A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Trial to Evaluate the Efficacy and Safety of ASLAN004 in Adult Patients With Moderate-to-Severe Atopic Dermatitis
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Trial to Evaluate the Efficacy and Safety of ASLAN004 in Adult Patients With Moderate-to-Severe Atopic Dermatitis
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).
Inclusion Criteria:
Exclusion Criteria:
Immunosuppressive/immunomodulating drugs, systemic therapies or phototherapy within 4 weeks prior to randomization;
Treatment with leukotriene inhibitors within 4 weeks prior to randomization;
Treatment with topical therapies (including TCS, TCI, topical phosphodiesterase inhibitors, topical JAK inhibitors) or prescription moisturizers, within 1 week prior to randomization;
Previous treatment at any time prior to randomization with monoclonal antibody / biologic therapeutic agents as follows;
Inadequate organ function, abnormal lab result, uncontrolled blood pressure or other health condition considered clinically significant by the investigator at the Screening visit;
History of HIV, Hepatitis B, Hepatitis C or active/latent Tuberculosis infection;
History of immunosuppression including history of invasive opportunistic infections;
Treatment with live attenuated vaccine within 8 weeks prior to randomization;
Parasitic infection within 4 weeks prior to baseline travel within 3 months prior to randomization to areas of high parasitic exposure;
Have skin comorbidities that in the opinion of the Investigator may interfere with study assessments;
Pregnant or breastfeeding women;
Patients unwilling to use adequate birth control.
Active COVID infection at baseline.
North York, Ontario M3B 3S6, Canada
Nagpur, Maharashtra 440019, India