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Sphingosine 1-phosphate receptor modulator

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

Phase 2
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ole period: from first dosing date in ole up to last dosing date + 4 weeks + 3 days (maximum up to 33 weeks)

Summary

This trial is testing the safety and effectiveness of etrasimod, a medication taken alone, in people with significant hair loss due to alopecia areata. The drug works by adjusting the immune system to help reduce hair loss.

Eligible Conditions
  • Alopecia Areata

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent Change From Baseline in Severity of Alopecia Tool I (SALT I) at Week 24: DB Treatment Period
Secondary study objectives
Change From Baseline in SALT I at Week 24: DB Treatment Period
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
Other study objectives
Number of Participants With Adverse Events (AE): DB Treatment Period
Number of Participants With Adverse Events: OLE Period

Side effects data

From 2022 Phase 3 trial • 42 Patients • NCT04706793
14%
Headache
11%
Malaise
11%
Pyrexia
7%
Colitis ulcerative
7%
Vaccination site pain
4%
Back pain
4%
COVID-19
4%
Contusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Comparator: Placebo
Experimental: Etrasimod 2 mg

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Etrasimod 3 mgExperimental Treatment1 Intervention
Group II: Etrasimod 2 mgExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etrasimod
2020
Completed Phase 3
~1580

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,675 Previous Clinical Trials
28,717,102 Total Patients Enrolled
14 Trials studying Alopecia Areata
85,992 Patients Enrolled for Alopecia Areata
Arena is a wholly owned subsidiary of PfizerIndustry Sponsor
10 Previous Clinical Trials
2,491 Total Patients Enrolled
Arena PharmaceuticalsLead Sponsor
28 Previous Clinical Trials
5,722 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,556 Previous Clinical Trials
25,757,958 Total Patients Enrolled
7 Trials studying Alopecia Areata
2,886 Patients Enrolled for Alopecia Areata
Arena CT.gov AdministratorStudy DirectorArena Pharmaceuticals
21 Previous Clinical Trials
4,728 Total Patients Enrolled
~15 spots leftby Jan 2026
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