The purpose of this study is to evaluate the efficacy and safety of bermekimab in participants with moderate to severe atopic dermatitis (AD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
199
Placebo will be administered subcutaneously.
Bermekimab will be administered subcutaneously.
Dupilumab will be administered subcutaneously.
Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) (Greater Than or Equal to [>=] 75 Percent [%] Improvement From Baseline) at Week 16
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
Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 and a Reduction From Baseline of >=2 Points at Week 16
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
Percentage of Participants With Improvement (Reduction From Baseline) in Eczema-Related Itch Numeric Rating Scale (NRS) of Score >=4 at Week 16 Among Participants With a Baseline Itch Value >=4
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.
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California Allergy & Asthma Medical Group Inc.
Los Angeles, California, United States
Wolverine Clinical Trials
Santa Ana, California, United States
Park Avenue Dermatology
Orange Park, Florida, United States
Forcare Clinical Research, Inc.
Tampa, Florida, United States
Arlington Dermatology
Rolling Meadows, Illinois, United States
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, United States
Grekin Skin Institute
Warren, Michigan, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Ohio State University
Columbus, Ohio, United States
...and 32 more locations
Time frame: Week 16
Percentage of Participants Achieving EASI-90 (>= 90% Improvement in EASI From Baseline) at Week 16
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
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
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
Serum Bermekimab Concentration Over Time
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
Number of Participants With Anti-Bermekimab Antibodies
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