NCT05694884RecruitingPhase 2
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- ASLAN Pharmaceuticals
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 16
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •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;
- •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;
- •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:
- •Systemic (oral and/or parenteral) corticosteroid treatment;
- •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
Arms & Interventions
Placebo
Placebo Comparator
Placebo loading dose equivalents at Baseline and Week 1, then placebo dose equivalents every week (QW) from Week 2 to Week 15
Intervention: Placebo (Drug)
ASLAN004
Experimental
Week 0, 1: LD of 600 mg; Week 2 through Week 15 QW: 400 mg dose
Intervention: ASLAN004 (Drug)
Outcomes
Primary Outcomes
Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 16
Time Frame: Baseline, Week 16
The EASI score is used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD
Secondary Outcomes
- Proportion of participants achieving EASI 50(Week 16)
- Proportion of participants with EASI <7(Week 16)
- Proportion of participants achieving validated Investigator's Global Assessment (vIGA) response of 0 (clear) or 1 (almost clear) at Week 16(Week 16)
- Proportion of participants achieving EASI 90(Week 16)
- Change in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm(Week 16 and Week 24)
- Proportion of participants with a 75% reduction Eczema Area and Severity Index 75 (EASI)(Week 16)
- Change in Dermatology Life Quality Index (DLQI)(Week 16 and Week 24)
- Change in Patient-Oriented Eczema Measure (POEM)(Week 16 and Week 24)
- Absolute and percent change in peak Pruritus Numerical Rating Scale (P-NRS)(Week 16 and Week 24)
- Change in Body Surface Area (BSA) affected with AD(Week 16 and Week 24)
- Proportion of participants achieving a 4-point reduction in peak Pruritus Numerical Rating Scale(Week 16)
- Change in SCORing Atopic Dermatitis (SCORAD)(Week 16 and Week 24)
- Absolute and percent change in sleep disturbance numerical rating scale (SD-NRS)(Week 16 and Week 24)
- Proportion of participants achieving a 4-point reduction in sleep disturbance numerical rating scale(Week 16)
- Percent change from baseline of validated Investigator's Global Assessment (vIGA)(Week 24)
- Percent change from baseline of Eczema Area and Severity Index(Week 24)
- Number of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) from study drug administration(Week 24)
Investigators
Study Sites (1)
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