Study of Eblasakimab in Male or Female Moderate-to-Severe Atopic Dermatitis Patients Previously Treated With Dupilumab

Last updated: January 17, 2024
Sponsor: ASLAN Pharmaceuticals
Overall Status: Active - Recruiting

Phase

2

Condition

Hives (Urticaria)

Rosacea

Atopic Dermatitis

Treatment

Placebo

ASLAN004

Clinical Study ID

NCT05694884
ASLAN004-004
  • Ages > 18
  • All Genders

Study Summary

Multicenter, randomized, double-blind, placebo-controlled, parallel arm clinical study designed to evaluate the efficacy and safety of eblasakimab in participants with moderate-to-severe atopic dermatitis (AD) previously treated with dupilumab.The study consists of a 16-week treatment period and an 8-week follow-up period up to Week 24. Eligible participants will be randomized into one of the 2 treatment arms.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female participants ≥18 years
  • Willing and able to comply with clinic visits and study-related procedures
  • Chronic AD present for at least 1 year prior to screening
  • Have vIGA score of ≥3 (5-scale of 0 to 4) at baseline
  • Have ≥10% BSA of AD involvement at baseline
  • Have EASI ≥18 at screening and baseline
  • History of inadequate response to, intolerance to or contraindication to a stableregimen of topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) astreatment for AD
  • All participants must have previously been treated with dupilumab meeting one of thefollowing conditions:
  1. Participants who stopped dupilumab treatment due to non-response, partialresponse, loss of efficacy must have been previously treated with dupilumab forat least 16 weeks duration;
  2. Participants who stopped dupilumab treatment due to intolerance or adverse events (AEs) to the drug may enter the study with no required prior length of dupilumabtreatment;
  3. Participants who stopped dupilumab treatment due to cost or loss of access todupilumab or for any other reasons may enter the study with no required priorlength of dupilumab treatment;

Exclusion

Exclusion Criteria:

  • Use of immunosuppressive/immunomodulating drugs and/or therapies, JAK inhibitors, orphototherapy (including tanning booth/parlor) within 4 weeks prior to the Baselinevisit
  • Have an uncontrolled chronic disease that may require multiple intermittent use ofsystemic corticosteroids at Screening, as defined by the Investigator
  • Have uncontrolled asthma that might require bursts of oral or systemiccorticosteroids, or require either of the following due to ≥1 exacerbations within 12months before Baseline:
  1. Systemic (oral and/or parenteral) corticosteroid treatment;
  2. Hospitalization for >24 hours;
  • Have had systemic treatment with small molecule investigational drugs within 8 weeksor 5 half-lives (if known), whichever is longer, prior to the Baseline visit
  • Have received treatment with topical corticosteroids (TCS), topical calcineurininhibitors (TCI) such as tacrolimus and pimecrolimus, topical phosphodiesteraseinhibitors such as crisaborole, topical JAK inhibitors (commercial or investigationaluse), within 1 week prior to randomization
  • Have inadequate organ function or abnormal lab results considered clinicallysignificant by the Investigator at the Screening visit
  • History of human immunodeficiency virus (HIV) or positive HIV serology at Screening
  • Infected with hepatitis B or hepatitis C viruses. For Hepatitis B, all subjects willundergo testing for Hepatitis B Surface Antigen (HBsAg) and Hepatitis B Core Antibody (HBcAb) during Screening. Subjects who are HBsAg positive are not eligible for thestudy. Subjects who are HBsAg negative and HBcAb positive will be tested for HepatitisB Surface Antibody (HBsAb) and if HBsAb is positive, may be enrolled in the study; ifHBsAb is negative, the subject is not eligible for the study. For Hepatitis C, allsubjects will undergo testing for Hepatitis C antibody (HCVAb) during Screening.Subjects who are HCVAb positive are not eligible for the study. Active COVID-19infection at Baseline.
  • Have known liver cirrhosis and/or chronic hepatitis of any etiology
  • Known diagnosis of active tuberculosis or non-tuberculous mycobacterial infection orlatent tuberculosis unless it is well documented by a specialist that the patient hasbeen adequately treated
  • Allergen immunotherapy should be discontinued 6 months before randomization

Study Design

Total Participants: 75
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
December 21, 2022
Estimated Completion Date:
February 28, 2025

Connect with a study center

  • ASLAN Investigative Site

    Hamilton, Ontario L8LCC3
    Canada

    Active - Recruiting

  • ASLAN Investigative Site

    Ottawa, Ontario K1H1E4
    Canada

    Active - Recruiting

  • ASLAN Investigative Site

    Toronto, Ontario
    Canada

    Active - Recruiting

  • ASLAN Investigative Site

    Birmingham, Alabama 35244
    United States

    Active - Recruiting

  • ASLAN Investigative Site

    Encino, California 91436
    United States

    Active - Recruiting

  • ASLAN Investigative Site

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • ASLAN Investigative Site

    Long Beach, California 90806
    United States

    Active - Recruiting

  • ASLAN Investigative Site

    Los Angeles, California 90025
    United States

    Active - Recruiting

  • ASLAN Investigative Site

    Sherman Oaks, California 91403
    United States

    Active - Recruiting

  • ASLAN Investigative Site

    Boca Raton, Florida 33486
    United States

    Active - Recruiting

  • ASLAN Investigative Site

    Hollywood, Florida 33436
    United States

    Active - Recruiting

  • ASLAN Investigative Site

    Miami Lakes, Florida 33014
    United States

    Active - Recruiting

  • ASLAN Investigative Site

    North Miami Beach, Florida 33162
    United States

    Active - Recruiting

  • ASLAN Investigative Site

    Orange City, Florida 32720
    United States

    Active - Recruiting

  • ASLAN Investigative Site

    Orlando, Florida 32819
    United States

    Site Not Available

  • ASLAN Investigative Site

    Saint Augustine, Florida 32080
    United States

    Active - Recruiting

  • ASLAN Investigative Site

    Saint Petersburg, Florida 33705
    United States

    Active - Recruiting

  • ASLAN Investigative Site

    Tampa, Florida 33607
    United States

    Site Not Available

  • ASLAN Investigative Site

    Columbus, Georgia 31904
    United States

    Site Not Available

  • ASLAN Investigative Site

    New Albany, Indiana 47150
    United States

    Active - Recruiting

  • ASLAN Investigative Site

    Louisville, Kentucky 40217
    United States

    Active - Recruiting

  • ASLAN Investigative Site

    Quincy, Massachusetts 02169
    United States

    Active - Recruiting

  • ASLAN Investigative Site

    Auburn Hills, Michigan 48326
    United States

    Active - Recruiting

  • ASLAN Investigative Site

    Las Vegas, Nevada 89148
    United States

    Active - Recruiting

  • ASLAN Investigative Site

    E. Amherst, New York 14051
    United States

    Active - Recruiting

  • ASLAN Investigative Site

    Charlotte, North Carolina 28277
    United States

    Active - Recruiting

  • ASLAN Investigative Site

    Oklahoma City, Oklahoma 73118
    United States

    Active - Recruiting

  • ASLAN Investigative Site

    Johnston, Rhode Island 02919
    United States

    Active - Recruiting

  • ASLAN Investigative Site

    Charleston, South Carolina 29407
    United States

    Active - Recruiting

  • ASLAN Investigative Site

    Rapid City, South Dakota 57702
    United States

    Site Not Available

  • ASLAN Investigative Site

    Nashville, Tennessee 37215
    United States

    Site Not Available

  • ASLAN Investigative Site

    Webster, Texas 77598
    United States

    Site Not Available

  • ASLAN Investigative Site

    Mill Creek, Washington 98102
    United States

    Site Not Available

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