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

• Status: Not yet recruiting
• Trial end date: 2023-04-15
• Target enrollment: 0
• Participant gender: All

Summary

Phase 2b study designed to evaluate the efficacy and safety of ASLAN004 in adult patients with moderate-to-severe Atopic Dermatitis (AD) who are candidates for systemic therapy. This study will have 5 treatment arms (4 active and 1 placebo).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aslan Pharmaceuticals

Criteria

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. 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;

2. Immunosuppressive/immunomodulating drugs, systemic therapies or phototherapy within 4 weeks prior to randomization;

3. Treatment with leukotriene inhibitors within 4 weeks prior to randomization;

4. Treatment with topical therapies (including TCS, TCI, topical phosphodiesterase inhibitors, topical JAK inhibitors) or prescription moisturizers, within 1 week prior to randomization;

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.