Evaluating eblasakimab for moderate-to-severe atopic dermatitis in patients previously treated with dupilumab
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
This study is testing if a new treatment called eblasakimab can help adults with moderate-to-severe atopic dermatitis who have already tried dupilumab feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ASLAN Pharmaceuticals Academic / other |
| Drugs / interventions | dupilumab, immunotherapy, eblasakimab |
| Locations | 27 sites (Birmingham, Alabama and 26 other locations) |
| Trial ID | NCT05694884 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a multicenter, randomized, double-blind, placebo-controlled study aimed at assessing the efficacy and safety of eblasakimab in adults with moderate-to-severe atopic dermatitis who have previously been treated with dupilumab. Participants will be randomly assigned to receive either eblasakimab or a placebo over a 16-week treatment period, followed by an 8-week follow-up. The study will evaluate various clinical outcomes, including the severity of atopic dermatitis and patient-reported symptoms.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a history of moderate-to-severe atopic dermatitis who have previously been treated with dupilumab.
Not a fit: Patients who have not previously been treated with dupilumab or those with mild atopic dermatitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with moderate-to-severe atopic dermatitis who have not responded adequately to dupilumab.
How similar studies have performed: Other studies have shown promise in targeting IL-13 pathways for atopic dermatitis, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham, Alabama and 26 other locations
- ASLAN Investigative Site — Birmingham, Alabama, United States (Recruiting)
- ASLAN Investigative Site — Encino, California, United States (Recruiting)
- ASLAN Investigative Site — Fountain Valley, California, United States (Recruiting)
- ASLAN Investigative Site — Long Beach, California, United States (Recruiting)
- ASLAN Investigative Site — Los Angeles, California, United States (Recruiting)
- ASLAN Investigative Site — Sherman Oaks, California, United States (Recruiting)
- ASLAN Investigative Site — Boca Raton, Florida, United States (Recruiting)
- ASLAN Investigative Site — Hollywood, Florida, United States (Recruiting)
- ASLAN Investigative Site — Hollywood, Florida, United States (Recruiting)
- ASLAN Investigative Site — Miami Lakes, Florida, United States (Recruiting)
- ASLAN Investigative Site — North Miami Beach, Florida, United States (Recruiting)
- ASLAN Investigative Site — Orange City, Florida, United States (Recruiting)
- ASLAN Investigative Site — Saint Augustine, Florida, United States (Recruiting)
- ASLAN Investigative Site — Saint Petersburg, Florida, United States (Recruiting)
- ASLAN Investigative Site — New Albany, Indiana, United States (Recruiting)
- ASLAN Investigative Site — Louisville, Kentucky, United States (Recruiting)
- ASLAN Investigative Site — Quincy, Massachusetts, United States (Recruiting)
- ASLAN Investigative Site — Auburn Hills, Michigan, United States (Recruiting)
- ASLAN Investigative Site — Las Vegas, Nevada, United States (Recruiting)
- ASLAN Investigative Site — E. Amherst, New York, United States (Recruiting)
- ASLAN Investigative Site — Charlotte, North Carolina, United States (Recruiting)
- ASLAN Investigative Site — Oklahoma City, Oklahoma, United States (Recruiting)
- ASLAN Investigative Site — Johnston, Rhode Island, United States (Recruiting)
- ASLAN Investigative Site — Charleston, South Carolina, United States (Recruiting)
- ASLAN Investigative Site — Hamilton, Ontario, Canada (Recruiting)
- ASLAN Investigative Site — Ottawa, Ontario, Canada (Recruiting)
- ASLAN Investigative Site — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: ASLAN Pharmaceuticals
- Email: contact@aslanpharma.com
- Phone: +65 6817 9598
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.