Phase 2b Study of ASLAN004 in Adults With Moderate-to-Severe Atopic Dermatitis

This is an interventional treatment trial for Atopic Dermatitis focused on measuring atopic dermatitis, IL-13, ASLAN004, IL-13Rα1, Eczema, Anti-IL-13Rα1, atopic eczema Read More

Inclusion Criteria:

1. Male or female patients with a clinical diagnosis of AD for at least 1 year;
2. vIGA score of ≥3 at Screening and Baseline;
3. ≥10% BSA of AD involvement at Screening and Baseline;
4. EASI score ≥16 at Screening and Baseline;
5. History of inadequate response to treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI);
6. Twice daily application of a consistent amount of topical emollient for at least 7 days prior to randomization.

Exclusion Criteria:

1. Immunosuppressive/immunomodulating drugs, systemic therapies or phototherapy within 4 weeks prior to randomization;
2. Treatment with leukotriene inhibitors within 4 weeks prior to randomization;
3. Treatment with topical therapies (including TCS, TCI, topical phosphodiesterase inhibitors, topical JAK inhibitors) or prescription moisturizers, within 1 week prior to randomization;

4. Previous treatment at any time prior to randomization with monoclonal antibody / biologic therapeutic agents as follows;

   1. Prior exposure to dupilumab (Dupixent®) which was discontinued due to lack of efficacy, loss of response, or adverse event;
   2. Investigational or approved agents targeting interleukins IL-4 or IL-13 ligands or receptors of IL-4 or IL-13, including but not limited to lebrikizumab, tralokinumab or ASLAN004;
   3. Other investigational or approved biologic drug within 16 weeks or within 5 half-lives (if known), whichever is longer, prior to the Baseline visit;
   4. Cell-depleting biologics, including, but not limited to, rituximab within 6 months prior to the Baseline visit;
5. Inadequate organ function, abnormal lab result, uncontrolled blood pressure or other health condition considered clinically significant by the investigator at the Screening visit;
6. History of HIV, Hepatitis B, Hepatitis C or active/latent Tuberculosis infection;
7. History of immunosuppression including history of invasive opportunistic infections;
8. Treatment with live attenuated vaccine within 8 weeks prior to randomization;
9. Parasitic infection within 4 weeks prior to randomization travel within 3 months prior to randomization to areas of high parasitic exposure;
10. Have skin comorbidities that in the opinion of the Investigator may interfere with study assessments;
11. Pregnant or breastfeeding women;
12. Patients unwilling to use adequate birth control.