Study of Eblasakimab in Male or Female Moderate-to-Severe Atopic Dermatitis Patients Previously Treated With Dupilumab

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05694884
• Other study ID #: ASLAN004-004
• Status: Recruiting
• Phase: Phase 2
• Start date: December 21, 2022
• Est. completion date: February 28, 2025

Study information

• Verified date: January 2024
• Source: ASLAN Pharmaceuticals
• Contact: ASLAN Pharmaceuticals
• Phone: +65 6817 9598
• Email: contact[@]aslanpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: February 28, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Placebo
Placebo Comparator
• ASLAN004
ASLAN004

Locations

Country	Name	City	State
Canada	ASLAN Investigative Site	Hamilton	Ontario
Canada	ASLAN Investigative Site	Ottawa	Ontario
Canada	ASLAN Investigative Site	Toronto	Ontario
United States	ASLAN Investigative Site	Auburn Hills	Michigan
United States	ASLAN Investigative Site	Birmingham	Alabama
United States	ASLAN Investigative Site	Boca Raton	Florida
United States	ASLAN Investigative Site	Charleston	South Carolina
United States	ASLAN Investigative Site	Charlotte	North Carolina
United States	ASLAN Investigative Site	E. Amherst	New York
United States	ASLAN Investigative Site	Encino	California
United States	ASLAN Investigative Site	Fountain Valley	California
United States	ASLAN Investigative Site	Hollywood	Florida
United States	ASLAN Investigative Site	Hollywood	Florida
United States	ASLAN Investigative Site	Johnston	Rhode Island
United States	ASLAN Investigative Site	Las Vegas	Nevada
United States	ASLAN Investigative Site	Long Beach	California
United States	ASLAN Investigative Site	Los Angeles	California
United States	ASLAN Investigative Site	Louisville	Kentucky
United States	ASLAN Investigative Site	Miami Lakes	Florida
United States	ASLAN Investigative Site	New Albany	Indiana
United States	ASLAN Investigative Site	North Miami Beach	Florida
United States	ASLAN Investigative Site	Oklahoma City	Oklahoma
United States	ASLAN Investigative Site	Orange City	Florida
United States	ASLAN Investigative Site	Quincy	Massachusetts
United States	ASLAN Investigative Site	Saint Augustine	Florida
United States	ASLAN Investigative Site	Saint Petersburg	Florida
United States	ASLAN Investigative Site	Sherman Oaks	California

Sponsors (1)

Lead Sponsor	Collaborator
ASLAN Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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)	Week 16
Secondary	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
Secondary	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
Secondary	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
Secondary	Proportion of participants with EASI <7	EASI scores range from 0 to 72 (severe)	Week 16
Secondary	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
Secondary	Proportion of participants achieving a 4-point reduction in peak Pruritus Numerical Rating Scale	Pruritus Numerical Rating Scale	Week 16
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Proportion of participants achieving a 4-point reduction in sleep disturbance numerical rating scale		Week 16
Secondary	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
Secondary	Percent change from baseline of Eczema Area and Severity Index	EASI scores range from 0 to 72 (severe)	Week 24
Secondary	Number of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) from study drug administration		Week 24