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

January 17, 2024 updated by: ASLAN Pharmaceuticals

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
    • California
      • Encino, California, United States, 91436
      • Fountain Valley, California, United States, 92708
      • Long Beach, California, United States, 90806
      • Los Angeles, California, United States, 90025
      • Sherman Oaks, California, United States, 91403
    • Florida
      • Boca Raton, Florida, United States, 33486
      • Hollywood, Florida, United States, 33021
      • Hollywood, Florida, United States, 33436
      • Miami Lakes, Florida, United States, 33014
      • North Miami Beach, Florida, United States, 33162
      • Orange City, Florida, United States, 32720
      • Saint Augustine, Florida, United States, 32080
      • Saint Petersburg, Florida, United States, 33705
    • Indiana
      • New Albany, Indiana, United States, 47150
    • Kentucky
      • Louisville, Kentucky, United States, 40217
    • Massachusetts
      • Quincy, Massachusetts, United States, 02169
    • Michigan
      • Auburn Hills, Michigan, United States, 48326
    • Nevada
      • Las Vegas, Nevada, United States, 89148
    • New York
      • E. Amherst, New York, United States, 14051
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73118
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
    • South Carolina
      • Charleston, South Carolina, United States, 29407

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ASLAN004
Week 0, 1: LD of 600 mg; Week 2 through Week 15 QW: 400 mg dose
Drug: ASLAN004
ASLAN004
Placebo Comparator: Placebo
Placebo loading dose equivalents at Baseline and Week 1, then placebo dose equivalents every week (QW) from Week 2 to Week 15
Drug: Placebo
Placebo Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 16
Time Frame: Baseline, 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 Outcome Measures

Outcome Measure
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
Time Frame: 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
Proportion of participants with a 75% reduction Eczema Area and Severity Index 75 (EASI)
Time Frame: Week 16
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
Time Frame: Week 16
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
Time Frame: Week 16
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
Time Frame: Week 16
EASI scores range from 0 to 72 (severe)
Week 16
Absolute and percent change in peak Pruritus Numerical Rating Scale (P-NRS)
Time Frame: Week 16 and Week 24
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
Time Frame: Week 16
Pruritus Numerical Rating Scale
Week 16
Change in Body Surface Area (BSA) affected with AD
Time Frame: Week 16 and Week 24
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)
Time Frame: Week 16 and Week 24
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)
Time Frame: Week 16 and Week 24
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)
Time Frame: Week 16 and Week 24
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
Time Frame: Week 16 and Week 24
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)
Time Frame: Week 16 and Week 24
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
Time Frame: Week 16
Week 16
Percent change from baseline of validated Investigator's Global Assessment (vIGA)
Time Frame: Week 24
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
Time Frame: Week 24
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
Time Frame: Week 24
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ASLAN Pharmaceuticals

Investigators

  • Study Director: Chief Medical Officer, 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 Major Dates

Study Start (Actual)

December 21, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

January 9, 2023

First Submitted That Met QC Criteria

January 20, 2023

First Posted (Actual)

January 23, 2023

Study Record Updates

Last Update Posted (Actual)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASLAN004-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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