Efficacy and Safety of MEDI3506 in Adult Subjects With At... | NCT04212169

ID	Type	Description	Link
2019-003304-12	EudraCT Number

Label	Type	Description	Intervention Names
MEDI3506 at dose level 1	Experimental	Participant will receive multiple doses of MEDI3506 at dose level 1.	Drug: MEDI3506
MEDI3506 at dose level 2	Experimental	Participant will receive multiple doses of MEDI3506 at dose level 2.	Drug: MEDI3506
MEDI3506 at dose level 3	Experimental	Participant will receive multiple doses of MEDI3506 at dose level 3.	Drug: MEDI3506
Placebo	Placebo Comparator	Participant will receive multiple doses of Placebo	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
MEDI3506	Drug	multiple doses	MEDI3506 at dose level 1 MEDI3506 at dose level 2 MEDI3506 at dose level 3

Measure	Description	Time Frame
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.	Week 16

Measure	Description	Time Frame
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.	Week 16

Eligibility Module

Eligibility Criteria

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.

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham	Alabama	35209	United States
Research Site

Label	URL
Redacted CSP	View source
Redacted SAP	View source

IPD Sharing Statement Module

ID	Title	Description
FG000	Placebo	Pooled Placebo
FG001	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 15, 2022	Jul 19, 2023

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

ITT population. Data after study withdrawal or use of rescue therapy was excluded.

Posted

Least Squares Mean

Standard Error

Percentage of change from baseline

Week 16

ID	Title	Description
OG000	Placebo	Pooled placebo
OG001	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
OG002	MEDI3506 Dose 2	MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
OG003	MEDI3506 Dose 3	MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks

Units	Counts
Participants	OG00055 OG00119 OG00217 OG003

Title

Denominators

Categories

Percent change from baseline to Week 16 in EASI score analysed using MCP-mod dose response model

Title	Measurements
	OG000NA± NANo dose response model selected from the MCP-mod analysis because the dose response was absent OG001NA± NANo dose response model selected from the MCP-mod analysis because the dose response was absent OG002

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG001		Mixed Models Analysis		0.888		Mean Difference (Final Values)	1.27	Standard Error of the Mean	8.981	2-Sided	90	-13.67	16.22			Differences less than 0 favours MEDI3506		Superiority
OG002		Mixed Models Analysis

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.

ITT population. Subjects who discontinued IP, withdrew from study or used rescue medication were considered as non-responders.

Posted

Count of Participants

Participants

Week 16

ID	Title	Description
OG000	Placebo	Pooled Placebo
OG001	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
OG002	MEDI3506 Dose 2	MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
OG003	MEDI3506 Dose 3	MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks

Secondary

Percentage of Subjects Achieving a 75% Reduction From Baseline in EASI Score at Week 16

ITT population. Subjects who discontinued IP, withdrew from study or used rescue medication were considered as non-responders.

Posted

Count of Participants

Participants

Week 16

ID	Title	Description
OG000	Placebo	Pooled Placebo
OG001	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
OG002	MEDI3506 Dose 2	MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
OG003	MEDI3506 Dose 3	MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks

Secondary

Percentage of Subjects Achieving a 50% Reduction From Baseline in EASI Score at Week 16

ITT population. Subjects who discontinued IP, withdrew from study or used rescue medication were considered as non-responders.

Posted

Count of Participants

Participants

Week 16

ID	Title	Description
OG000	Placebo	Pooled Placebo
OG001	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
OG002	MEDI3506 Dose 2	MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
OG003	MEDI3506 Dose 3	MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks

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).

ITT population. Subjects who discontinued IP, withdrew from the study, or required rescue therapy were considered as non responders.

Posted

Count of Participants

Participants

Week 16

ID	Title	Description
OG000	Placebo	Pooled Placebo
OG001	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
OG002	MEDI3506 Dose 2	MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
OG003	MEDI3506 Dose 3	MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks

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.

ITT population. Subjects who withdrew from the study or required rescue therapy considered as non-responders.

Posted

Count of Participants

Participants

Week 16

ID	Title	Description
OG000	Placebo	Pooled Placebo
OG001	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
OG002	MEDI3506 Dose 2	MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
OG003	MEDI3506 Dose 3	MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks

Secondary

Change From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS

ITT population, excluding missing data at baseline or week 16.

Posted

Mean

Standard Deviation

Scores on a scale

Week 16

ID	Title	Description
OG000	Placebo	Pooled Placebo
OG001	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
OG002	MEDI3506 Dose 2	MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
OG003	MEDI3506 Dose 3	MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks

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.

ITT population, excluding missing data at baseline or week 16.

Posted

Mean

Standard Deviation

Scores on a scale

Week 16

ID	Title	Description
OG000	Placebo	Pooled Placebo
OG001	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
OG002	MEDI3506 Dose 2	MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
OG003	MEDI3506 Dose 3	MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks

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.

ITT population, excluding missing data at baseline or week 16.

Posted

Mean

Standard Deviation

Percentage of change from baseline

Week 16

ID	Title	Description
OG000	Placebo	Pooled Placebo
OG001	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
OG002	MEDI3506 Dose 2	MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
OG003	MEDI3506 Dose 3	MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks

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.

ITT population, excluding missing data at baseline or week 16.

Posted

Mean

Standard Deviation

Percentage of body surface area

Week 16

ID	Title	Description
OG000	Placebo	Pooled Placebo
OG001	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
OG002	MEDI3506 Dose 2	MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
OG003	MEDI3506 Dose 3	MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks

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.

ITT population, excluding missing data at baseline or week 16.

Posted

Mean

Standard Deviation

Scores on scale

Week 16

ID	Title	Description
OG000	Placebo	Pooled Placebo
OG001	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
OG002	MEDI3506 Dose 2	MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
OG003	MEDI3506 Dose 3	MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks

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".

ITT population

Posted

Count of Participants

Participants

Week 16

ID	Title	Description
OG000	Placebo	Pooled Placebo
OG001	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
OG002	MEDI3506 Dose 2	MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
OG003	MEDI3506 Dose 3	MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks

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

ITT population, excluding missing data at baseline or week 16.

Posted

Mean

Standard Deviation

Scores on scale

Week 16

ID	Title	Description
OG000	Placebo	Pooled Placebo
OG001	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
OG002	MEDI3506 Dose 2	MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
OG003	MEDI3506 Dose 3

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

ITT population, excluding missing data at baseline or week 16.

Posted

Mean

Standard Deviation

Scores on scale

Week 16

ID	Title	Description
OG000	Placebo	Pooled Placebo
OG001	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
OG002	MEDI3506 Dose 2	MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
OG003	MEDI3506 Dose 3	MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks

Secondary

Occurrence of Adverse Events

To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.

As-treated population

Posted

Count of Participants

Participants

up to 24 weeks

ID	Title	Description
OG000	Placebo	Pooled Placebo
OG001	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
OG002	MEDI3506 Dose 2	MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
OG003	MEDI3506 Dose 3	MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks

Units	Counts

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.

As-treated population

Posted

Mean

Standard Deviation

degrees C

Baseline, week 16 and week 24

ID	Title	Description
OG000	Placebo	Pooled Placebo
OG001	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
OG002	MEDI3506 Dose 2	MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
OG003	MEDI3506 Dose 3	MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks

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.

As-treated population

Posted

Mean

Standard Deviation

mmHg

Baseline, week 16 and week 24

ID	Title	Description
OG000	Placebo	Pooled Placebo
OG001	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
OG002	MEDI3506 Dose 2	MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
OG003	MEDI3506 Dose 3	MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks

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.

As-treated population

Posted

Mean

Standard Deviation

Pulse Rate (beats/min)

Baseline, week 16 and week 24

ID	Title	Description
OG000	Placebo	Pooled Placebo
OG001	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
OG002	MEDI3506 Dose 2	MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
OG003	MEDI3506 Dose 3	MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks

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.

As-treated population

Posted

Mean

Standard Deviation

breaths/min

Baseline, week 16 and week 24

ID	Title	Description
OG000	Placebo	Pooled Placebo
OG001	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
OG002	MEDI3506 Dose 2	MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
OG003	MEDI3506 Dose 3	MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks

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.

As-treated population

Posted

Count of Participants

Participants

up to 24 weeks

ID	Title	Description
OG000	Placebo	Pooled Placebo
OG001	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
OG002	MEDI3506 Dose 2	MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
OG003	MEDI3506 Dose 3	MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks

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.

As-treated population

Posted

Count of Participants

Participants

up to 24 weeks

ID	Title	Description
OG000	Placebo	Pooled Placebo
OG001	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
OG002	MEDI3506 Dose 2	MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
OG003	MEDI3506 Dose 3	MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks

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.

As-treated population

Posted

Count of Participants

Participants

up to 24 weeks

ID	Title	Description
OG000	Placebo	Pooled Placebo
OG001	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
OG002	MEDI3506 Dose 2	MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
OG003	MEDI3506 Dose 3	MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks

Units

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.

As-treated population

Posted

Mean

Standard Deviation

beats per minute

Baseline, week 16 and week 24

ID	Title	Description
OG000	Placebo	Pooled Placebo
OG001	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
OG002	MEDI3506 Dose 2	MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
OG003	MEDI3506 Dose 3	MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks

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.

As-treated population

Posted

Mean

Standard Deviation

milliseconds

Baseline, week 16 and week 24

ID	Title	Description
OG000	Placebo	Pooled Placebo
OG001	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
OG002	MEDI3506 Dose 2	MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
OG003	MEDI3506 Dose 3	MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks

Units

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.

As-treated population

Posted

Count of Participants

Participants

Week 16 and week 24

ID	Title	Description
OG000	Placebo	Pooled Placebo
OG001	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
OG002	MEDI3506 Dose 2	MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
OG003	MEDI3506 Dose 3	MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks

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.

As-treated population

Posted

Mean

Standard Deviation

% LVEF

Baseline and week 16

ID	Title	Description
OG000	Placebo	Pooled Placebo
OG001	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
OG002	MEDI3506 Dose 2	MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
OG003	MEDI3506 Dose 3	MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks

Units	Counts

Secondary

Serum MEDI3506 Concentration Profiles

To evaluate the PK of MEDI3506 in adult subjects with moderate-to-severe AD.

PK population

Posted

Geometric Mean

Geometric Coefficient of Variation

μg/mL

Week 16 and week 24

ID	Title	Description
OG000	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
OG001	MEDI3506 Dose 2	MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
OG002	MEDI3506 Dose 3	MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks

Units	Counts
Participants	OG000

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.

As-treated population

Posted

Count of Participants

Participants

up to 24 weeks

ID	Title	Description
OG000	Placebo	Pooled Placebo
OG001	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
OG002	MEDI3506 Dose 2	MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
OG003	MEDI3506 Dose 3	MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks

Units	Counts

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Injection site bruising	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected56 at risk EG0010 events0 affected19 at risk EG0021 events1 affected18 at risk EG0031 events1 affected55 at risk
Injection site reaction	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected56 at risk EG0010 events0 affected19 at risk EG0021 events1 affected18 at risk EG003
Injection site swelling	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected56 at risk EG0010 events0 affected19 at risk EG0021 events1 affected18 at risk EG003
Acarodermatitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected56 at risk EG0011 events1 affected19 at risk EG0020 events0 affected18 at risk EG003
Bronchitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected56 at risk EG0010 events0 affected19 at risk EG0021 events1 affected18 at risk EG003
Covid-19	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0007 events7 affected56 at risk EG0010 events0 affected19 at risk EG0020 events0 affected18 at risk EG003
Cellulitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected56 at risk EG0010 events0 affected19 at risk EG0022 events1 affected18 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected56 at risk EG0010 events0 affected19 at risk EG0021 events1 affected18 at risk EG003
Palpitations	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected56 at risk EG0010 events0 affected19 at risk EG0021 events1 affected18 at risk EG003
Dermatitis infected	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected56 at risk EG0011 events1 affected19 at risk EG0020 events0 affected18 at risk EG003
Eczema infected	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected56 at risk EG0010 events0 affected19 at risk EG0021 events1 affected18 at risk EG003
Folliculitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected56 at risk EG0011 events1 affected19 at risk EG0020 events0 affected18 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected56 at risk EG0010 events0 affected19 at risk EG0021 events1 affected18 at risk EG003
Influenza	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected56 at risk EG0010 events0 affected19 at risk EG0021 events1 affected18 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected56 at risk EG0011 events1 affected19 at risk EG0022 events2 affected18 at risk EG003
Oral herpes	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected56 at risk EG0011 events1 affected19 at risk EG0022 events1 affected18 at risk EG003
Otitis externa	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected56 at risk EG0010 events0 affected19 at risk EG0021 events1 affected18 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected56 at risk EG0010 events0 affected19 at risk EG0021 events1 affected18 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected56 at risk EG0010 events0 affected19 at risk EG0021 events1 affected18 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected56 at risk EG0010 events0 affected19 at risk EG0020 events0 affected18 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected56 at risk EG0010 events0 affected19 at risk EG0021 events1 affected18 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected56 at risk EG0011 events1 affected19 at risk EG0020 events0 affected18 at risk EG003
Liver function test increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected56 at risk EG0011 events1 affected19 at risk EG0020 events0 affected18 at risk EG003
Urine analysis abnormal	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected56 at risk EG0011 events1 affected19 at risk EG0020 events0 affected18 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected56 at risk EG0010 events0 affected19 at risk EG0021 events1 affected18 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected56 at risk EG0010 events0 affected19 at risk EG0023 events2 affected18 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected56 at risk EG0011 events1 affected19 at risk EG0020 events0 affected18 at risk EG003
Headache	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected56 at risk EG0011 events1 affected19 at risk EG0020 events0 affected18 at risk EG003
Presyncope	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected56 at risk EG0011 events1 affected19 at risk EG0020 events0 affected18 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected56 at risk EG0010 events0 affected19 at risk EG0021 events1 affected18 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected56 at risk EG0010 events0 affected19 at risk EG0021 events1 affected18 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected56 at risk EG0010 events0 affected19 at risk EG0021 events1 affected18 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected56 at risk EG0010 events0 affected19 at risk EG0021 events1 affected18 at risk EG003
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG00014 events12 affected56 at risk EG0012 events2 affected19 at risk EG0020 events0 affected18 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected56 at risk EG0010 events0 affected19 at risk EG0022 events2 affected18 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected56 at risk EG0011 events1 affected19 at risk EG0022 events2 affected18 at risk EG003
Hypotension	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected56 at risk EG0011 events1 affected19 at risk EG0020 events0 affected18 at risk EG003
Aphthous ulcer	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected56 at risk EG0011 events1 affected19 at risk EG0020 events0 affected18 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected56 at risk EG0010 events0 affected19 at risk EG0021 events1 affected18 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected56 at risk EG0010 events0 affected19 at risk EG0022 events1 affected18 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected56 at risk EG0011 events1 affected19 at risk EG0020 events0 affected18 at risk EG003
Influenza like illness	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected56 at risk EG0010 events0 affected19 at risk EG0021 events1 affected18 at risk EG003

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D017443	Skin Diseases, Eczematous
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Title	Description
BG000	Placebo	Pooled Placebo
BG001	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks
BG002	MEDI3506 Dose 2	MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks
BG003	MEDI3506 Dose 3	MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks
BG004	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Pooled Placebo	56	2	56	29	56
EG001	MEDI3506 Dose 1	MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks	19	0	19	11	19
EG002	MEDI3506 Dose 2	MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks	18	2	18	14	18
EG003	MEDI3506 Dose 3	MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks	55	1	55	25	55

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Food allergy	Immune system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected56 at risk EG0010 events0 affected19 at risk EG0020 events0 affected18 at risk EG0030 events0 affected55 at risk
Covid-19 pneumonia	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected56 at risk EG0010 events0 affected19 at risk EG0021 events1 affected18 at risk EG003
Dermatitis exfoliative generalised	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected56 at risk EG0010 events0 affected19 at risk EG0020 events0 affected18 at risk EG003
Medical device removal	Surgical and medical procedures	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected56 at risk EG0010 events0 affected19 at risk EG0020 events0 affected18 at risk EG003
Venous thrombosis limb	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected56 at risk EG0010 events0 affected19 at risk EG0021 events1 affected18 at risk EG003