The purpose of this study is to assess how well JNJ-95597528 works compared to placebo in participants with moderate to severe atopic dermatitis (AD).

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

Dermatitis, Atopic

Atopic Dermatitis

Dermatology

Immune system conditions

Placebo

JNJ-95597528

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-95597528 for the Treatment of Adult Participants With Moderate to Severe Atopic Dermatitis

EASI-75 response is defined as at least 75 percent (%) 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-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.

Participants will receive JNJ-95597528 Dose 1 on Weeks 0, 2, 12, and 24.

Participants will receive JNJ-95597528 Dose 2 on Week 0 followed by JNJ-95597528 Dose 3 on Weeks 12, and 24.

Participants will receive JNJ-95597528 Dose 4 on Week 0 followed by JNJ-95597528 Dose 5 on Weeks 12, and 24.

Participants will receive placebo from Weeks 0 to 12 , then switch to receive JNJ-95597528 Dose 2 administered at Week 12 followed by Dose 3 at Week 24.

The purpose of this study is to assess how well JNJ-95597528 works compared to placebo in
participants with moderate to severe atopic dermatitis (AD).

EASI-75 response is defined as at least 75 percent (%) 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-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.

Participants will receive JNJ-95597528 Dose 2 on Week 0 followed by JNJ-95597528 Dose 3
on Weeks 12, and 24.

Participants will receive JNJ-95597528 Dose 4 on Week 0 followed by JNJ-95597528 Dose 5
on Weeks 12, and 24.

Participants will receive placebo from Weeks 0 to 12 , then switch to receive
JNJ-95597528 Dose 2 administered at Week 12 followed by Dose 3 at Week 24.

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

Trials at a glance

Trials at a glance

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

Outcome measures

Primary outcome measures

Secondary outcome measures