A Study of Bermekimab (JNJ-77474462) in the Treatment of Participants With Moderate to Severe Atopic Dermatitis

Percentage of participants achieving EASI-75 at Week 16 were reported. EASI-75 response is defined as at least 75% improvement from baseline in EASI total score. The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration/papulation, excoriation and lichenification on 4 anatomic regions of the body: head/neck, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.

Time frame: Week 16

Population: The modified full analysis set (mFAS) included all participants who were randomized at Week 0 and received at least 1 dose of study intervention and had reached a visit by the time of the decision was made to terminate the study on 02 February 2022. Participants were excluded from the analysis after projected visit. Projected visit (weeks) = (decision date of study termination - first dose date +1) /7.

Number of participants with anti-bermekimab antibodies were reported. Data are presented by individual dose of investigational medicinal product received by participants during active treatment period as preplanned in protocol.

Time frame: Up to Week 36

Population: The immunogenicity analysis set included all participants who had received at least 1 dose of bermekimab and who had at least 1 sample obtained after their first dose of bermekimab for the detection of antibodies to bermekimab.

An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were AEs with onset during the intervention period or that were a consequence of a pre-existing condition that has worsened since baseline. AEs are presented by individual dose received by participants during placebo-controlled period and by responders individual dose received during active treatment period.

Time frame: Up to Week 36

Population: The safety analysis set included all participants who had received at least 1 dose of study intervention.

An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Any SAE with onset during the intervention period or that were a consequence of a pre-existing condition that has worsened since baseline was considered to be TESAEs. AEs are presented by individual dose received by participants during placebo-controlled period and active treatment period.

Time frame: Up to Week 36

Population: The safety analysis set included all participants who had received at least 1 dose of study intervention.

Percentage of participants achieving EASI-90 at Week 16 were reported. EASI-90 response is defined as at least 90% improvement from baseline in EASI total score. The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration/papulation, excoriation and lichenification on 4 anatomic regions of the body: head/neck, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.

Time frame: Week 16

Population: The mFAS included all participants who were randomized at Week 0 and received at least 1 dose of study intervention and had reached a visit by the time of the decision was made to terminate the study on 02 February 2022. Participants were excluded from the analysis after projected visit. Projected visit (weeks) = (decision date of study termination - first dose date +1) /7.

Percentage of participants achieving vIGA-AD at Week 16 were reported. It is an assessment instrument used in clinical studies to rate the severity of AD, based on a 5-point scale ranging from 0, where 0=Clear: No inflammatory signs of AD; 1=almost clear: Barely perceptible erythema, induration/papulation and/or lichenification; 2=mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting; 3=moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present and 4=severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present. Higher score indicated more severity of AD.

Time frame: Week 16

Population: The mFAS included all participants who were randomized at Week 0 and received at least 1 dose of study intervention and had reached a visit by the time of the decision was made to terminate the study on 02 February 2022. Participants were excluded from the analysis after projected visit. Projected visit (weeks) = (decision date of study termination - first dose date +1) /7.

Percentage of participants with improvement (reduction from baseline) in eczema-related itch NRS of score \>=4 at Week 16 among participants with a baseline itch value \>=4 were reported. The eczema skin pain and Itch NRS is a 2-item patient-reported outcome that participants used to rate the severity of their eczema-related skin pain and eczema related itch daily. Participants were asked the following questions: Please rate the severity of your eczema-related skin pain at its worst in the past 24 hours; and please rate the severity of your eczema-related itch at its worst in the past 24 hours. Each item was on a 0 to 10 NRS ranging from 0 none to 10 worst possible and were scored separately. Higher score indicated more severity.

Time frame: Week 16

Population: The mFAS included all participants who were randomized at Week 0 and received at least 1 dose of study intervention and had reached a visit by the time of the decision was made to terminate the study on 02 February 2022. Participants were excluded from the analysis after projected visit. Projected visit (weeks) = (decision date of study termination - first dose date +1) /7. Here, N (number of participants analyzed) signifies participants who were evaluated for this outcome measure.

Serum bermekimab concentration over time were reported. Data are presented by individual dose of investigational medicinal product received by participants during active treatment period as preplanned in protocol.

Time frame: Pre-dose at Week 0, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, and Week 36

Population: The pharmacokinetic (PK) analysis set included all participants who had received at least 1 dose of bermekimab and had at least 1 valid blood sample drawn for PK analysis. Here, n (number analyzed) specifies number of participants who were analyzed at the specified timepoint and '0' in the number analyzed field signifies that none of the participants were evaluable at the specified timepoint.