Participants0 Participants0 Participants3 Participants0 Participants0 Participants0 Participants2 Participants1 Participants
Race (NIH/OMB)
DB Treatment Period
American Indian or Alaska Native
1 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
DB Treatment Period
Asian
1 Participants3 Participants0 Participants4 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
DB Treatment Period
Black or African American
2 Participants3 Participants6 Participants11 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
DB Treatment Period
More than one race
2 Participants1 Participants0 Participants3 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
DB Treatment Period
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants1 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
DB Treatment Period
Unknown or Not Reported
0 Participants2 Participants0 Participants2 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
DB Treatment Period
White
25 Participants16 Participants17 Participants58 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
OLE Period
American Indian or Alaska Native
0 Participants0 Participants0 Participants1 Participants1 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
OLE Period
Asian
0 Participants0 Participants0 Participants4 Participants1 Participants0 Participants3 Participants0 Participants0 Participants
Race (NIH/OMB)
OLE Period
Black or African American
0 Participants0 Participants0 Participants10 Participants0 Participants1 Participants3 Participants2 Participants4 Participants
Race (NIH/OMB)
OLE Period
More than one race
0 Participants0 Participants0 Participants3 Participants0 Participants0 Participants1 Participants2 Participants0 Participants
Race (NIH/OMB)
OLE Period
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants1 Participants0 Participants1 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
OLE Period
Unknown or Not Reported
0 Participants0 Participants0 Participants2 Participants0 Participants0 Participants2 Participants0 Participants0 Participants
Race (NIH/OMB)
OLE Period
White
0 Participants0 Participants0 Participants44 Participants2 Participants2 Participants15 Participants16 Participants9 Participants
Sex: Female, Male
DB Treatment Period
Female
16 Participants21 Participants22 Participants59 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
DB Treatment Period
Male
15 Participants4 Participants2 Participants21 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
OLE Period
Female
0 Participants0 Participants0 Participants46 Participants1 Participants3 Participants20 Participants9 Participants13 Participants
Sex: Female, Male
OLE Period
Male
0 Participants0 Participants0 Participants19 Participants3 Participants1 Participants4 Participants11 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
deaths
Total, all-cause mortality
0 / 310 / 250 / 230 / 40 / 40 / 240 / 200 / 13
other
Total, other adverse events
11 / 3112 / 2511 / 233 / 42 / 414 / 2411 / 2011 / 13
serious
Total, serious adverse events
0 / 310 / 250 / 231 / 40 / 41 / 240 / 200 / 13

Outcome results

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.

Time frame: DB Treatment Period: Baseline (before dose on Day 1), Week 24

Population: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
DB Treatment Period: Etrasimod 2 mgPercent Change From Baseline in Severity of Alopecia Tool I (SALT I) at Week 24: DB Treatment Period-13.79 Percent change of scalp surface areaStandard Error 8.557
DB Treatment Period: Etrasimod 3 mgPercent Change From Baseline in Severity of Alopecia Tool I (SALT I) at Week 24: DB Treatment Period-21.43 Percent change of scalp surface areaStandard Error 6.926
DB Treatment Period: PlaceboPercent Change From Baseline in Severity of Alopecia Tool I (SALT I) at Week 24: DB Treatment Period0.35 Percent change of scalp surface areaStandard Error 8.933
Comparison: 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.p-value: 0.257995% CI: [-38.933, 10.648]Mixed Models Analysis
Comparison: 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.p-value: 0.059295% CI: [-44.446, 0.871]Mixed Models Analysis
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.

Time frame: DBT Period: Baseline, Week 24

Population: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
DB Treatment Period: Etrasimod 2 mgChange From Baseline in SALT I at Week 24: DB Treatment Period-8.87 % of scalp surface areaStandard Error 4.142
DB Treatment Period: Etrasimod 3 mgChange From Baseline in SALT I at Week 24: DB Treatment Period-8.62 % of scalp surface areaStandard Error 3.351
DB Treatment Period: PlaceboChange From Baseline in SALT I at Week 24: DB Treatment Period0.36 % of scalp surface areaStandard Error 4.314
Comparison: 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.p-value: 0.128395% CI: [-21.217, 2.748]Mixed Models Analysis
Comparison: 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.p-value: 0.105795% CI: [-19.936, 1.962]Mixed Models Analysis
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.

Time frame: DB Treatment Period: Baseline, Week 24

Population: 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.

ArmMeasureGroupValue (NUMBER)
DB Treatment Period: Etrasimod 2 mgPercentage 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>= 50% Improvement11.8 Percentage of participants
DB Treatment Period: Etrasimod 2 mgPercentage 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>= 30% Improvement23.5 Percentage of participants
DB Treatment Period: Etrasimod 2 mgPercentage 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>= 75% Improvement5.9 Percentage of participants
DB Treatment Period: Etrasimod 3 mgPercentage 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>= 50% Improvement28.0 Percentage of participants
DB Treatment Period: Etrasimod 3 mgPercentage 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>= 30% Improvement36.0 Percentage of participants
DB Treatment Period: Etrasimod 3 mgPercentage 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>= 75% Improvement12.0 Percentage of participants
DB Treatment Period: PlaceboPercentage 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>= 30% Improvement12.5 Percentage of participants
DB Treatment Period: PlaceboPercentage 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>= 75% Improvement0.000 Percentage of participants
DB Treatment Period: PlaceboPercentage 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>= 50% Improvement12.5 Percentage of participants
Comparison: \>= 30% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 2 mg and DB Treatment period: Placebop-value: 0.406795% CI: [-14.22, 37.31]Cochran-Mantel-Haenszel
Comparison: \>= 30% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 3 mg and DB Treatment period: Placebop-value: 0.217195% CI: [-8.23, 43.19]Cochran-Mantel-Haenszel
Comparison: \>= 50% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 2 mg and DB Treatment period: Placebop-value: 0.942595% CI: [-23.18, 21.48]Cochran-Mantel-Haenszel
Comparison: \>= 50% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 3 mg and DB Treatment period: Placebop-value: 0.495995% CI: [-15.19, 32.94]Cochran-Mantel-Haenszel
Comparison: \>= 75% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 2 mg and DB Treatment period: Placebop-value: 0.357695% CI: [-5.39, 16.59]Cochran-Mantel-Haenszel
Comparison: \>= 75% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 3 mg and DB Treatment period: Placebo.p-value: 0.290495% CI: [-3.43, 20.12]Cochran-Mantel-Haenszel
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.

Time frame: 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)

Population: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
DB Treatment Period: Etrasimod 2 mgNumber of Participants With Adverse Events (AE): DB Treatment Period21 Participants
DB Treatment Period: Etrasimod 3 mgNumber of Participants With Adverse Events (AE): DB Treatment Period20 Participants
DB Treatment Period: PlaceboNumber of Participants With Adverse Events (AE): DB Treatment Period18 Participants
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.

Time frame: OLE period: From first dosing date in OLE up to last dosing date + 4 weeks + 3 days (maximum up to 33 weeks)

Population: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
DB Treatment Period: Etrasimod 2 mgNumber of Participants With Adverse Events: OLE Period3 Participants
DB Treatment Period: Etrasimod 3 mgNumber of Participants With Adverse Events: OLE Period2 Participants
DB Treatment Period: PlaceboNumber of Participants With Adverse Events: OLE Period18 Participants
OLE Period: Etrasimod 3 mg [Etrasimod 2 mg in DB Treatment Period]Number of Participants With Adverse Events: OLE Period14 Participants
OLE Period: Etrasimod 3 mg [Placebo in DB Treatment Period]Number of Participants With Adverse Events: OLE Period11 Participants

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026