Adults 18 to 70, any sex, with Alopecia Areata. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percent Change From Baseline in Severity of Alopecia Tool I (SALT I) at Week 24: DB Treatment PeriodPrimary· DB Treatment Period: Baseline (before dose on Day 1), Week 24
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
Group
Value
95% CI
DB Treatment Period: Etrasimod 2 mg
-13.79
± 8.557
DB Treatment Period: Etrasimod 3 mg
-21.43
± 6.926
DB Treatment Period: Placebo
0.35
± 8.933
Change From Baseline in SALT I at Week 24: DB Treatment PeriodSecondary· DBT Period: Baseline, Week 24
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
Group
Value
95% CI
DB Treatment Period: Etrasimod 2 mg
-8.87
± 4.142
DB Treatment Period: Etrasimod 3 mg
-8.62
± 3.351
DB Treatment Period: Placebo
0.36
± 4.314
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 PeriodSecondary· DB Treatment Period: Baseline, Week 24
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. Perc
>= 30% Improvement
Group
Value
95% CI
DB Treatment Period: Etrasimod 2 mg
23.5
6.81 – 49.90
DB Treatment Period: Etrasimod 3 mg
36.0
17.97 – 57.48
DBT Period: Placebo
12.5
1.55 – 38.35
>= 50% Improvement
Group
Value
95% CI
DB Treatment Period: Etrasimod 2 mg
11.8
1.46 – 36.44
DB Treatment Period: Etrasimod 3 mg
28.0
12.07 – 49.39
DBT Period: Placebo
12.5
1.55 – 38.35
>= 75% Improvement
Group
Value
95% CI
DB Treatment Period: Etrasimod 2 mg
5.9
0.15 – 28.69
DB Treatment Period: Etrasimod 3 mg
12.0
2.55 – 31.22
DBT Period: Placebo
0.000
0.00 – 20.59
Number of Participants With Adverse Events (AE): DB Treatment PeriodSecondary· 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)
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.
Group
Value
95% CI
DB Treatment Period: Etrasimod 2 mg
21
DB Treatment Period: Etrasimod 3 mg
20
DB Treatment Period: Placebo
18
Number of Participants With Adverse Events: OLE PeriodSecondary· OLE 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.
Group
Value
95% CI
OLE Period: Etrasimod 2 mg [Etrasimod 2 mg in DB Treatment Period]
3
OLE Period: Etrasimod 2 mg [Placebo in DB Treatment Period]
2
OLE Period: Etrasimod 3 mg [Etrasimod 3 mg in DBT]
18
OLE Period: Etrasimod 3 mg [Etrasimod 2 mg in DB Treatment Period]
14
OLE Period: Etrasimod 3 mg [Placebo in DB Treatment Period]
11
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
DB Treatment Period: Etrasimod 2 mg
Serious: 0/31 (0%)
Deaths: 0/31
DB Treatment Period: Etrasimod 3 mg
Serious: 0/25 (0%)
Deaths: 0/25
DB Treatment Period: Placebo
Serious: 0/23 (0%)
Deaths: 0/23
OLE Period: Etrasimod 2 mg [Etrasimod 2 mg in DB Treatment Period]
Serious: 1/4 (25%)
Deaths: 0/4
OLE Period: Etrasimod 2 mg [Placebo in DB Treatment Period]
Serious: 0/4 (0%)
Deaths: 0/4
OLE Period: Etrasimod 3 mg [Etrasimod 3 mg in DB Treatment Period]
Serious: 1/24 (4%)
Deaths: 0/24
OLE Period: Etrasimod 3 mg [Etrasimod 2 mg in DB Treatment Period]
Serious: 0/20 (0%)
Deaths: 0/20
OLE Period: Etrasimod 3 mg [Placebo in DB Treatment Period]
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).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07470879 — A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis
· Phase 2
· not yet recruiting
NCT07153159 — A Study to Learn How the Study Medicine Called Etrasimod is Taken up Into Blood and Breastmilk of Healthy Breastfeeding
· Phase 1
· recruiting
NCT06398626 — An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis
· recruiting
NCT06294925 — A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis
· recruiting
NCT05287126 — A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
· Phase 2
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 26 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04556734.