A Study to Evaluate the Safety and Efficacy of Bermekimab in Patients With Moderate to Severe Atopic Dermatitis

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Bermekimab in Patients With Moderate to Severe Atopic Dermatitis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04021862

Enrollment

Registered

2019-07-16

Start date

2019-10-16

Completion date

2020-11-19

Last updated

2025-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis, Eczema

Brief summary

A Study to Evaluate the Safety and Efficacy of Bermekimab in Patients With Moderate to Severe Atopic Dermatitis

Detailed description

This is a phase II, randomized, double-blind, placebo-controlled study of bermekimab in patients with moderate to severe atopic dermatitis. The primary objective of the study is to analyze the safety and efficacy of different dose regimens of bermekimab compared to placebo treatment in adult patients with moderate-to-severe AD. The study is multicenter and will consist of three groups: Treatment Arm 1: Bermekimab every week (qw) Treatment Arm 2: Bermekimab every other week (q2w) Arm 3 (Placebo): Placebo every week (qw)

Interventions

DRUGBermekimab Monoclonal Antibody

Bermekimab 400 mg or 800 mg will be administered subcutaneously.

DRUGPlacebo

Placebo will be administered subcutaneously.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female, at least 18 years * Willing and able to attend all clinic visits and comply with study-related procedures * Participant can understand and complete study-related questionnaires * Written informed consent provided by the participant * Chronic atopic dermatitis present for at least 3 years * Eczema Area and Severity Index Score (EASI) score greater than or equal to (\>=) 16 at screening and baseline visits * Investigators Global Assessment (IGA) \>= 3 at screening and baseline visits * Baseline pruritis numerical rating scale average score for maximum intensity of at least 3, based on the average of daily pruritis numerical rating scale scores for maximum itch intensity reported during the 7 days prior to randomization * Has applied a stable dose of topical moisturizer twice daily for at least 7 consecutive days immediately prior to the baseline visit and is willing to continue this regimen on a daily basis for the duration of the study * \>= 10 percent (%) body surface area (BSA) of Atopic Dermatitis (AD) involvement at screening and baseline visits * Documented recent history (within 6 months prior to screening) of inadequate response to treatment with topical medications, or participants for whom topical treatments are medically inadvisable (because of important side effects or safety risks): (a) Inadequate response is defined as failure to achieve and maintain remission or a low disease activity state (comparable to an IGA score of 0-2), despite treatment with a daily regimen of topical corticosteroids of medium to higher potency (with or without topical calcineurin inhibitors as appropriate), applied for at least 28 days or for the maximum duration recommended by the product prescribing information, whichever is shorter; (b) Participants with documented systemic treatment for atopic dermatitis in the preceding 6 months are also considered to be inadequate responders to topical treatments and are potentially eligible for treatment with MABp1, after appropriate washout; (c) Important side effects or risks are those that outweigh the potential treatment benefits, and include: intolerance to treatment, hypersensitivity reactions, significant skin atrophy, and adverse systemic effects; and (d) Acceptable documentation includes contemporaneous chart notes that record topical medication prescription and treatment outcome, or investigator documentation based on communication with the participant's treating physician.

Exclusion criteria

* Participants has been treated for AD with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug prior to baseline * Treatment with bermekimab at any time in the past * Treatment with immunosuppressive/immunomodulatory drugs or phototherapy for atopic dermatitis within 4 weeks of baseline, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment * Treatment with topical corticosteroids or topical calcineurin inhibitors for the treatment of AD within 14 days prior to baseline * Treatment with biologics as follows: (a) Any cell-depleting agents including, but not limited to, rituximab, within 5 half-lives (if known) or 30 days prior to baseline visit, or until lymphocyte count returns to normal, whichever is longer; (b) Other biologics: within 5 half-lives (if known) or 30 days prior to baseline visit, whichever is longer * Initiation of treatment of atopic dermatitis with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (participants may continue to use stable doses of such moisturizers if initiated before the screening visit) * Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit * Planned or anticipated use of any prohibited medications and procedures during study treatment * Treatment with a live (attenuated) vaccine within 30 days prior to the screening visit * Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks prior to the baseline visit, or superficial skin infections within 1 week prior to the baseline visit * Known or suspected history of immunosuppression, including history of invasive opportunistic infections (for example, tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis, aspergillosis) despite infection resolution; or unusually frequent, recurrent, or prolonged infections, per investigator judgment * History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening * Positive for hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody at the screening visit * At baseline, presence of any conditions listed as criteria for study drug discontinuation * Presence of skin comorbidities that may interfere with study assessments * History of malignancy within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, and completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin diagnosed active endoparasitic infections; suspected or high risk of endoparasitic, unless clinical and (if necessary) laboratory assessments have ruled out active infection before randomization * Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the Participant's participation in the study. Examples include, but are not limited to, participants with short life expectancy, participants with uncontrolled diabetes (HbA1c \>= 9%), participants with cardiovascular conditions (for example, stage III or IV cardiac failure according to the New York Heart Association classification), severe renal conditions (for example, participants on dialysis), hepato-biliary conditions (for example, Child-Pugh class B or C), neurological conditions (for example, demyelinating diseases), active major autoimmune diseases (for example, lupus, inflammatory bowel disease, rheumatoid arthritis, etc.), other severe endocrinological, gastrointestinal, metabolic, pulmonary or lymphatic diseases. The specific justification for participants excluded under this criterion will be noted in study documents (chart notes, case report forms \[CRFs\], etc.) * Planned or anticipated major surgical procedure during the participant's participation in this study * Membership of the investigational team or his/her immediate family * Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study * Women unwilling to use adequate birth control, if of reproductive potential and sexually active. Adequate birth control is defined as consistent practice of an effective and accepted method of contraception throughout the duration of the study and for 120 days after the last dose of study drug. These methods include hormonal contraceptives, intrauterine device, double barrier contraception (that is, condom + diaphragm), or male partner with a documented vasectomy * History of severe allergic or anaphylactic reactions to monoclonal antibodies * Any other medical or psychological condition (including relevant laboratory abnormalities at screening) that, in the opinion the investigator, may suggest a new and/or insufficiently understood disease, may present an unreasonable risk to the study participant as a result of his/her participation in the study, may make participant's participation unreliable, or may interfere with study assessments. The specific justification for participant excluded under this criterion will be noted in study documents (chart notes, case report forms, etc.)

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) Response at Week 16	Week 16	Percentage of participants achieving EASI-75 at Week 16 were reported. EASI-75 response was 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 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 total EASI score is the sum of four body-region scores ranged from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. This outcome measure was planned to be analyzed for specified arms only.

Secondary

Measure	Time frame	Description
Percentage of Participants Achieving >= 4 Point Improvement (Reduction From Baseline) in Weekly Average of Average Daily Pruritis (Itch) NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Weeks 4, 8, 12, 16 and 32	Percentage of participants achieving \>= 4 improvement (reduction from baseline) in weekly average of average daily pruritis NRS score from baseline at Weeks 4, 8, 12, 16 and 32 among participants with a baseline score \>=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. To rate the severity of eczema-related itch participants were asked the following question: please rate the severity of your eczema-related average itch in the past 24 hours. The response was rated on a 0 to 10 NRS. Higher score indicated more severity. Seven daily averaged NRS scores were averaged into a weekly score.
Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Weeks 4, 8, 12, 16 and 32	Percentage of participants achieving \>=4 improvement (reduction from baseline) in weekly average peak (worst) daily skin pain NRS score from baseline at Weeks 4, 8, 12, 16 and 32 among participants with a baseline score \>=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. To rate the severity of eczema-related skin pain participants were asked the following question: Please rate the severity of your eczema-related skin pain at its worst in the past 24 hours. The response was rated on a 0 to 10 NRS ranging from 0 none to 10 worst possible. Seven daily NRS scores were averaged into a weekly score. Higher score indicated more severity.
Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average of Average Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Weeks 4, 8, 12, 16 and 32	Percentage of participants achieving \>=4 improvement (reduction from baseline) in weekly average of average daily skin pain NRS score from baseline to Weeks 4, 8, 12, 16 and 32 among participants with a baseline score \>=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. To rate the severity of eczema-related skin pain participants were asked the following question: Please rate the severity of your eczema-related average skin pain in the past 24 hours; The response was rated on a 0 to 10 NRS. Higher score indicated more severity. Seven daily averaged NRS scores were averaged into a weekly score.
Percentage of Participants Achieving EASI-75 Response at Weeks 4, 8, 12, and 32	Weeks 4, 8, 12, and 32	Percentage of participants achieving EASI-75 response at Weeks 4, 8, 12, and 32 were reported. EASI-75 response was defined as at least 75% improvement from baseline in EASI total score. The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration/papulation, excoriation and lichenification on 4 anatomic regions of the body: head/neck, trunk, upper and lower extremities. 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 total EASI score is the sum of four body-region scores ranged from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of >=2 Points at Week 16	Week 16	Percentage of participants with both IGA score of 0 or 1 and a reduction from baseline of \>=2 points was reported. IGA assesses AD severity and clinical response using a 5-point scale: 0 = clear, 1= almost clear, 2 = mild, 3 = moderate, 4 = severe. A higher score indicated more severity of AD. The score was determined by ranking the extent of erythema and population/infiltration. A clinical response to therapy was an IGA score of 0 (clear) or 1 (almost clear). This outcome measure was planned to be analyzed for specified arms only.
Percentage of Participants Achieving EASI-90 Response at Weeks 12, 16, and 32	Weeks 12, 16, and 32	Percentage of participants achieving EASI-90 response at Weeks 12, 16 and 32 were reported. EASI-90 response was 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 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 total EASI score is the sum of four body-region scores ranged from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Percentage of Participants Achieving >=4 Point Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Pruritus (Itch) Numeric Rating Scale (NRS) Score From Baseline at Week 4, 8, 12, 16 and 32 Among Participants With Baseline Score >=4	Weeks 4, 8, 12, 16 and 32	Percentage of participants achieving greater than or equal to (\>=4) point improvement (reduction from baseline) in weekly average peak (worst) daily pruritus NRS score from baseline at Weeks 4, 8, 12, 16 and 32 among participants with a baseline score \>=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. To rate the severity of eczema-related itch participants were asked the following question: please rate the severity of your eczema-related itch at its worst in the past 24 hours. The response was rated on a 0 to 10 NRS ranging from 0 none to 10 worst possible. Higher score indicated more severity. Seven daily average NRS scores are into a weekly score.
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) (Anxiety) Score at Weeks 8, 12, 16, and 32	Baseline, Weeks 8,12,16 and 32	In this outcome measure, change from baseline in HADS-Anxiety score at weeks 8, 12, 16 and 32 were reported. The HADS is an instrument for screening anxiety and depression in non-psychiatric populations; repeated administration also provides information about changes to a participant's emotional state. The HADS is a 14-item self-administered questionnaire, 7 each for anxiety and depression symptoms. Each item is scored from 0-3, resulting in total anxiety score ranging from 0 (less severity of anxiety) to 21 (greater severity of anxiety). Higher score indicated more anxiety symptoms. The following cut-off scores are recommended: 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety.
Change From Baseline in HADS (Depression) Score at Weeks 8, 12, 16, and 32	Baseline, Weeks 8,12,16 and 32	In this outcome measure, change from baseline in HADS-depression score at weeks 8, 12, 16 and 32 were reported. The HADS is an instrument for screening anxiety and depression in non-psychiatric populations; repeated administration also provides information about changes to a participant's emotional state. The HADS is a 14-item self-administered questionnaire, and consists of 7 items each for anxiety and depression symptoms. Each item is scored from 0-3, resulting in total depression score ranging from 0 (less severity of depression) to 21 (greater severity of depression). Higher score indicated more depression symptoms. The following cut-off scores are recommended: 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe depression.
Change From Baseline in Patient Oriented Eczema Measure (POEM) Scores at Weeks 8, 12, 16, and 32	Baseline, Weeks 8, 12, 16, and 32	The POEM is a 7-item, validated questionnaire used to assess disease symptoms in both children and adults. Participants respond to 7 questions, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency of occurrence during the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores are added to provide a total score ranging from 0 (clear) to 28 (very severe atopic eczema). Higher scores indicated more severe disease and poor quality of life.
Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score at Weeks 8, 12, 16, and 32.	Baseline to Weeks 8, 12, 16 and 32	SCORAD is a validated scoring index for AD, which consists of 3 components that is A =extent or affected body surface area assessed as percentage of each defined body area and reported as the sum of all areas, with a maximum score of 100%. B=severity of 6 specific symptoms of AD (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) assessed using the following scale: none (0), mild (1), moderate (2), or severe (3) (for a maximum of 18 total points) and C=subjective symptoms scored by participants on visual analogue scale, where 0 is no itch (or no sleeplessness) and 10 is worst imaginable itch (or sleeplessness) with a maximum score of 20. SCORAD total score was calculated using these 3 aspects: extent (A: 0-100), severity (B: 0-18), and subjective symptoms (C: 0-20) using the formula: A/5 + 7\*B/2+ C to give the SCORAD total score range of 0 to 103, where 0 = no disease to 103 = severe disease. Higher values of SCORAD represent worse outcome.
Change From Baseline in Global Individual Signs Score (GISS) at Weeks 8, 12, 16, and 32.	Baseline, Weeks 8,12,16 and 32	GISS assesses AD lesions for erythema, excoriations, lichenification and edema/papulation. Each component was rated on a global basis (over the entire body surface rather than region) using a 4-point scale (0=none, 1=mild, 2=moderate and 3=severe) according to the EASI grading severity. The cumulative score, which ranges from 0 to 12, is the sum of the four components. A higher score indicates more severe disease.
Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 8, 12, 16, and 32	Baseline, Weeks 8, 12, 16 and 32	The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The format is a simple response (0 to 3 where 0 is not at all and 3 is very much) to 10 questions, which assess QOL over the past week, with an overall scoring system of 0 to 30. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. A higher score indicates more severe disease and poor QoL.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Placebo (Week 0 - 16) Participants received placebo matching to bermekimab (4 milliliters \[mL\]) subcutaneous (SC) injection at Week 0, followed by weekly (qw) placebo SC injections from Week 1 through Week 16.	29
Bermekimab 400 mg q2w (Week 0 - 16) Participants received bermekimab 800 milligrams (mg) (400mg\*2) loading dose SC injection at Week 0 followed by bermekimab 400 mg SC injections every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.	29
Bermekimab 400 mg qw (Week 0 - 16) Participants received bermekimab 400 mg loading dose SC injection along with matching placebo loading dose SC injection at Week 0 followed by weekly (qw) SC injections of bermekimab 400 mg (2\*200 mg per mL) through Week 16.	29
Total	87

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Active Treatment Period (Week 16-32)	Withdrawal by Subject	0	0	0	1
Placebo Controlled Period (Week 0-16)	Adverse Event	2	0	0	0
Placebo Controlled Period (Week 0-16)	Other	0	0	1	0
Placebo Controlled Period (Week 0-16)	Pregnancy	0	0	1	0
Placebo Controlled Period (Week 0-16)	Withdrawal by Subject	0	1	0	0

Baseline characteristics

Characteristic	Bermekimab 400 mg q2w (Week 0 - 16)	Bermekimab 400 mg qw (Week 0 - 16)	Total	Placebo (Week 0 - 16)
Age, Continuous	44 years STANDARD_DEVIATION 15.71	41.9 years STANDARD_DEVIATION 16.65	45.5 years STANDARD_DEVIATION 16.25	50.7 years STANDARD_DEVIATION 15.59
Age, Customized 85 years and over	0 participants	0 participants	1 participants	1 participants
Age, Customized Adults (18-64 years)	27 participants	27 participants	77 participants	23 participants
Age, Customized From 65 to 84 years	2 participants	2 participants	9 participants	5 participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	2 Participants	1 Participants	3 Participants	0 Participants
Race (NIH/OMB) Black or African American	8 Participants	8 Participants	22 Participants	6 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	19 Participants	20 Participants	62 Participants	23 Participants
Region of Enrollment UNITED STATES	29 Participants	29 Participants	87 Participants	29 Participants
Sex: Female, Male Female	18 Participants	20 Participants	58 Participants	20 Participants
Sex: Female, Male Male	11 Participants	9 Participants	29 Participants	9 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk
deaths Total, all-cause mortality	0 / 29	0 / 29	0 / 29	0 / 27	0 / 28	0 / 27
other Total, other adverse events	2 / 29	7 / 29	2 / 29	3 / 27	3 / 28	1 / 27
serious Total, serious adverse events	0 / 29	0 / 29	1 / 29	0 / 27	0 / 28	0 / 27

Outcome results

Primary

Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) Response at Week 16

Percentage of participants achieving EASI-75 at Week 16 were reported. EASI-75 response was 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 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 total EASI score is the sum of four body-region scores ranged from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. This outcome measure was planned to be analyzed for specified arms only.

Time frame: Week 16

Population: Full analysis set (FAS) included all randomized participants who received at least 1 dose of study agent.

Arm	Measure	Value (NUMBER)
Placebo (Week 0 - 16)	Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) Response at Week 16	13.8 percentage of participants
Bermekimab 400 mg q2w (Week 0 - 16)	Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) Response at Week 16	24.1 percentage of participants
Bermekimab 400 mg qw (Week 0 - 16)	Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) Response at Week 16	34.5 percentage of participants

Secondary

Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 8, 12, 16, and 32

The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The format is a simple response (0 to 3 where 0 is not at all and 3 is very much) to 10 questions, which assess QOL over the past week, with an overall scoring system of 0 to 30. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. A higher score indicates more severe disease and poor QoL.

Time frame: Baseline, Weeks 8, 12, 16 and 32

Population: FAS; N (number of participants analyzed)=participants evaluated for this outcome measure, n (number analyzed)=participants analyzed at specified timepoints, 0=no participant analyzed. Week 16 data were collected and analyzed only for placebo crossover participants during active treatment period as pre-planned. For active treatment period assessments, participants who discontinued placebo controlled period in Bermekimab 400 mg q2w and Bermekimab 400 mg qw arms were also included as pre-planned.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo (Week 0 - 16)	Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 8, 12, 16, and 32	Week 8	-4.86 score on a scale	Standard Deviation 5.598
Placebo (Week 0 - 16)	Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 8, 12, 16, and 32	Week 12	-4.86 score on a scale	Standard Deviation 5.774
Placebo (Week 0 - 16)	Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 8, 12, 16, and 32	Week 16	-6.07 score on a scale	Standard Deviation 7.151
Bermekimab 400 mg q2w (Week 0 - 16)	Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 8, 12, 16, and 32	Week 8	-3.03 score on a scale	Standard Deviation 4.136
Bermekimab 400 mg q2w (Week 0 - 16)	Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 8, 12, 16, and 32	Week 16	-3.38 score on a scale	Standard Deviation 3.886
Bermekimab 400 mg q2w (Week 0 - 16)	Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 8, 12, 16, and 32	Week 12	-3.29 score on a scale	Standard Deviation 3.505
Bermekimab 400 mg qw (Week 0 - 16)	Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 8, 12, 16, and 32	Week 8	-3.41 score on a scale	Standard Deviation 4.694
Bermekimab 400 mg qw (Week 0 - 16)	Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 8, 12, 16, and 32	Week 12	-4.72 score on a scale	Standard Deviation 5.028
Bermekimab 400 mg qw (Week 0 - 16)	Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 8, 12, 16, and 32	Week 16	-5.93 score on a scale	Standard Deviation 5.12
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)	Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 8, 12, 16, and 32	Week 16	-6.52 score on a scale	Standard Deviation 7.213
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)	Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 8, 12, 16, and 32	Week 32	-9.15 score on a scale	Standard Deviation 6.413
Bermekimab 400 mg q2w (Week 16 - 31)	Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 8, 12, 16, and 32	Week 32	-4.10 score on a scale	Standard Deviation 5.759
Bermekimab 400 mg qw (Week 16 - 31)	Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 8, 12, 16, and 32	Week 32	-7.76 score on a scale	Standard Deviation 6.122

Secondary

Change From Baseline in Global Individual Signs Score (GISS) at Weeks 8, 12, 16, and 32.

GISS assesses AD lesions for erythema, excoriations, lichenification and edema/papulation. Each component was rated on a global basis (over the entire body surface rather than region) using a 4-point scale (0=none, 1=mild, 2=moderate and 3=severe) according to the EASI grading severity. The cumulative score, which ranges from 0 to 12, is the sum of the four components. A higher score indicates more severe disease.

Time frame: Baseline, Weeks 8,12,16 and 32

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo (Week 0 - 16)	Change From Baseline in Global Individual Signs Score (GISS) at Weeks 8, 12, 16, and 32.	Week 8	2.97 score on a scale	Standard Deviation 1.973
Placebo (Week 0 - 16)	Change From Baseline in Global Individual Signs Score (GISS) at Weeks 8, 12, 16, and 32.	Week 12	3.48 score on a scale	Standard Deviation 2.385
Placebo (Week 0 - 16)	Change From Baseline in Global Individual Signs Score (GISS) at Weeks 8, 12, 16, and 32.	Week 16	3.34 score on a scale	Standard Deviation 2.768
Bermekimab 400 mg q2w (Week 0 - 16)	Change From Baseline in Global Individual Signs Score (GISS) at Weeks 8, 12, 16, and 32.	Week 8	3.24 score on a scale	Standard Deviation 2.247
Bermekimab 400 mg q2w (Week 0 - 16)	Change From Baseline in Global Individual Signs Score (GISS) at Weeks 8, 12, 16, and 32.	Week 16	3.69 score on a scale	Standard Deviation 2.647
Bermekimab 400 mg q2w (Week 0 - 16)	Change From Baseline in Global Individual Signs Score (GISS) at Weeks 8, 12, 16, and 32.	Week 12	3.54 score on a scale	Standard Deviation 2.516
Bermekimab 400 mg qw (Week 0 - 16)	Change From Baseline in Global Individual Signs Score (GISS) at Weeks 8, 12, 16, and 32.	Week 8	2.07 score on a scale	Standard Deviation 2.034
Bermekimab 400 mg qw (Week 0 - 16)	Change From Baseline in Global Individual Signs Score (GISS) at Weeks 8, 12, 16, and 32.	Week 12	2.93 score on a scale	Standard Deviation 2.313
Bermekimab 400 mg qw (Week 0 - 16)	Change From Baseline in Global Individual Signs Score (GISS) at Weeks 8, 12, 16, and 32.	Week 16	2.97 score on a scale	Standard Deviation 2.514
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)	Change From Baseline in Global Individual Signs Score (GISS) at Weeks 8, 12, 16, and 32.	Week 16	3.59 score on a scale	Standard Deviation 2.707
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)	Change From Baseline in Global Individual Signs Score (GISS) at Weeks 8, 12, 16, and 32.	Week 32	5.70 score on a scale	Standard Deviation 2.799
Bermekimab 400 mg q2w (Week 16 - 31)	Change From Baseline in Global Individual Signs Score (GISS) at Weeks 8, 12, 16, and 32.	Week 32	3.97 score on a scale	Standard Deviation 2.934
Bermekimab 400 mg qw (Week 16 - 31)	Change From Baseline in Global Individual Signs Score (GISS) at Weeks 8, 12, 16, and 32.	Week 32	3.97 score on a scale	Standard Deviation 2.86

Secondary

Change From Baseline in HADS (Depression) Score at Weeks 8, 12, 16, and 32

In this outcome measure, change from baseline in HADS-depression score at weeks 8, 12, 16 and 32 were reported. The HADS is an instrument for screening anxiety and depression in non-psychiatric populations; repeated administration also provides information about changes to a participant's emotional state. The HADS is a 14-item self-administered questionnaire, and consists of 7 items each for anxiety and depression symptoms. Each item is scored from 0-3, resulting in total depression score ranging from 0 (less severity of depression) to 21 (greater severity of depression). Higher score indicated more depression symptoms. The following cut-off scores are recommended: 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe depression.

Time frame: Baseline, Weeks 8,12,16 and 32

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo (Week 0 - 16)	Change From Baseline in HADS (Depression) Score at Weeks 8, 12, 16, and 32	Week 8	0.86 score on a scale	Standard Deviation 1.941
Placebo (Week 0 - 16)	Change From Baseline in HADS (Depression) Score at Weeks 8, 12, 16, and 32	Week 12	0.97 score on a scale	Standard Deviation 2.291
Placebo (Week 0 - 16)	Change From Baseline in HADS (Depression) Score at Weeks 8, 12, 16, and 32	Week 16	0.93 score on a scale	Standard Deviation 2.103
Bermekimab 400 mg q2w (Week 0 - 16)	Change From Baseline in HADS (Depression) Score at Weeks 8, 12, 16, and 32	Week 8	0.59 score on a scale	Standard Deviation 3.088
Bermekimab 400 mg q2w (Week 0 - 16)	Change From Baseline in HADS (Depression) Score at Weeks 8, 12, 16, and 32	Week 16	0.31 score on a scale	Standard Deviation 2.989
Bermekimab 400 mg q2w (Week 0 - 16)	Change From Baseline in HADS (Depression) Score at Weeks 8, 12, 16, and 32	Week 12	0.57 score on a scale	Standard Deviation 3.132
Bermekimab 400 mg qw (Week 0 - 16)	Change From Baseline in HADS (Depression) Score at Weeks 8, 12, 16, and 32	Week 8	1.31 score on a scale	Standard Deviation 2.904
Bermekimab 400 mg qw (Week 0 - 16)	Change From Baseline in HADS (Depression) Score at Weeks 8, 12, 16, and 32	Week 12	0.90 score on a scale	Standard Deviation 3.426
Bermekimab 400 mg qw (Week 0 - 16)	Change From Baseline in HADS (Depression) Score at Weeks 8, 12, 16, and 32	Week 16	1.07 score on a scale	Standard Deviation 3.139
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)	Change From Baseline in HADS (Depression) Score at Weeks 8, 12, 16, and 32	Week 16	1.00 score on a scale	Standard Deviation 2.166
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)	Change From Baseline in HADS (Depression) Score at Weeks 8, 12, 16, and 32	Week 32	1.93 score on a scale	Standard Deviation 2.235
Bermekimab 400 mg q2w (Week 16 - 31)	Change From Baseline in HADS (Depression) Score at Weeks 8, 12, 16, and 32	Week 32	0.28 score on a scale	Standard Deviation 3.401
Bermekimab 400 mg qw (Week 16 - 31)	Change From Baseline in HADS (Depression) Score at Weeks 8, 12, 16, and 32	Week 32	1.55 score on a scale	Standard Deviation 4.188

Secondary

Change From Baseline in Hospital Anxiety and Depression Scale (HADS) (Anxiety) Score at Weeks 8, 12, 16, and 32

In this outcome measure, change from baseline in HADS-Anxiety score at weeks 8, 12, 16 and 32 were reported. The HADS is an instrument for screening anxiety and depression in non-psychiatric populations; repeated administration also provides information about changes to a participant's emotional state. The HADS is a 14-item self-administered questionnaire, 7 each for anxiety and depression symptoms. Each item is scored from 0-3, resulting in total anxiety score ranging from 0 (less severity of anxiety) to 21 (greater severity of anxiety). Higher score indicated more anxiety symptoms. The following cut-off scores are recommended: 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety.

Time frame: Baseline, Weeks 8,12,16 and 32

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo (Week 0 - 16)	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) (Anxiety) Score at Weeks 8, 12, 16, and 32	Week 8	1.59 score on a scale	Standard Deviation 2.732
Placebo (Week 0 - 16)	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) (Anxiety) Score at Weeks 8, 12, 16, and 32	Week 12	1.45 score on a scale	Standard Deviation 2.898
Placebo (Week 0 - 16)	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) (Anxiety) Score at Weeks 8, 12, 16, and 32	Week 16	1.59 score on a scale	Standard Deviation 2.771
Bermekimab 400 mg q2w (Week 0 - 16)	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) (Anxiety) Score at Weeks 8, 12, 16, and 32	Week 8	2.00 score on a scale	Standard Deviation 3.77
Bermekimab 400 mg q2w (Week 0 - 16)	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) (Anxiety) Score at Weeks 8, 12, 16, and 32	Week 16	1.97 score on a scale	Standard Deviation 3.669
Bermekimab 400 mg q2w (Week 0 - 16)	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) (Anxiety) Score at Weeks 8, 12, 16, and 32	Week 12	1.89 score on a scale	Standard Deviation 3.755
Bermekimab 400 mg qw (Week 0 - 16)	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) (Anxiety) Score at Weeks 8, 12, 16, and 32	Week 8	1.90 score on a scale	Standard Deviation 2.257
Bermekimab 400 mg qw (Week 0 - 16)	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) (Anxiety) Score at Weeks 8, 12, 16, and 32	Week 12	2.62 score on a scale	Standard Deviation 2.846
Bermekimab 400 mg qw (Week 0 - 16)	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) (Anxiety) Score at Weeks 8, 12, 16, and 32	Week 16	2.66 score on a scale	Standard Deviation 3.062
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) (Anxiety) Score at Weeks 8, 12, 16, and 32	Week 16	1.70 score on a scale	Standard Deviation 2.839
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) (Anxiety) Score at Weeks 8, 12, 16, and 32	Week 32	2.93 score on a scale	Standard Deviation 3.419
Bermekimab 400 mg q2w (Week 16 - 31)	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) (Anxiety) Score at Weeks 8, 12, 16, and 32	Week 32	2.34 score on a scale	Standard Deviation 3.467
Bermekimab 400 mg qw (Week 16 - 31)	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) (Anxiety) Score at Weeks 8, 12, 16, and 32	Week 32	3.14 score on a scale	Standard Deviation 3.114

Secondary

Change From Baseline in Patient Oriented Eczema Measure (POEM) Scores at Weeks 8, 12, 16, and 32

The POEM is a 7-item, validated questionnaire used to assess disease symptoms in both children and adults. Participants respond to 7 questions, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency of occurrence during the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores are added to provide a total score ranging from 0 (clear) to 28 (very severe atopic eczema). Higher scores indicated more severe disease and poor quality of life.

Time frame: Baseline, Weeks 8, 12, 16, and 32

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo (Week 0 - 16)	Change From Baseline in Patient Oriented Eczema Measure (POEM) Scores at Weeks 8, 12, 16, and 32	Week 8	-4.79 score on a scale	Standard Deviation 3.949
Placebo (Week 0 - 16)	Change From Baseline in Patient Oriented Eczema Measure (POEM) Scores at Weeks 8, 12, 16, and 32	Week 12	-5.07 score on a scale	Standard Deviation 5.021
Placebo (Week 0 - 16)	Change From Baseline in Patient Oriented Eczema Measure (POEM) Scores at Weeks 8, 12, 16, and 32	Week 16	-5.76 score on a scale	Standard Deviation 5.68
Bermekimab 400 mg q2w (Week 0 - 16)	Change From Baseline in Patient Oriented Eczema Measure (POEM) Scores at Weeks 8, 12, 16, and 32	Week 8	-5.66 score on a scale	Standard Deviation 5.627
Bermekimab 400 mg q2w (Week 0 - 16)	Change From Baseline in Patient Oriented Eczema Measure (POEM) Scores at Weeks 8, 12, 16, and 32	Week 16	-6.00 score on a scale	Standard Deviation 5.542
Bermekimab 400 mg q2w (Week 0 - 16)	Change From Baseline in Patient Oriented Eczema Measure (POEM) Scores at Weeks 8, 12, 16, and 32	Week 12	-6.14 score on a scale	Standard Deviation 5.543
Bermekimab 400 mg qw (Week 0 - 16)	Change From Baseline in Patient Oriented Eczema Measure (POEM) Scores at Weeks 8, 12, 16, and 32	Week 8	-6.59 score on a scale	Standard Deviation 4.939
Bermekimab 400 mg qw (Week 0 - 16)	Change From Baseline in Patient Oriented Eczema Measure (POEM) Scores at Weeks 8, 12, 16, and 32	Week 12	-7.55 score on a scale	Standard Deviation 4.903
Bermekimab 400 mg qw (Week 0 - 16)	Change From Baseline in Patient Oriented Eczema Measure (POEM) Scores at Weeks 8, 12, 16, and 32	Week 16	-8.07 score on a scale	Standard Deviation 5.618
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)	Change From Baseline in Patient Oriented Eczema Measure (POEM) Scores at Weeks 8, 12, 16, and 32	Week 16	-6.19 score on a scale	Standard Deviation 5.657
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)	Change From Baseline in Patient Oriented Eczema Measure (POEM) Scores at Weeks 8, 12, 16, and 32	Week 32	-10.48 score on a scale	Standard Deviation 6.659
Bermekimab 400 mg q2w (Week 16 - 31)	Change From Baseline in Patient Oriented Eczema Measure (POEM) Scores at Weeks 8, 12, 16, and 32	Week 32	-8.66 score on a scale	Standard Deviation 6.726
Bermekimab 400 mg qw (Week 16 - 31)	Change From Baseline in Patient Oriented Eczema Measure (POEM) Scores at Weeks 8, 12, 16, and 32	Week 32	-10.66 score on a scale	Standard Deviation 6.8

Secondary

Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score at Weeks 8, 12, 16, and 32.

SCORAD is a validated scoring index for AD, which consists of 3 components that is A =extent or affected body surface area assessed as percentage of each defined body area and reported as the sum of all areas, with a maximum score of 100%. B=severity of 6 specific symptoms of AD (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) assessed using the following scale: none (0), mild (1), moderate (2), or severe (3) (for a maximum of 18 total points) and C=subjective symptoms scored by participants on visual analogue scale, where 0 is no itch (or no sleeplessness) and 10 is worst imaginable itch (or sleeplessness) with a maximum score of 20. SCORAD total score was calculated using these 3 aspects: extent (A: 0-100), severity (B: 0-18), and subjective symptoms (C: 0-20) using the formula: A/5 + 7\*B/2+ C to give the SCORAD total score range of 0 to 103, where 0 = no disease to 103 = severe disease. Higher values of SCORAD represent worse outcome.

Time frame: Baseline to Weeks 8, 12, 16 and 32

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo (Week 0 - 16)	Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score at Weeks 8, 12, 16, and 32.	Week 8	21.53 score on a scale	Standard Deviation 11.468
Placebo (Week 0 - 16)	Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score at Weeks 8, 12, 16, and 32.	Week 12	24.27 score on a scale	Standard Deviation 13.13
Placebo (Week 0 - 16)	Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score at Weeks 8, 12, 16, and 32.	Week 16	25.90 score on a scale	Standard Deviation 15.916
Bermekimab 400 mg q2w (Week 0 - 16)	Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score at Weeks 8, 12, 16, and 32.	Week 8	21.29 score on a scale	Standard Deviation 15.632
Bermekimab 400 mg q2w (Week 0 - 16)	Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score at Weeks 8, 12, 16, and 32.	Week 16	27.56 score on a scale	Standard Deviation 13.661
Bermekimab 400 mg q2w (Week 0 - 16)	Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score at Weeks 8, 12, 16, and 32.	Week 12	26.50 score on a scale	Standard Deviation 12.894
Bermekimab 400 mg qw (Week 0 - 16)	Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score at Weeks 8, 12, 16, and 32.	Week 8	19.39 score on a scale	Standard Deviation 11.632
Bermekimab 400 mg qw (Week 0 - 16)	Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score at Weeks 8, 12, 16, and 32.	Week 12	22.45 score on a scale	Standard Deviation 12.849
Bermekimab 400 mg qw (Week 0 - 16)	Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score at Weeks 8, 12, 16, and 32.	Week 16	24.11 score on a scale	Standard Deviation 14.961
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)	Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score at Weeks 8, 12, 16, and 32.	Week 16	27.82 score on a scale	Standard Deviation 14.743
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)	Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score at Weeks 8, 12, 16, and 32.	Week 32	44.35 score on a scale	Standard Deviation 16.479
Bermekimab 400 mg q2w (Week 16 - 31)	Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score at Weeks 8, 12, 16, and 32.	Week 32	31.92 score on a scale	Standard Deviation 18.467
Bermekimab 400 mg qw (Week 16 - 31)	Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score at Weeks 8, 12, 16, and 32.	Week 32	35.05 score on a scale	Standard Deviation 18.461

Secondary

Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average of Average Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4

Percentage of participants achieving \>=4 improvement (reduction from baseline) in weekly average of average daily skin pain NRS score from baseline to Weeks 4, 8, 12, 16 and 32 among participants with a baseline score \>=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. To rate the severity of eczema-related skin pain participants were asked the following question: Please rate the severity of your eczema-related average skin pain in the past 24 hours; The response was rated on a 0 to 10 NRS. Higher score indicated more severity. Seven daily averaged NRS scores were averaged into a weekly score.

Time frame: Weeks 4, 8, 12, 16 and 32

Population: FAS included all randomized participants who received at least 1 dose of study agent. Here, N (number of participants analyzed) signifies participants who were evaluated for this outcome measure, n (number analyzed) signifies number of participants who were analyzed at the specified timepoints and '0' in the number analyzed field signifies that none of the participants were evaluable at the specified timepoint.

Arm	Measure	Group	Value (NUMBER)
Placebo (Week 0 - 16)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average of Average Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 4	40.0 percentage of participants
Placebo (Week 0 - 16)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average of Average Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 8	33.3 percentage of participants
Placebo (Week 0 - 16)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average of Average Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 12	40.0 percentage of participants
Placebo (Week 0 - 16)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average of Average Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 16	33.3 percentage of participants
Bermekimab 400 mg q2w (Week 0 - 16)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average of Average Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 4	33.3 percentage of participants
Bermekimab 400 mg q2w (Week 0 - 16)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average of Average Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 8	50.0 percentage of participants
Bermekimab 400 mg q2w (Week 0 - 16)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average of Average Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 16	25.0 percentage of participants
Bermekimab 400 mg q2w (Week 0 - 16)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average of Average Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 12	33.3 percentage of participants
Bermekimab 400 mg qw (Week 0 - 16)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average of Average Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 16	47.1 percentage of participants
Bermekimab 400 mg qw (Week 0 - 16)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average of Average Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 8	35.3 percentage of participants
Bermekimab 400 mg qw (Week 0 - 16)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average of Average Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 12	52.9 percentage of participants
Bermekimab 400 mg qw (Week 0 - 16)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average of Average Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 4	17.6 percentage of participants
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average of Average Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 16	35.7 percentage of participants
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average of Average Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 32	71.4 percentage of participants
Bermekimab 400 mg q2w (Week 16 - 31)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average of Average Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 16	25.0 percentage of participants
Bermekimab 400 mg q2w (Week 16 - 31)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average of Average Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 32	66.7 percentage of participants
Bermekimab 400 mg qw (Week 16 - 31)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average of Average Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 16	47.1 percentage of participants
Bermekimab 400 mg qw (Week 16 - 31)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average of Average Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 32	58.8 percentage of participants

Secondary

Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4

Percentage of participants achieving \>=4 improvement (reduction from baseline) in weekly average peak (worst) daily skin pain NRS score from baseline at Weeks 4, 8, 12, 16 and 32 among participants with a baseline score \>=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. To rate the severity of eczema-related skin pain participants were asked the following question: Please rate the severity of your eczema-related skin pain at its worst in the past 24 hours. The response was rated on a 0 to 10 NRS ranging from 0 none to 10 worst possible. Seven daily NRS scores were averaged into a weekly score. Higher score indicated more severity.

Time frame: Weeks 4, 8, 12, 16 and 32

Arm	Measure	Group	Value (NUMBER)
Placebo (Week 0 - 16)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 4	47.1 percentage of participants
Placebo (Week 0 - 16)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 8	41.2 percentage of participants
Placebo (Week 0 - 16)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 12	41.2 percentage of participants
Placebo (Week 0 - 16)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 16	35.3 percentage of participants
Bermekimab 400 mg q2w (Week 0 - 16)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 4	23.5 percentage of participants
Bermekimab 400 mg q2w (Week 0 - 16)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 8	29.4 percentage of participants
Bermekimab 400 mg q2w (Week 0 - 16)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 16	29.4 percentage of participants
Bermekimab 400 mg q2w (Week 0 - 16)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 12	17.6 percentage of participants
Bermekimab 400 mg qw (Week 0 - 16)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 16	40.0 percentage of participants
Bermekimab 400 mg qw (Week 0 - 16)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 8	30.0 percentage of participants
Bermekimab 400 mg qw (Week 0 - 16)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 12	40.0 percentage of participants
Bermekimab 400 mg qw (Week 0 - 16)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 4	25.0 percentage of participants
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 16	37.5 percentage of participants
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 32	56.3 percentage of participants
Bermekimab 400 mg q2w (Week 16 - 31)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 16	29.4 percentage of participants
Bermekimab 400 mg q2w (Week 16 - 31)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 32	52.9 percentage of participants
Bermekimab 400 mg qw (Week 16 - 31)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 16	40.0 percentage of participants
Bermekimab 400 mg qw (Week 16 - 31)	Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 32	50.0 percentage of participants

Secondary

Percentage of Participants Achieving >= 4 Point Improvement (Reduction From Baseline) in Weekly Average of Average Daily Pruritis (Itch) NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4

Percentage of participants achieving \>= 4 improvement (reduction from baseline) in weekly average of average daily pruritis NRS score from baseline at Weeks 4, 8, 12, 16 and 32 among participants with a baseline score \>=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. To rate the severity of eczema-related itch participants were asked the following question: please rate the severity of your eczema-related average itch in the past 24 hours. The response was rated on a 0 to 10 NRS. Higher score indicated more severity. Seven daily averaged NRS scores were averaged into a weekly score.

Time frame: Weeks 4, 8, 12, 16 and 32

Arm	Measure	Group	Value (NUMBER)
Placebo (Week 0 - 16)	Percentage of Participants Achieving >= 4 Point Improvement (Reduction From Baseline) in Weekly Average of Average Daily Pruritis (Itch) NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 4	23.1 percentage of participants
Placebo (Week 0 - 16)	Percentage of Participants Achieving >= 4 Point Improvement (Reduction From Baseline) in Weekly Average of Average Daily Pruritis (Itch) NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 8	30.8 percentage of participants
Placebo (Week 0 - 16)	Percentage of Participants Achieving >= 4 Point Improvement (Reduction From Baseline) in Weekly Average of Average Daily Pruritis (Itch) NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 12	50.0 percentage of participants
Placebo (Week 0 - 16)	Percentage of Participants Achieving >= 4 Point Improvement (Reduction From Baseline) in Weekly Average of Average Daily Pruritis (Itch) NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 16	50.0 percentage of participants
Bermekimab 400 mg q2w (Week 0 - 16)	Percentage of Participants Achieving >= 4 Point Improvement (Reduction From Baseline) in Weekly Average of Average Daily Pruritis (Itch) NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 4	13.6 percentage of participants
Bermekimab 400 mg q2w (Week 0 - 16)	Percentage of Participants Achieving >= 4 Point Improvement (Reduction From Baseline) in Weekly Average of Average Daily Pruritis (Itch) NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 8	22.7 percentage of participants
Bermekimab 400 mg q2w (Week 0 - 16)	Percentage of Participants Achieving >= 4 Point Improvement (Reduction From Baseline) in Weekly Average of Average Daily Pruritis (Itch) NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 16	50.0 percentage of participants
Bermekimab 400 mg q2w (Week 0 - 16)	Percentage of Participants Achieving >= 4 Point Improvement (Reduction From Baseline) in Weekly Average of Average Daily Pruritis (Itch) NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 12	27.3 percentage of participants
Bermekimab 400 mg qw (Week 0 - 16)	Percentage of Participants Achieving >= 4 Point Improvement (Reduction From Baseline) in Weekly Average of Average Daily Pruritis (Itch) NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 16	54.5 percentage of participants
Bermekimab 400 mg qw (Week 0 - 16)	Percentage of Participants Achieving >= 4 Point Improvement (Reduction From Baseline) in Weekly Average of Average Daily Pruritis (Itch) NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 8	27.3 percentage of participants
Bermekimab 400 mg qw (Week 0 - 16)	Percentage of Participants Achieving >= 4 Point Improvement (Reduction From Baseline) in Weekly Average of Average Daily Pruritis (Itch) NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 12	40.9 percentage of participants
Bermekimab 400 mg qw (Week 0 - 16)	Percentage of Participants Achieving >= 4 Point Improvement (Reduction From Baseline) in Weekly Average of Average Daily Pruritis (Itch) NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 4	9.1 percentage of participants
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)	Percentage of Participants Achieving >= 4 Point Improvement (Reduction From Baseline) in Weekly Average of Average Daily Pruritis (Itch) NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 16	35.7 percentage of participants
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)	Percentage of Participants Achieving >= 4 Point Improvement (Reduction From Baseline) in Weekly Average of Average Daily Pruritis (Itch) NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 32	71.4 percentage of participants
Bermekimab 400 mg q2w (Week 16 - 31)	Percentage of Participants Achieving >= 4 Point Improvement (Reduction From Baseline) in Weekly Average of Average Daily Pruritis (Itch) NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 16	25.0 percentage of participants
Bermekimab 400 mg q2w (Week 16 - 31)	Percentage of Participants Achieving >= 4 Point Improvement (Reduction From Baseline) in Weekly Average of Average Daily Pruritis (Itch) NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 32	66.7 percentage of participants
Bermekimab 400 mg qw (Week 16 - 31)	Percentage of Participants Achieving >= 4 Point Improvement (Reduction From Baseline) in Weekly Average of Average Daily Pruritis (Itch) NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 16	47.1 percentage of participants
Bermekimab 400 mg qw (Week 16 - 31)	Percentage of Participants Achieving >= 4 Point Improvement (Reduction From Baseline) in Weekly Average of Average Daily Pruritis (Itch) NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4	Week 32	58.8 percentage of participants

Secondary

Percentage of Participants Achieving >=4 Point Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Pruritus (Itch) Numeric Rating Scale (NRS) Score From Baseline at Week 4, 8, 12, 16 and 32 Among Participants With Baseline Score >=4

Percentage of participants achieving greater than or equal to (\>=4) point improvement (reduction from baseline) in weekly average peak (worst) daily pruritus NRS score from baseline at Weeks 4, 8, 12, 16 and 32 among participants with a baseline score \>=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. To rate the severity of eczema-related itch participants were asked the following question: please rate the severity of your eczema-related itch at its worst in the past 24 hours. The response was rated on a 0 to 10 NRS ranging from 0 none to 10 worst possible. Higher score indicated more severity. Seven daily average NRS scores are into a weekly score.

Time frame: Weeks 4, 8, 12, 16 and 32

Arm	Measure	Group	Value (NUMBER)
Placebo (Week 0 - 16)	Percentage of Participants Achieving >=4 Point Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Pruritus (Itch) Numeric Rating Scale (NRS) Score From Baseline at Week 4, 8, 12, 16 and 32 Among Participants With Baseline Score >=4	Week 4	26.9 percentage of participants
Placebo (Week 0 - 16)	Percentage of Participants Achieving >=4 Point Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Pruritus (Itch) Numeric Rating Scale (NRS) Score From Baseline at Week 4, 8, 12, 16 and 32 Among Participants With Baseline Score >=4	Week 8	34.6 percentage of participants
Placebo (Week 0 - 16)	Percentage of Participants Achieving >=4 Point Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Pruritus (Itch) Numeric Rating Scale (NRS) Score From Baseline at Week 4, 8, 12, 16 and 32 Among Participants With Baseline Score >=4	Week 12	46.2 percentage of participants
Placebo (Week 0 - 16)	Percentage of Participants Achieving >=4 Point Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Pruritus (Itch) Numeric Rating Scale (NRS) Score From Baseline at Week 4, 8, 12, 16 and 32 Among Participants With Baseline Score >=4	Week 16	53.8 percentage of participants
Bermekimab 400 mg q2w (Week 0 - 16)	Percentage of Participants Achieving >=4 Point Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Pruritus (Itch) Numeric Rating Scale (NRS) Score From Baseline at Week 4, 8, 12, 16 and 32 Among Participants With Baseline Score >=4	Week 4	8.0 percentage of participants
Bermekimab 400 mg q2w (Week 0 - 16)	Percentage of Participants Achieving >=4 Point Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Pruritus (Itch) Numeric Rating Scale (NRS) Score From Baseline at Week 4, 8, 12, 16 and 32 Among Participants With Baseline Score >=4	Week 8	16.0 percentage of participants
Bermekimab 400 mg q2w (Week 0 - 16)	Percentage of Participants Achieving >=4 Point Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Pruritus (Itch) Numeric Rating Scale (NRS) Score From Baseline at Week 4, 8, 12, 16 and 32 Among Participants With Baseline Score >=4	Week 16	32.0 percentage of participants
Bermekimab 400 mg q2w (Week 0 - 16)	Percentage of Participants Achieving >=4 Point Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Pruritus (Itch) Numeric Rating Scale (NRS) Score From Baseline at Week 4, 8, 12, 16 and 32 Among Participants With Baseline Score >=4	Week 12	28.0 percentage of participants
Bermekimab 400 mg qw (Week 0 - 16)	Percentage of Participants Achieving >=4 Point Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Pruritus (Itch) Numeric Rating Scale (NRS) Score From Baseline at Week 4, 8, 12, 16 and 32 Among Participants With Baseline Score >=4	Week 16	52.2 percentage of participants
Bermekimab 400 mg qw (Week 0 - 16)	Percentage of Participants Achieving >=4 Point Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Pruritus (Itch) Numeric Rating Scale (NRS) Score From Baseline at Week 4, 8, 12, 16 and 32 Among Participants With Baseline Score >=4	Week 8	26.1 percentage of participants
Bermekimab 400 mg qw (Week 0 - 16)	Percentage of Participants Achieving >=4 Point Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Pruritus (Itch) Numeric Rating Scale (NRS) Score From Baseline at Week 4, 8, 12, 16 and 32 Among Participants With Baseline Score >=4	Week 12	30.4 percentage of participants
Bermekimab 400 mg qw (Week 0 - 16)	Percentage of Participants Achieving >=4 Point Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Pruritus (Itch) Numeric Rating Scale (NRS) Score From Baseline at Week 4, 8, 12, 16 and 32 Among Participants With Baseline Score >=4	Week 4	8.7 percentage of participants
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)	Percentage of Participants Achieving >=4 Point Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Pruritus (Itch) Numeric Rating Scale (NRS) Score From Baseline at Week 4, 8, 12, 16 and 32 Among Participants With Baseline Score >=4	Week 16	56.0 percentage of participants
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)	Percentage of Participants Achieving >=4 Point Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Pruritus (Itch) Numeric Rating Scale (NRS) Score From Baseline at Week 4, 8, 12, 16 and 32 Among Participants With Baseline Score >=4	Week 32	80.0 percentage of participants
Bermekimab 400 mg q2w (Week 16 - 31)	Percentage of Participants Achieving >=4 Point Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Pruritus (Itch) Numeric Rating Scale (NRS) Score From Baseline at Week 4, 8, 12, 16 and 32 Among Participants With Baseline Score >=4	Week 16	32.0 percentage of participants
Bermekimab 400 mg q2w (Week 16 - 31)	Percentage of Participants Achieving >=4 Point Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Pruritus (Itch) Numeric Rating Scale (NRS) Score From Baseline at Week 4, 8, 12, 16 and 32 Among Participants With Baseline Score >=4	Week 32	64.0 percentage of participants
Bermekimab 400 mg qw (Week 16 - 31)	Percentage of Participants Achieving >=4 Point Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Pruritus (Itch) Numeric Rating Scale (NRS) Score From Baseline at Week 4, 8, 12, 16 and 32 Among Participants With Baseline Score >=4	Week 16	52.2 percentage of participants
Bermekimab 400 mg qw (Week 16 - 31)	Percentage of Participants Achieving >=4 Point Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Pruritus (Itch) Numeric Rating Scale (NRS) Score From Baseline at Week 4, 8, 12, 16 and 32 Among Participants With Baseline Score >=4	Week 32	65.2 percentage of participants

Secondary

Percentage of Participants Achieving EASI-75 Response at Weeks 4, 8, 12, and 32

Percentage of participants achieving EASI-75 response at Weeks 4, 8, 12, and 32 were reported. EASI-75 response was defined as at least 75% improvement from baseline in EASI total score. The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration/papulation, excoriation and lichenification on 4 anatomic regions of the body: head/neck, trunk, upper and lower extremities. 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 total EASI score is the sum of four body-region scores ranged from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.

Time frame: Weeks 4, 8, 12, and 32

Population: FAS included all randomized participants who received at least 1 dose of study agent. Here, n (number analyzed) signifies number of participants who were analyzed at the specified timepoints and '0' in the number analyzed field signifies that none of the participants were evaluable at the specified timepoint.

Arm	Measure	Group	Value (NUMBER)
Placebo (Week 0 - 16)	Percentage of Participants Achieving EASI-75 Response at Weeks 4, 8, 12, and 32	Week 4	10.3 percentage of participants
Placebo (Week 0 - 16)	Percentage of Participants Achieving EASI-75 Response at Weeks 4, 8, 12, and 32	Week 8	10.3 percentage of participants
Placebo (Week 0 - 16)	Percentage of Participants Achieving EASI-75 Response at Weeks 4, 8, 12, and 32	Week 12	13.8 percentage of participants
Bermekimab 400 mg q2w (Week 0 - 16)	Percentage of Participants Achieving EASI-75 Response at Weeks 4, 8, 12, and 32	Week 4	17.2 percentage of participants
Bermekimab 400 mg q2w (Week 0 - 16)	Percentage of Participants Achieving EASI-75 Response at Weeks 4, 8, 12, and 32	Week 12	20.7 percentage of participants
Bermekimab 400 mg q2w (Week 0 - 16)	Percentage of Participants Achieving EASI-75 Response at Weeks 4, 8, 12, and 32	Week 8	13.8 percentage of participants
Bermekimab 400 mg qw (Week 0 - 16)	Percentage of Participants Achieving EASI-75 Response at Weeks 4, 8, 12, and 32	Week 4	10.3 percentage of participants
Bermekimab 400 mg qw (Week 0 - 16)	Percentage of Participants Achieving EASI-75 Response at Weeks 4, 8, 12, and 32	Week 8	17.2 percentage of participants
Bermekimab 400 mg qw (Week 0 - 16)	Percentage of Participants Achieving EASI-75 Response at Weeks 4, 8, 12, and 32	Week 12	37.9 percentage of participants
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)	Percentage of Participants Achieving EASI-75 Response at Weeks 4, 8, 12, and 32	Week 32	77.8 percentage of participants
Bermekimab 400 mg q2w (Week 16 - 31)	Percentage of Participants Achieving EASI-75 Response at Weeks 4, 8, 12, and 32	Week 32	69.0 percentage of participants
Bermekimab 400 mg qw (Week 16 - 31)	Percentage of Participants Achieving EASI-75 Response at Weeks 4, 8, 12, and 32	Week 32	65.5 percentage of participants

Secondary

Percentage of Participants Achieving EASI-90 Response at Weeks 12, 16, and 32

Percentage of participants achieving EASI-90 response at Weeks 12, 16 and 32 were reported. EASI-90 response was 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 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 total EASI score is the sum of four body-region scores ranged from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.

Time frame: Weeks 12, 16, and 32

Arm	Measure	Group	Value (NUMBER)
Placebo (Week 0 - 16)	Percentage of Participants Achieving EASI-90 Response at Weeks 12, 16, and 32	Week 12	6.9 percentage of participants
Placebo (Week 0 - 16)	Percentage of Participants Achieving EASI-90 Response at Weeks 12, 16, and 32	Week 16	0 percentage of participants
Bermekimab 400 mg q2w (Week 0 - 16)	Percentage of Participants Achieving EASI-90 Response at Weeks 12, 16, and 32	Week 16	10.3 percentage of participants
Bermekimab 400 mg q2w (Week 0 - 16)	Percentage of Participants Achieving EASI-90 Response at Weeks 12, 16, and 32	Week 12	6.9 percentage of participants
Bermekimab 400 mg qw (Week 0 - 16)	Percentage of Participants Achieving EASI-90 Response at Weeks 12, 16, and 32	Week 12	10.3 percentage of participants
Bermekimab 400 mg qw (Week 0 - 16)	Percentage of Participants Achieving EASI-90 Response at Weeks 12, 16, and 32	Week 16	10.3 percentage of participants
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)	Percentage of Participants Achieving EASI-90 Response at Weeks 12, 16, and 32	Week 16	0 percentage of participants
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)	Percentage of Participants Achieving EASI-90 Response at Weeks 12, 16, and 32	Week 32	37.0 percentage of participants
Bermekimab 400 mg q2w (Week 16 - 31)	Percentage of Participants Achieving EASI-90 Response at Weeks 12, 16, and 32	Week 32	24.1 percentage of participants
Bermekimab 400 mg qw (Week 16 - 31)	Percentage of Participants Achieving EASI-90 Response at Weeks 12, 16, and 32	Week 32	34.5 percentage of participants

Secondary

Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of >=2 Points at Week 16

Percentage of participants with both IGA score of 0 or 1 and a reduction from baseline of \>=2 points was reported. IGA assesses AD severity and clinical response using a 5-point scale: 0 = clear, 1= almost clear, 2 = mild, 3 = moderate, 4 = severe. A higher score indicated more severity of AD. The score was determined by ranking the extent of erythema and population/infiltration. A clinical response to therapy was an IGA score of 0 (clear) or 1 (almost clear). This outcome measure was planned to be analyzed for specified arms only.

Time frame: Week 16

Population: FAS included all randomized participants who received at least 1 dose of study agent.

Arm	Measure	Group	Value (NUMBER)
Placebo (Week 0 - 16)	Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of >=2 Points at Week 16	IGA score of clear (0)	0 percentage of participants
Placebo (Week 0 - 16)	Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of >=2 Points at Week 16	IGA score of mild or better (reduction from baseline of >=2 points)	24.1 percentage of participants
Placebo (Week 0 - 16)	Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of >=2 Points at Week 16	IGA score of clear (0) or almost clear (1)	6.9 percentage of participants
Bermekimab 400 mg q2w (Week 0 - 16)	Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of >=2 Points at Week 16	IGA score of clear (0)	6.9 percentage of participants
Bermekimab 400 mg q2w (Week 0 - 16)	Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of >=2 Points at Week 16	IGA score of mild or better (reduction from baseline of >=2 points)	34.5 percentage of participants
Bermekimab 400 mg q2w (Week 0 - 16)	Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of >=2 Points at Week 16	IGA score of clear (0) or almost clear (1)	17.2 percentage of participants
Bermekimab 400 mg qw (Week 0 - 16)	Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of >=2 Points at Week 16	IGA score of mild or better (reduction from baseline of >=2 points)	34.5 percentage of participants
Bermekimab 400 mg qw (Week 0 - 16)	Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of >=2 Points at Week 16	IGA score of clear (0) or almost clear (1)	13.8 percentage of participants
Bermekimab 400 mg qw (Week 0 - 16)	Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of >=2 Points at Week 16	IGA score of clear (0)	6.9 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026

A Study to Evaluate the Safety and Efficacy of Bermekimab in Patients With Moderate to Severe Atopic Dermatitis

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) Response at Week 16

Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 8, 12, 16, and 32

Change From Baseline in Global Individual Signs Score (GISS) at Weeks 8, 12, 16, and 32.

Change From Baseline in HADS (Depression) Score at Weeks 8, 12, 16, and 32

Change From Baseline in Hospital Anxiety and Depression Scale (HADS) (Anxiety) Score at Weeks 8, 12, 16, and 32

Change From Baseline in Patient Oriented Eczema Measure (POEM) Scores at Weeks 8, 12, 16, and 32

Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score at Weeks 8, 12, 16, and 32.

Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average of Average Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4

Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4

Percentage of Participants Achieving >= 4 Point Improvement (Reduction From Baseline) in Weekly Average of Average Daily Pruritis (Itch) NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4

Percentage of Participants Achieving >=4 Point Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Pruritus (Itch) Numeric Rating Scale (NRS) Score From Baseline at Week 4, 8, 12, 16 and 32 Among Participants With Baseline Score >=4

Percentage of Participants Achieving EASI-75 Response at Weeks 4, 8, 12, and 32

Percentage of Participants Achieving EASI-90 Response at Weeks 12, 16, and 32

Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of >=2 Points at Week 16