Clinical trial NCT05694884: Study of Eblasakimab in Male or Female Moderate-to-Severe Atopic Dermatitis Patients Previously Treated With Dupilumab
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Eblasakimab in Male or Female Moderate-to-Severe Atopic Dermatitis Patients Previously Treated With Dupilumab
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis
IL-13
ASLAN004
IL-13Rα1
Eczema
Anti-IL-13Rα1
atopic eczema
Lead sponsor: ASLAN Pharmaceuticals
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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 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:

* Use of immunosuppressive/immunomodulating drugs and/or therapies, JAK inhibitors, or phototherapy (including tanning booth/parlor) within 4 weeks prior to the Baseline visit
* 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

Primary outcomes:
measure: Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 16
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Proportion of participants achieving validated Investigator's Global Assessment (vIGA) response of 0 (clear) or 1 (almost clear) at Week 16
timeFrame: Week 16
measure: Proportion of participants with a 75% reduction Eczema Area and Severity Index 75 (EASI)
timeFrame: Week 16
measure: Proportion of participants achieving EASI 50
timeFrame: Week 16
measure: Proportion of participants achieving EASI 90
timeFrame: Week 16
measure: Proportion of participants with EASI <7
timeFrame: Week 16
measure: Absolute and percent change in peak Pruritus Numerical Rating Scale (P-NRS)
timeFrame: Week 16 and Week 24
measure: Proportion of participants achieving a 4-point reduction in peak Pruritus Numerical Rating Scale
timeFrame: Week 16
measure: Change in Body Surface Area (BSA) affected with AD
timeFrame: Week 16 and Week 24
measure: Change in SCORing Atopic Dermatitis (SCORAD)
timeFrame: Week 16 and Week 24
measure: Change in Dermatology Life Quality Index (DLQI)
timeFrame: Week 16 and Week 24
measure: Change in Patient-Oriented Eczema Measure (POEM)
timeFrame: Week 16 and Week 24
measure: Change in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm
timeFrame: Week 16 and Week 24
measure: Absolute and percent change in sleep disturbance numerical rating scale (SD-NRS)
timeFrame: Week 16 and Week 24
measure: Proportion of participants achieving a 4-point reduction in sleep disturbance numerical rating scale
timeFrame: Week 16
measure: Percent change from baseline of validated Investigator's Global Assessment (vIGA)
timeFrame: Week 24
measure: Percent change from baseline of Eczema Area and Severity Index
timeFrame: Week 24
measure: Number of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) from study drug administration
timeFrame: Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: ASLAN Investigative Site
state: Alabama
city: Encino
country: United States
facility: ASLAN Investigative Site
state: California
city: Fountain Valley
country: United States
facility: ASLAN Investigative Site
state: California
city: Long Beach
country: United States
facility: ASLAN Investigative Site
state: California
city: Los Angeles
country: United States
facility: ASLAN Investigative Site
state: California
city: Sherman Oaks
country: United States
facility: ASLAN Investigative Site
state: California
city: Boca Raton
country: United States
facility: ASLAN Investigative Site
state: Florida
city: Hollywood
country: United States
facility: ASLAN Investigative Site
state: Florida
city: Hollywood
country: United States
facility: ASLAN Investigative Site
state: Florida
city: Miami Lakes
country: United States
facility: ASLAN Investigative Site
state: Florida
city: North Miami Beach
country: United States
facility: ASLAN Investigative Site
state: Florida
city: Orange City
country: United States
facility: ASLAN Investigative Site
state: Florida
city: Saint Augustine
country: United States
facility: ASLAN Investigative Site
state: Florida
city: Saint Petersburg
country: United States
facility: ASLAN Investigative Site
state: Florida
city: New Albany
country: United States
facility: ASLAN Investigative Site
state: Indiana
city: Louisville
country: United States
facility: ASLAN Investigative Site
state: Kentucky
city: Quincy
country: United States
facility: ASLAN Investigative Site
state: Massachusetts
city: Auburn Hills
country: United States
facility: ASLAN Investigative Site
state: Michigan
city: Las Vegas
country: United States
facility: ASLAN Investigative Site
state: Nevada
city: E. Amherst
country: United States
facility: ASLAN Investigative Site
state: New York
city: Charlotte
country: United States
facility: ASLAN Investigative Site
state: North Carolina
city: Oklahoma City
country: United States
facility: ASLAN Investigative Site
state: Oklahoma
city: Johnston
country: United States
facility: ASLAN Investigative Site
state: Rhode Island
city: Charleston
country: United States
facility: ASLAN Investigative Site
state: South Carolina
city: Hamilton
country: Canada
facility: ASLAN Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: ASLAN Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: ASLAN Investigative Site
state: Ontario
Study officials:
affiliation: ASLAN Pharmaceuticals
name: Chief Medical Officer
role: STUDY_DIRECTOR
References: