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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
75
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
Time frame: Baseline, Week 16
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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Week 16
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
ASLAN Investigative Site
Birmingham, Alabama, United States
RECRUITINGASLAN Investigative Site
Encino, California, United States
RECRUITINGASLAN Investigative Site
Fountain Valley, California, United States
RECRUITINGASLAN Investigative Site
Long Beach, California, United States
RECRUITINGASLAN Investigative Site
Los Angeles, California, United States
RECRUITINGASLAN Investigative Site
Sherman Oaks, California, United States
RECRUITINGASLAN Investigative Site
Boca Raton, Florida, United States
RECRUITINGASLAN Investigative Site
Hollywood, Florida, United States
RECRUITINGASLAN Investigative Site
Hollywood, Florida, United States
RECRUITINGASLAN Investigative Site
Miami Lakes, Florida, United States
RECRUITING...and 17 more locations
Proportion of participants with EASI <7
EASI scores range from 0 to 72 (severe)
Time frame: 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
Time frame: Week 16 and Week 24
Proportion of participants achieving a 4-point reduction in peak Pruritus Numerical Rating Scale
Pruritus Numerical Rating Scale
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Week 16 and Week 24
Proportion of participants achieving a 4-point reduction in sleep disturbance numerical rating scale
Time frame: 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)
Time frame: Week 24
Percent change from baseline of Eczema Area and Severity Index
EASI scores range from 0 to 72 (severe)
Time frame: Week 24
Number of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) from study drug administration
Time frame: Week 24