Recruiting

Phase 2

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

Sponsor:

ASLAN Pharmaceuticals

Code:

NCT05694884

Conditions

Atopic Dermatitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Placebo

ASLAN004

Study Details

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

Study ID

NCT05694884

Start date

Dec 21, 2022

Status verified date

Jan, 2024

Completion date

Feb 28, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

experimental: ASLAN004

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

Interventions

Placebo

Placebo Comparator

ASLAN004

Primary outcome measure

Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 16 [ Time Frame: Baseline, Week 16 ]

Central Contacts and Locations

Central contacts

ASLAN Pharmaceuticals

+65 6817 9598 contact@aslanpharma.com

Locations

ASLAN Investigative Site

Recruiting

Birmingham, Alabama, United States, 35244

Contacts

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

Study Details

Eligibility Criteria

Study Design

Interventions and Outcome Measures

Central Contacts and Locations

More Information