- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04556734
Safety and Efficacy of Oral Etrasimod in Adult Participants With Moderate-to-Severe Alopecia Areata
July 11, 2023 updated by: Pfizer
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
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Arena CT.gov Administrator
- Phone Number: +1 855-218-9153
- Email: ct.gov@arenapharm.com
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T2J 7E1
- Dermatology Research Institute
-
Edmonton, Alberta, Canada, T5J 3S9
- Laser Rejuvenation Clinics Edmonton D.T. Inc.
-
-
Quebec
-
Montreal, Quebec, Canada, H2X 2V1
- Innovaderm Research
-
-
-
-
Arizona
-
Scottsdale, Arizona, United States, 85255
- Investigate MD
-
-
Arkansas
-
Bryant, Arkansas, United States, 72022
- Dermatology Trial Associates
-
-
California
-
Encinitas, California, United States, 92024
- California Dermatology & Clinical Research Institute
-
Fountain Valley, California, United States, 92708
- First OC Dermatology
-
Irvine, California, United States, 92697
- University of California,Irvine
-
Lomita, California, United States, 90717
- Prospect Optometry
-
Lomita, California, United States, 90717
- Torrance Clinical Research Institute,Inc.
-
-
Connecticut
-
New Haven, Connecticut, United States, 06519
- Yale Center for Clinical Investigation
-
New Haven, Connecticut, United States, 06511
- Yale Eye Center
-
New Haven, Connecticut, United States, 06511
- Yale Investigational Drug Services
-
New Haven, Connecticut, United States, 06519
- Yale New Haven Hospital Department of Respiratory Care
-
-
Florida
-
Daytona Beach, Florida, United States, 32117
- Advanced Sleep & Respiratory Institute, PA
-
Ormond Beach, Florida, United States, 32174
- International Eye Associates
-
Ormond Beach, Florida, United States, 32174
- Leavitt Medical Associates of Florida d/ba Ameriderm Research
-
Tampa, Florida, United States, 33607
- Advanced Clinical Research Institute
-
-
Georgia
-
Sandy Springs, Georgia, United States, 30328
- Advanced Medical Research Pc
-
-
Indiana
-
Indianapolis, Indiana, United States, 46250
- Dawes Fretzin Clinical Research Group, LLC
-
Indianapolis, Indiana, United States, 46260
- Eye Surgeons of Indiana
-
Lafayette, Indiana, United States, 47905
- Magnante Eye Care (Ophthalmological Assessments)
-
Noblesville, Indiana, United States, 46060
- Physicians Research Group (Administrative Office Location)
-
West Lafayette, Indiana, United States, 47906
- Physicians Research Group
-
West Lafayette, Indiana, United States, 47906
- Randall Dermatology, PC
-
-
Maryland
-
Rockville, Maryland, United States, 20850
- Lawrence J. Green, MD LLC
-
-
Michigan
-
Clinton Township, Michigan, United States, 48038
- Michigan Center for Skin Care Research
-
-
Missouri
-
Saint Joseph, Missouri, United States, 64506
- MediSearch Clinical Trials
-
-
New York
-
New York, New York, United States, 10003
- NYC Retina- Manhattan
-
New York, New York, United States, 10012
- Bobby Buka MD, PC
-
Rochester, New York, United States, 14623
- Skin Search of Rochester, Inc.
-
Rochester, New York, United States, 14623
- Rochester Ophthalmological Group
-
-
North Carolina
-
Wilmington, North Carolina, United States, 28405
- WDC Cosmetic and Research, PLLC
-
-
Oregon
-
Portland, Oregon, United States, 97210
- NW Dermatology Institute
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- UPMC Eye Center
-
Pittsburgh, Pennsylvania, United States, 15213
- UPMC Department of Dermatology
-
-
Tennessee
-
Murfreesboro, Tennessee, United States, 37130
- International Clinical Research - Tennessee LLC
-
-
Texas
-
San Antonio, Texas, United States, 78213
- Progressive Clinical Research, PA
-
-
Virginia
-
Lynchburg, Virginia, United States, 24501
- The Education & Research Foundation, Inc.
-
-
Washington
-
Spokane, Washington, United States, 99202
- Dermatology Specialists of Spokane
-
Spokane, Washington, United States, 99204
- PRINCIPLE RESEARCH SOLUTIONS (pulmonary function testing)
-
Spokane, Washington, United States, 99204
- SPOKANE EYE CLINIC (OCT and optical exam
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Etrasimod matching placebo tablet by mouth, once daily
|
Experimental: Etrasimod 2 mg
|
Etrasimod 2 mg tablet by mouth, once daily
Other Names:
Etrasimod 3 mg (1 mg and 2 mg tablets) by mouth, once daily
Other Names:
|
Experimental: Etrasimod 3 mg
|
Etrasimod 2 mg tablet by mouth, once daily
Other Names:
Etrasimod 3 mg (1 mg and 2 mg tablets) by mouth, once daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent Change From Baseline in Severity of Alopecia Tool (SALT)
Time Frame: Baseline to Week 24
|
Baseline to Week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in SALT
Time Frame: Baseline to Week 24
|
Baseline to Week 24
|
|
Proportion of Participants Achieving ≥30% Improvement From Baseline in SALT
Time Frame: Baseline to Week 24
|
Baseline to Week 24
|
|
Proportion of Participants Achieving ≥50% Improvement From Baseline in SALT
Time Frame: Baseline to Week 24
|
Baseline to Week 24
|
|
Proportion of Participants Achieving ≥75% Improvement From Baseline in SALT
Time Frame: Baseline to Week 24
|
Baseline to Week 24
|
|
Number and Severity of Adverse Events (Double-Blind Treatment Period and Open-Label Extension Period)
Time Frame: Up to approximately 56 weeks (24-weeks of Double-Blind Treatment Period, 28-weeks of Open-Label Extension Period, and 4-weeks of Safety Follow-Up Period)
|
Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
|
Up to approximately 56 weeks (24-weeks of Double-Blind Treatment Period, 28-weeks of Open-Label Extension Period, and 4-weeks of Safety Follow-Up Period)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 29, 2020
Primary Completion (Actual)
June 7, 2023
Study Completion (Actual)
June 7, 2023
Study Registration Dates
First Submitted
September 15, 2020
First Submitted That Met QC Criteria
September 15, 2020
First Posted (Actual)
September 21, 2020
Study Record Updates
Last Update Posted (Actual)
July 12, 2023
Last Update Submitted That Met QC Criteria
July 11, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- APD334-205
- C5041008 (Other Identifier: Alias Study Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alopecia Areata
-
Eli Lilly and CompanyRecruitingSkin Diseases | Pathological Conditions, Anatomical | Alopecia | Hypotrichosis | Hair Diseases | Areata AlopeciaUnited States, Taiwan, Japan, Spain, Korea, Republic of, Germany, France, Mexico, Canada, Poland, Australia, Hungary, Argentina
-
Suzhou Zelgen Biopharmaceuticals Co.,LtdActive, not recruitingAlopecia Areata(AA)China
-
University Hospital, RouenCompletedALOPECIA AREATAFrance
-
Services Institute of Medical Sciences, PakistanCompletedExtensive Alopecia AreataPakistan
-
Yale UniversityCompletedAlopecia Areata (AA) | Alopecia Totalis (AT) | Alopecia Universalis (AU)United States
-
Inmagene LLCRecruitingAlopecia Areata (AA)United States, Canada
-
Siriraj HospitalCompletedRecalcitrant Alopecia Totalis | Recalcitrant Alopecia UniversalisThailand
-
EquilliumWithdrawnAlopecia Areata | Alopecia Totalis | Alopecia Universalis
-
Lindsey BordoneWithdrawnAlopecia Areata | Alopecia Totalis | Alopecia Universalis
-
Aclaris Therapeutics, Inc.Completed
Clinical Trials on Etrasimod
-
Arena PharmaceuticalsCompletedAtopic DermatitisUnited States, Australia, Canada
-
PfizerNot yet recruiting
-
PfizerCompletedHealthy ParticipantsBelgium
-
PfizerIn Expanded Access, treating physicians are the SponsorsAvailable
-
PfizerArena is a wholly owned subsidiary of PfizerRecruitingUlcerative ColitisUnited States, Spain, Japan, Belgium, Austria, Poland
-
Everstar Therapeutics LimitedActive, not recruitingModerately to Severely Active Ulcerative ColitisChina
-
Arena PharmaceuticalsTerminatedPrimary Biliary CholangitisUnited States, Australia, New Zealand
-
Arena PharmaceuticalsTerminatedInflammatory Bowel Diseases | Skin Extra-intestinal ManifestationsBelgium, Germany, Serbia
-
PfizerArena is a wholly owned subsidiary of PfizerRecruitingUlcerative ColitisPoland, Japan, Georgia, Estonia, United States, Czechia, Australia, Korea, Republic of, Lithuania, Italy, Hungary, Turkey, Spain, Romania, Serbia, Germany, France, Bulgaria, Austria, Belarus, Canada, Croatia, Denmark, Israel, Latvia, Lebanon and more
-
Arena PharmaceuticalsTerminatedPyoderma GangrenosumAustralia, New Zealand