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| ID | Type | Description | Link |
|---|---|---|---|
| 77474462ADM2002 | Other Identifier | Janssen Research & Development, LLC |
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A Study to Evaluate the Safety and Efficacy of Bermekimab in Patients With Moderate to Severe Atopic Dermatitis
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm 1 (bermekimab every week) | Experimental | Loading Dose: 400 mg subcutaneous (SC) injection of bermekimab and a SC injection of matching placebo at week 0 (Baseline). Treatment Dose: 400 mg subcutaneous injection of bermekimab administered weekly (qw) from week 1 through Week 31. |
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| Treatment Arm 2 (bermekimab every other week) | Experimental | Loading Dose: 800 mg SC injection of bermekimab at week 0 (Baseline). Treatment Dose: 400 mg SC injection of bermekimab administered every other week (q2w) alternating with matching placebo q2w through Week 31. |
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| Placebo | Placebo Comparator | Loading Dose: Placebo matching to bermekimab (4 milliliters [mL]) SC injection at Week 0, (Baseline). Treatment Dose: SC injection of matching placebo administered once weekly (qw) from week 1 to week 15 during placebo-controlled period. After completion of placebo-controlled period, participants will cross-over and receive bermekimab 400 mg SC injection qw at Week 16 through Week 31. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bermekimab Monoclonal Antibody | Drug | Bermekimab 400 mg or 800 mg will be administered subcutaneously. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beach Clinical Research Inc | Huntington Beach | California | 92647 | United States | ||
| Florida Academic Dermatology Centers |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Bermekimab 400 mg q2w (Week 0 - 16) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Placebo Controlled Period (Week 0-16) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 27, 2020 | Jun 28, 2023 |
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| Placebo | Drug | Placebo will be administered subcutaneously. |
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| Weeks 4, 8, 12, 16 and 32 |
| 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. | 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 | 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. | 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 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. | Weeks 4, 8, 12, 16 and 32 |
| 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. | Weeks 4, 8, 12, 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 | 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. | Week 16 |
| 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. | Weeks 12, 16, and 32 |
| 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. | Baseline, 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 | 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. | Baseline, Weeks 8,12,16 and 32 |
| 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. | Baseline, Weeks 8,12,16 and 32 |
| 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. | Baseline, Weeks 8, 12, 16, and 32 |
| 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. | Baseline to Weeks 8, 12, 16 and 32 |
| 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. | Baseline, Weeks 8,12,16 and 32 |
| Coral Gables |
| Florida |
| 33134 |
| United States |
| Doral Medical Research | Doral | Florida | 33166 | United States |
| Floridian Research Institute | Miami | Florida | 33145 | United States |
| Florida International Medical Research | Miami | Florida | 33155 | United States |
| Premier Research Associate, Inc | Miami | Florida | 33165 | United States |
| CNS HealthCare | Orlando | Florida | 32801 | United States |
| Avita Clinical Research | Tampa | Florida | 33613 | United States |
| Forcare Clinical Research Inc | Tampa | Florida | 33613 | United States |
| Advanced Medical Research | Sandy Springs | Georgia | 30328 | United States |
| Dawes Fretzin Clinical Research Group | Indianapolis | Indiana | 46256 | United States |
| Randall Dermatology & Cosmetic Surgery | West Lafayette | Indiana | 47906 | United States |
| Revival Research Institute LLC | Troy | Michigan | 48084 | United States |
| ClinOhio Research Services | Columbus | Ohio | 43213 | United States |
| Helios Clinical Research, LLC | Milan | Tennessee | 38358 | United States |
| Progressive Clinical Research | San Antonio | Texas | 78213 | United States |
| Dominion Medical Associates, Inc. | Richmond | Virginia | 23233 | United States |
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. |
| FG002 | 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. |
| FG003 | Placebo Then Bermekimab 400 mg qw (Week 16 - 31) | After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31. |
| FG004 | Bermekimab 400 mg q2w (Week 16 - 31) | After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31. |
| FG005 | Bermekimab 400 mg qw (Week 16 - 31) | After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31. |
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| NOT COMPLETED |
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| Active Treatment Period (Week 16-32) |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
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| 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. | Full analysis set (FAS) included all randomized participants who received at least 1 dose of study agent. | Posted | Number | percentage of participants | Week 16 |
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| 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. | 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. | Posted | Number | percentage of participants | Weeks 4, 8, 12, 16 and 32 |
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| 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. | 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. | Posted | Number | percentage of participants | Weeks 4, 8, 12, 16 and 32 |
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| 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. | 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. | Posted | Number | percentage of participants | Weeks 4, 8, 12, 16 and 32 |
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| 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. | 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. | Posted | Number | percentage of participants | Weeks 4, 8, 12, 16 and 32 |
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| 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. | 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. | Posted | Number | percentage of participants | Weeks 4, 8, 12, and 32 |
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| 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. | FAS included all randomized participants who received at least 1 dose of study agent. | Posted | Number | percentage of participants | Week 16 |
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| 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. | 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. | Posted | Number | percentage of participants | Weeks 12, 16, and 32 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 8, 12, 16 and 32 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 8,12,16 and 32 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 8,12,16 and 32 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 8, 12, 16, and 32 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Weeks 8, 12, 16 and 32 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 8,12,16 and 32 |
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Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 29 | 0 | 29 | 2 | 29 |
| EG001 | 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. | 0 | 29 | 0 | 29 | 7 | 29 |
| EG002 | 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. | 0 | 29 | 1 | 29 | 2 | 29 |
| EG003 | Placebo Then Bermekimab 400 mg qw (Week 16 - 31) | After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31. | 0 | 27 | 0 | 27 | 3 | 27 |
| EG004 | Bermekimab 400 mg q2w (Week 16 - 31) | After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31. | 0 | 28 | 0 | 28 | 3 | 28 |
| EG005 | Bermekimab 400 mg qw (Week 16 - 31) | After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31. | 0 | 27 | 0 | 27 | 1 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Dermatitis Atopic | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Injection Site Swelling | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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The relatively small sample size combined with the heterogeneity of the atopic dermatitis (AD) population were considered limitations of this study.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Clinical Research Dermatology | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 24, 2020 | Jun 28, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| From 65 to 84 years |
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| 85 years and over |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | Placebo Then Bermekimab 400 mg qw (Week 16 - 31) | After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31. |
| OG004 | Bermekimab 400 mg q2w (Week 16 - 31) | After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31. |
| OG005 | Bermekimab 400 mg qw (Week 16 - 31) | After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31. |
|
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | Placebo Then Bermekimab 400 mg qw (Week 16 - 31) | After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31. |
| OG004 | Bermekimab 400 mg q2w (Week 16 - 31) | After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31. |
| OG005 | Bermekimab 400 mg qw (Week 16 - 31) | After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31. |
|
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | Placebo Then Bermekimab 400 mg qw (Week 16 - 31) | After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31. |
| OG004 | Bermekimab 400 mg q2w (Week 16 - 31) | After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31. |
| OG005 | Bermekimab 400 mg qw (Week 16 - 31) | After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31. |
|
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | Placebo Then Bermekimab 400 mg qw (Week 16 - 31) | After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31. |
| OG004 | Bermekimab 400 mg q2w (Week 16 - 31) | After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31. |
| OG005 | Bermekimab 400 mg qw (Week 16 - 31) | After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31. |
|
|
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.
| OG002 | 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. |
| OG003 | Placebo Then Bermekimab 400 mg qw (Week 16 - 31) | After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31. |
| OG004 | Bermekimab 400 mg q2w (Week 16 - 31) | After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31. |
| OG005 | Bermekimab 400 mg qw (Week 16 - 31) | After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31. |
|
|
| 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. |
|
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| OG001 |
| 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. |
| OG002 | 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. |
| OG003 | Placebo Then Bermekimab 400 mg qw (Week 16 - 31) | After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31. |
| OG004 | Bermekimab 400 mg q2w (Week 16 - 31) | After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31. |
| OG005 | Bermekimab 400 mg qw (Week 16 - 31) | After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31. |
|
|
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.
| OG002 | 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. |
| OG003 | Placebo Then Bermekimab 400 mg qw (Week 16 - 31) | After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31. |
| OG004 | Bermekimab 400 mg q2w (Week 16 - 31) | After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31. |
| OG005 | Bermekimab 400 mg qw (Week 16 - 31) | After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31. |
|
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | Placebo Then Bermekimab 400 mg qw (Week 16 - 31) | After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31. |
| OG004 | Bermekimab 400 mg q2w (Week 16 - 31) | After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31. |
| OG005 | Bermekimab 400 mg qw (Week 16 - 31) | After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31. |
|
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | Placebo Then Bermekimab 400 mg qw (Week 16 - 31) | After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31. |
| OG004 | Bermekimab 400 mg q2w (Week 16 - 31) | After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31. |
| OG005 | Bermekimab 400 mg qw (Week 16 - 31) | After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31. |
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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. |
| OG002 | 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. |
| OG003 | Placebo Then Bermekimab 400 mg qw (Week 16 - 31) | After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31. |
| OG004 | Bermekimab 400 mg q2w (Week 16 - 31) | After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31. |
| OG005 | Bermekimab 400 mg qw (Week 16 - 31) | After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31. |
|
|
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.
| OG001 | 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. |
| OG002 | 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. |
| OG003 | Placebo Then Bermekimab 400 mg qw (Week 16 - 31) | After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31. |
| OG004 | Bermekimab 400 mg q2w (Week 16 - 31) | After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31. |
| OG005 | Bermekimab 400 mg qw (Week 16 - 31) | After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31. |
|
|
| OG002 | 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. |
| OG003 | Placebo Then Bermekimab 400 mg qw (Week 16 - 31) | After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31. |
| OG004 | Bermekimab 400 mg q2w (Week 16 - 31) | After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31. |
| OG005 | Bermekimab 400 mg qw (Week 16 - 31) | After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31. |
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