Study of Eblasakimab in Male or Female Moderate-to-Severe Atopic Dermatitis Patients Previously Treated With Dupilumab
NCT ID: NCT05694884
Last Updated: 2024-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
75 participants
INTERVENTIONAL
2022-12-21
2025-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo loading dose equivalents at Baseline and Week 1, then placebo dose equivalents every week (QW) from Week 2 to Week 15
Placebo
Placebo Comparator
ASLAN004
Week 0, 1: LD of 600 mg; Week 2 through Week 15 QW: 400 mg dose
ASLAN004
ASLAN004
Interventions
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Placebo
Placebo Comparator
ASLAN004
ASLAN004
Eligibility Criteria
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Inclusion Criteria
* 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 stable regimen of topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) as treatment for AD
* All participants must have previously been treated with dupilumab meeting one of the following conditions:
1. Participants who stopped dupilumab treatment due to non-response, partial response, loss of efficacy must have been previously treated with dupilumab for at 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 dupilumab treatment;
3. Participants who stopped dupilumab treatment due to cost or loss of access to dupilumab or for any other reasons may enter the study with no required prior length of dupilumab treatment;
Exclusion Criteria
* Have an uncontrolled chronic disease that may require multiple intermittent use of systemic corticosteroids at Screening, as defined by the Investigator
* Have uncontrolled asthma that might require bursts of oral or systemic corticosteroids, or require either of the following due to ≥1 exacerbations within 12 months 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 weeks or 5 half-lives (if known), whichever is longer, prior to the Baseline visit
* Have received treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI) such as tacrolimus and pimecrolimus, topical phosphodiesterase inhibitors such as crisaborole, topical JAK inhibitors (commercial or investigational use), within 1 week prior to randomization
* Have inadequate organ function or abnormal lab results considered clinically significant 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 will undergo testing for Hepatitis B Surface Antigen (HBsAg) and Hepatitis B Core Antibody (HBcAb) during Screening. Subjects who are HBsAg positive are not eligible for the study. Subjects who are HBsAg negative and HBcAb positive will be tested for Hepatitis B Surface Antibody (HBsAb) and if HBsAb is positive, may be enrolled in the study; if HBsAb is negative, the subject is not eligible for the study. For Hepatitis C, all subjects will undergo testing for Hepatitis C antibody (HCVAb) during Screening. Subjects who are HCVAb positive are not eligible for the study. Active COVID-19 infection at Baseline.
* Have known liver cirrhosis and/or chronic hepatitis of any etiology
* Known diagnosis of active tuberculosis or non-tuberculous mycobacterial infection or latent tuberculosis unless it is well documented by a specialist that the patient has been adequately treated
* Allergen immunotherapy should be discontinued 6 months before randomization
18 Years
ALL
No
Sponsors
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ASLAN Pharmaceuticals
OTHER
Responsible Party
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Principal Investigators
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Chief Medical Officer
Role: STUDY_DIRECTOR
ASLAN Pharmaceuticals
Locations
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ASLAN Investigative Site
Birmingham, Alabama, United States
ASLAN Investigative Site
Encino, California, United States
ASLAN Investigative Site
Fountain Valley, California, United States
ASLAN Investigative Site
Long Beach, California, United States
ASLAN Investigative Site
Los Angeles, California, United States
ASLAN Investigative Site
Sherman Oaks, California, United States
ASLAN Investigative Site
Boca Raton, Florida, United States
ASLAN Investigative Site
Hollywood, Florida, United States
ASLAN Investigative Site
Hollywood, Florida, United States
ASLAN Investigative Site
Miami Lakes, Florida, United States
ASLAN Investigative Site
North Miami Beach, Florida, United States
ASLAN Investigative Site
Orange City, Florida, United States
ASLAN Investigative Site
Saint Augustine, Florida, United States
ASLAN Investigative Site
St. Petersburg, Florida, United States
ASLAN Investigative Site
New Albany, Indiana, United States
ASLAN Investigative Site
Louisville, Kentucky, United States
ASLAN Investigative Site
Quincy, Massachusetts, United States
ASLAN Investigative Site
Auburn Hills, Michigan, United States
ASLAN Investigative Site
Las Vegas, Nevada, United States
ASLAN Investigative Site
East Amherst, New York, United States
ASLAN Investigative Site
Charlotte, North Carolina, United States
ASLAN Investigative Site
Oklahoma City, Oklahoma, United States
ASLAN Investigative Site
Johnston, Rhode Island, United States
ASLAN Investigative Site
Charleston, South Carolina, United States
ASLAN Investigative Site
Hamilton, Ontario, Canada
ASLAN Investigative Site
Ottawa, Ontario, Canada
ASLAN Investigative Site
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Role: primary
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Role: primary
Other Identifiers
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ASLAN004-004
Identifier Type: -
Identifier Source: org_study_id
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