Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ASLAN Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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 baseline 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.
13. Active COVID infection at baseline.
Clareo Health | Phase 2b Study of ASLAN004 in Adults With Moderate-to-Severe Atopic Dermatitis
