Clinical trial NCT04162769: A Study to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Atopic Dermatitis
Official title: A Multicenter, Randomized, Double-Blinded, Placebo-Controlled 16-Week Study (With a 52-Week Open-Label Extension) to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Moderate-to-severe atopic dermatitis
Etrasimod
APD334
Lead sponsor: Arena Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-11-14
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderate-to-severe atopic dermatitis (AD).


Eligibility criteria: Inclusion criteria:

* Participants with chronic atopic dermatitis, defined by Hanifin and Rajka criteria, that has been present for at least 1 year prior to the Screening Visit
* Participants with Eczema Area and Severity Index (EASI) ≥ 12 at the Screening Visit and ≥ 16 at the Baseline Visit
* Participants with validated Investigator's Global Assessment (vIGA) score ≥ 3 (on the 0 to 4 vIGA scale, in which 3 = moderate and 4 = severe) involvement at the Screening and Baseline visits

Exclusion Criteria:

* Presence of skin comorbidities that would interfere with study assessments of the underlying disease.

Primary outcomes:
measure: Double-blind Treatment Period: Percent Change in Eczema Area and Severity Index (EASI) Score
timeFrame: Baseline (Day 1) and Week 12
Secondary outcomes:
measure: Double-blind Treatment Period: Percentage of Participants Achieving EASI-75
timeFrame: Baseline (Day 1) and Week 12
measure: Double-blind Treatment Period: Percentage of Participants Achieving a Validated Investigator Global Assessment (vIGA) 0 or 1 Score and a Reduction From Baseline of >= 2 Points
timeFrame: Baseline (Day 1) and Week 12
measure: Double-blind Treatment Period: Percent Change in Weekly Peak Pruritus Numerical Rating Scale (NRS) From an Itch Daily Diary
timeFrame: Baseline (Day 1) and Week 12
measure: Double-blind Treatment Period: Percentage of Participants With Improvement (Reduction) in Peak Pruritus NRS Greater Than or Equal to (>=)3 From an Itch Daily Diary
timeFrame: Baseline (Day 1) and Week 12
measure: Double-blind Treatment Period: Percentage of Participants Achieving EASI-50
timeFrame: Baseline (Day 1) and Week 12
measure: Double-blind Treatment Period: Percentage of Participants Achieving EASI-90
timeFrame: Baseline (Day 1) and Week 12
measure: Double-blind Treatment Period: Percent Change in Percent Body Surface Area (BSA)
timeFrame: Baseline (Day 1) and Week 12
measure: Open-label Extension (OLE) Period: Percent Change in EASI
timeFrame: Baseline (Week 16) and Week 68
measure: OLE Period: Number of Participants Achieving a EASI-75 Score
timeFrame: Baseline (Week 16) and Week 68
measure: OLE Period: Number of Participants Achieving a Validated Investigator Global Assessment (vIGA) 0 or 1 Score and a Reduction From Baseline of ≥ 2 Points
timeFrame: Baseline (Week 16) and Week 68
measure: OLE Period: Percent Change in SCORing Atopic Dermatitis (SCORAD) Total Score
timeFrame: Baseline (Week 16) and Week 68
measure: OLE Period: Percent Change in Percent BSA
timeFrame: Baseline (Week 16) and Week 68
measure: OLE Period: Percent Change in Weekly Peak Pruritus NRS From an Itch Daily Diary
timeFrame: Baseline (Week 16) and Week 28
measure: OLE Period: Change in Patient-Oriented Eczema Measure (POEM)
timeFrame: Baseline (Week 16) and Week 68
measure: OLE Period: Change in Dermatology Life Quality Index (DLQI)
timeFrame: Baseline (Week 16) and Week 68
measure: OLE Period: Change in Patient Global Assessment (PGA) of Disease
timeFrame: Baseline (Week 16) and Week 68
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Noble Clinical Research
state: Arizona
city: Canoga Park
country: United States
facility: Hope Clinical Research
state: California
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Huntington Beach
country: United States
facility: Marvel Research LLC
state: California
city: Inglewood
country: United States
facility: ADVA Clinical Research, Inc
state: California
city: North Hollywood
country: United States
facility: Providence Clinical Research
state: California
city: San Diego
country: United States
facility: TCR Medical Corporation
state: California
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Doral
country: United States
facility: Prohealth Research Center
state: Florida
city: Hialeah
country: United States
facility: Aby's New Generation Research, Inc.
state: Florida
city: Hollywood
country: United States
facility: Skin Care Research, LLC
state: Florida
city: Homestead
country: United States
facility: Advanced Research Institute of Miami LLC
state: Florida
city: Homestead
country: United States
facility: Amber Pediatrics Research, LLC
state: Florida
city: Miami Shores
country: United States
facility: Amber Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: South Miami Medical & Research Group. Inc
state: Florida
city: Miami
country: United States
facility: Amber Pediatrics Research, LLC
state: Florida
city: Miami
country: United States
facility: Skin Research of South Florida
state: Florida
city: Saint Petersburg
country: United States
facility: IMA Clinical Research, LLC
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Union City
country: United States
facility: Rophe Adult and Pediatric Medicine/SKYCRNG
state: Georgia
city: Louisville
country: United States
facility: Skin Sciences PLLC
state: Kentucky
city: Ridgeland
country: United States
facility: Quinn Healthcare/SKYCRNG
state: Mississippi
city: Omaha
country: United States
facility: Quality Clinical Research Inc
state: Nebraska
city: Las Vegas
country: United States
facility: Excel Clinical Research
state: Nevada
city: New York
country: United States
facility: Greenwich Village Dermatology
state: New York
city: Portland
country: United States
facility: ODRC Enterprises, LLC dba Oregon Dermatology and Research Center
state: Oregon
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Beaumont
country: United States
facility: Gadolin Research
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates, PLLC
state: Texas
city: Georgetown
country: United States
facility: FMC Science
state: Texas
city: Lampasas
country: United States
facility: FMC Science
state: Texas
city: Norfolk
country: United States
facility: Alliance for Multispecialty Research
state: Virginia
city: Richmond
country: United States
facility: Clinical Research Partners, LLC
state: Virginia
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Kogarah
country: Australia
facility: Premier Specialists PTY LTD
state: New South Wales
city: East Melbourne
country: Australia
facility: Sinclair Dermatology
state: Victoria
city: Sherbrooke
country: Canada
facility: Diex Recherche Sherbrooke Inc.
state: Quebec
Study officials:
affiliation: Arena Pharmaceuticals
name: Arena CT.gov Administrator
role: STUDY_DIRECTOR
References: