Trials Sponsors Conditions Drugs Pricing

Conditions

Atopic Dermatitis

Keywords

Moderate-to-severe atopic dermatitisEtrasimodAPD334

Outcome Measures

Primary Outcomes (1)

Double-blind Treatment Period: Percent Change in Eczema Area and Severity Index (EASI) Score
EASI evaluates severity of participant's AD based on severity of AD clinical signs and percent (%) of body surface area (BSA) affected. EASI is a composite scoring assessment of the affected area in 4 specific disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification), which was each assessed on a scale of "0" (absent) through "3" (severe). The EASI Area Score is documented for 4 regions of the body. Region 1: head and neck; Region 2: trunk (including genital area); Region 3: upper limbs; and Region 4: lower limbs (including buttocks), with the area of AD involvement assessed as a percentage by body area and converted to a score of 0 to 6. Total EASI score ranged from 0 to 72; higher score indicated greater severity of AD. Baseline is defined as Day 1 pre-randomization assessments.
Baseline (Day 1) and Week 12

Secondary Outcomes (16)

Double-blind Treatment Period: Percentage of Participants Achieving EASI-75
Baseline (Day 1) and Week 12
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
Baseline (Day 1) and Week 12
Double-blind Treatment Period: Percent Change in Weekly Peak Pruritus Numerical Rating Scale (NRS) From an Itch Daily Diary
Baseline (Day 1) and Week 12
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
Baseline (Day 1) and Week 12
Double-blind Treatment Period: Percentage of Participants Achieving EASI-50
Baseline (Day 1) and Week 12
+11 more secondary outcomes

Study Arms (4)

12-Week Double-Blind Treatment Period: Etrasimod 1 milligrams (mg)

EXPERIMENTAL

Drug: Etrasimod 1 mg

12-Week Double-Blind Treatment Period: Etrasimod 2 mg

EXPERIMENTAL

Drug: Etrasimod 2 mg

12-Week Double-Blind Treatment Period: Placebo

PLACEBO COMPARATOR

Drug: Etrasimod matching placebo

52-Week Open-Label Extension Period: Etrasimod 2 mg

Interventions

Etrasimod 1 mgDrug

Etrasimod 1 mg tablet taken by mouth, once daily

Also known as: APD334

12-Week Double-Blind Treatment Period: Etrasimod 1 milligrams (mg)

Etrasimod 2 mgDrug

Etrasimod 2 mg tablet taken by mouth, once daily.

Also known as: APD334

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

Arena Pharmaceuticals
Industrylead

Study Sites (38)

Noble Clinical Research

Tucson, Arizona, 85704, United States

Hope Clinical Research

Canoga Park, California, 91303, United States

First OC Dermatology

Fountain Valley, California, 92708, United States

Marvel Research LLC

Huntington Beach, California, 92647, United States

ADVA Clinical Research, Inc

Inglewood, California, 90301, United States

Providence Clinical Research

North Hollywood, California, 91606, United States

TCR Medical Corporation

San Diego, California, 92123, United States

Related Publications (1)

Dubinsky MC, Wu J, McDonnell A, Lazin K, Goetsch M, Branquinho D, Modesto I, Armuzzi A. Low Incidence of Macular Edema and Other Ocular Events in the Etrasimod Development Program. J Crohns Colitis. 2025 May 8;19(5):jjae173. doi: 10.1093/ecco-jcc/jjae173.
PMID: 39575597DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

etrasimod

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title: Arena CT.gov Administrator
Organization: Arena Pharmaceuticals, Inc.

Study Officials

Arena CT.gov Administrator
Arena Pharmaceuticals
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

140 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 12, 2019

First Posted

November 14, 2019

Study Start

October 4, 2019

Actual (reported)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (16)

Study Arms (4)

12-Week Double-Blind Treatment Period: Etrasimod 1 milligrams (mg)

12-Week Double-Blind Treatment Period: Etrasimod 2 mg

12-Week Double-Blind Treatment Period: Placebo

52-Week Open-Label Extension Period: Etrasimod 2 mg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (38)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations