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

NCT05694884 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: ASLAN004-004
• Study Type: interventional
• Target: 75
• Locations: 2 countries
• Sites: 27

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.

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis; IL-13; ASLAN004; IL-13Rα1; Eczema; Anti-IL-13Rα1; atopic eczema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• 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 with a 75% reduction Eczema Area and Severity Index 75 (EASI)

  Week 16

• Proportion of participants achieving EASI 50

  Week 16

• Proportion of participants achieving EASI 90

  Week 16

• Proportion of participants with EASI <7

  Week 16

Study Arms (2)

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

Drug: Placebo

ASLAN004

EXPERIMENTAL

Week 0, 1: LD of 600 mg; Week 2 through Week 15 QW: 400 mg dose

Drug: ASLAN004

Interventions

Placebo DRUG

Placebo Comparator

Placebo

ASLAN004 DRUG

ASLAN004

ASLAN004

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• ASLAN Pharmaceuticals: lead

Study Sites (27)

ASLAN Investigative Site

Birmingham, Alabama, 35244, United States

RECRUITING

ASLAN Investigative Site

Encino, California, 91436, United States

RECRUITING

ASLAN Investigative Site

Fountain Valley, California, 92708, United States

RECRUITING

ASLAN Investigative Site

Long Beach, California, 90806, United States

RECRUITING

ASLAN Investigative Site

Los Angeles, California, 90025, United States

RECRUITING

ASLAN Investigative Site

Sherman Oaks, California, 91403, United States

RECRUITING

ASLAN Investigative Site

Boca Raton, Florida, 33486, United States

RECRUITING

ASLAN Investigative Site

Hollywood, Florida, 33021, United States

RECRUITING

ASLAN Investigative Site

Hollywood, Florida, 33436, United States

RECRUITING

ASLAN Investigative Site

Miami Lakes, Florida, 33014, United States

RECRUITING

ASLAN Investigative Site

North Miami Beach, Florida, 33162, United States

RECRUITING

ASLAN Investigative Site

Orange City, Florida, 32720, United States

RECRUITING

ASLAN Investigative Site

Saint Augustine, Florida, 32080, United States

RECRUITING

ASLAN Investigative Site

St. Petersburg, Florida, 33705, United States

RECRUITING

ASLAN Investigative Site

New Albany, Indiana, 47150, United States

RECRUITING

ASLAN Investigative Site

Louisville, Kentucky, 40217, United States

RECRUITING

ASLAN Investigative Site

Quincy, Massachusetts, 02169, United States

RECRUITING

ASLAN Investigative Site

Auburn Hills, Michigan, 48326, United States

RECRUITING

ASLAN Investigative Site

Las Vegas, Nevada, 89148, United States

RECRUITING

ASLAN Investigative Site

East Amherst, New York, 14051, United States

RECRUITING

ASLAN Investigative Site

Charlotte, North Carolina, 28277, United States

RECRUITING

ASLAN Investigative Site

Oklahoma City, Oklahoma, 73118, United States

RECRUITING

ASLAN Investigative Site

Johnston, Rhode Island, 02919, United States

RECRUITING

ASLAN Investigative Site

Charleston, South Carolina, 29407, United States

RECRUITING

ASLAN Investigative Site

Hamilton, Ontario, L8LCC3, Canada

RECRUITING

ASLAN Investigative Site

Ottawa, Ontario, K1H1E4, Canada

RECRUITING

ASLAN Investigative Site

Toronto, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Chief Medical Officer

  ASLAN Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

ASLAN Pharmaceuticals

CONTACT

+65 6817 9598; contact@aslanpharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 23, 2023
• Study Start: December 21, 2022
• Primary Completion: December 31, 2024
• Study Completion: February 28, 2025
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (24); CA (3)