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Phase 2a Study to Evaluate the Efficacy and Safety of MEDI9929 in Adults With Atopic Dermatitis (ALLEVIAD)

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ClinicalTrials.gov Identifier: NCT02525094
Recruitment Status : Completed
First Posted : August 17, 2015
Results First Posted : February 15, 2018
Last Update Posted : February 15, 2018
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
MedImmune LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Atopic Dermatitis
Interventions Biological: MEDI9929
Biological: Placebo
Enrollment 113
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.
Arm/Group Title Placebo MEDI9929 280 mg
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 57 56
Treated 56 55
Completed 49 48
Not Completed 8 8
Reason Not Completed
Lost to Follow-up             2             1
Withdrawal by Subject             5             6
Not Treated             1             1
Arm/Group Title Placebo MEDI9929 280 mg Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 56 55 111
Hide Baseline Analysis Population Description
Intent-To-Treat (ITT) population included all participants who were randomized and received any study investigational product.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants 55 participants 111 participants
38.8  (15.3) 38.5  (14.9) 38.7  (15.0)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 55 participants 111 participants
18-35 years
28
  50.0%
27
  49.1%
55
  49.5%
36-75 years
28
  50.0%
28
  50.9%
56
  50.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 55 participants 111 participants
Female
26
  46.4%
23
  41.8%
49
  44.1%
Male
30
  53.6%
32
  58.2%
62
  55.9%
Eczema Area and Severity Index Score   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 55 participants 111 participants
<= 25 points
36
  64.3%
33
  60.0%
69
  62.2%
> 25 points
20
  35.7%
22
  40.0%
42
  37.8%
[1]
Measure Description: 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.
Investigator's Global Assessment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 55 participants 111 participants
Category 2
0
   0.0%
1
   1.8%
1
   0.9%
Category 3
46
  82.1%
44
  80.0%
90
  81.1%
Category 4
10
  17.9%
10
  18.2%
20
  18.0%
[1]
Measure Description: 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).
Atopic Dermatitis Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 55 participants 111 participants
IgE >= 150 kU/L and Positive Serum Specific IgEa
50
  89.3%
47
  85.5%
97
  87.4%
IgE >= 150 kU/L and Negative Serum Specific IgE
2
   3.6%
0
   0.0%
2
   1.8%
IgE < 150 kU/L and Positive Serum Specific IgE
3
   5.4%
3
   5.5%
6
   5.4%
IgE < 150 kU/L and Negative Serum Specific IgEb
1
   1.8%
3
   5.5%
4
   3.6%
Missing
0
   0.0%
2
   3.6%
2
   1.8%
1.Primary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat (ITT) population included all participants who were randomized and received any study investigational product.
Arm/Group Title Placebo MEDI9929 280 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 56 55
Measure Type: Number
Unit of Measure: Percentage of participants
48.2 64.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI9929 280 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.97
Confidence Interval (2-Sided) 95%
0.90 to 4.33
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Achieving >= 75 % Reduction From Baseline in EASI75 at Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized and received any study investigational product.
Arm/Group Title Placebo MEDI9929 280 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 56 55
Measure Type: Number
Unit of Measure: Percentage of participants
19.8 24.4
3.Secondary Outcome
Title Mean Change From Baseline in EASI Total Score at Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized and received any study investigational product.
Arm/Group Title Placebo MEDI9929 280 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 56 55
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 56 participants 55 participants
24.48  (11.21) 24.05  (12.38)
Week 12 Number Analyzed 50 participants 49 participants
-11.23  (8.73) -12.16  (9.96)
4.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized and received any study investigational product.
Arm/Group Title Placebo MEDI9929 280 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 56 55
Measure Type: Number
Unit of Measure: Percentage of participants
12.8 19.3
5.Secondary Outcome
Title Mean Change From Baseline in the Scoring of Atopic Dermatitis (SCORAD) at Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized and received any study investigational product.
Arm/Group Title Placebo MEDI9929 280 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 56 55
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 56 participants 55 participants
58.66  (13.32) 57.68  (14.80)
Week 12 Number Analyzed 50 participants 49 participants
-19.35  (17.49) -24.24  (16.94)
6.Secondary Outcome
Title Percentage of Participants Achieving >= 50% Reduction From Baseline in SCORAD 50
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized and received any study investigational product.
Arm/Group Title Placebo MEDI9929 280 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 56 55
Measure Type: Number
Unit of Measure: Percentage of participants
29.4 41.0
7.Secondary Outcome
Title Percentage of Participants Achieving >= 75% Reduction From Baseline in SCORAD 75
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized and received any study investigational product.
Arm/Group Title Placebo MEDI9929 280 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 56 55
Measure Type: Number
Unit of Measure: Percentage of participants
7.4 9.8
8.Secondary Outcome
Title Mean Change From Baseline in Average Pruritus Numeric Rating Scale (NRS) at Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized and received any study investigational product.
Arm/Group Title Placebo MEDI9929 280 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 56 55
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 55 participants 55 participants
5.15  (2.10) 5.26  (2.02)
Week 12 Number Analyzed 48 participants 47 participants
-1.39  (1.93) -1.90  (1.99)
9.Secondary Outcome
Title Mean Change From Baseline in 5-D Pruritus Score at Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized and received any study investigational product.
Arm/Group Title Placebo MEDI9929 280 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 56 55
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 52 participants 50 participants
16.7  (3.7) 16.0  (3.7)
Week 12 Number Analyzed 47 participants 46 participants
-3.9  (4.5) -3.6  (4.4)
10.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo MEDI9929 280 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 55 56
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
40
  72.7%
38
  67.9%
TESAEs
3
   5.5%
2
   3.6%
11.Secondary Outcome
Title Mean Trough Serum Concentration of MEDI9929
Hide Description The mean serum concentrations of MEDI9929 was observed at specified timepoints.
Time Frame Week 0 (Pre dose), Weeks 4, 8, and 12 (post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included all participants who received MEDI9929 and had a sufficient number of serum concentration measurements for computing PK parameters.
Arm/Group Title MEDI9929 280 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 55
Mean (Standard Deviation)
Unit of Measure: mcg/mL
Week 0 Number Analyzed 50 participants
NA [1]   (NA)
Week 4 Number Analyzed 50 participants
34.7  (10.9)
Week 8 Number Analyzed 48 participants
50.5  (17.5)
Week 12 Number Analyzed 50 participants
54.9  (21.5)
[1]
All pre-first-dose values were below the limit of quantification and not calculated.
12.Secondary Outcome
Title Number of Participants Who Developed Detectable MEDI9929 Anti-drug Antibodies
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized and received any study investigational product.
Arm/Group Title Placebo MEDI9929 280 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 56 55
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 56 participants 55 participants
2
   3.6%
1
   1.8%
Week 22 Number Analyzed 47 participants 48 participants
2
   4.3%
0
   0.0%
Time Frame From treatment administration (Day1) to 22 weeks
Adverse Event Reporting Description AEs were reported for As-treated population, which included all participants who received any study drug. Participants who received at least one dose of MEDI9929, regardless of randomized treatment, were analyzed under MEDI9929. One participant who randomized to placebo but received an incorrect first dose of MEDI9929 was included in MEDI9929 group
 
Arm/Group Title Placebo MEDI9929 280 mg
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Placebo MEDI9929 280 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo MEDI9929 280 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/55 (5.45%)      2/56 (3.57%)    
General disorders     
Chest pain  1  1/55 (1.82%)  1 0/56 (0.00%)  0
Infections and infestations     
Cellulitis  1  1/55 (1.82%)  1 0/56 (0.00%)  0
Infected dermal cyst  1  0/55 (0.00%)  0 1/56 (1.79%)  1
Nervous system disorders     
Syncope  1  1/55 (1.82%)  1 0/56 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermatitis atopic  1  1/55 (1.82%)  1 1/56 (1.79%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Placebo MEDI9929 280 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/55 (60.00%)      29/56 (51.79%)    
Gastrointestinal disorders     
Abdominal pain  1  0/55 (0.00%)  0 2/56 (3.57%)  2
Diarrhoea  1  3/55 (5.45%)  3 5/56 (8.93%)  6
General disorders     
Influenza like illness  1  0/55 (0.00%)  0 2/56 (3.57%)  2
Injection site erythema  1  0/55 (0.00%)  0 3/56 (5.36%)  3
Immune system disorders     
Food allergy  1  0/55 (0.00%)  0 2/56 (3.57%)  2
Infections and infestations     
Cellulitis  1  2/55 (3.64%)  2 0/56 (0.00%)  0
Conjunctivitis  1  1/55 (1.82%)  1 1/56 (1.79%)  1
Folliculitis  1  1/55 (1.82%)  1 1/56 (1.79%)  1
Herpes simplex  1  1/55 (1.82%)  1 1/56 (1.79%)  1
Nasopharyngitis  1  11/55 (20.00%)  14 13/56 (23.21%)  15
Sinusitis  1  2/55 (3.64%)  2 2/56 (3.57%)  2
Upper respiratory tract infection  1  7/55 (12.73%)  8 1/56 (1.79%)  1
Urinary tract infection  1  1/55 (1.82%)  1 1/56 (1.79%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/55 (3.64%)  2 1/56 (1.79%)  1
Muscle spasms  1  1/55 (1.82%)  1 1/56 (1.79%)  1
Musculoskeletal pain  1  0/55 (0.00%)  0 2/56 (3.57%)  2
Myalgia  1  0/55 (0.00%)  0 2/56 (3.57%)  2
Nervous system disorders     
Headache  1  1/55 (1.82%)  1 3/56 (5.36%)  4
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain  1  0/55 (0.00%)  0 2/56 (3.57%)  2
Skin and subcutaneous tissue disorders     
Dermatitis atopic  1  7/55 (12.73%)  9 5/56 (8.93%)  6
Pruritus  1  1/55 (1.82%)  1 1/56 (1.79%)  1
Rash  1  2/55 (3.64%)  4 0/56 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises on-going studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
Name/Title: Rene van der Merwe
Organization: MedImmune, LLC
Phone: 301-398-2532
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02525094     History of Changes
Other Study ID Numbers: D5240C00001
First Submitted: July 29, 2015
First Posted: August 17, 2015
Results First Submitted: October 13, 2017
Results First Posted: February 15, 2018
Last Update Posted: February 15, 2018