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ADVISE: A Study to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Atopic Dermatitis

Sponsor
Arena Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT04162769
Collaborator
(none)
140
Enrollment
11
Locations
4
Arms
23.5
Actual Duration (Months)
12.7
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 24, 2019
Actual Primary Completion Date :
Sep 14, 2020
Actual Study Completion Date :
Oct 8, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 12-Week Double-Blind Treatment Period: Etrasimod Dose A

Drug: Etrasimod
Etrasimod "Dose A" tablet taken by mouth, once daily up to 12 weeks during the Double-Blind Treatment Period
Other Names:
  • APD334

    		•
    Experimental: 12-Week Double-Blind Treatment Period: Etrasimod Dose B

    Drug: Etrasimod
    Etrasimod "Dose B" tablet taken by mouth, once daily up to 12 weeks during the Double-Blind Treatment Period
    Other Names:
  • APD334

    		•
    Placebo Comparator: 12-Week Double-Blind Treatment Period: Placebo

    Drug: Etrasimod matching placebo
    Etrasimod matching placebo tablet by mouth, once daily up to 12 weeks during the Double-Blind Treatment Period
    Experimental: 52-Week Open-Label Extension Period: Etrasimod Dose B

    Drug: Etrasimod
    Etrasimod "Dose B" tablet taken by mouth, once daily up to 52 weeks during the Open-Label Extension Period
    Other Names:
  • APD334

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percent Change in Eczema Area and Severity Index (EASI) [Baseline to Week 12]

    Secondary Outcome Measures

    1. Proportion of Participants Achieving EASI-75 [Baseline to Week 12]

      EASI-75, defined as a 75% reduction of EASI from Baseline to Week 12.

    2. Proportion of Participants With a Validated Investigator's Global Assessment (vIGA) 0 to 1 (on a 5-point Scale) Score and a Reduction From Baseline of ≥ 2 Points [Baseline to Week 12]

    3. Percent Change in EASI [Baseline to Week 52]

    4. Percent Change in vIGA Score [Baseline to Week 52]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Noble Clinical Research Tucson Arizona United States 85704
    2 Providence Clinical Research North Hollywood California United States 91606
    3 Clinical Research of West Florida Clearwater Florida United States 33765
    4 Prohealth Research Center Doral Florida United States 33166
    5 Aby's New Generation Research, Inc. Hialeah Florida United States 33016
    6 South Miami Medical & Research Group. Inc Miami Florida United States 33155
    7 Skin Research of South Florida Miami Florida United States 33173
    8 Quality Clinical Research Inc Omaha Nebraska United States 68114
    9 Spartanburg Medical Research Spartanburg South Carolina United States 29369
    10 Modern Research Associates, PLLC Dallas Texas United States 75231
    11 Premier Clinical Research, LLC Spokane Washington United States 99202

    Sponsors and Collaborators

    • Arena Pharmaceuticals

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Arena Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04162769
    Other Study ID Numbers:
    • APD334-201
    First Posted:
    Nov 14, 2019
    Last Update Posted:
    Nov 22, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    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
    Moderate-to-severe atopic dermatitis
    Etrasimod
    APD334
    Additional relevant MeSH terms:
    Dermatitis, Atopic
    Dermatitis
    Eczema

    Study Results

    No Results Posted as of Nov 22, 2021