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

• ClinicalTrials.gov Identifier: NCT04556734
• Recruitment Status: Recruiting
• First Posted: September 21, 2020
• Last Update Posted: February 9, 2021
• Sponsor: Arena Pharmaceuticals
• Information provided by (Responsible Party): Arena Pharmaceuticals

Study Description

Brief Summary:

The purpose of this study is to evaluate the safety and efficacy of etrasimod monotherapy (2 milligrams [mg]) in participants with moderate-to-severe alopecia areata.

Condition or disease	Intervention/treatment	Phase
Alopecia Areata	Drug: Etrasimod; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Estimated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Double-Blind, Placebo-Controlled
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: August 31, 2020
• Estimated Primary Completion Date: December 2021
• Estimated Study Completion Date: June 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Etrasimod 2 mg	Drug: Etrasimod; Etrasimod 2 mg tablet by mouth, once daily; Other Name: APD334
Placebo Comparator: Placebo	Drug: Placebo; Etrasimod 2 mg matching placebo tablet by mouth, once daily

Outcome Measures

Primary Outcome Measures :

1. Percent Change From Baseline in Severity of Alopecia Tool (SALT) [ Time Frame: Baseline to Week 24 ]

Secondary Outcome Measures :

1. Change From Baseline in SALT [ Time Frame: Baseline to Week 24 ]
2. Proportion of Participants Achieving a 30% Improvement From Baseline in SALT (SALT30) [ Time Frame: Baseline to Week 24 ]
3. Proportion of Participants Achieving a 50% Improvement From Baseline in SALT (SALT50) [ Time Frame: Baseline to Week 24 ]
4. Proportion of Participants Achieving a 75% Improvement From Baseline in SALT (SALT75) [ Time Frame: Baseline to Week 24 ]
5. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 (AA) as assessed by a SALT score of ≥50
• Current episode of hair loss for ≥6 months but <8 years
• Stable disease condition (ie, no significant growth or loss 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

Contacts and Locations

Contacts

Contact: Arena CT.gov Administrator; +1 855-218-9153; ct.gov@arenapharm.com

Locations

United States, Arizona

Investigate MD; Recruiting

Scottsdale, Arizona, United States, 85255

United States, Arkansas

Dermatology Trial Associates; Recruiting

Bryant, Arkansas, United States, 72022

United States, California

University of California; Recruiting

Irvine, California, United States, 92697

United States, Connecticut

Yale Center for Clinical Investigation; Recruiting

New Haven, Connecticut, United States, 06519

United States, Florida

Leavitt Medical Associates of Florida, Inc d/b/a Ameriderm Research; Recruiting

Ormond Beach, Florida, United States, 32174

United States, Michigan

Michigan Center for Skin Care Research; Recruiting

Clinton Township, Michigan, United States, 48038

United States, Oregon

NW Dermatology Institute; Recruiting

Portland, Oregon, United States, 97210

United States, Tennessee

International Clinical Research - Tennessee LLC; Recruiting

Murfreesboro, Tennessee, United States, 37130

United States, Texas

Progressive Clinical Research, PA; Recruiting

San Antonio, Texas, United States, 78213

United States, Washington

Dermatology Specialists of Spokane; Recruiting

Spokane, Washington, United States, 99202

Canada, Quebec

Innovaderm Research Inc.; Recruiting

Montreal, Quebec, Canada, H2X 2V1

Sponsors and Collaborators

Arena Pharmaceuticals

Investigators

• Study Director: Arena CT.gov Administrator; Arena Pharmaceuticals

More Information

• Responsible Party: Arena Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT04556734
• Other Study ID Numbers: APD334-205
• First Posted: September 21, 2020
• Last Update Posted: February 9, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Arena Pharmaceuticals:

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

Additional relevant MeSH terms:

Alopecia; Alopecia Areata; Hypotrichosis; Hair Diseases; Skin Diseases; Pathological Conditions, Anatomical