Atopic Dermatitis
Conditions
Brief summary
The aim of the study is to evaluate the efficacy and safety of tralokinumab in adults with atopic dermatitis
Interventions
OTHERPlacebo
Subcutaneous injection with placebo
BIOLOGICALTralokinumab Dose 1
Subcutaneous injection with tralokinumab
BIOLOGICALTralokinumab Dose 2
Subcutaneous injection with tralokinumab
BIOLOGICALTralokinumab Dose 3
Subcutaneous injection with tralokinumab
Sponsors
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Physician diagnosis of atopic dermatitis for greater than (\>) 1 year * Atopic dermatitis involvement of greater than or equal to (\>=) 10 percent (%) body surface area * EASI score of \>= 12 * SCORAD of \>= 25 * IGA score of \>= 3 * Effective birth control in line with protocol details
Exclusion criteria
* History of anaphylaxis following any biologic therapy * Hepatitis B, C or human immunodeficiency virus * Pregnant or breastfeeding * History of cancer * Previous receipt of tralokinumab
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12 | Baseline (Day 1) and Week 12 | EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The maximum total score is 72, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications. |
| Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline at Week 12 | Week 12 | The IGA allows investigators to assess overall disease severity at one given time point and consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). A participant has IGA response if they achieve a score of 0 (clear) or 1 (almost clear) and at least a 2-grade reduction from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | From Study Drug Administration (Day 1) to Week 22 | An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed. |
| Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment Emergent Adverse Events | From Study Drug Administration (Day 1) to Week 22 | AEs observed in participants with clinically significant ECG abnormalities were assessed. ECG parameters included heart rate, RR, PR, QRS and QT intervals. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state. |
| Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12 | Week 12 | EASI50 responder is defined as a participant who achieves at least a 50% reduction in EASI score from baseline. Data from participants who took prohibited medications were excluded from this analysis and a last observation carried forward (LOCF) analysis was used. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | From Study Drug Administration (Day 1) to Week 22 | An adverse event (AE) present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of study drug until Week 22. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received Tralokinumab. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state. |
| Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in SCORAD at Week 12 | Week 12 | SCORAD 50 responder is defined as a participant who achieves at least a 50% reduction in SCORAD score from baseline. Data from participants who took prohibited medications were excluded from this analysis and a LOCF analysis was used. |
| Change From Baseline in Pruritus Numeric Rating Scale (NRS) (7-day Mean Score) at Week 12 | Baseline (Day 1) and Week 12 | Pruritus assessed using an NRS (0 - 10) with 0= no itch and 10= worst imaginable itch. Daily pruritus assessments were summarized as weekly peak score and a change from baseline in weekly peak score was calculated. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications. |
| Absolute Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 12 | Baseline (Day 1) and Week 12 | The SCORAD is a clinical tool for assessing the severity (that is, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with participant symptoms. The maximum total score is 103, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications. |
| Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events | From Study Drug Administration (Day 1) to Week 22 | Vital sign parameters included blood pressure, temperature, pulse rate, and respiratory rate. TEAEs were present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug until Week 22. |
Countries
Australia, Canada, Germany, Japan, Poland, United States
Participant flow
Recruitment details
A total of 299 participants participated in the study at 55 sites worldwide, including 24 sites in the United States of America, 8 sites in Germany, 6 sites each in Japan, Poland, and Canada, and 5 sites in Australia.
Pre-assignment details
95 participants were considered screen failures and 204 participants were randomized and treated in the study.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks. | 51 |
| Tralokinumab Dose 1 Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks. | 50 |
| Tralokinumab Dose 2 Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks. | 51 |
| Tralokinumab Dose 3 Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks. | 52 |
| Total | 204 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 3 | 1 | 1 |
| Overall Study | Other | 1 | 2 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 9 | 5 | 5 | 3 |
Baseline characteristics
| Characteristic | Placebo | Tralokinumab Dose 1 | Tralokinumab Dose 2 | Tralokinumab Dose 3 | Total |
|---|---|---|---|---|---|
| Age, Continuous | 39.4 Years STANDARD_DEVIATION 14.5 | 39.1 Years STANDARD_DEVIATION 15.1 | 37.1 Years STANDARD_DEVIATION 14 | 35.7 Years STANDARD_DEVIATION 14.6 | 37.8 Years STANDARD_DEVIATION 14.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 3 Participants | 4 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants | 48 Participants | 48 Participants | 48 Participants | 193 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 11 Participants | 8 Participants | 16 Participants | 45 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 4 Participants | 10 Participants | 7 Participants | 29 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 31 Participants | 33 Participants | 33 Participants | 28 Participants | 125 Participants |
| Sex: Female, Male Female | 29 Participants | 21 Participants | 25 Participants | 19 Participants | 94 Participants |
| Sex: Female, Male Male | 22 Participants | 29 Participants | 26 Participants | 33 Participants | 110 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 1 / 50 | 0 / 51 | 0 / 52 |
| other Total, other adverse events | 15 / 51 | 20 / 50 | 21 / 51 | 22 / 52 |
| serious Total, serious adverse events | 1 / 51 | 3 / 50 | 2 / 51 | 0 / 52 |
Outcome results
Primary
Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12
EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The maximum total score is 72, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.
Time frame: Baseline (Day 1) and Week 12
Population: The intent-to-treat (ITT) population included all randomized and treated participants, grouped according to assigned treatment. Here, the category Number Analyzed is number of participants analyzed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12 | -10.78 units on a scale | Standard Error 1.398 |
| Tralokinumab Dose 1 | Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12 | -13.67 units on a scale | Standard Error 1.386 |
| Tralokinumab Dose 2 | Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12 | -15.14 units on a scale | Standard Error 1.361 |
| Tralokinumab Dose 3 | Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12 | -15.72 units on a scale | Standard Error 1.334 |
p-value: 0.14395% CI: [-6.78, 0.99]Mixed Model Repeated Measures Analysis
p-value: 0.02795% CI: [-8.22, -0.51]Mixed Model Repeated Measures Analysis
p-value: 0.01195% CI: [-8.76, -1.13]Mixed Model Repeated Measures Analysis
Primary
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline at Week 12
The IGA allows investigators to assess overall disease severity at one given time point and consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). A participant has IGA response if they achieve a score of 0 (clear) or 1 (almost clear) and at least a 2-grade reduction from baseline.
Time frame: Week 12
Population: The ITT population included all randomized and treated participants, grouped according to assigned treatment. Here, the category Number Analyzed is number of participants analyzed for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline at Week 12 | 11.8 Percentage of participants |
| Tralokinumab Dose 1 | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline at Week 12 | 11.6 Percentage of participants |
| Tralokinumab Dose 2 | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline at Week 12 | 19.5 Percentage of participants |
| Tralokinumab Dose 3 | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline at Week 12 | 26.7 Percentage of participants |
p-value: 0.97495% CI: [0.29, 3.32]Regression, Logistic
p-value: 0.28195% CI: [0.61, 5.65]Regression, Logistic
p-value: 0.06195% CI: [0.95, 8.37]Regression, Logistic
Secondary
Absolute Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 12
The SCORAD is a clinical tool for assessing the severity (that is, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with participant symptoms. The maximum total score is 103, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.
Time frame: Baseline (Day 1) and Week 12
Population: The ITT population included all randomized and treated participants, grouped according to assigned treatment. Here, the category Number Analyzed is number of participants analyzed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Absolute Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 12 | -16.67 units on a scale | Standard Error 2.224 |
| Tralokinumab Dose 1 | Absolute Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 12 | -21.97 units on a scale | Standard Error 2.204 |
| Tralokinumab Dose 2 | Absolute Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 12 | -26.09 units on a scale | Standard Error 2.168 |
| Tralokinumab Dose 3 | Absolute Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 12 | -26.50 units on a scale | Standard Error 2.123 |
Secondary
Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12
EASI50 responder is defined as a participant who achieves at least a 50% reduction in EASI score from baseline. Data from participants who took prohibited medications were excluded from this analysis and a last observation carried forward (LOCF) analysis was used.
Time frame: Week 12
Population: The ITT population included all randomized and treated participants, grouped according to assigned treatment. Here, the category Number Analyzed is number of participants analyzed for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12 | 51.9 Percentage of participants |
| Tralokinumab Dose 1 | Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12 | 54.3 Percentage of participants |
| Tralokinumab Dose 2 | Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12 | 67.3 Percentage of participants |
| Tralokinumab Dose 3 | Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12 | 73.4 Percentage of participants |
Secondary
Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in SCORAD at Week 12
SCORAD 50 responder is defined as a participant who achieves at least a 50% reduction in SCORAD score from baseline. Data from participants who took prohibited medications were excluded from this analysis and a LOCF analysis was used.
Time frame: Week 12
Population: The ITT population included all randomized and treated participants, grouped according to assigned treatment. Here, the category Number Analyzed is number of participants analyzed for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in SCORAD at Week 12 | 19.5 Percentage of participants |
| Tralokinumab Dose 1 | Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in SCORAD at Week 12 | 26.9 Percentage of participants |
| Tralokinumab Dose 2 | Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in SCORAD at Week 12 | 44.2 Percentage of participants |
| Tralokinumab Dose 3 | Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in SCORAD at Week 12 | 44.1 Percentage of participants |
Secondary
Change From Baseline in Pruritus Numeric Rating Scale (NRS) (7-day Mean Score) at Week 12
Pruritus assessed using an NRS (0 - 10) with 0= no itch and 10= worst imaginable itch. Daily pruritus assessments were summarized as weekly peak score and a change from baseline in weekly peak score was calculated. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.
Time frame: Baseline (Day 1) and Week 12
Population: The ITT population included all randomized and treated participants, grouped according to assigned treatment. Here, the category Number Analyzed is number of participants analyzed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Pruritus Numeric Rating Scale (NRS) (7-day Mean Score) at Week 12 | -1.03 units on a scale | Standard Error 0.27 |
| Tralokinumab Dose 1 | Change From Baseline in Pruritus Numeric Rating Scale (NRS) (7-day Mean Score) at Week 12 | -1.80 units on a scale | Standard Error 0.266 |
| Tralokinumab Dose 2 | Change From Baseline in Pruritus Numeric Rating Scale (NRS) (7-day Mean Score) at Week 12 | -1.59 units on a scale | Standard Error 0.26 |
| Tralokinumab Dose 3 | Change From Baseline in Pruritus Numeric Rating Scale (NRS) (7-day Mean Score) at Week 12 | -2.17 units on a scale | Standard Error 0.256 |
Secondary
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events
An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.
Time frame: From Study Drug Administration (Day 1) to Week 22
Population: As-treated population included all treated participants, grouped according to actual treatment received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Anaemia | 0 Participants |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Lymphopenia | 1 Participants |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Alanine aminotransferase increased | 0 Participants |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Aspartate aminotransferase increased | 0 Participants |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Blood alkaline phosphatase increased | 0 Participants |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Blood creatinine increased | 0 Participants |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Blood immunoglobulin E increased | 0 Participants |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Gamma-glutamyltransferase increased | 0 Participants |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Hepatic function abnormal | 0 Participants |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Hyperbilirubinaemia | 1 Participants |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Liver function test abnormal | 0 Participants |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Glycosuria | 0 Participants |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Leukocyturia | 1 Participants |
| Tralokinumab Dose 1 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Aspartate aminotransferase increased | 1 Participants |
| Tralokinumab Dose 1 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Leukocyturia | 0 Participants |
| Tralokinumab Dose 1 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Liver function test abnormal | 0 Participants |
| Tralokinumab Dose 1 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Gamma-glutamyltransferase increased | 1 Participants |
| Tralokinumab Dose 1 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Alanine aminotransferase increased | 1 Participants |
| Tralokinumab Dose 1 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Anaemia | 1 Participants |
| Tralokinumab Dose 1 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Hyperbilirubinaemia | 0 Participants |
| Tralokinumab Dose 1 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Hepatic function abnormal | 1 Participants |
| Tralokinumab Dose 1 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Blood creatinine increased | 1 Participants |
| Tralokinumab Dose 1 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Blood alkaline phosphatase increased | 0 Participants |
| Tralokinumab Dose 1 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Lymphopenia | 0 Participants |
| Tralokinumab Dose 1 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Glycosuria | 1 Participants |
| Tralokinumab Dose 1 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Blood immunoglobulin E increased | 0 Participants |
| Tralokinumab Dose 2 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Liver function test abnormal | 1 Participants |
| Tralokinumab Dose 2 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Aspartate aminotransferase increased | 0 Participants |
| Tralokinumab Dose 2 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Blood alkaline phosphatase increased | 1 Participants |
| Tralokinumab Dose 2 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Leukocyturia | 0 Participants |
| Tralokinumab Dose 2 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Blood creatinine increased | 0 Participants |
| Tralokinumab Dose 2 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Blood immunoglobulin E increased | 1 Participants |
| Tralokinumab Dose 2 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Glycosuria | 0 Participants |
| Tralokinumab Dose 2 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Gamma-glutamyltransferase increased | 0 Participants |
| Tralokinumab Dose 2 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Hepatic function abnormal | 0 Participants |
| Tralokinumab Dose 2 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Hyperbilirubinaemia | 0 Participants |
| Tralokinumab Dose 2 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Anaemia | 0 Participants |
| Tralokinumab Dose 2 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Lymphopenia | 0 Participants |
| Tralokinumab Dose 2 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Alanine aminotransferase increased | 0 Participants |
| Tralokinumab Dose 3 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Hyperbilirubinaemia | 0 Participants |
| Tralokinumab Dose 3 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Gamma-glutamyltransferase increased | 0 Participants |
| Tralokinumab Dose 3 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Aspartate aminotransferase increased | 0 Participants |
| Tralokinumab Dose 3 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Anaemia | 0 Participants |
| Tralokinumab Dose 3 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Blood immunoglobulin E increased | 0 Participants |
| Tralokinumab Dose 3 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Blood creatinine increased | 0 Participants |
| Tralokinumab Dose 3 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Alanine aminotransferase increased | 0 Participants |
| Tralokinumab Dose 3 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Lymphopenia | 0 Participants |
| Tralokinumab Dose 3 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Blood alkaline phosphatase increased | 0 Participants |
| Tralokinumab Dose 3 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Hepatic function abnormal | 0 Participants |
| Tralokinumab Dose 3 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Leukocyturia | 0 Participants |
| Tralokinumab Dose 3 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Glycosuria | 0 Participants |
| Tralokinumab Dose 3 | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events | Liver function test abnormal | 0 Participants |
Secondary
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment Emergent Adverse Events
AEs observed in participants with clinically significant ECG abnormalities were assessed. ECG parameters included heart rate, RR, PR, QRS and QT intervals. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state.
Time frame: From Study Drug Administration (Day 1) to Week 22
Population: As-treated population included all treated participants, grouped according to actual treatment received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment Emergent Adverse Events | 0 Participants |
| Tralokinumab Dose 1 | Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment Emergent Adverse Events | 0 Participants |
| Tralokinumab Dose 2 | Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment Emergent Adverse Events | 0 Participants |
| Tralokinumab Dose 3 | Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment Emergent Adverse Events | 0 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of study drug until Week 22. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received Tralokinumab. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state.
Time frame: From Study Drug Administration (Day 1) to Week 22
Population: As-treated population included all treated participants, grouped according to actual treatment received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TEAEs | 31 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TESAEs | 1 Participants |
| Tralokinumab Dose 1 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TESAEs | 3 Participants |
| Tralokinumab Dose 1 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TEAEs | 36 Participants |
| Tralokinumab Dose 2 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TEAEs | 35 Participants |
| Tralokinumab Dose 2 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TESAEs | 2 Participants |
| Tralokinumab Dose 3 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TEAEs | 30 Participants |
| Tralokinumab Dose 3 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TESAEs | 0 Participants |
Secondary
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events
Vital sign parameters included blood pressure, temperature, pulse rate, and respiratory rate. TEAEs were present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug until Week 22.
Time frame: From Study Drug Administration (Day 1) to Week 22
Population: As-treated population included all treated participants, grouped according to actual treatment received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events | Hypertension | 0 Participants |
| Placebo | Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events | Pyrexia | 1 Participants |
| Placebo | Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events | Pallor | 0 Participants |
| Placebo | Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events | Acute coronary syndrome | 0 Participants |
| Placebo | Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events | Angina pectoris | 1 Participants |
| Placebo | Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events | Blood pressure increased | 0 Participants |
| Tralokinumab Dose 1 | Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events | Pyrexia | 0 Participants |
| Tralokinumab Dose 1 | Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events | Blood pressure increased | 1 Participants |
| Tralokinumab Dose 1 | Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events | Acute coronary syndrome | 1 Participants |
| Tralokinumab Dose 1 | Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events | Angina pectoris | 0 Participants |
| Tralokinumab Dose 1 | Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events | Pallor | 0 Participants |
| Tralokinumab Dose 1 | Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events | Hypertension | 0 Participants |
| Tralokinumab Dose 2 | Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events | Blood pressure increased | 1 Participants |
| Tralokinumab Dose 2 | Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events | Pyrexia | 1 Participants |
| Tralokinumab Dose 2 | Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events | Hypertension | 1 Participants |
| Tralokinumab Dose 2 | Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events | Angina pectoris | 0 Participants |
| Tralokinumab Dose 2 | Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events | Pallor | 0 Participants |
| Tralokinumab Dose 2 | Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events | Acute coronary syndrome | 0 Participants |
| Tralokinumab Dose 3 | Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events | Pallor | 1 Participants |
| Tralokinumab Dose 3 | Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events | Blood pressure increased | 0 Participants |
| Tralokinumab Dose 3 | Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events | Pyrexia | 0 Participants |
| Tralokinumab Dose 3 | Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events | Acute coronary syndrome | 0 Participants |
| Tralokinumab Dose 3 | Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events | Angina pectoris | 0 Participants |
| Tralokinumab Dose 3 | Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events | Hypertension | 0 Participants |