A Study of Bermekimab for the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis

Percentage of participants with EASI-75 (\>=75% improvement from Baseline in EASI score) was planned to be reported in this outcome measure. The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. The severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The area of AD involvement on each of the 4 anatomic regions was assessed as a percentage by body area: 0=no eruption, 1=1% to 9%, 2=10% to 29%, 3=30% to 49%, 4=50% to 60%, 5=70% to 80% and 6=90% to 100%. The total score is the sum of the four body-region scores ranged from 0.0 to 72.0, with higher scores reflecting greater disease severity.

Time frame: Week 16

Population: The full analysis set (FAS) included all participants who were randomized at Week 0 and received at least 1 dose of study intervention. Due to premature study termination, planned data collection and analysis could not be performed for this outcome measure.

Number of participants with ADAs and NAbs to bermekimab was planned to be reported up to Week 16 but due to premature study termination, planned data collection and analysis could not be performed for this outcome measure.

Time frame: Up to Week 16

Population: Immunogenicity analysis set included all participants who received at least one dose of bermekimab and had at least one post-dose sample collection.

Percentage of participants with adverse events of infusion-related reactions was reported. An AE was 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. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.

Time frame: Up to Week 6

Population: The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned.

Percentage of participants with AEs leading to discontinuation of study intervention was reported. An AE was 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. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.

Time frame: Up to Week 6

Population: The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned.

Percentage of participants with AEs of infections (including serious infections and infections requiring oral or parenteral antimicrobial treatment) was reported. An AE was 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. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.

Time frame: Up to Week 6

Population: The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned.

Percentage of participants with AEs reasonably related to study intervention was reported. An AE was 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. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.

Time frame: Up to Week 6

Population: The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned.

Percentage of participants with both vIGA-AD score of 0 or 1 and a reduction from baseline of \>=2 points was reported. IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale ranged from 0 to 4, where 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe. Higher scores indicated greater severity. The IGA score was selected using the morphological descriptors that best described the overall appearance (erythema and population/infiltration) of the AD lesions at a given time point.

Time frame: Week 16

Population: FAS included all participants who were randomized at Week 0 and received at least 1 dose of study intervention. Due to premature study termination, planned data collection and analysis could not be performed for this outcome measure.

In this outcome measure, percentage of participants with \>=2 National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade in laboratory parameter 'clinical chemistry-potassium (normal range: 3.5 to 5.2 mmol/L)' was reported. Grading was done as: Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening). The clinical significance was determined by the investigator. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.

Time frame: Up to Week 6

Population: The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned.

In this outcome measure, percentage of participants with clinically significant abnormalities in vital sign (respiratory rate) was reported. The clinical significance was determined by the investigator. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.

Time frame: Up to Week 6

Population: The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned.

Percentage of participants with EASI-90 was planned to be reported. The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. The severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The area of AD involvement on each of the 4 anatomic regions was assessed as a percentage by body area: 0=no eruption, 1=1% to 9%, 2=10% to 29%, 3=30% to 49%, 4=50% to 60%, 5=70% to 80% and 6=90% to 100%. The total score is the sum of the four body-region scores ranged from 0.0 to 72.0, with higher scores reflecting greater disease severity.

Time frame: Week 16

Population: FAS included all participants who were randomized at Week 0 and received at least 1 dose of study intervention. Due to premature study termination, planned data collection and analysis could not be performed for this outcome measure.

Percentage of participants with improvement (reduction) of eczema-related itch NRS score of \>=4 from baseline among participants with a baseline itch value \>=4 was reported in this outcome measure. The eczema skin pain and itch NRS was a 2-item (pain and itch) patient-reported outcome (PRO) developed by the sponsor that participants used to rate the severity of their eczema-related skin pain and itch daily. To rate the severity of eczema-related itch, participants were asked the following question: 'how would you rate your itch at the worst moment during the previous 24 hours' and the response was scored on a scale of 0 (no itch) to 10 (worst itch imaginable).

Time frame: Week 16

Population: FAS included all participants who were randomized at Week 0 and received at least 1 dose of study intervention. Due to premature study termination, planned data collection and analysis could not be performed for this outcome measure.

An adverse event (AE) was 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. Any AE occurring at or after the initial administration of study intervention up to end of study was considered as treatment-emergent. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.

Time frame: Up to Week 6

Population: The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product. Any SAEs occurring at or after the initial administration of study intervention up to end of the study was considered as treatment-emergent. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.

Time frame: Up to Week 6

Population: The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned.

Serum concentrations of bermekimab was planned to be reported up to Week 20 but due to premature study termination, planned data collection and analysis could not be performed for this outcome measure.

Time frame: Up to Week 20

Population: Pharmacokinetic (PK) analysis set included all participants who received at least one dose of bermekimab and had at least one post-dose sample collection.