Trial Outcomes & Findings for A Phase II Study of Bermekimab (MABp1) in Patients With Moderate to Severe Atopic Dermatitis (NCT NCT03496974)
NCT ID: NCT03496974
Last Updated: 2021-03-12
Results Overview
Safety and tolerability endpoints were evaluated by monitoring all the adverse events from clinical and laboratory reporting, vital signs, physical examinations, ECG and urinalysis. All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. AEs are coded using medical dictionary - MedDRA Version 21.0 and the severity was assigned using CTCAE version 4.03.
COMPLETED
PHASE2
38 participants
From Visit 1 (Post-injection) until 7 days after the last administration of the study drug.
2021-03-12
Participant Flow
Participant milestones
| Measure |
200 mg Cohort
Bermekimab Monoclonal Antibody 200 mg: 200 mg subcutaneous injection
|
400 mg Cohort
Bermekimab Monoclonal Antibody 400 mg: 400 mg subcutaneous injection
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
28
|
|
Overall Study
COMPLETED
|
9
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase II Study of Bermekimab (MABp1) in Patients With Moderate to Severe Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Group A: 200 mg Cohort
n=10 Participants
Bermekimab Monoclonal Antibody 200 mg: 200 mg subcutaneous injection
|
Group B: 400 mg Cohort
n=28 Participants
Bermekimab Monoclonal Antibody 400 mg: 400 mg subcutaneous injection
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 16.78 • n=5 Participants
|
48.54 years
STANDARD_DEVIATION 19.14 • n=7 Participants
|
47.92 years
STANDARD_DEVIATION 18.35 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Weight
|
78.2 kg
STANDARD_DEVIATION 23.34 • n=5 Participants
|
74.76 kg
STANDARD_DEVIATION 16.4 • n=7 Participants
|
75.66 kg
STANDARD_DEVIATION 18.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: From Visit 1 (Post-injection) until 7 days after the last administration of the study drug.Population: All subjects who have received at least one dose of bermekimab were included in the safety analysis.
Safety and tolerability endpoints were evaluated by monitoring all the adverse events from clinical and laboratory reporting, vital signs, physical examinations, ECG and urinalysis. All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. AEs are coded using medical dictionary - MedDRA Version 21.0 and the severity was assigned using CTCAE version 4.03.
Outcome measures
| Measure |
Group A: 200 mg Cohort
n=10 Participants
Bermekimab Monoclonal Antibody 200 mg: 200 mg subcutaneous injection
|
Group B: 400 mg Cohort
n=28 Participants
Bermekimab Monoclonal Antibody 400 mg: 400 mg subcutaneous injection
|
|---|---|---|
|
Number of Patients With Treatment Emergent Adverse Events (TEAEs)
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Group A: Baseline to Week 4; Group B: Baseline to Week 7Population: Number of participants analyzed = participants with EASI score assessment at specified time-points. Missing values imputed by last observation carried forward (LOCF).
EASI score will assess severity and extent of AD with respect to erythema, excoriation, infiltration and lichenification at 4 anatomic sites of the body: lower and upper extremities, trunk and head. The total EASI score shall be in a range of 0 to 72 points (from no disease to maximum disease severity, respectively). Group A: Change= (Baseline - Week 4 score); Group B: Change= (Baseline - Week 7 score)
Outcome measures
| Measure |
Group A: 200 mg Cohort
n=10 Participants
Bermekimab Monoclonal Antibody 200 mg: 200 mg subcutaneous injection
|
Group B: 400 mg Cohort
n=28 Participants
Bermekimab Monoclonal Antibody 400 mg: 400 mg subcutaneous injection
|
|---|---|---|
|
Change in Eczema Area and Severity Index (EASI) Score, From Baseline to Week 7 (or Last Visit)
Baseline
|
28.18 score on a scale
Interval 20.16 to 36.2
|
29.79 score on a scale
Interval 26.38 to 33.2
|
|
Change in Eczema Area and Severity Index (EASI) Score, From Baseline to Week 7 (or Last Visit)
Week 4/ Week 7
|
22.73 score on a scale
Interval 12.61 to 32.85
|
7.35 score on a scale
Interval 4.56 to 10.14
|
|
Change in Eczema Area and Severity Index (EASI) Score, From Baseline to Week 7 (or Last Visit)
Change
|
5.45 score on a scale
Interval -1.85 to 12.75
|
22.44 score on a scale
Interval 17.75 to 27.13
|
SECONDARY outcome
Timeframe: Group A: Week 4; Group B: Week 7Population: Number of participants analyzed = participants with pk analysis data at specified time-point. Missing values were not included in this analysis.
An enzyme-linked immunosorbent assay (ELISA) has been developed to specifically measure bermekimab levels in human plasma. Blood will be drawn into a single 6 ml Na-Heparin collection tube at each PK collection time point. These samples will be collected per the study lab manual and immediately shipped to the Sponsor for PK analysis. The PK samples will also be used to test for the presence of antibodies against bermekimab. PK sample collection time points are as follows: Group A: Pre-dose at visits 1-5; visit 5 is reported Group B: Pre-dose at visit 1, visit 3, visit 5 and visit 8; visit 8 is reported
Outcome measures
| Measure |
Group A: 200 mg Cohort
n=6 Participants
Bermekimab Monoclonal Antibody 200 mg: 200 mg subcutaneous injection
|
Group B: 400 mg Cohort
n=22 Participants
Bermekimab Monoclonal Antibody 400 mg: 400 mg subcutaneous injection
|
|---|---|---|
|
Pharmacokinetics (PK) Assessment at Week 7
|
12.6 (μg/mL)
Interval 9.7 to 15.5
|
47.1 (μg/mL)
Interval 36.7 to 57.6
|
SECONDARY outcome
Timeframe: Group A: Week 4; Group B: Week 7Population: All subjects who have received at least one dose of bermekimab were included in the analysis.
IGA assesses disease severity and clinical response using a 5-point scale: 0 = clear, 1= almost clear, 2 = mild, 3 = moderate, 4 = severe. The score is determined by ranking the extent of erythema and population/infiltration. A clinical response to therapy will be an IGA score of 0 (clear) or 1 (almost clear). Patients receiving more than one treatment with additional medication for AD exacerbation during the study or who are missing IGA scores at visit 8 (week 7) will be treated as non-responders. For the 200 mg group, IGA was recorded at visits 1,3, and 5; visit 5 is reported. For the 400 mg group, IGA was recorded at visits 1-8, visit 8 was reported.
Outcome measures
| Measure |
Group A: 200 mg Cohort
n=10 Participants
Bermekimab Monoclonal Antibody 200 mg: 200 mg subcutaneous injection
|
Group B: 400 mg Cohort
n=28 Participants
Bermekimab Monoclonal Antibody 400 mg: 400 mg subcutaneous injection
|
|---|---|---|
|
Number of Patients Achieving Investigator's Global Assessment (IGA) Response (0 or 1) at Week 7
|
0 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Group A: Week 4; Group B: Week 7Population: Number of participants analyzed = participants with IGA score assessment at specified time-points. Missing values imputed by LOCF.
IGA assesses disease severity and clinical response using a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe. The score is determined by ranking the extent of erythema and papulation/infiltration. A clinical response to therapy will be an IGA score of 0 (clear) or 1 (almost clear).
Outcome measures
| Measure |
Group A: 200 mg Cohort
n=10 Participants
Bermekimab Monoclonal Antibody 200 mg: 200 mg subcutaneous injection
|
Group B: 400 mg Cohort
n=28 Participants
Bermekimab Monoclonal Antibody 400 mg: 400 mg subcutaneous injection
|
|---|---|---|
|
Number of Patients Achieving ≥2 IGA Score Reduction at Week 7
|
1 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Group A: Baseline to Week 4; Group B: Baseline to Week 7Population: Number of participants analyzed = participants with pruritus NRS score assessment at specified time-points. Missing values imputed by LOCF.
The NRS rating system captures the intensity of patient's itch, both maximum and average intensity over a 24-hour period. The following question was presented to patients: "How would you rate your itch at the worst moment and on average during the previous 24 hours a scale of 0-10 (0=no itch and 10=worst possible itch)?
Outcome measures
| Measure |
Group A: 200 mg Cohort
n=10 Participants
Bermekimab Monoclonal Antibody 200 mg: 200 mg subcutaneous injection
|
Group B: 400 mg Cohort
n=28 Participants
Bermekimab Monoclonal Antibody 400 mg: 400 mg subcutaneous injection
|
|---|---|---|
|
Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (Overall Itch) From Baseline to Week 7
Baseline
|
6.50 score on a scale
Interval 4.56 to 8.44
|
7.91 score on a scale
Interval 7.51 to 8.3
|
|
Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (Overall Itch) From Baseline to Week 7
Week 4/ Week 7
|
3.66 score on a scale
Interval 1.48 to 5.84
|
2.51 score on a scale
Interval 1.44 to 3.59
|
|
Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (Overall Itch) From Baseline to Week 7
Change
|
2.84 score on a scale
Interval 0.65 to 5.03
|
5.4 score on a scale
Interval 4.32 to 6.47
|
SECONDARY outcome
Timeframe: Group A: Baseline to Week 4; Group B: Baseline to Week 7Population: Number of participants analyzed = participants with pruritus NRS score assessment at specified time-points. Missing values imputed by LOCF.
The NRS rating system captures the intensity of patient's itch, both maximum and average intensity over a 24-hour period. The following question was presented to patients: "How would you rate your itch at the worst moment and on average during the previous 24 hours a scale of 0-10 (0=no itch and 10=worst possible itch)?
Outcome measures
| Measure |
Group A: 200 mg Cohort
n=10 Participants
Bermekimab Monoclonal Antibody 200 mg: 200 mg subcutaneous injection
|
Group B: 400 mg Cohort
n=28 Participants
Bermekimab Monoclonal Antibody 400 mg: 400 mg subcutaneous injection
|
|---|---|---|
|
Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (Worst Moment Itch) From Baseline to Week 7
Baseline
|
6.8 score on a scale
Interval 4.59 to 9.01
|
7.96 score on a scale
Interval 7.42 to 8.51
|
|
Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (Worst Moment Itch) From Baseline to Week 7
Week 4/ Week 7
|
3.71 score on a scale
Interval 1.54 to 5.88
|
2.34 score on a scale
Interval 1.33 to 3.36
|
|
Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (Worst Moment Itch) From Baseline to Week 7
Change
|
3.09 score on a scale
Interval 0.64 to 5.54
|
5.62 score on a scale
Interval 4.55 to 6.69
|
SECONDARY outcome
Timeframe: Group A: Baseline to Week 4; Group B: Baseline to Week 7Population: Number of participants analyzed = participants with SCORAD score assessment at specified time-points. Missing values imputed by LOCF.
SCORAD was developed by the European Task Force on Atopic Dermatitis. (Severity scoring of Atopic Dermatitis: the SCORAD index), as a measure of disease severity in AD. It includes assessment of the eczema in addition to patient-reported symptoms. Total score ranges from 0 to 103 (no disease to most severe disease, respectively).
Outcome measures
| Measure |
Group A: 200 mg Cohort
n=10 Participants
Bermekimab Monoclonal Antibody 200 mg: 200 mg subcutaneous injection
|
Group B: 400 mg Cohort
n=28 Participants
Bermekimab Monoclonal Antibody 400 mg: 400 mg subcutaneous injection
|
|---|---|---|
|
Change in SCORing Atopic Dermatitis (SCORAD) Score From Baseline to Week 7
Baseline
|
59.44 score on a scale
Interval 51.6 to 67.27
|
70.80 score on a scale
Interval 65.93 to 75.67
|
|
Change in SCORing Atopic Dermatitis (SCORAD) Score From Baseline to Week 7
Week 4/ Week 7
|
48.4 score on a scale
Interval 36.49 to 60.3
|
26.10 score on a scale
Interval 18.56 to 33.63
|
|
Change in SCORing Atopic Dermatitis (SCORAD) Score From Baseline to Week 7
Change
|
11.04 score on a scale
Interval 0.36 to 21.71
|
44.70 score on a scale
Interval 35.88 to 53.53
|
SECONDARY outcome
Timeframe: Group A: Week 4; Group B: Week 7Population: Number of participants analyzed = participants with EASI score assessment at specified time-points. Missing values imputed by LOCF.
EASI score will assess severity and extent of AD with respect to erythema, excoriation, infiltration and lichenification at 4 anatomic sites of the body: lower and upper extremities, trunk and head. The total EASI score shall be in a range of 0 to 72 points (from no disease to maximum disease severity, respectively).
Outcome measures
| Measure |
Group A: 200 mg Cohort
n=10 Participants
Bermekimab Monoclonal Antibody 200 mg: 200 mg subcutaneous injection
|
Group B: 400 mg Cohort
n=28 Participants
Bermekimab Monoclonal Antibody 400 mg: 400 mg subcutaneous injection
|
|---|---|---|
|
Number of Patients Achieving 50% or Greater Reduction in EASI Score at Week 7
|
2 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Group A: Week 4; Group B: Week 7Population: Number of participants analyzed = participants with SCORAD score assessment at specified time-points. Missing values imputed by LOCF.
Calculated as per description in Outcome 8.
Outcome measures
| Measure |
Group A: 200 mg Cohort
n=10 Participants
Bermekimab Monoclonal Antibody 200 mg: 200 mg subcutaneous injection
|
Group B: 400 mg Cohort
n=28 Participants
Bermekimab Monoclonal Antibody 400 mg: 400 mg subcutaneous injection
|
|---|---|---|
|
Number of Patients Achieving 50% or Greater Reduction in SCORAD Score at Week 7
|
1 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Group A: Baseline to Week 4; Group B: Baseline to Week 7Population: Number of participants analyzed = participants with POEM score assessment at specified time-points. Missing values imputed by LOCF.
POEM is a 7-item patient-reported quality of life outcome measure based on a questionnaire to determine disease symptoms, including bleeding, cracking, dryness, flaking, itching, sleep loss and weeping. The scoring range is from 0 to 28 (no disease to most severe disease, respectively).
Outcome measures
| Measure |
Group A: 200 mg Cohort
n=10 Participants
Bermekimab Monoclonal Antibody 200 mg: 200 mg subcutaneous injection
|
Group B: 400 mg Cohort
n=28 Participants
Bermekimab Monoclonal Antibody 400 mg: 400 mg subcutaneous injection
|
|---|---|---|
|
Change in Patient Oriented Eczema Measure (POEM) Scores From Baseline to Week 7.
Baseline
|
17.3 score on a scale
Interval 11.55 to 23.05
|
16.82 score on a scale
Interval 14.26 to 19.38
|
|
Change in Patient Oriented Eczema Measure (POEM) Scores From Baseline to Week 7.
Week 4/ Week 7
|
11.8 score on a scale
Interval 6.79 to 16.81
|
5.93 score on a scale
Interval 3.41 to 8.44
|
|
Change in Patient Oriented Eczema Measure (POEM) Scores From Baseline to Week 7.
Change
|
5.50 score on a scale
Interval 2.9 to 8.1
|
10.89 score on a scale
Interval 7.99 to 13.8
|
SECONDARY outcome
Timeframe: Group A: Baseline to Week 4; Group B: Baseline to Week 7Population: Number of participants analyzed = participants with GISS score assessment at specified time-points. Missing values imputed by LOCF.
GISS assesses AD lesions for erythema, excoriations, lichenification and edema/papulation. Each component will be 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. Total score will range from 0 to 12 (no disease to most severe disease, respectively).
Outcome measures
| Measure |
Group A: 200 mg Cohort
n=10 Participants
Bermekimab Monoclonal Antibody 200 mg: 200 mg subcutaneous injection
|
Group B: 400 mg Cohort
n=28 Participants
Bermekimab Monoclonal Antibody 400 mg: 400 mg subcutaneous injection
|
|---|---|---|
|
Change in Global Individual Signs Score (GISS) From Baseline to Week 7
Baseline
|
8.4 score on a scale
Interval 6.92 to 9.88
|
9.64 score on a scale
Interval 9.03 to 10.25
|
|
Change in Global Individual Signs Score (GISS) From Baseline to Week 7
Week 4/ Week 7
|
7.5 score on a scale
Interval 5.36 to 9.64
|
4.36 score on a scale
Interval 3.23 to 5.48
|
|
Change in Global Individual Signs Score (GISS) From Baseline to Week 7
Change
|
0.9 score on a scale
Interval -0.19 to 1.99
|
5.28 score on a scale
Interval 3.99 to 6.58
|
SECONDARY outcome
Timeframe: Group A: Baseline to Week 4; Group B: Baseline to Week 7Population: Number of participants analyzed = participants with DLQI score assessment at specified time-points. Missing values imputed by LOCF.
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 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; a high score is indicative of a poor QOL.
Outcome measures
| Measure |
Group A: 200 mg Cohort
n=10 Participants
Bermekimab Monoclonal Antibody 200 mg: 200 mg subcutaneous injection
|
Group B: 400 mg Cohort
n=28 Participants
Bermekimab Monoclonal Antibody 400 mg: 400 mg subcutaneous injection
|
|---|---|---|
|
Change in Dermatology Life Quality Index (DLQI) From Baseline to Week 7
Baseline
|
11.8 score on a scale
Interval 7.18 to 16.42
|
12.93 score on a scale
Interval 10.11 to 15.75
|
|
Change in Dermatology Life Quality Index (DLQI) From Baseline to Week 7
Week 4/ Week 7
|
6.1 score on a scale
Interval 1.99 to 10.21
|
4.00 score on a scale
Interval 1.43 to 6.57
|
|
Change in Dermatology Life Quality Index (DLQI) From Baseline to Week 7
Change
|
5.70 score on a scale
Interval 1.9 to 9.5
|
8.93 score on a scale
Interval 6.15 to 11.7
|
SECONDARY outcome
Timeframe: Group A: Baseline to Week 4; Group B: Baseline to Week 7Population: Number of participants analyzed = participants with HADS score assessment at specified time-points. Missing values imputed by LOCF.
The HADS is a set of fourteen questions to be rated by a patient on a four point (0-3) response category so the possible scores range from 0 to 21 for anxiety and 0 to 21 for depression. Scoring is as follows: (0-7)= Normal (8-10)= Borderline Abnormal (11-21)= Abnormal
Outcome measures
| Measure |
Group A: 200 mg Cohort
n=10 Participants
Bermekimab Monoclonal Antibody 200 mg: 200 mg subcutaneous injection
|
Group B: 400 mg Cohort
n=28 Participants
Bermekimab Monoclonal Antibody 400 mg: 400 mg subcutaneous injection
|
|---|---|---|
|
Change in HADS (Anxiety) Score From Baseline to Week 7
Baseline
|
4.6 score on a scale
Interval 2.41 to 6.79
|
7.29 score on a scale
Interval 5.2 to 9.37
|
|
Change in HADS (Anxiety) Score From Baseline to Week 7
Week 4/ Week 7
|
3.2 score on a scale
Interval 1.02 to 5.38
|
2.64 score on a scale
Interval 1.35 to 3.93
|
|
Change in HADS (Anxiety) Score From Baseline to Week 7
Change
|
1.40 score on a scale
Interval 0.43 to 2.37
|
4.65 score on a scale
Interval 2.84 to 6.45
|
SECONDARY outcome
Timeframe: Group A: Baseline to Week 4; Group B: Baseline to Week 7Population: Number of participants analyzed = participants with HADS score assessment at specified time-points. Missing values imputed by LOCF.
The HADS is a set of fourteen questions to be rated by a patient on a four point (0-3) response category so the possible scores range from 0 to 21 for anxiety and 0 to 21 for depression. Scoring is as follows: (0-7)= Normal (8-10)= Borderline Abnormal (11-21)= Abnormal
Outcome measures
| Measure |
Group A: 200 mg Cohort
n=10 Participants
Bermekimab Monoclonal Antibody 200 mg: 200 mg subcutaneous injection
|
Group B: 400 mg Cohort
n=28 Participants
Bermekimab Monoclonal Antibody 400 mg: 400 mg subcutaneous injection
|
|---|---|---|
|
Change in HADS (Depression) Score From Baseline to Week 7
Baseline
|
5.6 score on a scale
Interval 1.59 to 9.61
|
7.11 score on a scale
Interval 5.25 to 8.97
|
|
Change in HADS (Depression) Score From Baseline to Week 7
Week 4/ Week 7
|
4.2 score on a scale
Interval -0.98 to 9.38
|
3.18 score on a scale
Interval 1.98 to 4.38
|
|
Change in HADS (Depression) Score From Baseline to Week 7
Change
|
1.40 score on a scale
Interval -0.19 to 2.99
|
3.93 score on a scale
Interval 2.35 to 5.51
|
Adverse Events
200 mg Cohort
400 mg Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
200 mg Cohort
n=10 participants at risk
Bermekimab Monoclonal Antibody 200 mg: 200 mg subcutaneous injection
|
400 mg Cohort
n=28 participants at risk
Bermekimab Monoclonal Antibody 400 mg: 400 mg subcutaneous injection
|
|---|---|---|
|
General disorders
Site injection erythema
|
10.0%
1/10 • Number of events 2 • Baseline to Week 7
All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. The severity of adverse events was assigned using CTCAE version 4.03.
|
0.00%
0/28 • Baseline to Week 7
All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. The severity of adverse events was assigned using CTCAE version 4.03.
|
|
General disorders
site injection redness
|
0.00%
0/10 • Baseline to Week 7
All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. The severity of adverse events was assigned using CTCAE version 4.03.
|
7.1%
2/28 • Number of events 4 • Baseline to Week 7
All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. The severity of adverse events was assigned using CTCAE version 4.03.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/10 • Baseline to Week 7
All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. The severity of adverse events was assigned using CTCAE version 4.03.
|
3.6%
1/28 • Number of events 1 • Baseline to Week 7
All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. The severity of adverse events was assigned using CTCAE version 4.03.
|
|
Cardiac disorders
Asymptomatic sinus tachycardia
|
10.0%
1/10 • Number of events 2 • Baseline to Week 7
All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. The severity of adverse events was assigned using CTCAE version 4.03.
|
0.00%
0/28 • Baseline to Week 7
All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. The severity of adverse events was assigned using CTCAE version 4.03.
|
|
General disorders
Bilateral Peripheral Edema in lower extremities
|
0.00%
0/10 • Baseline to Week 7
All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. The severity of adverse events was assigned using CTCAE version 4.03.
|
3.6%
1/28 • Number of events 1 • Baseline to Week 7
All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. The severity of adverse events was assigned using CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Facial swelling
|
0.00%
0/10 • Baseline to Week 7
All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. The severity of adverse events was assigned using CTCAE version 4.03.
|
3.6%
1/28 • Number of events 1 • Baseline to Week 7
All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. The severity of adverse events was assigned using CTCAE version 4.03.
|
|
Blood and lymphatic system disorders
Inguinal Lymphadenopathy
|
0.00%
0/10 • Baseline to Week 7
All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. The severity of adverse events was assigned using CTCAE version 4.03.
|
3.6%
1/28 • Number of events 1 • Baseline to Week 7
All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. The severity of adverse events was assigned using CTCAE version 4.03.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Baseline to Week 7
All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. The severity of adverse events was assigned using CTCAE version 4.03.
|
7.1%
2/28 • Number of events 2 • Baseline to Week 7
All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. The severity of adverse events was assigned using CTCAE version 4.03.
|
|
General disorders
Swelling on right hand
|
0.00%
0/10 • Baseline to Week 7
All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. The severity of adverse events was assigned using CTCAE version 4.03.
|
3.6%
1/28 • Number of events 1 • Baseline to Week 7
All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. The severity of adverse events was assigned using CTCAE version 4.03.
|
|
Infections and infestations
Urinary Track Infection
|
0.00%
0/10 • Baseline to Week 7
All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. The severity of adverse events was assigned using CTCAE version 4.03.
|
3.6%
1/28 • Number of events 1 • Baseline to Week 7
All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. The severity of adverse events was assigned using CTCAE version 4.03.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • Baseline to Week 7
All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. The severity of adverse events was assigned using CTCAE version 4.03.
|
3.6%
1/28 • Number of events 1 • Baseline to Week 7
All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. The severity of adverse events was assigned using CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/10 • Baseline to Week 7
All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. The severity of adverse events was assigned using CTCAE version 4.03.
|
3.6%
1/28 • Number of events 1 • Baseline to Week 7
All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. The severity of adverse events was assigned using CTCAE version 4.03.
|
|
Cardiac disorders
worsening hypertension
|
10.0%
1/10 • Number of events 1 • Baseline to Week 7
All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. The severity of adverse events was assigned using CTCAE version 4.03.
|
0.00%
0/28 • Baseline to Week 7
All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. The severity of adverse events was assigned using CTCAE version 4.03.
|
Additional Information
Ashley Otero, Corporate and Clinical Relations Manager
XBiotech
Results disclosure agreements
- Principal investigator is a sponsor employee The Institution shall provide the Sponsor a copy of each proposed publication, abstract or presentation at least ninety days in advance for a proposed publication to a journal, editor or other third party. The Sponsor shall, within sixty days, advise Institution if there is any of the Sponsor's Confidential Information in proposed publication. Institution shall delete any of the Sponsor's Confidential Information prior to submitting and/or presenting.
- Publication restrictions are in place
Restriction type: OTHER