Atopic Dermatitis
Conditions
Keywords
MEDI3506, Safety, Efficacy, Atopic Dermatitis, Eczema
Brief summary
This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Atopic Dermatitis.
Detailed description
This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Atopic Dermatitis. Each participant will be assigned randomly to a treatment arm, which could be different strengths of the active treatment or a placebo which does not contain active treatment. Both Participants and investigators will be masked to the treatment assignment. Approximately 152 participants will take part in this study. There is a 4 weeks screening period to determine eligibility. After eligibility is confirmed, participants will receive investigational drug or placebo during the 16 weeks treatment period. This is then followed by an 8-week follow-up period.
Interventions
DRUGMEDI3506
multiple doses
DRUGPlacebo
multiple doses
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Investigation product only will be prepared and administered by unmasked personnel. All subjects will receive the same number of injections at each dose.
Intervention model description
Participants will be randomised to receive MEDI3506 dose 1, MEDI3506 Dose 2 or MEDI3506 dose 3 or placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 65 years inclusive at the time of consent. * Body mass index between 19.0 and 40.0 kg/m2 inclusive. * Documented history of chronic AD, for at least 1 year prior to screening Visit 1. * Meets at minimum 1 of the criteria, as follows: * History of inadequate response to topical medications for AD * Subject intolerance to treatment with topical medications for AD, or * Topical medications are otherwise medically inadvisable * AD that affects ≥ 10% of the body surface area (BSA). * An EASI score of ≥ 12 at Visit 1 and ≥ 16 at Visit 3 (Day 1). * An IGA score of ≥ 3.
Exclusion criteria
* Any active medical or psychiatric condition, or other reason, that would interfere with evaluation of the investigational product or interpretation of subject safety or study results. * Any other clinically relevant abnormal findings from physical examination (including vital signs and electrocardiogram \[ECG\]) or from safety laboratory analysis. * Active dermatologic conditions that might confound the diagnosis of AD or would interfere with the assessment of the skin. * Known active allergic or irritant contact dermatitis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline to Week 16 in EASI Score | Week 16 | The EASI evaluates 4 anatomic regions for severity and extent of key disease signs and focuses on the acute and chronic signs of inflammation (ie, erythema, edema, papulation, excoriation, and lichenification). The maximum score is 72, with higher values indicating more severe disease. Analysis was performed using mixed effect model for repeated measures and MCP-mod dose response model. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Achieving a 75% Reduction From Baseline in EASI Score at Week 16 | Week 16 | To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. Responders are subjects who achieved at least 75% reduction from baseline in EASI score. |
| Percentage of Subjects Achieving a 50% Reduction From Baseline in EASI Score at Week 16 | Week 16 | To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. Responders are subjects who achieved at least 50% reduction from baseline in EASI score. |
| Percentage of Subjects Achieving an IGA of 0 (Clear) or 1 (Almost Clear) With at Least a 2 Grade Reduction From Baseline Score at Week 16 | Week 16 | The IGA allows investigators to assess overall AD disease severity at 1 given time point and consists of a 5-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, and 4 = severe disease). |
| Percentage of Subjects Achieving a Reduction of ≥ 3 From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS | Week 16 | Peak pruritus (ie, worst itch experienced in the previous 24 hours) assessed using an Numerical Rating Scale (NRS; 0 to 10) with 0 = no itch and 10 = worst imaginable itch. The daily assessments were summarised as a weekly mean. |
| Change From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS | Week 16 | Peak pruritus (ie, worst itch experienced in the previous 24 hours) assessed using an Numerical Rating Scale (NRS; 0 to 10) with 0 = no itch and 10 = worst imaginable itch. The daily assessments were summarised as a weekly mean. |
| Change From Baseline to Week 16 in Weekly Mean of Daily Peak Skin Pain NRS | Week 16 | Skin pain (ie, worst skin pain experienced in the previous 24 hours) assessed using an NRS (0 to 10) with 0 = no pain and 10 = worst imaginable pain. The daily assessments were summarised as a weekly mean. |
| SCORAD: Percent Change From Baseline to Week 16 | Week 16 | SCORAD is a clinical tool for assessing the severity of AD that evaluates the extent and intensity of AD lesions, in addition to subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease. |
| Change From Baseline to Week 16 in Percentage Body Surface Area (BSA) Affected by AD | Week 16 | Change in percentage of body surface area (BSA) affected by AD from baseline at week 16. |
| Change From Baseline to Week 16 in DLQI | Week 16 | The Dermatology Life Quality Index (DLQI) is a 10-item, patient- completed, health-related quality of life assessment of dermatology conditions with a recall period of 1 week. Each item is scored on a 4-point Likert scale with 0 = not at all ⁄not relevant, 1 = a little, 2 = a lot, and 3 = very much. The score from each item is summed, and the maximum total score is 30 while the minimum score is 0. Higher score means highest (adverse) effect on participant's life. |
| Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16 | Week 16 | The Patient Global Impression of Severity (PGI-S) is a tool that allows patients to rate the severity of a condition over the past 7 days with response options of No symptoms, Very mild, Mild, Moderate, Severe and Very severe. |
| Change From Baseline to Week 16 in POEM | Week 16 | The Patient-Oriented Eczema Measure (POEM) is a 7-item questionnaire for assessing disease symptoms including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping occurring in the past week. Each item is scored on a 5-point scale with 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = every day. The total POEM score is calculated by summing the score of each item resulting in a maximum of 28 and a minimum of 0, with higher values indicating severe disease |
| Change From Baseline to Week 16 in 5-D Itch | Week 16 | The 5-D Itch Scale is a questionnaire consisting of 5 items used specifically to measure the course of itch by asking for the degree, duration, disability and distribution of the pruritus within the last 2 weeks. The scores from each item are summed, with maximum score of 25 and minimum score of 5. Higher score represent worse outcome |
| Occurrence of Adverse Events | up to 24 weeks | To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD. |
| Percentage of Subjects Achieving a 90% Reduction From Baseline in EASI Score at Week 16 | Week 16 | To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. Responders are subjects who achieved at least 90% reduction from baseline in EASI score. |
| Systolic Blood Pressure Taken During Vital Signs Assessment | Baseline, week 16 and week 24 | Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD. |
| Heart Rate Taken During Vital Signs Assessment | Baseline, week 16 and week 24 | Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD. |
| Respiratory Rate Collected During Vital Signs Assessment | Baseline, week 16 and week 24 | Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD. |
| Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | up to 24 weeks | To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD. |
| Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | up to 24 weeks | To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD. |
| Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | up to 24 weeks | To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD. |
| Heart Rate (Beats/Min) Recorded on ECGs | Baseline, week 16 and week 24 | Collectively with other ECG parameters are used t assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD. |
| QT (Miliseconds) Recorded on ECGs | Baseline, week 16 and week 24 | Collectively with other ECG parameters are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD. |
| Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 16 and week 24 | Collectively with other ECG parameters are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD. |
| Left Ventricular Ejection Fraction Measured by Echocardiogram | Baseline and week 16 | To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD. |
| Serum MEDI3506 Concentration Profiles | Week 16 and week 24 | To evaluate the PK of MEDI3506 in adult subjects with moderate-to-severe AD. |
| Occurence of Anti-drug Antibody During the Treatment and Follow-up Periods | up to 24 weeks | To evaluate the immunogenicity of MEDI3506 in adult subjects with moderate-to-severe AD. |
| Oral or Tympanic Temperature Taken During Vital Signs Assessment | Baseline, week 16 and week 24 | Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD. |
Countries
Australia, Germany, Poland, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Pooled Placebo | 56 |
| MEDI3506 Dose 1 MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks | 19 |
| MEDI3506 Dose 2 MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks | 18 |
| MEDI3506 Dose 3 MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks | 55 |
| Total | 148 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 2 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 2 |
| Overall Study | Other reason, unspecified | 3 | 1 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 10 | 2 | 5 | 7 |
Baseline characteristics
| Characteristic | Placebo | Total | MEDI3506 Dose 3 | MEDI3506 Dose 2 | MEDI3506 Dose 1 |
|---|---|---|---|---|---|
| Age, Continuous | 32.3 Years STANDARD_DEVIATION 11.4 | 33.4 Years STANDARD_DEVIATION 11.8 | 34.6 Years STANDARD_DEVIATION 11.8 | 37.9 Years STANDARD_DEVIATION 14.3 | 28.7 Years STANDARD_DEVIATION 8.9 |
| Eczema Area and Severity Index (EASI) score | 28.81 Scores on a scale STANDARD_DEVIATION 8.9 | 30.07 Scores on a scale STANDARD_DEVIATION 10.43 | 32.30 Scores on a scale STANDARD_DEVIATION 10.86 | 28.36 Scores on a scale STANDARD_DEVIATION 11.87 | 28.94 Scores on a scale STANDARD_DEVIATION 11.66 |
| Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized ASIAN | 8 Participants | 22 Participants | 6 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN | 1 Participants | 6 Participants | 2 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized MULTIPLE CATEGORIES CHECKED | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized OTHER | 0 Participants | 3 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized WHITE | 46 Participants | 115 Participants | 45 Participants | 11 Participants | 13 Participants |
| Region of Enrollment Australia | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Region of Enrollment Germany | 5 Participants | 11 Participants | 2 Participants | 3 Participants | 1 Participants |
| Region of Enrollment Poland | 4 Participants | 16 Participants | 5 Participants | 2 Participants | 5 Participants |
| Region of Enrollment Spain | 7 Participants | 12 Participants | 5 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United Kingdom | 34 Participants | 91 Participants | 35 Participants | 9 Participants | 13 Participants |
| Region of Enrollment USA | 6 Participants | 16 Participants | 7 Participants | 3 Participants | 0 Participants |
| Sex: Female, Male Female | 27 Participants | 67 Participants | 25 Participants | 7 Participants | 8 Participants |
| Sex: Female, Male Male | 29 Participants | 81 Participants | 30 Participants | 11 Participants | 11 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 / 56 | 0 / 19 | 0 / 18 | 0 / 55 |
| other Total, other adverse events | 29 / 56 | 11 / 19 | 14 / 18 | 25 / 55 |
| serious Total, serious adverse events | 2 / 56 | 0 / 19 | 2 / 18 | 1 / 55 |
Outcome results
Primary
Percent Change From Baseline to Week 16 in EASI Score
The EASI evaluates 4 anatomic regions for severity and extent of key disease signs and focuses on the acute and chronic signs of inflammation (ie, erythema, edema, papulation, excoriation, and lichenification). The maximum score is 72, with higher values indicating more severe disease. Analysis was performed using mixed effect model for repeated measures and MCP-mod dose response model.
Time frame: Week 16
Population: ITT population. Data after study withdrawal or use of rescue therapy was excluded.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline to Week 16 in EASI Score | Percent change from baseline to Week 16 in EASI score analysed using MCP-mod dose response model | NA Percentage of change from baseline | — |
| Placebo | Percent Change From Baseline to Week 16 in EASI Score | Percent change from baseline to Week 16 in EASI score analysed using a repeated measures mixed model | -51.31 Percentage of change from baseline | Standard Error 5.214 |
| MEDI3506 Dose 1 | Percent Change From Baseline to Week 16 in EASI Score | Percent change from baseline to Week 16 in EASI score analysed using a repeated measures mixed model | -50.03 Percentage of change from baseline | Standard Error 7.419 |
| MEDI3506 Dose 1 | Percent Change From Baseline to Week 16 in EASI Score | Percent change from baseline to Week 16 in EASI score analysed using MCP-mod dose response model | NA Percentage of change from baseline | — |
| MEDI3506 Dose 2 | Percent Change From Baseline to Week 16 in EASI Score | Percent change from baseline to Week 16 in EASI score analysed using a repeated measures mixed model | -45.43 Percentage of change from baseline | Standard Error 8.402 |
| MEDI3506 Dose 2 | Percent Change From Baseline to Week 16 in EASI Score | Percent change from baseline to Week 16 in EASI score analysed using MCP-mod dose response model | NA Percentage of change from baseline | — |
| MEDI3506 Dose 3 | Percent Change From Baseline to Week 16 in EASI Score | Percent change from baseline to Week 16 in EASI score analysed using a repeated measures mixed model | -53.02 Percentage of change from baseline | Standard Error 4.858 |
| MEDI3506 Dose 3 | Percent Change From Baseline to Week 16 in EASI Score | Percent change from baseline to Week 16 in EASI score analysed using MCP-mod dose response model | NA Percentage of change from baseline | — |
p-value: 0.88890% CI: [-13.67, 16.22]Mixed Models Analysis
p-value: 0.54990% CI: [-10.36, 22.1]Mixed Models Analysis
p-value: 0.80790% CI: [-13.38, 9.95]Mixed Models Analysis
Secondary
Change From Baseline to Week 16 in 5-D Itch
The 5-D Itch Scale is a questionnaire consisting of 5 items used specifically to measure the course of itch by asking for the degree, duration, disability and distribution of the pruritus within the last 2 weeks. The scores from each item are summed, with maximum score of 25 and minimum score of 5. Higher score represent worse outcome
Time frame: Week 16
Population: ITT population, excluding missing data at baseline or week 16.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Week 16 in 5-D Itch | -3.0 Scores on scale | Standard Deviation 4.9 |
| MEDI3506 Dose 1 | Change From Baseline to Week 16 in 5-D Itch | -3.0 Scores on scale | Standard Deviation 2.6 |
| MEDI3506 Dose 2 | Change From Baseline to Week 16 in 5-D Itch | -3.8 Scores on scale | Standard Deviation 3.4 |
| MEDI3506 Dose 3 | Change From Baseline to Week 16 in 5-D Itch | -4.0 Scores on scale | Standard Deviation 5.1 |
Secondary
Change From Baseline to Week 16 in DLQI
The Dermatology Life Quality Index (DLQI) is a 10-item, patient- completed, health-related quality of life assessment of dermatology conditions with a recall period of 1 week. Each item is scored on a 4-point Likert scale with 0 = not at all ⁄not relevant, 1 = a little, 2 = a lot, and 3 = very much. The score from each item is summed, and the maximum total score is 30 while the minimum score is 0. Higher score means highest (adverse) effect on participant's life.
Time frame: Week 16
Population: ITT population, excluding missing data at baseline or week 16.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Week 16 in DLQI | -2.9 Scores on scale | Standard Deviation 5.3 |
| MEDI3506 Dose 1 | Change From Baseline to Week 16 in DLQI | -2.1 Scores on scale | Standard Deviation 6.5 |
| MEDI3506 Dose 2 | Change From Baseline to Week 16 in DLQI | -2.4 Scores on scale | Standard Deviation 4.9 |
| MEDI3506 Dose 3 | Change From Baseline to Week 16 in DLQI | -2.7 Scores on scale | Standard Deviation 4.9 |
Secondary
Change From Baseline to Week 16 in Percentage Body Surface Area (BSA) Affected by AD
Change in percentage of body surface area (BSA) affected by AD from baseline at week 16.
Time frame: Week 16
Population: ITT population, excluding missing data at baseline or week 16.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Week 16 in Percentage Body Surface Area (BSA) Affected by AD | -17.81 Percentage of body surface area | Standard Deviation 17.09 |
| MEDI3506 Dose 1 | Change From Baseline to Week 16 in Percentage Body Surface Area (BSA) Affected by AD | -11.07 Percentage of body surface area | Standard Deviation 10.92 |
| MEDI3506 Dose 2 | Change From Baseline to Week 16 in Percentage Body Surface Area (BSA) Affected by AD | -9.46 Percentage of body surface area | Standard Deviation 13.23 |
| MEDI3506 Dose 3 | Change From Baseline to Week 16 in Percentage Body Surface Area (BSA) Affected by AD | -23.13 Percentage of body surface area | Standard Deviation 19.35 |
Secondary
Change From Baseline to Week 16 in POEM
The Patient-Oriented Eczema Measure (POEM) is a 7-item questionnaire for assessing disease symptoms including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping occurring in the past week. Each item is scored on a 5-point scale with 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = every day. The total POEM score is calculated by summing the score of each item resulting in a maximum of 28 and a minimum of 0, with higher values indicating severe disease
Time frame: Week 16
Population: ITT population, excluding missing data at baseline or week 16.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Week 16 in POEM | -5.4 Scores on scale | Standard Deviation 7.9 |
| MEDI3506 Dose 1 | Change From Baseline to Week 16 in POEM | -2.5 Scores on scale | Standard Deviation 4.8 |
| MEDI3506 Dose 2 | Change From Baseline to Week 16 in POEM | -3.7 Scores on scale | Standard Deviation 8.7 |
| MEDI3506 Dose 3 | Change From Baseline to Week 16 in POEM | -6.3 Scores on scale | Standard Deviation 6.9 |
Secondary
Change From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS
Peak pruritus (ie, worst itch experienced in the previous 24 hours) assessed using an Numerical Rating Scale (NRS; 0 to 10) with 0 = no itch and 10 = worst imaginable itch. The daily assessments were summarised as a weekly mean.
Time frame: Week 16
Population: ITT population, excluding missing data at baseline or week 16.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS | -1.41 Scores on a scale | Standard Deviation 0.356 |
| MEDI3506 Dose 1 | Change From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS | -1.06 Scores on a scale | Standard Deviation 0.519 |
| MEDI3506 Dose 2 | Change From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS | -2.01 Scores on a scale | Standard Deviation 0.595 |
| MEDI3506 Dose 3 | Change From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS | -2.24 Scores on a scale | Standard Deviation 0.348 |
Secondary
Change From Baseline to Week 16 in Weekly Mean of Daily Peak Skin Pain NRS
Skin pain (ie, worst skin pain experienced in the previous 24 hours) assessed using an NRS (0 to 10) with 0 = no pain and 10 = worst imaginable pain. The daily assessments were summarised as a weekly mean.
Time frame: Week 16
Population: ITT population, excluding missing data at baseline or week 16.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Week 16 in Weekly Mean of Daily Peak Skin Pain NRS | -1.44 Scores on a scale | Standard Deviation 2.39 |
| MEDI3506 Dose 1 | Change From Baseline to Week 16 in Weekly Mean of Daily Peak Skin Pain NRS | -1.66 Scores on a scale | Standard Deviation 2.62 |
| MEDI3506 Dose 2 | Change From Baseline to Week 16 in Weekly Mean of Daily Peak Skin Pain NRS | -1.52 Scores on a scale | Standard Deviation 1.61 |
| MEDI3506 Dose 3 | Change From Baseline to Week 16 in Weekly Mean of Daily Peak Skin Pain NRS | -1.63 Scores on a scale | Standard Deviation 2.3 |
Secondary
Heart Rate (Beats/Min) Recorded on ECGs
Collectively with other ECG parameters are used t assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Time frame: Baseline, week 16 and week 24
Population: As-treated population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Heart Rate (Beats/Min) Recorded on ECGs | Week 24 | 68.17 beats per minute | Standard Deviation 13.94 |
| Placebo | Heart Rate (Beats/Min) Recorded on ECGs | Week 16 | 66.02 beats per minute | Standard Deviation 9.97 |
| Placebo | Heart Rate (Beats/Min) Recorded on ECGs | Baseline | 67.59 beats per minute | Standard Deviation 9.82 |
| MEDI3506 Dose 1 | Heart Rate (Beats/Min) Recorded on ECGs | Week 16 | 63.80 beats per minute | Standard Deviation 8.56 |
| MEDI3506 Dose 1 | Heart Rate (Beats/Min) Recorded on ECGs | Baseline | 65.61 beats per minute | Standard Deviation 6.87 |
| MEDI3506 Dose 1 | Heart Rate (Beats/Min) Recorded on ECGs | Week 24 | 63.88 beats per minute | Standard Deviation 10.41 |
| MEDI3506 Dose 2 | Heart Rate (Beats/Min) Recorded on ECGs | Baseline | 72.63 beats per minute | Standard Deviation 9.82 |
| MEDI3506 Dose 2 | Heart Rate (Beats/Min) Recorded on ECGs | Week 16 | 65.42 beats per minute | Standard Deviation 9.08 |
| MEDI3506 Dose 2 | Heart Rate (Beats/Min) Recorded on ECGs | Week 24 | 72.46 beats per minute | Standard Deviation 9.12 |
| MEDI3506 Dose 3 | Heart Rate (Beats/Min) Recorded on ECGs | Week 16 | 63.05 beats per minute | Standard Deviation 10.61 |
| MEDI3506 Dose 3 | Heart Rate (Beats/Min) Recorded on ECGs | Week 24 | 64.58 beats per minute | Standard Deviation 9.43 |
| MEDI3506 Dose 3 | Heart Rate (Beats/Min) Recorded on ECGs | Baseline | 65.18 beats per minute | Standard Deviation 9.43 |
Secondary
Heart Rate Taken During Vital Signs Assessment
Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Time frame: Baseline, week 16 and week 24
Population: As-treated population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Heart Rate Taken During Vital Signs Assessment | Week 16 | 69.4 Pulse Rate (beats/min) | Standard Deviation 10.1 |
| Placebo | Heart Rate Taken During Vital Signs Assessment | Week 24 | 72.0 Pulse Rate (beats/min) | Standard Deviation 13.5 |
| Placebo | Heart Rate Taken During Vital Signs Assessment | Baseline | 68.1 Pulse Rate (beats/min) | Standard Deviation 9.8 |
| MEDI3506 Dose 1 | Heart Rate Taken During Vital Signs Assessment | Baseline | 66.6 Pulse Rate (beats/min) | Standard Deviation 8.7 |
| MEDI3506 Dose 1 | Heart Rate Taken During Vital Signs Assessment | Week 16 | 66.9 Pulse Rate (beats/min) | Standard Deviation 10.6 |
| MEDI3506 Dose 1 | Heart Rate Taken During Vital Signs Assessment | Week 24 | 67.0 Pulse Rate (beats/min) | Standard Deviation 10.4 |
| MEDI3506 Dose 2 | Heart Rate Taken During Vital Signs Assessment | Week 24 | 74.1 Pulse Rate (beats/min) | Standard Deviation 8.7 |
| MEDI3506 Dose 2 | Heart Rate Taken During Vital Signs Assessment | Baseline | 71.3 Pulse Rate (beats/min) | Standard Deviation 9.3 |
| MEDI3506 Dose 2 | Heart Rate Taken During Vital Signs Assessment | Week 16 | 65.9 Pulse Rate (beats/min) | Standard Deviation 8.6 |
| MEDI3506 Dose 3 | Heart Rate Taken During Vital Signs Assessment | Week 24 | 67.6 Pulse Rate (beats/min) | Standard Deviation 10.1 |
| MEDI3506 Dose 3 | Heart Rate Taken During Vital Signs Assessment | Baseline | 68.2 Pulse Rate (beats/min) | Standard Deviation 11.1 |
| MEDI3506 Dose 3 | Heart Rate Taken During Vital Signs Assessment | Week 16 | 66.4 Pulse Rate (beats/min) | Standard Deviation 11 |
Secondary
Left Ventricular Ejection Fraction Measured by Echocardiogram
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Time frame: Baseline and week 16
Population: As-treated population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Left Ventricular Ejection Fraction Measured by Echocardiogram | Week 16 | 64.3 % LVEF | Standard Deviation 5.9 |
| Placebo | Left Ventricular Ejection Fraction Measured by Echocardiogram | Baseline | 64.3 % LVEF | Standard Deviation 6.3 |
| MEDI3506 Dose 1 | Left Ventricular Ejection Fraction Measured by Echocardiogram | Baseline | 64.7 % LVEF | Standard Deviation 6.2 |
| MEDI3506 Dose 1 | Left Ventricular Ejection Fraction Measured by Echocardiogram | Week 16 | 63.0 % LVEF | Standard Deviation 4.4 |
| MEDI3506 Dose 2 | Left Ventricular Ejection Fraction Measured by Echocardiogram | Baseline | 62.8 % LVEF | Standard Deviation 5.2 |
| MEDI3506 Dose 2 | Left Ventricular Ejection Fraction Measured by Echocardiogram | Week 16 | 61.0 % LVEF | Standard Deviation 3.6 |
| MEDI3506 Dose 3 | Left Ventricular Ejection Fraction Measured by Echocardiogram | Baseline | 63.6 % LVEF | Standard Deviation 4.7 |
| MEDI3506 Dose 3 | Left Ventricular Ejection Fraction Measured by Echocardiogram | Week 16 | 65.2 % LVEF | Standard Deviation 5.1 |
Secondary
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Time frame: up to 24 weeks
Population: As-treated population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Haemoglobin | Values within normal range | 51 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | White blood cell count | Values within normal range | 44 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Hematocrit | Values within normal range | 52 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Haemoglobin | At Least One Post-Baseline Value Below LLN | 5 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Basophils | At Least One Post-Baseline Value Above ULN | 3 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Basophils | Values within normal range | 53 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Erythrocytes | Values within normal range | 46 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Hematocrit | At Least One Post-Baseline Value Below LLN | 4 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Eosinophils | Values within normal range | 34 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Haemoglobin | At Least One Post-Baseline Value Above ULN | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | White blood cell count | At Least One Post-Baseline Value Above ULN | 5 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Lymphocytes | At Least One Post-Baseline Value Above ULN | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Basophils | At Least One Post-Baseline Value Below LLN | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Erythrocytes | At Least One Post-Baseline Value Above ULN | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Lymphocytes | Values within normal range | 50 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Monocytes | At Least One Post-Baseline Value Below LLN | 1 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Eosinophils | At Least One Post-Baseline Value Above ULN | 22 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Platelet count | At Least One Post-Baseline Value Above ULN | 3 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Monocytes | Values within normal range | 53 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Platelet count | At Least One Post-Baseline Value Below LLN | 1 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | White blood cell count | At Least One Post-Baseline Value Below LLN | 7 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Monocytes | At Least One Post-Baseline Value Above ULN | 2 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Hematocrit | At Least One Post-Baseline Value Above ULN | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Platelet count | Values within normal range | 52 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Lymphocytes | At Least One Post-Baseline Value Below LLN | 6 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Erythrocytes | At Least One Post-Baseline Value Below LLN | 10 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Eosinophils | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | White blood cell count | At Least One Post-Baseline Value Below LLN | 1 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Platelet count | At Least One Post-Baseline Value Above ULN | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | White blood cell count | Values within normal range | 16 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Erythrocytes | At Least One Post-Baseline Value Below LLN | 3 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Haemoglobin | At Least One Post-Baseline Value Below LLN | 1 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Basophils | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Hematocrit | Values within normal range | 16 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Monocytes | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Lymphocytes | Values within normal range | 19 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Basophils | At Least One Post-Baseline Value Above ULN | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Eosinophils | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Hematocrit | At Least One Post-Baseline Value Below LLN | 3 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Erythrocytes | Values within normal range | 16 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Basophils | Values within normal range | 19 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Platelet count | Values within normal range | 18 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Monocytes | Values within normal range | 19 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Eosinophils | At Least One Post-Baseline Value Above ULN | 4 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Eosinophils | Values within normal range | 15 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Monocytes | At Least One Post-Baseline Value Above ULN | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Haemoglobin | At Least One Post-Baseline Value Above ULN | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | White blood cell count | At Least One Post-Baseline Value Above ULN | 2 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Lymphocytes | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Hematocrit | At Least One Post-Baseline Value Above ULN | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Erythrocytes | At Least One Post-Baseline Value Above ULN | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Platelet count | At Least One Post-Baseline Value Below LLN | 1 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Lymphocytes | At Least One Post-Baseline Value Above ULN | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Haemoglobin | Values within normal range | 18 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Lymphocytes | At Least One Post-Baseline Value Above ULN | 0 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Basophils | Values within normal range | 18 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Eosinophils | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Hematocrit | At Least One Post-Baseline Value Above ULN | 1 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Hematocrit | Values within normal range | 15 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Haemoglobin | At Least One Post-Baseline Value Above ULN | 1 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Lymphocytes | At Least One Post-Baseline Value Below LLN | 3 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Monocytes | At Least One Post-Baseline Value Below LLN | 1 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Monocytes | Values within normal range | 15 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Platelet count | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Platelet count | At Least One Post-Baseline Value Above ULN | 2 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Platelet count | Values within normal range | 16 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Erythrocytes | At Least One Post-Baseline Value Below LLN | 4 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | White blood cell count | At Least One Post-Baseline Value Below LLN | 2 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | White blood cell count | Values within normal range | 16 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Basophils | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Basophils | At Least One Post-Baseline Value Above ULN | 0 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Eosinophils | At Least One Post-Baseline Value Above ULN | 5 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Eosinophils | Values within normal range | 13 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Hematocrit | At Least One Post-Baseline Value Below LLN | 2 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Haemoglobin | At Least One Post-Baseline Value Below LLN | 3 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Haemoglobin | Values within normal range | 14 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Lymphocytes | Values within normal range | 15 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Monocytes | At Least One Post-Baseline Value Above ULN | 2 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Erythrocytes | At Least One Post-Baseline Value Above ULN | 0 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Erythrocytes | Values within normal range | 14 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | White blood cell count | At Least One Post-Baseline Value Above ULN | 0 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Haemoglobin | At Least One Post-Baseline Value Above ULN | 0 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | White blood cell count | At Least One Post-Baseline Value Below LLN | 6 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Erythrocytes | At Least One Post-Baseline Value Below LLN | 17 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Erythrocytes | Values within normal range | 38 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Haemoglobin | Values within normal range | 47 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Platelet count | Values within normal range | 50 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Platelet count | At Least One Post-Baseline Value Above ULN | 5 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Hematocrit | At Least One Post-Baseline Value Below LLN | 7 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Lymphocytes | Values within normal range | 45 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Platelet count | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Monocytes | Values within normal range | 49 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Eosinophils | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Monocytes | At Least One Post-Baseline Value Above ULN | 3 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Monocytes | At Least One Post-Baseline Value Below LLN | 3 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Lymphocytes | At Least One Post-Baseline Value Above ULN | 0 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Lymphocytes | At Least One Post-Baseline Value Below LLN | 10 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Basophils | Values within normal range | 55 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Erythrocytes | At Least One Post-Baseline Value Above ULN | 0 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Haemoglobin | At Least One Post-Baseline Value Below LLN | 8 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Eosinophils | Values within normal range | 41 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Eosinophils | At Least One Post-Baseline Value Above ULN | 14 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Basophils | At Least One Post-Baseline Value Above ULN | 0 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Hematocrit | At Least One Post-Baseline Value Above ULN | 0 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Hematocrit | Values within normal range | 48 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | Basophils | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | White blood cell count | Values within normal range | 47 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology | White blood cell count | At Least One Post-Baseline Value Above ULN | 2 Participants |
Secondary
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Time frame: up to 24 weeks
Population: As-treated population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Potassium | Values within normal range | 54 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Urea Nitrogen | At Least One Post-Baseline Value Above ULN | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Urea Nitrogen | At Least One Post-Baseline Value Below LLN | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Alanine Aminotransferase | Values within normal range | 49 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Alanine Aminotransferase | At Least One Post-Baseline Value Below LLN | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Bilirubin | Values within normal range | 53 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Bilirubin | At Least One Post-Baseline Value Above ULN | 3 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Aspartate Aminotransferase | At Least One Post-Baseline Value Below LLN | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Alkaline Phosphatase | At Least One Post-Baseline Value Above ULN | 3 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Bilirubin | At Least One Post-Baseline Value Below LLN | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Aspartate Aminotransferase | Values within normal range | 50 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Aspartate Aminotransferase | At Least One Post-Baseline Value Above ULN | 6 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Potassium | At Least One Post-Baseline Value Above ULN | 1 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Albumin | At Least One Post-Baseline Value Above ULN | 21 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Albumin | At Least One Post-Baseline Value Below LLN | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Sodium | At Least One Post-Baseline Value Above ULN | 2 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Potassium | At Least One Post-Baseline Value Below LLN | 1 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Sodium | At Least One Post-Baseline Value Below LLN | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Gamma Glutamyl Transferase | Values within normal range | 50 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Gamma Glutamyl Transferase | At Least One Post-Baseline Value Above ULN | 2 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Albumin | Values within normal range | 35 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Alkaline Phosphatase | Values within normal range | 50 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Gamma Glutamyl Transferase | At Least One Post-Baseline Value Below LLN | 4 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Creatinine | Values within normal range | 56 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Alkaline Phosphatase | At Least One Post-Baseline Value Below LLN | 3 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Sodium | Values within normal range | 54 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Creatinine | At Least One Post-Baseline Value Above ULN | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Creatinine | At Least One Post-Baseline Value Below LLN | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Urea Nitrogen | Values within normal range | 56 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Alanine Aminotransferase | At Least One Post-Baseline Value Above ULN | 7 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Gamma Glutamyl Transferase | At Least One Post-Baseline Value Above ULN | 3 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Alkaline Phosphatase | At Least One Post-Baseline Value Above ULN | 2 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Alkaline Phosphatase | Values within normal range | 17 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Alanine Aminotransferase | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Bilirubin | Values within normal range | 19 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Albumin | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Albumin | At Least One Post-Baseline Value Above ULN | 5 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Albumin | Values within normal range | 14 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Alkaline Phosphatase | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Alanine Aminotransferase | At Least One Post-Baseline Value Above ULN | 4 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Alanine Aminotransferase | Values within normal range | 15 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Aspartate Aminotransferase | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Aspartate Aminotransferase | At Least One Post-Baseline Value Above ULN | 3 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Aspartate Aminotransferase | Values within normal range | 16 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Bilirubin | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Bilirubin | At Least One Post-Baseline Value Above ULN | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Urea Nitrogen | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Urea Nitrogen | At Least One Post-Baseline Value Above ULN | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Urea Nitrogen | Values within normal range | 19 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Creatinine | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Creatinine | At Least One Post-Baseline Value Above ULN | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Creatinine | Values within normal range | 19 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Gamma Glutamyl Transferase | At Least One Post-Baseline Value Below LLN | 2 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Gamma Glutamyl Transferase | Values within normal range | 14 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Potassium | At Least One Post-Baseline Value Below LLN | 1 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Potassium | At Least One Post-Baseline Value Above ULN | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Potassium | Values within normal range | 18 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Sodium | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Sodium | At Least One Post-Baseline Value Above ULN | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Sodium | Values within normal range | 19 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Gamma Glutamyl Transferase | At Least One Post-Baseline Value Above ULN | 2 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Alkaline Phosphatase | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Albumin | At Least One Post-Baseline Value Above ULN | 6 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Sodium | Values within normal range | 18 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Gamma Glutamyl Transferase | Values within normal range | 16 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Sodium | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Albumin | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Sodium | At Least One Post-Baseline Value Above ULN | 0 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Potassium | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Creatinine | At Least One Post-Baseline Value Above ULN | 1 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Alanine Aminotransferase | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Urea Nitrogen | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Potassium | At Least One Post-Baseline Value Above ULN | 1 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Aspartate Aminotransferase | At Least One Post-Baseline Value Above ULN | 3 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Urea Nitrogen | Values within normal range | 18 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Urea Nitrogen | At Least One Post-Baseline Value Above ULN | 0 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Creatinine | Values within normal range | 17 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Aspartate Aminotransferase | Values within normal range | 15 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Alkaline Phosphatase | Values within normal range | 16 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Aspartate Aminotransferase | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Albumin | Values within normal range | 12 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Bilirubin | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Alkaline Phosphatase | At Least One Post-Baseline Value Above ULN | 2 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Gamma Glutamyl Transferase | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Potassium | Values within normal range | 17 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Bilirubin | At Least One Post-Baseline Value Above ULN | 1 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Creatinine | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Alanine Aminotransferase | Values within normal range | 14 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Bilirubin | Values within normal range | 17 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Alanine Aminotransferase | At Least One Post-Baseline Value Above ULN | 4 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Bilirubin | Values within normal range | 54 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Urea Nitrogen | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Potassium | Values within normal range | 53 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Urea Nitrogen | At Least One Post-Baseline Value Above ULN | 2 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Alanine Aminotransferase | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Alkaline Phosphatase | At Least One Post-Baseline Value Above ULN | 4 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Urea Nitrogen | Values within normal range | 53 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Sodium | Values within normal range | 53 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Creatinine | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Creatinine | At Least One Post-Baseline Value Above ULN | 3 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Albumin | Values within normal range | 40 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Sodium | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Creatinine | Values within normal range | 52 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Gamma Glutamyl Transferase | At Least One Post-Baseline Value Below LLN | 5 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Albumin | At Least One Post-Baseline Value Above ULN | 15 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Albumin | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Gamma Glutamyl Transferase | At Least One Post-Baseline Value Above ULN | 1 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Gamma Glutamyl Transferase | Values within normal range | 49 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Potassium | At Least One Post-Baseline Value Below LLN | 1 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Sodium | At Least One Post-Baseline Value Above ULN | 2 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Aspartate Aminotransferase | At Least One Post-Baseline Value Above ULN | 8 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Aspartate Aminotransferase | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Potassium | At Least One Post-Baseline Value Above ULN | 1 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Aspartate Aminotransferase | Values within normal range | 47 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Alkaline Phosphatase | Values within normal range | 49 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Bilirubin | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Alanine Aminotransferase | Values within normal range | 50 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Alkaline Phosphatase | At Least One Post-Baseline Value Below LLN | 2 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Bilirubin | At Least One Post-Baseline Value Above ULN | 1 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry | Alanine Aminotransferase | At Least One Post-Baseline Value Above ULN | 5 Participants |
Secondary
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Time frame: up to 24 weeks
Population: As-treated population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | pH | Values within normal range | 56 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | pH | At Least One Post-Baseline Value Above ULN | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Leukocytes | Values within normal range | 52 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Specific gravity | At Least One Post-Baseline Value Below LLN | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | pH | At Least One Post-Baseline Value Below LLN | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Erythrocytes | Values within normal range | 48 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Leukocytes | At Least One Post-Baseline Value Below LLN | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Specific gravity | Values within normal range | 52 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Erythrocytes | At Least One Post-Baseline Value Above ULN | 8 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Erythrocytes | At Least One Post-Baseline Value Below LLN | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Leukocytes | At Least One Post-Baseline Value Above ULN | 4 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Specific gravity | At Least One Post-Baseline Value Above ULN | 4 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Erythrocytes | At Least One Post-Baseline Value Above ULN | 2 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Specific gravity | Values within normal range | 19 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Leukocytes | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Leukocytes | At Least One Post-Baseline Value Above ULN | 2 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Leukocytes | Values within normal range | 17 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | pH | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | pH | At Least One Post-Baseline Value Above ULN | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | pH | Values within normal range | 19 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Erythrocytes | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Erythrocytes | Values within normal range | 17 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Specific gravity | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Specific gravity | At Least One Post-Baseline Value Above ULN | 0 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Specific gravity | Values within normal range | 15 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Leukocytes | At Least One Post-Baseline Value Above ULN | 1 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | pH | Values within normal range | 18 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Specific gravity | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Erythrocytes | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Leukocytes | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Specific gravity | At Least One Post-Baseline Value Above ULN | 3 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Erythrocytes | At Least One Post-Baseline Value Above ULN | 1 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Erythrocytes | Values within normal range | 17 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Leukocytes | Values within normal range | 17 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | pH | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 2 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | pH | At Least One Post-Baseline Value Above ULN | 0 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Erythrocytes | Values within normal range | 49 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | pH | At Least One Post-Baseline Value Above ULN | 1 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Erythrocytes | At Least One Post-Baseline Value Above ULN | 6 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Specific gravity | At Least One Post-Baseline Value Above ULN | 7 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Specific gravity | Values within normal range | 48 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | pH | Values within normal range | 54 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Leukocytes | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Specific gravity | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Leukocytes | At Least One Post-Baseline Value Above ULN | 5 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Erythrocytes | At Least One Post-Baseline Value Below LLN | 0 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | Leukocytes | Values within normal range | 50 Participants |
| MEDI3506 Dose 3 | Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis | pH | At Least One Post-Baseline Value Below LLN | 0 Participants |
Secondary
Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance
Collectively with other ECG parameters are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Time frame: Week 16 and week 24
Population: As-treated population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 16 | Missing | 15 Participants |
| Placebo | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 16 | Abnormal ECG: Not Clinically significant | 3 Participants |
| Placebo | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 24 | Abnormal ECG: Clinically significant | 0 Participants |
| Placebo | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 16 | Abnormal ECG: Clinically significant | 0 Participants |
| Placebo | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 24 | Normal ECG | 38 Participants |
| Placebo | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 16 | Normal ECG | 38 Participants |
| Placebo | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 24 | Missing | 14 Participants |
| Placebo | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 24 | Abnormal ECG: Not Clinically significant | 4 Participants |
| MEDI3506 Dose 1 | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 24 | Abnormal ECG: Not Clinically significant | 4 Participants |
| MEDI3506 Dose 1 | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 16 | Missing | 4 Participants |
| MEDI3506 Dose 1 | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 24 | Abnormal ECG: Clinically significant | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 16 | Abnormal ECG: Clinically significant | 0 Participants |
| MEDI3506 Dose 1 | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 24 | Normal ECG | 12 Participants |
| MEDI3506 Dose 1 | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 16 | Abnormal ECG: Not Clinically significant | 2 Participants |
| MEDI3506 Dose 1 | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 24 | Missing | 3 Participants |
| MEDI3506 Dose 1 | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 16 | Normal ECG | 13 Participants |
| MEDI3506 Dose 2 | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 16 | Abnormal ECG: Clinically significant | 0 Participants |
| MEDI3506 Dose 2 | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 24 | Abnormal ECG: Not Clinically significant | 2 Participants |
| MEDI3506 Dose 2 | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 24 | Missing | 5 Participants |
| MEDI3506 Dose 2 | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 16 | Abnormal ECG: Not Clinically significant | 2 Participants |
| MEDI3506 Dose 2 | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 16 | Normal ECG | 10 Participants |
| MEDI3506 Dose 2 | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 16 | Missing | 6 Participants |
| MEDI3506 Dose 2 | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 24 | Abnormal ECG: Clinically significant | 0 Participants |
| MEDI3506 Dose 2 | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 24 | Normal ECG | 11 Participants |
| MEDI3506 Dose 3 | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 24 | Abnormal ECG: Clinically significant | 0 Participants |
| MEDI3506 Dose 3 | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 16 | Normal ECG | 32 Participants |
| MEDI3506 Dose 3 | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 16 | Abnormal ECG: Not Clinically significant | 10 Participants |
| MEDI3506 Dose 3 | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 16 | Abnormal ECG: Clinically significant | 0 Participants |
| MEDI3506 Dose 3 | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 24 | Abnormal ECG: Not Clinically significant | 11 Participants |
| MEDI3506 Dose 3 | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 24 | Normal ECG | 29 Participants |
| MEDI3506 Dose 3 | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 16 | Missing | 13 Participants |
| MEDI3506 Dose 3 | Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance | Week 24 | Missing | 15 Participants |
Secondary
Occurence of Anti-drug Antibody During the Treatment and Follow-up Periods
To evaluate the immunogenicity of MEDI3506 in adult subjects with moderate-to-severe AD.
Time frame: up to 24 weeks
Population: As-treated population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Occurence of Anti-drug Antibody During the Treatment and Follow-up Periods | Baseline ADA result | 1 Participants |
| Placebo | Occurence of Anti-drug Antibody During the Treatment and Follow-up Periods | Post-baseline ADA result | 1 Participants |
| MEDI3506 Dose 1 | Occurence of Anti-drug Antibody During the Treatment and Follow-up Periods | Post-baseline ADA result | 1 Participants |
| MEDI3506 Dose 1 | Occurence of Anti-drug Antibody During the Treatment and Follow-up Periods | Baseline ADA result | 0 Participants |
| MEDI3506 Dose 2 | Occurence of Anti-drug Antibody During the Treatment and Follow-up Periods | Baseline ADA result | 0 Participants |
| MEDI3506 Dose 2 | Occurence of Anti-drug Antibody During the Treatment and Follow-up Periods | Post-baseline ADA result | 0 Participants |
| MEDI3506 Dose 3 | Occurence of Anti-drug Antibody During the Treatment and Follow-up Periods | Baseline ADA result | 0 Participants |
| MEDI3506 Dose 3 | Occurence of Anti-drug Antibody During the Treatment and Follow-up Periods | Post-baseline ADA result | 2 Participants |
Secondary
Occurrence of Adverse Events
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Time frame: up to 24 weeks
Population: As-treated population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Occurrence of Adverse Events | At least one adverse event | 37 Participants |
| Placebo | Occurrence of Adverse Events | At least one investigational product related serious event | 0 Participants |
| Placebo | Occurrence of Adverse Events | At least one investigational product related event | 7 Participants |
| Placebo | Occurrence of Adverse Events | At least one serious event | 2 Participants |
| Placebo | Occurrence of Adverse Events | At least one event of ≥ grade 3 severity | 7 Participants |
| MEDI3506 Dose 1 | Occurrence of Adverse Events | At least one investigational product related event | 3 Participants |
| MEDI3506 Dose 1 | Occurrence of Adverse Events | At least one investigational product related serious event | 0 Participants |
| MEDI3506 Dose 1 | Occurrence of Adverse Events | At least one adverse event | 9 Participants |
| MEDI3506 Dose 1 | Occurrence of Adverse Events | At least one event of ≥ grade 3 severity | 2 Participants |
| MEDI3506 Dose 1 | Occurrence of Adverse Events | At least one serious event | 0 Participants |
| MEDI3506 Dose 2 | Occurrence of Adverse Events | At least one adverse event | 14 Participants |
| MEDI3506 Dose 2 | Occurrence of Adverse Events | At least one investigational product related event | 7 Participants |
| MEDI3506 Dose 2 | Occurrence of Adverse Events | At least one investigational product related serious event | 1 Participants |
| MEDI3506 Dose 2 | Occurrence of Adverse Events | At least one serious event | 2 Participants |
| MEDI3506 Dose 2 | Occurrence of Adverse Events | At least one event of ≥ grade 3 severity | 2 Participants |
| MEDI3506 Dose 3 | Occurrence of Adverse Events | At least one investigational product related serious event | 0 Participants |
| MEDI3506 Dose 3 | Occurrence of Adverse Events | At least one event of ≥ grade 3 severity | 5 Participants |
| MEDI3506 Dose 3 | Occurrence of Adverse Events | At least one investigational product related event | 8 Participants |
| MEDI3506 Dose 3 | Occurrence of Adverse Events | At least one serious event | 1 Participants |
| MEDI3506 Dose 3 | Occurrence of Adverse Events | At least one adverse event | 32 Participants |
Secondary
Oral or Tympanic Temperature Taken During Vital Signs Assessment
Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Time frame: Baseline, week 16 and week 24
Population: As-treated population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Oral or Tympanic Temperature Taken During Vital Signs Assessment | Week 24 | 36.44 degrees C | Standard Deviation 0.43 |
| Placebo | Oral or Tympanic Temperature Taken During Vital Signs Assessment | Baseline | 36.46 degrees C | Standard Deviation 0.35 |
| Placebo | Oral or Tympanic Temperature Taken During Vital Signs Assessment | Week 16 | 36.49 degrees C | Standard Deviation 0.36 |
| MEDI3506 Dose 1 | Oral or Tympanic Temperature Taken During Vital Signs Assessment | Week 16 | 36.71 degrees C | Standard Deviation 0.41 |
| MEDI3506 Dose 1 | Oral or Tympanic Temperature Taken During Vital Signs Assessment | Week 24 | 36.63 degrees C | Standard Deviation 0.5 |
| MEDI3506 Dose 1 | Oral or Tympanic Temperature Taken During Vital Signs Assessment | Baseline | 36.43 degrees C | Standard Deviation 0.52 |
| MEDI3506 Dose 2 | Oral or Tympanic Temperature Taken During Vital Signs Assessment | Baseline | 36.41 degrees C | Standard Deviation 0.43 |
| MEDI3506 Dose 2 | Oral or Tympanic Temperature Taken During Vital Signs Assessment | Week 16 | 36.50 degrees C | Standard Deviation 0.32 |
| MEDI3506 Dose 2 | Oral or Tympanic Temperature Taken During Vital Signs Assessment | Week 24 | 36.55 degrees C | Standard Deviation 0.42 |
| MEDI3506 Dose 3 | Oral or Tympanic Temperature Taken During Vital Signs Assessment | Baseline | 36.52 degrees C | Standard Deviation 0.39 |
| MEDI3506 Dose 3 | Oral or Tympanic Temperature Taken During Vital Signs Assessment | Week 24 | 36.51 degrees C | Standard Deviation 0.37 |
| MEDI3506 Dose 3 | Oral or Tympanic Temperature Taken During Vital Signs Assessment | Week 16 | 36.47 degrees C | Standard Deviation 0.39 |
Secondary
Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16
The Patient Global Impression of Severity (PGI-S) is a tool that allows patients to rate the severity of a condition over the past 7 days with response options of No symptoms, Very mild, Mild, Moderate, Severe and Very severe.
Time frame: Week 16
Population: ITT population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16 | Very severe | 1 Participants |
| Placebo | Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16 | Missing data | 18 Participants |
| Placebo | Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16 | Mild | 9 Participants |
| Placebo | Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16 | Very mild | 5 Participants |
| Placebo | Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16 | No symptoms | 1 Participants |
| Placebo | Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16 | Severe | 11 Participants |
| Placebo | Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16 | Moderate | 11 Participants |
| MEDI3506 Dose 1 | Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16 | No symptoms | 0 Participants |
| MEDI3506 Dose 1 | Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16 | Missing data | 4 Participants |
| MEDI3506 Dose 1 | Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16 | Severe | 4 Participants |
| MEDI3506 Dose 1 | Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16 | Very mild | 0 Participants |
| MEDI3506 Dose 1 | Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16 | Moderate | 5 Participants |
| MEDI3506 Dose 1 | Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16 | Mild | 4 Participants |
| MEDI3506 Dose 1 | Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16 | Very severe | 2 Participants |
| MEDI3506 Dose 2 | Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16 | Missing data | 6 Participants |
| MEDI3506 Dose 2 | Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16 | No symptoms | 1 Participants |
| MEDI3506 Dose 2 | Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16 | Very mild | 5 Participants |
| MEDI3506 Dose 2 | Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16 | Mild | 2 Participants |
| MEDI3506 Dose 2 | Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16 | Moderate | 1 Participants |
| MEDI3506 Dose 2 | Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16 | Severe | 2 Participants |
| MEDI3506 Dose 2 | Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16 | Very severe | 1 Participants |
| MEDI3506 Dose 3 | Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16 | Moderate | 14 Participants |
| MEDI3506 Dose 3 | Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16 | Mild | 8 Participants |
| MEDI3506 Dose 3 | Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16 | Missing data | 15 Participants |
| MEDI3506 Dose 3 | Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16 | Very severe | 1 Participants |
| MEDI3506 Dose 3 | Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16 | Very mild | 10 Participants |
| MEDI3506 Dose 3 | Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16 | No symptoms | 1 Participants |
| MEDI3506 Dose 3 | Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16 | Severe | 6 Participants |
Secondary
Percentage of Subjects Achieving a 50% Reduction From Baseline in EASI Score at Week 16
To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. Responders are subjects who achieved at least 50% reduction from baseline in EASI score.
Time frame: Week 16
Population: ITT population. Subjects who discontinued IP, withdrew from study or used rescue medication were considered as non-responders.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Percentage of Subjects Achieving a 50% Reduction From Baseline in EASI Score at Week 16 | 12 Participants |
| MEDI3506 Dose 1 | Percentage of Subjects Achieving a 50% Reduction From Baseline in EASI Score at Week 16 | 5 Participants |
| MEDI3506 Dose 2 | Percentage of Subjects Achieving a 50% Reduction From Baseline in EASI Score at Week 16 | 5 Participants |
| MEDI3506 Dose 3 | Percentage of Subjects Achieving a 50% Reduction From Baseline in EASI Score at Week 16 | 16 Participants |
Secondary
Percentage of Subjects Achieving a 75% Reduction From Baseline in EASI Score at Week 16
To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. Responders are subjects who achieved at least 75% reduction from baseline in EASI score.
Time frame: Week 16
Population: ITT population. Subjects who discontinued IP, withdrew from study or used rescue medication were considered as non-responders.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Percentage of Subjects Achieving a 75% Reduction From Baseline in EASI Score at Week 16 | 4 Participants |
| MEDI3506 Dose 1 | Percentage of Subjects Achieving a 75% Reduction From Baseline in EASI Score at Week 16 | 2 Participants |
| MEDI3506 Dose 2 | Percentage of Subjects Achieving a 75% Reduction From Baseline in EASI Score at Week 16 | 1 Participants |
| MEDI3506 Dose 3 | Percentage of Subjects Achieving a 75% Reduction From Baseline in EASI Score at Week 16 | 10 Participants |
p-value: 0.639690% CI: [0.19, 9.94]Fisher Exact
p-value: 0.999990% CI: [0.03, 6.38]Fisher Exact
p-value: 0.093590% CI: [0.91, 10.49]Regression, Logistic
Secondary
Percentage of Subjects Achieving a 90% Reduction From Baseline in EASI Score at Week 16
To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. Responders are subjects who achieved at least 90% reduction from baseline in EASI score.
Time frame: Week 16
Population: ITT population. Subjects who discontinued IP, withdrew from study or used rescue medication were considered as non-responders.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Percentage of Subjects Achieving a 90% Reduction From Baseline in EASI Score at Week 16 | 0 Participants |
| MEDI3506 Dose 1 | Percentage of Subjects Achieving a 90% Reduction From Baseline in EASI Score at Week 16 | 0 Participants |
| MEDI3506 Dose 2 | Percentage of Subjects Achieving a 90% Reduction From Baseline in EASI Score at Week 16 | 1 Participants |
| MEDI3506 Dose 3 | Percentage of Subjects Achieving a 90% Reduction From Baseline in EASI Score at Week 16 | 3 Participants |
Secondary
Percentage of Subjects Achieving an IGA of 0 (Clear) or 1 (Almost Clear) With at Least a 2 Grade Reduction From Baseline Score at Week 16
The IGA allows investigators to assess overall AD disease severity at 1 given time point and consists of a 5-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, and 4 = severe disease).
Time frame: Week 16
Population: ITT population. Subjects who discontinued IP, withdrew from the study, or required rescue therapy were considered as non responders.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Percentage of Subjects Achieving an IGA of 0 (Clear) or 1 (Almost Clear) With at Least a 2 Grade Reduction From Baseline Score at Week 16 | IGA response rate at Week 16 | 1 Participants |
| Placebo | Percentage of Subjects Achieving an IGA of 0 (Clear) or 1 (Almost Clear) With at Least a 2 Grade Reduction From Baseline Score at Week 16 | IGA response rate at Week 16 using MCP-Mod dose-response analysis | NA Participants |
| MEDI3506 Dose 1 | Percentage of Subjects Achieving an IGA of 0 (Clear) or 1 (Almost Clear) With at Least a 2 Grade Reduction From Baseline Score at Week 16 | IGA response rate at Week 16 using MCP-Mod dose-response analysis | NA Participants |
| MEDI3506 Dose 1 | Percentage of Subjects Achieving an IGA of 0 (Clear) or 1 (Almost Clear) With at Least a 2 Grade Reduction From Baseline Score at Week 16 | IGA response rate at Week 16 | 1 Participants |
| MEDI3506 Dose 2 | Percentage of Subjects Achieving an IGA of 0 (Clear) or 1 (Almost Clear) With at Least a 2 Grade Reduction From Baseline Score at Week 16 | IGA response rate at Week 16 | 0 Participants |
| MEDI3506 Dose 2 | Percentage of Subjects Achieving an IGA of 0 (Clear) or 1 (Almost Clear) With at Least a 2 Grade Reduction From Baseline Score at Week 16 | IGA response rate at Week 16 using MCP-Mod dose-response analysis | NA Participants |
| MEDI3506 Dose 3 | Percentage of Subjects Achieving an IGA of 0 (Clear) or 1 (Almost Clear) With at Least a 2 Grade Reduction From Baseline Score at Week 16 | IGA response rate at Week 16 | 5 Participants |
| MEDI3506 Dose 3 | Percentage of Subjects Achieving an IGA of 0 (Clear) or 1 (Almost Clear) With at Least a 2 Grade Reduction From Baseline Score at Week 16 | IGA response rate at Week 16 using MCP-Mod dose-response analysis | NA Participants |
p-value: 0.44590% CI: [0.08, 119.65]Fisher Exact
p-value: 0.999990% CI: [0, 28]Fisher Exact
p-value: 0.113290% CI: [0.75, 130.35]Fisher Exact
Secondary
Percentage of Subjects Achieving a Reduction of ≥ 3 From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS
Peak pruritus (ie, worst itch experienced in the previous 24 hours) assessed using an Numerical Rating Scale (NRS; 0 to 10) with 0 = no itch and 10 = worst imaginable itch. The daily assessments were summarised as a weekly mean.
Time frame: Week 16
Population: ITT population. Subjects who withdrew from the study or required rescue therapy considered as non-responders.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Percentage of Subjects Achieving a Reduction of ≥ 3 From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS | 9 Participants |
| MEDI3506 Dose 1 | Percentage of Subjects Achieving a Reduction of ≥ 3 From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS | 3 Participants |
| MEDI3506 Dose 2 | Percentage of Subjects Achieving a Reduction of ≥ 3 From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS | 3 Participants |
| MEDI3506 Dose 3 | Percentage of Subjects Achieving a Reduction of ≥ 3 From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS | 12 Participants |
Secondary
QT (Miliseconds) Recorded on ECGs
Collectively with other ECG parameters are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Time frame: Baseline, week 16 and week 24
Population: As-treated population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | QT (Miliseconds) Recorded on ECGs | Baseline | 385.43 milliseconds | Standard Deviation 27.75 |
| Placebo | QT (Miliseconds) Recorded on ECGs | Week 24 | 385.88 milliseconds | Standard Deviation 34.31 |
| Placebo | QT (Miliseconds) Recorded on ECGs | Week 16 | 387.05 milliseconds | Standard Deviation 26.14 |
| MEDI3506 Dose 1 | QT (Miliseconds) Recorded on ECGs | Baseline | 390.67 milliseconds | Standard Deviation 20.57 |
| MEDI3506 Dose 1 | QT (Miliseconds) Recorded on ECGs | Week 24 | 398.69 milliseconds | Standard Deviation 28.52 |
| MEDI3506 Dose 1 | QT (Miliseconds) Recorded on ECGs | Week 16 | 390.40 milliseconds | Standard Deviation 24.24 |
| MEDI3506 Dose 2 | QT (Miliseconds) Recorded on ECGs | Week 16 | 395.75 milliseconds | Standard Deviation 20.36 |
| MEDI3506 Dose 2 | QT (Miliseconds) Recorded on ECGs | Baseline | 380.04 milliseconds | Standard Deviation 26.38 |
| MEDI3506 Dose 2 | QT (Miliseconds) Recorded on ECGs | Week 24 | 383.15 milliseconds | Standard Deviation 19.05 |
| MEDI3506 Dose 3 | QT (Miliseconds) Recorded on ECGs | Baseline | 390.27 milliseconds | Standard Deviation 22.69 |
| MEDI3506 Dose 3 | QT (Miliseconds) Recorded on ECGs | Week 24 | 393.40 milliseconds | Standard Deviation 26.54 |
| MEDI3506 Dose 3 | QT (Miliseconds) Recorded on ECGs | Week 16 | 391.95 milliseconds | Standard Deviation 29.22 |
Secondary
Respiratory Rate Collected During Vital Signs Assessment
Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Time frame: Baseline, week 16 and week 24
Population: As-treated population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Respiratory Rate Collected During Vital Signs Assessment | Baseline | 15.4 breaths/min | Standard Deviation 2.2 |
| Placebo | Respiratory Rate Collected During Vital Signs Assessment | Week 24 | 15.8 breaths/min | Standard Deviation 2.4 |
| Placebo | Respiratory Rate Collected During Vital Signs Assessment | Week 16 | 16.0 breaths/min | Standard Deviation 2.3 |
| MEDI3506 Dose 1 | Respiratory Rate Collected During Vital Signs Assessment | Week 24 | 16.1 breaths/min | Standard Deviation 1.5 |
| MEDI3506 Dose 1 | Respiratory Rate Collected During Vital Signs Assessment | Baseline | 16.0 breaths/min | Standard Deviation 1.5 |
| MEDI3506 Dose 1 | Respiratory Rate Collected During Vital Signs Assessment | Week 16 | 15.7 breaths/min | Standard Deviation 1.8 |
| MEDI3506 Dose 2 | Respiratory Rate Collected During Vital Signs Assessment | Week 24 | 17.1 breaths/min | Standard Deviation 2.4 |
| MEDI3506 Dose 2 | Respiratory Rate Collected During Vital Signs Assessment | Week 16 | 16.3 breaths/min | Standard Deviation 1.9 |
| MEDI3506 Dose 2 | Respiratory Rate Collected During Vital Signs Assessment | Baseline | 16.2 breaths/min | Standard Deviation 1.8 |
| MEDI3506 Dose 3 | Respiratory Rate Collected During Vital Signs Assessment | Baseline | 15.5 breaths/min | Standard Deviation 1.8 |
| MEDI3506 Dose 3 | Respiratory Rate Collected During Vital Signs Assessment | Week 24 | 15.6 breaths/min | Standard Deviation 1.6 |
| MEDI3506 Dose 3 | Respiratory Rate Collected During Vital Signs Assessment | Week 16 | 15.9 breaths/min | Standard Deviation 1.4 |
Secondary
SCORAD: Percent Change From Baseline to Week 16
SCORAD is a clinical tool for assessing the severity of AD that evaluates the extent and intensity of AD lesions, in addition to subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
Time frame: Week 16
Population: ITT population, excluding missing data at baseline or week 16.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | SCORAD: Percent Change From Baseline to Week 16 | -31.79 Percentage of change from baseline | Standard Deviation 25.09 |
| MEDI3506 Dose 1 | SCORAD: Percent Change From Baseline to Week 16 | -29.88 Percentage of change from baseline | Standard Deviation 23.14 |
| MEDI3506 Dose 2 | SCORAD: Percent Change From Baseline to Week 16 | -36.22 Percentage of change from baseline | Standard Deviation 25.34 |
| MEDI3506 Dose 3 | SCORAD: Percent Change From Baseline to Week 16 | -39.42 Percentage of change from baseline | Standard Deviation 25.44 |
Secondary
Serum MEDI3506 Concentration Profiles
To evaluate the PK of MEDI3506 in adult subjects with moderate-to-severe AD.
Time frame: Week 16 and week 24
Population: PK population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Serum MEDI3506 Concentration Profiles | Week 16 | 0.377 μg/mL | Geometric Coefficient of Variation 242 |
| Placebo | Serum MEDI3506 Concentration Profiles | Week 24 | 0.018 μg/mL | Geometric Coefficient of Variation 184 |
| MEDI3506 Dose 1 | Serum MEDI3506 Concentration Profiles | Week 16 | 2.158 μg/mL | Geometric Coefficient of Variation 193 |
| MEDI3506 Dose 1 | Serum MEDI3506 Concentration Profiles | Week 24 | 0.118 μg/mL | Geometric Coefficient of Variation 298 |
| MEDI3506 Dose 2 | Serum MEDI3506 Concentration Profiles | Week 16 | 5.979 μg/mL | Geometric Coefficient of Variation 118 |
| MEDI3506 Dose 2 | Serum MEDI3506 Concentration Profiles | Week 24 | 0.188 μg/mL | Geometric Coefficient of Variation 234 |
Secondary
Systolic Blood Pressure Taken During Vital Signs Assessment
Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Time frame: Baseline, week 16 and week 24
Population: As-treated population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Systolic Blood Pressure Taken During Vital Signs Assessment | Baseline | 117.7 mmHg | Standard Deviation 12.9 |
| Placebo | Systolic Blood Pressure Taken During Vital Signs Assessment | Week 24 | 118.9 mmHg | Standard Deviation 11.1 |
| Placebo | Systolic Blood Pressure Taken During Vital Signs Assessment | Week 16 | 117.8 mmHg | Standard Deviation 9.6 |
| MEDI3506 Dose 1 | Systolic Blood Pressure Taken During Vital Signs Assessment | Baseline | 119.3 mmHg | Standard Deviation 9.2 |
| MEDI3506 Dose 1 | Systolic Blood Pressure Taken During Vital Signs Assessment | Week 24 | 117.6 mmHg | Standard Deviation 11.4 |
| MEDI3506 Dose 1 | Systolic Blood Pressure Taken During Vital Signs Assessment | Week 16 | 117.3 mmHg | Standard Deviation 7.2 |
| MEDI3506 Dose 2 | Systolic Blood Pressure Taken During Vital Signs Assessment | Week 24 | 120.1 mmHg | Standard Deviation 15.1 |
| MEDI3506 Dose 2 | Systolic Blood Pressure Taken During Vital Signs Assessment | Week 16 | 120.7 mmHg | Standard Deviation 13.6 |
| MEDI3506 Dose 2 | Systolic Blood Pressure Taken During Vital Signs Assessment | Baseline | 123.8 mmHg | Standard Deviation 9.9 |
| MEDI3506 Dose 3 | Systolic Blood Pressure Taken During Vital Signs Assessment | Week 24 | 120.6 mmHg | Standard Deviation 12.1 |
| MEDI3506 Dose 3 | Systolic Blood Pressure Taken During Vital Signs Assessment | Week 16 | 119.8 mmHg | Standard Deviation 10.6 |
| MEDI3506 Dose 3 | Systolic Blood Pressure Taken During Vital Signs Assessment | Baseline | 121.5 mmHg | Standard Deviation 12.5 |