A Study of JNJ-95597528 in Participants With Moderate to Severe Atopic Dermatitis

EASI-90 response is defined as at least 90% improvement from baseline in EASI total score. EASI is a validated measure used to assess the severity and extent of AD with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) will each be assessed for severity by the investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Here higher score indicates higher severity of AD.

EASI-100 response is defined as at least 100% improvement from baseline in EASI total score. EASI is a validated measure used to assess the severity and extent of AD with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) will each be assessed for severity by the investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Here higher score indicates higher severity of AD.

Percent change from baseline in EASI total score will be reported. EASI is a validated measure used to assess the severity and extent of AD with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) will each be assessed for severity by the investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Here higher score indicates higher severity of AD.

Proportion of participants with vIGA-AD score of 0 or 1 and a reduction of >=2 points from baseline at Week 12 will be reported. vIGA-AD is an assessment instrument used in clinical studies to rate the severity of AD, based on a 5-point scale ranging from 0 (clear) to 4 (severe). The IGA score is selected using the morphological descriptors that best describe the overall appearance of the AD lesions at a given time point. Higher scores are indicative of a more severe AD.

Proportion of participants with vIGA-AD score of 0 and a reduction of >=2 points from baseline at Week 12 will be reported. vIGA-AD is an assessment instrument used in clinical studies to rate the severity of AD, based on a 5-point scale ranging from 0 (clear) to 4 (severe). The IGA score is selected using the morphological descriptors that best describe the overall appearance of the AD lesions at a given time point. Higher scores are indicative of a more severe AD.

Proportion of participants with >=4-point improvement from baseline in PP-NRS scale at Week 12 will be reported. PP-NRS is a single item asking participants to assess their worst itch over the past 24 hours. There are 11 response categories, ranging from 0 (no itch) to 10 (worst itch imaginable). Higher score indicates greater severity.

Percent change from baseline in PP-NRS score will be reported. PP-NRS is a single item asking participants to assess their worst itch over the past 24 hours. There are 11 response categories, ranging from 0 (no itch) to 10 (worst itch imaginable). Higher score indicates greater severity.

Percent change from baseline in the score of Item 2 of AD Sleep Scale at Week 12 will be reported. The AD Sleep Scale is a validated 3-item participant-reported outcome (PRO) instrument to capture self-reported impact of itch on sleep disturbance each day, including difficulty falling asleep, number of night-time awakenings, and difficulty falling back asleep after waking during the previous night. For Item 2, participants select the number of times they woke up each night, ranging from 0 to 29 times. Higher score indicates more sleep disturbance.

Proportion of participants with >= 4 point improvement from baseline in skin pain NRS at Week 12 will be reported. Skin Pain NRS is a single item asking participants to assess their worst skin pain over the past 24 hours. There are 11 response categories, ranging from 0 (no pain) to 10 (worst pain imaginable). Higher score indicates more pain.

Percent change from baseline in Skin Pain NRS at Week 12 will be reported. Skin Pain NRS is a single item asking participants to assess their worst skin pain over the past 24 hours. There are 11 response categories, ranging from 0 (no pain) to 10 (worst pain imaginable). Higher score indicates more pain.

An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs are AEs with onset during the intervention phase or that are a consequence of a preexisting condition that has worsened since baseline. An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important.