Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ASB17061 Capsules in Adult Subjects With Atopic Dermatitis

Participants with an IGA score of 0 or 1 were considered IGA responders. The investigator provided an overall assessment of disease severity using the IGA, which consists of a 6-point scale from a minimum of 0 and a maximum of 6. Higher scores indicate a worse outcome and lower scores indicate a better outcome. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease).

Participants with an IGA score of 0 or 1 were considered IGA responders. The investigator provided an overall assessment of disease severity using the IGA which consists of a 6-point scale from the minimum of 0 to a maximum of 6. Higher scores indicate increasing severity.. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease) and an overall assessment of the disease severity of the entire body using the Eczema Area and Severity Index (EASI). A composite index, the EASI has a minimum score of 0 (clear) and a maximum score of 72 (very severe); A value less than 15 indicates less severe, and 15 or greater indicates more severe. Lichenification was evaluated on a scale of 0 (none) as the minimum to 3 (severe) as the maximum, and the score of each body region was summed (0 to 12). A percent body surface area (BSA) involved less than 15 is less severe and 15 or greater more severe.

The investigator provided an overall assessment of the disease severity of the entire body using the EASI. A composite index, the EASI has a minimum score of 0 (clear) and a maximum score of 72 (very severe); with a negative value indicating decreasing severity of eczema compared to baseline and a decreasing change in the EASI score. A negative value is an indication of a decrease in individual scores.

Participants' body surface area affected by atopic dermatitis was assessed for the change in percentage after treatment. A negative value indicates a decrease in the percent of body surface area (BSA) involved. A negative value is an indication of a decrease in individual scores.

Participants assessed the overall intensity of pruritus using a 4-point scale with 0 as the minimum and 3 as the maximum. (0 = absent; 1 = mild; 2 = moderate; and 3 = severe) A negative value indicates a decreasing change in the pruritus score. A negative value is an indication of a decrease in individual scores.

Participants assessed the extent of their insomnia using an 11-point scale ranging from the minimum, 0 (no insomnia) to the maximum, 10 (severe insomnia). A negative value indicates a decreasing change in the insomnia score. A negative value is an indication of a decrease in individual scores.

The minimum observed plasma drug concentration (Cmin) of ASB17061 and ASB17584 in the 4-week Treatment Period were estimated from the actual dosing records.

Pharmacokinetic (PK) metrics of ASB17061 and ASB17584 maximum observed plasma drug concentration (Cmax) in the 4-week Treatment Period were estimated from the individual PK parameters and the actual dosing records.

The average plasma drug concentration (Cmin) of ASB17061 and ASB17584 in the 4-week Treatment Period were estimated from the actual dosing records.

A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.