Atopic Dermatitis
Conditions
Keywords
Eczema
Brief summary
To assess the efficacy and safety of MEDI9929 in adult subjects with Atopic Dermatitis
Detailed description
This is a Phase 2a, randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of MEDI9929 administered subcutaneously to adult subjects with moderate to severe Atopic Dermatitis. Subjects will be randomized in a 1:1 fashion and will be stratified at screening. Approximately 100 subjects are planned to be randomized at approximately 35 sites in 6 countries
Interventions
BIOLOGICALMEDI9929
Participants will receive 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks, with the last dose at Week 10.
BIOLOGICALPlacebo
Participants will receive 6 subcutaneous doses of placebo every 2 weeks for 12 weeks, with the last dose at Week 10.
Sponsors
Amgen
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* AD meeting Hanifin and Rajka criteria * Age 18-75 years inclusive at screening * Atopic dermatitis that affects greater than/equal to 10% body surface area * Moderate to severe AD * Effective birth control in line with protocol details
Exclusion criteria
* Active dermatologic conditions which may confuse the diagnosis of Atopic Dermatitis * Hepatitis B, C or HIV * Pregnant or breastfeeding * History of anaphylaxis following any biologic therapy * History of clinically significant infections within 4 weeks prior to Visit 3 * Diagnosis of helminth parasitic infection within 6 months to screening * History of Cancer except basal cell * Receipt of any marketed or investigational biologic agent within 4 months to visit 3 * Any clinically relevant abnormal finding * Major surgery within 8 weeks prior to Visit 1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI 50) at Week 12 | Baseline (Day 1) and Week 12 | The eczema area and severity index (EASI) evaluates 4 natural anatomical regions for severity (0 \[none\] to 3 \[severe\]) and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The total score is the sum of the four body-region scores, maximum=72, minimum=0. The higher values indicating more severe disease. The EASI50 responder defined as a participant who achieved at least 50% reduction in EASI score from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in EASI Total Score at Week 12 | Baseline (Day 1) and Week 12 | The EASI evaluates 4 natural anatomical regions for severity (0 \[none\] to 3 \[severe\]) and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The total score is the sum of the four body-region scores, maximum=72, minimum=0. The higher values indicating more severe disease. |
| Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline | Baseline (Day 1) and Week 12 | The investigator's global assessment (IGA) allows investigators to assess overall disease severity at one given time point and consists of a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, and 4 = severe disease). A participant has IGA response if they achieve a score of 0 (clear) or 1 (almost clear) and at least a 2-grade reduction from baseline. |
| Mean Change From Baseline in the Scoring of Atopic Dermatitis (SCORAD) at Week 12 | Baseline (Day 1) and Week 12 | The scoring of atopic dermatitis (SCORAD) is a clinical tool for assessing the severity (that is, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with participant symptoms. The range of the SCORAD is 0-103, where 0 indicates no eczema. The higher values indicating more severe disease. |
| Percentage of Participants Achieving >= 50% Reduction From Baseline in SCORAD 50 | Baseline (Day 1) and Week 12 | The SCORAD is a clinical tool for assessing the severity (that is, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with participant symptoms. The range of the SCORAD is 0-103, where 0 indicates no eczema. The higher values indicating more severe disease. The SCORAD 50 responder defined as a participant who achieves at least a 50% reduction in SCORAD score from baseline. |
| Percentage of Participants Achieving >= 75% Reduction From Baseline in SCORAD 75 | Baseline (Day 1) and Week 12 | The SCORAD is a clinical tool for assessing the severity (that is, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with participant symptoms. The range of the SCORAD is 0-103, where 0 indicates no eczema. The higher values indicating more severe disease. The SCORAD 75 responder is defined as a participant who achieves at least a 75% reduction in SCORAD score from baseline. |
| Percentage of Participants Achieving >= 75 % Reduction From Baseline in EASI75 at Week 12 | Baseline (Day 1) and Week 12 | The EASI evaluates 4 natural anatomical regions for severity (0 \[none\] to 3 \[severe\]) and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The total score is the sum of the four body-region scores, maximum=72, minimum=0. The higher values indicating more severe disease. The EASI75 responder defined as a participant who achieves at least a 75% reduction in EASI score from baseline. |
| Mean Change From Baseline in 5-D Pruritus Score at Week 12 | Baseline (Day 1) and Week 12 | The 5-D pruritus scale is a brief questionnaire designed to assess itch. This scale takes into account the multidimensional nature of pruritus, its impact on quality of life, and is capable of detecting change over time. The 5-D pruritus scale included 5 domains (duration, degree, direction, disability, and distribution of pruritus). The total 5-D score was obtained by scoring each of the domains separately and then summing them together. 5-D total scores ranged between 5 (no pruritus) and 25 (most severe pruritus). The higher values indicating more severe pruritus. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | From treatment administration (Day1) to 22 weeks | An Adverse event is any unfavourable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with use of investigational product, whether or not considered related to investigational product. Serious adverse event is any AE that resulted in:death;inpatient hospitalization or prolongation of existing hospitalization;persistent or significant disability or incapacity;is life-threatening;is a congenital anomaly/birth defect in offspring of a study participant;or was an important medical event that may not have resulted in death, threatened life,or required hospitalization and that, based on appropriate medical judgment, may have jeopardized participant and may have required medical or surgical intervention to prevent one of outcomes above. TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug until Week 22. |
| Mean Trough Serum Concentration of MEDI9929 | Week 0 (Pre dose), Weeks 4, 8, and 12 (post dose) | The mean serum concentrations of MEDI9929 was observed at specified timepoints. |
| Number of Participants Who Developed Detectable MEDI9929 Anti-drug Antibodies | Baseline (Day 1) to Week 22 | A participant was considered ADA-positive across the study if they had a positive reading (titer of 50 or higher) at any time point during the study period. |
| Mean Change From Baseline in Average Pruritus Numeric Rating Scale (NRS) at Week 12 | Baseline (Day 1) and Week 12 | Pruritus is assessed using an Numeric Rating Scale (NRS) (0 - 10) with 0= no itch and 10= worst imaginable itch. Daily pruritus assessments were summarized as weekly peak score and a change from baseline in weekly peak score was calculated. |
Countries
Australia, Canada, Germany, Hungary, New Zealand, United States
Participant flow
Recruitment details
The study was conducted from 15Aug2015 to 15Jul2016.
Pre-assignment details
A total of 155 participants were screened, of which 113 were randomized into the study.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22. | 56 |
| MEDI9929 280 mg Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22. | 55 |
| Total | 111 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Not Treated | 1 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 6 |
Baseline characteristics
| Characteristic | Placebo | MEDI9929 280 mg | Total |
|---|---|---|---|
| Age, Continuous | 38.8 Years STANDARD_DEVIATION 15.3 | 38.5 Years STANDARD_DEVIATION 14.9 | 38.7 Years STANDARD_DEVIATION 15 |
| Age, Customized 18-35 years | 28 Participants | 27 Participants | 55 Participants |
| Age, Customized 36-75 years | 28 Participants | 28 Participants | 56 Participants |
| Atopic Dermatitis Status IgE >= 150 kU/L and Negative Serum Specific IgE | 2 Participants | 0 Participants | 2 Participants |
| Atopic Dermatitis Status IgE < 150 kU/L and Negative Serum Specific IgEb | 1 Participants | 3 Participants | 4 Participants |
| Atopic Dermatitis Status IgE < 150 kU/L and Positive Serum Specific IgE | 3 Participants | 3 Participants | 6 Participants |
| Atopic Dermatitis Status IgE >= 150 kU/L and Positive Serum Specific IgEa | 50 Participants | 47 Participants | 97 Participants |
| Atopic Dermatitis Status Missing | 0 Participants | 2 Participants | 2 Participants |
| Eczema Area and Severity Index Score <= 25 points | 36 Participants | 33 Participants | 69 Participants |
| Eczema Area and Severity Index Score > 25 points | 20 Participants | 22 Participants | 42 Participants |
| Investigator's Global Assessment Category 2 | 0 Participants | 1 Participants | 1 Participants |
| Investigator's Global Assessment Category 3 | 46 Participants | 44 Participants | 90 Participants |
| Investigator's Global Assessment Category 4 | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Female | 26 Participants | 23 Participants | 49 Participants |
| Sex: Female, Male Male | 30 Participants | 32 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 33 / 55 | 29 / 56 |
| serious Total, serious adverse events | 3 / 55 | 2 / 56 |
Outcome results
Primary
Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI 50) at Week 12
The eczema area and severity index (EASI) evaluates 4 natural anatomical regions for severity (0 \[none\] to 3 \[severe\]) and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The total score is the sum of the four body-region scores, maximum=72, minimum=0. The higher values indicating more severe disease. The EASI50 responder defined as a participant who achieved at least 50% reduction in EASI score from baseline.
Time frame: Baseline (Day 1) and Week 12
Population: Intent-To-Treat (ITT) population included all participants who were randomized and received any study investigational product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI 50) at Week 12 | 48.2 Percentage of participants |
| MEDI9929 280 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI 50) at Week 12 | 64.7 Percentage of participants |
95% CI: [0.9, 4.33]
Secondary
Mean Change From Baseline in 5-D Pruritus Score at Week 12
The 5-D pruritus scale is a brief questionnaire designed to assess itch. This scale takes into account the multidimensional nature of pruritus, its impact on quality of life, and is capable of detecting change over time. The 5-D pruritus scale included 5 domains (duration, degree, direction, disability, and distribution of pruritus). The total 5-D score was obtained by scoring each of the domains separately and then summing them together. 5-D total scores ranged between 5 (no pruritus) and 25 (most severe pruritus). The higher values indicating more severe pruritus.
Time frame: Baseline (Day 1) and Week 12
Population: ITT population included all participants who were randomized and received any study investigational product.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in 5-D Pruritus Score at Week 12 | Baseline | 16.7 units on a scale | Standard Deviation 3.7 |
| Placebo | Mean Change From Baseline in 5-D Pruritus Score at Week 12 | Week 12 | -3.9 units on a scale | Standard Deviation 4.5 |
| MEDI9929 280 mg | Mean Change From Baseline in 5-D Pruritus Score at Week 12 | Baseline | 16.0 units on a scale | Standard Deviation 3.7 |
| MEDI9929 280 mg | Mean Change From Baseline in 5-D Pruritus Score at Week 12 | Week 12 | -3.6 units on a scale | Standard Deviation 4.4 |
Secondary
Mean Change From Baseline in Average Pruritus Numeric Rating Scale (NRS) at Week 12
Pruritus is assessed using an Numeric Rating Scale (NRS) (0 - 10) with 0= no itch and 10= worst imaginable itch. Daily pruritus assessments were summarized as weekly peak score and a change from baseline in weekly peak score was calculated.
Time frame: Baseline (Day 1) and Week 12
Population: ITT population included all participants who were randomized and received any study investigational product.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Average Pruritus Numeric Rating Scale (NRS) at Week 12 | Baseline | 5.15 units on a scale | Standard Deviation 2.1 |
| Placebo | Mean Change From Baseline in Average Pruritus Numeric Rating Scale (NRS) at Week 12 | Week 12 | -1.39 units on a scale | Standard Deviation 1.93 |
| MEDI9929 280 mg | Mean Change From Baseline in Average Pruritus Numeric Rating Scale (NRS) at Week 12 | Baseline | 5.26 units on a scale | Standard Deviation 2.02 |
| MEDI9929 280 mg | Mean Change From Baseline in Average Pruritus Numeric Rating Scale (NRS) at Week 12 | Week 12 | -1.90 units on a scale | Standard Deviation 1.99 |
Secondary
Mean Change From Baseline in EASI Total Score at Week 12
The EASI evaluates 4 natural anatomical regions for severity (0 \[none\] to 3 \[severe\]) and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The total score is the sum of the four body-region scores, maximum=72, minimum=0. The higher values indicating more severe disease.
Time frame: Baseline (Day 1) and Week 12
Population: ITT population included all participants who were randomized and received any study investigational product.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in EASI Total Score at Week 12 | Baseline | 24.48 units on a scale | Standard Deviation 11.21 |
| Placebo | Mean Change From Baseline in EASI Total Score at Week 12 | Week 12 | -11.23 units on a scale | Standard Deviation 8.73 |
| MEDI9929 280 mg | Mean Change From Baseline in EASI Total Score at Week 12 | Baseline | 24.05 units on a scale | Standard Deviation 12.38 |
| MEDI9929 280 mg | Mean Change From Baseline in EASI Total Score at Week 12 | Week 12 | -12.16 units on a scale | Standard Deviation 9.96 |
Secondary
Mean Change From Baseline in the Scoring of Atopic Dermatitis (SCORAD) at Week 12
The scoring of atopic dermatitis (SCORAD) is a clinical tool for assessing the severity (that is, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with participant symptoms. The range of the SCORAD is 0-103, where 0 indicates no eczema. The higher values indicating more severe disease.
Time frame: Baseline (Day 1) and Week 12
Population: ITT population included all participants who were randomized and received any study investigational product.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in the Scoring of Atopic Dermatitis (SCORAD) at Week 12 | Baseline | 58.66 units on a scale | Standard Deviation 13.32 |
| Placebo | Mean Change From Baseline in the Scoring of Atopic Dermatitis (SCORAD) at Week 12 | Week 12 | -19.35 units on a scale | Standard Deviation 17.49 |
| MEDI9929 280 mg | Mean Change From Baseline in the Scoring of Atopic Dermatitis (SCORAD) at Week 12 | Baseline | 57.68 units on a scale | Standard Deviation 14.8 |
| MEDI9929 280 mg | Mean Change From Baseline in the Scoring of Atopic Dermatitis (SCORAD) at Week 12 | Week 12 | -24.24 units on a scale | Standard Deviation 16.94 |
Secondary
Mean Trough Serum Concentration of MEDI9929
The mean serum concentrations of MEDI9929 was observed at specified timepoints.
Time frame: Week 0 (Pre dose), Weeks 4, 8, and 12 (post dose)
Population: PK population included all participants who received MEDI9929 and had a sufficient number of serum concentration measurements for computing PK parameters.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Trough Serum Concentration of MEDI9929 | Week 0 | NA mcg/mL | — |
| Placebo | Mean Trough Serum Concentration of MEDI9929 | Week 4 | 34.7 mcg/mL | Standard Deviation 10.9 |
| Placebo | Mean Trough Serum Concentration of MEDI9929 | Week 8 | 50.5 mcg/mL | Standard Deviation 17.5 |
| Placebo | Mean Trough Serum Concentration of MEDI9929 | Week 12 | 54.9 mcg/mL | Standard Deviation 21.5 |
Secondary
Number of Participants Who Developed Detectable MEDI9929 Anti-drug Antibodies
A participant was considered ADA-positive across the study if they had a positive reading (titer of 50 or higher) at any time point during the study period.
Time frame: Baseline (Day 1) to Week 22
Population: ITT population included all participants who were randomized and received any study investigational product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Who Developed Detectable MEDI9929 Anti-drug Antibodies | Baseline | 2 Participants |
| Placebo | Number of Participants Who Developed Detectable MEDI9929 Anti-drug Antibodies | Week 22 | 2 Participants |
| MEDI9929 280 mg | Number of Participants Who Developed Detectable MEDI9929 Anti-drug Antibodies | Baseline | 1 Participants |
| MEDI9929 280 mg | Number of Participants Who Developed Detectable MEDI9929 Anti-drug Antibodies | Week 22 | 0 Participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An Adverse event is any unfavourable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with use of investigational product, whether or not considered related to investigational product. Serious adverse event is any AE that resulted in:death;inpatient hospitalization or prolongation of existing hospitalization;persistent or significant disability or incapacity;is life-threatening;is a congenital anomaly/birth defect in offspring of a study participant;or was an important medical event that may not have resulted in death, threatened life,or required hospitalization and that, based on appropriate medical judgment, may have jeopardized participant and may have required medical or surgical intervention to prevent one of outcomes above. TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug until Week 22.
Time frame: From treatment administration (Day1) to 22 weeks
Population: As-treated population included all participants who received any study drug. Participants who received at least one dose of MEDI9929 during study, regardless of randomized treatment assignment, were analyzed under MEDI9929. One participant who randomized to placebo but received an incorrect first dose of MEDI9929 was included in MEDI9929 group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 40 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 3 Participants |
| MEDI9929 280 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 38 Participants |
| MEDI9929 280 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 2 Participants |
Secondary
Percentage of Participants Achieving >= 50% Reduction From Baseline in SCORAD 50
The SCORAD is a clinical tool for assessing the severity (that is, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with participant symptoms. The range of the SCORAD is 0-103, where 0 indicates no eczema. The higher values indicating more severe disease. The SCORAD 50 responder defined as a participant who achieves at least a 50% reduction in SCORAD score from baseline.
Time frame: Baseline (Day 1) and Week 12
Population: ITT population included all participants who were randomized and received any study investigational product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving >= 50% Reduction From Baseline in SCORAD 50 | 29.4 Percentage of participants |
| MEDI9929 280 mg | Percentage of Participants Achieving >= 50% Reduction From Baseline in SCORAD 50 | 41.0 Percentage of participants |
Secondary
Percentage of Participants Achieving >= 75 % Reduction From Baseline in EASI75 at Week 12
The EASI evaluates 4 natural anatomical regions for severity (0 \[none\] to 3 \[severe\]) and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The total score is the sum of the four body-region scores, maximum=72, minimum=0. The higher values indicating more severe disease. The EASI75 responder defined as a participant who achieves at least a 75% reduction in EASI score from baseline.
Time frame: Baseline (Day 1) and Week 12
Population: ITT population included all participants who were randomized and received any study investigational product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving >= 75 % Reduction From Baseline in EASI75 at Week 12 | 19.8 Percentage of participants |
| MEDI9929 280 mg | Percentage of Participants Achieving >= 75 % Reduction From Baseline in EASI75 at Week 12 | 24.4 Percentage of participants |
Secondary
Percentage of Participants Achieving >= 75% Reduction From Baseline in SCORAD 75
The SCORAD is a clinical tool for assessing the severity (that is, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with participant symptoms. The range of the SCORAD is 0-103, where 0 indicates no eczema. The higher values indicating more severe disease. The SCORAD 75 responder is defined as a participant who achieves at least a 75% reduction in SCORAD score from baseline.
Time frame: Baseline (Day 1) and Week 12
Population: ITT population included all participants who were randomized and received any study investigational product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving >= 75% Reduction From Baseline in SCORAD 75 | 7.4 Percentage of participants |
| MEDI9929 280 mg | Percentage of Participants Achieving >= 75% Reduction From Baseline in SCORAD 75 | 9.8 Percentage of participants |
Secondary
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline
The investigator's global assessment (IGA) allows investigators to assess overall disease severity at one given time point and consists of a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, and 4 = severe disease). A participant has IGA response if they achieve a score of 0 (clear) or 1 (almost clear) and at least a 2-grade reduction from baseline.
Time frame: Baseline (Day 1) and Week 12
Population: ITT population included all participants who were randomized and received any study investigational product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline | 12.8 Percentage of participants |
| MEDI9929 280 mg | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline | 19.3 Percentage of participants |