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    Summary
    The value 'Show more Show more Revision: v2.9.0' has been updated to 'Show less MedlinePlus Genetics related topics: Atopic dermatitis MedlinePlus related topics: Eczema FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : Randomized Interventional Model : Parallel Assignment Interventional Model Description: Double Blind, Placebo-controlled, Randomized Masking : Quadruple ( Participant Care Provider Investigator Outcomes Assessor ) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : ASLAN004 Drug : ASLAN004 Subcutaneous injections of ASLAN004 100 mg/mL will be administered into the thigh or abdomen, except for the 2 inches (5 cm) around the navel. Placebo Comparator : ASLAN004 Placebo Drug : ASLAN004 Placebo Subcutaneous injections of ASLAN004 Placebo will be administered into the thigh or abdomen, except for the 2 inches (5 cm) around the navel. Primary Outcome Measures Outcome Measure Measure Description Time Frame To assess the safety and tolerability of multiple ascending doses of ASLAN004: Incidence of treatment-emergent adverse events (TEAEs) Incidence of treatment-emergent adverse events (TEAEs) reported from the administration of study drug on Day 1 until the completion of the study. Baseline to 12 weeks safety follow up Secondary Outcome Measures Outcome Measure Measure Description Time Frame Percentage change from baseline in Eczema Area and Severity Index (EASI) score weekly up to Week 8. Baseline up to Week 8 Proportion of patients with 50%, 75%, and 90% improvement in the EASI score (EASI50, EASI75, and EASI90) weekly up to Week 8. Baseline up to Week 8 Percentage change from baseline in the Pruritus Numerical Rating Scale (NRS) score weekly up to Week 8. Baseline up to Week 8 Proportion of patients with at least a 4-point improvement in the Pruritus NRS score weekly up to Week 8. Baseline up to Week 8 Proportion of patients who achieve an Investigator Global Assessment (IGA) score of 0 or 1 weekly up to Week 8. Baseline up to Week 8 Percentage change from baseline in the Patient-Oriented Eczema Measure (POEM) weekly up to Week 8. Baseline up to Week 8 Percentage change from baseline in percent body surface area (%BSA) affected weekly up to Week 8. Baseline up to Week 8 PK parameters throughout the dosing period, and serum concentrations by scheduled timepoints. Measurement of area under the curve (AUC) at Week 8 (AUC0-last), maximum observed concentration (Cmax) at Week 1, time to Cmax (tmax) at Week 1, Ctrough throughout the dosing period, and serum concentrations by scheduled timepoints. Baseline to 12 weeks safety follow up Change from baseline in PD markers of allergic inflammation (TARC and total IgE) weekly up to Week 8. Measurement of absolute values of TARC and total IgE in serum concentration and percentage of change Baseline up to Week 8 Measurement of ASLAN004 Anti-Drug Antibody over time. Measurement of ADA levels in serum Baseline to 12 weeks safety follow up Additional Relevant MeSH Terms Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Dermatitis, Atopic Dermatitis Eczema Plan to Share Individual Participant Data (IPD)? No Studies a U.S. FDA-Regulated Drug Product Yes Studies a U.S. FDA-Regulated Device Product No Product Manufactured in and Exported from the U.S. No Revision: v2.9.1'
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