RECRUITING

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

Conditions

Atopic Dermatitis IL-13 ASLAN004 IL-13Rα1 Eczema Anti-IL-13Rα1 atopic eczema

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-12-21

Study Completion:2025-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05694884

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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;	* 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

Inclusion Criteria

Exclusion 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;

* 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

Contacts and Locations

Study Contact

ASLAN Pharmaceuticals

CONTACT

+65 6817 9598

contact@aslanpharma.com

Principal Investigator

Chief Medical Officer

STUDY_DIRECTOR

ASLAN Pharmaceuticals

Study Locations (Sites)

ASLAN Investigative Site

Birmingham, Alabama, 35244

United States

ASLAN Investigative Site

Encino, California, 91436

United States

ASLAN Investigative Site

Fountain Valley, California, 92708

United States

ASLAN Investigative Site

Long Beach, California, 90806

United States

ASLAN Investigative Site

Los Angeles, California, 90025

United States

ASLAN Investigative Site

Sherman Oaks, California, 91403

United States

ASLAN Investigative Site

Boca Raton, Florida, 33486

United States

ASLAN Investigative Site

Hollywood, Florida, 33021

United States

ASLAN Investigative Site

Hollywood, Florida, 33436

United States

ASLAN Investigative Site

Miami Lakes, Florida, 33014

United States

ASLAN Investigative Site

North Miami Beach, Florida, 33162

United States

ASLAN Investigative Site

Orange City, Florida, 32720

United States

ASLAN Investigative Site

Saint Augustine, Florida, 32080

United States

ASLAN Investigative Site

Saint Petersburg, Florida, 33705

United States

ASLAN Investigative Site

New Albany, Indiana, 47150

United States

ASLAN Investigative Site

Louisville, Kentucky, 40217

United States

ASLAN Investigative Site

Quincy, Massachusetts, 02169

United States

ASLAN Investigative Site

Auburn Hills, Michigan, 48326

United States

ASLAN Investigative Site

Las Vegas, Nevada, 89148

United States

ASLAN Investigative Site

E. Amherst, New York, 14051

United States

ASLAN Investigative Site

Charlotte, North Carolina, 28277

United States

ASLAN Investigative Site

Oklahoma City, Oklahoma, 73118

United States

ASLAN Investigative Site

Johnston, Rhode Island, 02919

United States

ASLAN Investigative Site

Charleston, South Carolina, 29407

United States

Collaborators and Investigators

Sponsor: ASLAN Pharmaceuticals

Chief Medical Officer, STUDY_DIRECTOR, ASLAN Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-21

Study Completion Date2025-02-28

Study Record Updates

Study Start Date2022-12-21

Study Completion Date2025-02-28

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Atopic Dermatitis