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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| ASLAN004 | Experimental | Week 0, 1: LD of 600 mg; Week 2 through Week 15 QW: 400 mg dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo Comparator |
| |
| ASLAN004 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from Baseline in Eczema Area and Severity Index (EASI) at 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 | Baseline, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving validated Investigator's Global Assessment (vIGA) response of 0 (clear) or 1 (almost clear) at Week 16 | IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear) |
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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:
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ASLAN Pharmaceuticals | Contact | +65 6817 9598 | contact@aslanpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | ASLAN Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASLAN Investigative Site | Recruiting | Birmingham | Alabama | 35244 | United States |
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| Drug |
ASLAN004 |
|
| Week 16 |
| Proportion of participants with a 75% reduction Eczema Area and Severity Index 75 (EASI) | EASI scores range from 0 to 72 (severe)The EASI responder is defined as a participant who achieves a ≥75% improvement (EASI 75) from baseline in the EASI score | Week 16 |
| Proportion of participants achieving EASI 50 | EASI scores range from 0 to 72 (severe)The EASI responder is defined as a participant who achieves a ≥50% improvement (EASI 50) from baseline in the EASI score | Week 16 |
| Proportion of participants achieving EASI 90 | EASI scores range from 0 to 72 (severe)The EASI responder is defined as a participant who achieves a ≥90% improvement (EASI 90) from baseline in the EASI score | Week 16 |
| Proportion of participants with EASI <7 | EASI scores range from 0 to 72 (severe) | Week 16 |
| Absolute and percent change in peak Pruritus Numerical Rating Scale (P-NRS) | The P-NRS is an 11-point scale used by patients to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating the worst itch imaginable. Pruritus assessments will be recorded daily by the patient using an electronic diary | Week 16 and Week 24 |
| Proportion of participants achieving a 4-point reduction in peak Pruritus Numerical Rating Scale | Pruritus Numerical Rating Scale | Week 16 |
| Change in Body Surface Area (BSA) affected with AD | BSA ranges from 0% to 100 % with higher values representing greater extent of AD | Week 16 and Week 24 |
| Change in SCORing Atopic Dermatitis (SCORAD) | The SCORAD is a validated measure of the extent and severity of atopic dermatitis lesions, along with subjective symptoms. The score ranges from 0 to 103, with higher values indicating a more extensive and/or severe condition | Week 16 and Week 24 |
| Change in Dermatology Life Quality Index (DLQI) | The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the patient's perception of the impact of AD disease symptoms and treatment on their quality of life (QoL). The 10 questions assess QoL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease). A high score is indicative of a poor QoL | Week 16 and Week 24 |
| Change in Patient-Oriented Eczema Measure (POEM) | The POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor QoL) | Week 16 and Week 24 |
| Change in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm | The EQ-5D-5L is a 2-part measurement. The second part is assessed using a visual analog scale (VAS) that ranges from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine | Week 16 and Week 24 |
| Absolute and percent change in sleep disturbance numerical rating scale (SD-NRS) | The SD-NRS is an 11-point scale used by patients to assess their sleep disturbance severity over the past 24 hours, with 0 indicating no or minimal sleep disturbance and 10 indicating the worst imaginable sleep disturbance. SD-NRS assessments will be recorded daily by the patient using an electronic diary | 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) | IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear) | Week 24 |
| Percent change from baseline of Eczema Area and Severity Index | EASI scores range from 0 to 72 (severe) | Week 24 |
| Number of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) from study drug administration | Week 24 |
| ASLAN Investigative Site | Recruiting | Encino | California | 91436 | United States |
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| ASLAN Investigative Site | Recruiting | Fountain Valley | California | 92708 | United States |
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| ASLAN Investigative Site | Recruiting | Long Beach | California | 90806 | United States |
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| ASLAN Investigative Site | Recruiting | Los Angeles | California | 90025 | United States |
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| ASLAN Investigative Site | Recruiting | Sherman Oaks | California | 91403 | United States |
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| ASLAN Investigative Site | Recruiting | Boca Raton | Florida | 33486 | United States |
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| ASLAN Investigative Site | Recruiting | Hollywood | Florida | 33021 | United States |
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| ASLAN Investigative Site | Recruiting | Hollywood | Florida | 33436 | United States |
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| ASLAN Investigative Site | Recruiting | Miami Lakes | Florida | 33014 | United States |
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| ASLAN Investigative Site | Recruiting | North Miami Beach | Florida | 33162 | United States |
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| ASLAN Investigative Site | Recruiting | Orange City | Florida | 32720 | United States |
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| ASLAN Investigative Site | Recruiting | Saint Augustine | Florida | 32080 | United States |
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| ASLAN Investigative Site | Recruiting | St. Petersburg | Florida | 33705 | United States |
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| ASLAN Investigative Site | Recruiting | New Albany | Indiana | 47150 | United States |
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| ASLAN Investigative Site | Recruiting | Louisville | Kentucky | 40217 | United States |
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| ASLAN Investigative Site | Recruiting | Quincy | Massachusetts | 02169 | United States |
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| ASLAN Investigative Site | Recruiting | Auburn Hills | Michigan | 48326 | United States |
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| ASLAN Investigative Site | Recruiting | Las Vegas | Nevada | 89148 | United States |
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| ASLAN Investigative Site | Recruiting | East Amherst | New York | 14051 | United States |
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| ASLAN Investigative Site | Recruiting | Charlotte | North Carolina | 28277 | United States |
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| ASLAN Investigative Site | Recruiting | Oklahoma City | Oklahoma | 73118 | United States |
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| ASLAN Investigative Site | Recruiting | Johnston | Rhode Island | 02919 | United States |
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| ASLAN Investigative Site | Recruiting | Charleston | South Carolina | 29407 | United States |
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| ASLAN Investigative Site | Recruiting | Hamilton | Ontario | L8LCC3 | Canada |
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| ASLAN Investigative Site | Recruiting | Ottawa | Ontario | K1H1E4 | Canada |
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| ASLAN Investigative Site | Recruiting | Toronto | Ontario | Canada |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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