Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase 2 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults With Atopic Dermatitis (D2213C00001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02347176
Recruitment Status : Completed
First Posted : January 27, 2015
Results First Posted : June 7, 2017
Last Update Posted : May 23, 2018
Sponsor:
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 Other: Placebo
Biological: Tralokinumab Dose 1
Biological: Tralokinumab Dose 2
Biological: Tralokinumab Dose 3
Enrollment 204
Recruitment Details A total of 299 participants participated in the study at 55 sites worldwide, including 24 sites in the United States of America, 8 sites in Germany, 6 sites each in Japan, Poland, and Canada, and 5 sites in Australia.
Pre-assignment Details 95 participants were considered screen failures and 204 participants were randomized and treated in the study.
Arm/Group Title Placebo Tralokinumab Dose 1 Tralokinumab Dose 2 Tralokinumab Dose 3
Hide Arm/Group Description Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks. Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks. Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks. Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Period Title: Overall Study
Started 51 50 51 52
Completed 39 40 43 48
Not Completed 12 10 8 4
Reason Not Completed
Lost to Follow-up             2             3             1             1
Withdrawal by Subject             9             5             5             3
Other             1             2             2             0
Arm/Group Title Placebo Tralokinumab Dose 1 Tralokinumab Dose 2 Tralokinumab Dose 3 Total
Hide Arm/Group Description Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks. Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks. Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks. Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 51 50 51 52 204
Hide Baseline Analysis Population Description
The intent-to-treat (ITT) population included all randomized and treated participants, grouped according to assigned treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 50 participants 51 participants 52 participants 204 participants
39.4  (14.5) 39.1  (15.1) 37.1  (14.0) 35.7  (14.6) 37.8  (14.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 50 participants 51 participants 52 participants 204 participants
Female
29
  56.9%
21
  42.0%
25
  49.0%
19
  36.5%
94
  46.1%
Male
22
  43.1%
29
  58.0%
26
  51.0%
33
  63.5%
110
  53.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 50 participants 51 participants 52 participants 204 participants
Hispanic or Latino
2
   3.9%
2
   4.0%
3
   5.9%
4
   7.7%
11
   5.4%
Not Hispanic or Latino
49
  96.1%
48
  96.0%
48
  94.1%
48
  92.3%
193
  94.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 50 participants 51 participants 52 participants 204 participants
American Indian or Alaska Native
0
   0.0%
1
   2.0%
0
   0.0%
0
   0.0%
1
   0.5%
Asian
10
  19.6%
11
  22.0%
8
  15.7%
16
  30.8%
45
  22.1%
Native Hawaiian or Other Pacific Islander
1
   2.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.5%
Black or African American
8
  15.7%
4
   8.0%
10
  19.6%
7
  13.5%
29
  14.2%
White
31
  60.8%
33
  66.0%
33
  64.7%
28
  53.8%
125
  61.3%
More than one race
1
   2.0%
1
   2.0%
0
   0.0%
1
   1.9%
3
   1.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12
Hide Description EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The maximum total score is 72, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.
Time Frame Baseline (Day 1) and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized and treated participants, grouped according to assigned treatment. Here, the category "Number Analyzed" is number of participants analyzed for this outcome measure.
Arm/Group Title Placebo Tralokinumab Dose 1 Tralokinumab Dose 2 Tralokinumab Dose 3
Hide Arm/Group Description:
Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Overall Number of Participants Analyzed 51 50 51 52
Mean (Standard Error)
Unit of Measure: units on a scale
-10.78  (1.398) -13.67  (1.386) -15.14  (1.361) -15.72  (1.334)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tralokinumab Dose 1
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.143
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -2.89
Confidence Interval (2-Sided) 95%
-6.78 to 0.99
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.968
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tralokinumab Dose 2
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -4.36
Confidence Interval (2-Sided) 95%
-8.22 to -0.51
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.951
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Tralokinumab Dose 3
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -4.94
Confidence Interval (2-Sided) 95%
-8.76 to -1.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.932
Estimation Comments [Not Specified]
2.Primary 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 at Week 12
Hide Description The IGA allows investigators to assess overall disease severity at one given time point and consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). A participant has IGA response if they achieve a score of 0 (clear) or 1 (almost clear) and at least a 2-grade reduction from baseline.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomized and treated participants, grouped according to assigned treatment. Here, the category "Number Analyzed" is number of participants analyzed for this outcome measure.
Arm/Group Title Placebo Tralokinumab Dose 1 Tralokinumab Dose 2 Tralokinumab Dose 3
Hide Arm/Group Description:
Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Overall Number of Participants Analyzed 51 50 51 52
Measure Type: Number
Unit of Measure: Percentage of participants
11.8 11.6 19.5 26.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tralokinumab Dose 1
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.974
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.29 to 3.32
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tralokinumab Dose 2
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.281
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.85
Confidence Interval (2-Sided) 95%
0.61 to 5.65
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Tralokinumab Dose 3
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.061
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.83
Confidence Interval (2-Sided) 95%
0.95 to 8.37
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Hide Description An adverse event (AE) present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of study drug until Week 22. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received Tralokinumab. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state.
Time Frame From Study Drug Administration (Day 1) to Week 22
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population included all treated participants, grouped according to actual treatment received.
Arm/Group Title Placebo Tralokinumab Dose 1 Tralokinumab Dose 2 Tralokinumab Dose 3
Hide Arm/Group Description:
Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Overall Number of Participants Analyzed 51 50 51 52
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
31
  60.8%
36
  72.0%
35
  68.6%
30
  57.7%
TESAEs
1
   2.0%
3
   6.0%
2
   3.9%
0
   0.0%
4.Secondary Outcome
Title Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events
Hide Description Vital sign parameters included blood pressure, temperature, pulse rate, and respiratory rate. TEAEs were present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug until Week 22.
Time Frame From Study Drug Administration (Day 1) to Week 22
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population included all treated participants, grouped according to actual treatment received.
Arm/Group Title Placebo Tralokinumab Dose 1 Tralokinumab Dose 2 Tralokinumab Dose 3
Hide Arm/Group Description:
Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Overall Number of Participants Analyzed 51 50 51 52
Measure Type: Count of Participants
Unit of Measure: Participants
Blood pressure increased
0
   0.0%
1
   2.0%
1
   2.0%
0
   0.0%
Pyrexia
1
   2.0%
0
   0.0%
1
   2.0%
0
   0.0%
Acute coronary syndrome
0
   0.0%
1
   2.0%
0
   0.0%
0
   0.0%
Angina pectoris
1
   2.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hypertension
0
   0.0%
0
   0.0%
1
   2.0%
0
   0.0%
Pallor
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.9%
5.Secondary Outcome
Title Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events
Hide Description An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.
Time Frame From Study Drug Administration (Day 1) to Week 22
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population included all treated participants, grouped according to actual treatment received.
Arm/Group Title Placebo Tralokinumab Dose 1 Tralokinumab Dose 2 Tralokinumab Dose 3
Hide Arm/Group Description:
Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Overall Number of Participants Analyzed 51 50 51 52
Measure Type: Count of Participants
Unit of Measure: Participants
Anaemia
0
   0.0%
1
   2.0%
0
   0.0%
0
   0.0%
Lymphopenia
1
   2.0%
0
   0.0%
0
   0.0%
0
   0.0%
Alanine aminotransferase increased
0
   0.0%
1
   2.0%
0
   0.0%
0
   0.0%
Aspartate aminotransferase increased
0
   0.0%
1
   2.0%
0
   0.0%
0
   0.0%
Blood alkaline phosphatase increased
0
   0.0%
0
   0.0%
1
   2.0%
0
   0.0%
Blood creatinine increased
0
   0.0%
1
   2.0%
0
   0.0%
0
   0.0%
Blood immunoglobulin E increased
0
   0.0%
0
   0.0%
1
   2.0%
0
   0.0%
Gamma-glutamyltransferase increased
0
   0.0%
1
   2.0%
0
   0.0%
0
   0.0%
Hepatic function abnormal
0
   0.0%
1
   2.0%
0
   0.0%
0
   0.0%
Hyperbilirubinaemia
1
   2.0%
0
   0.0%
0
   0.0%
0
   0.0%
Liver function test abnormal
0
   0.0%
0
   0.0%
1
   2.0%
0
   0.0%
Glycosuria
0
   0.0%
1
   2.0%
0
   0.0%
0
   0.0%
Leukocyturia
1
   2.0%
0
   0.0%
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment Emergent Adverse Events
Hide Description AEs observed in participants with clinically significant ECG abnormalities were assessed. ECG parameters included heart rate, RR, PR, QRS and QT intervals. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state.
Time Frame From Study Drug Administration (Day 1) to Week 22
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population included all treated participants, grouped according to actual treatment received.
Arm/Group Title Placebo Tralokinumab Dose 1 Tralokinumab Dose 2 Tralokinumab Dose 3
Hide Arm/Group Description:
Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Overall Number of Participants Analyzed 51 50 51 52
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12
Hide Description EASI50 responder is defined as a participant who achieves at least a 50% reduction in EASI score from baseline. Data from participants who took prohibited medications were excluded from this analysis and a last observation carried forward (LOCF) analysis was used.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomized and treated participants, grouped according to assigned treatment. Here, the category "Number Analyzed" is number of participants analyzed for this outcome measure.
Arm/Group Title Placebo Tralokinumab Dose 1 Tralokinumab Dose 2 Tralokinumab Dose 3
Hide Arm/Group Description:
Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Overall Number of Participants Analyzed 51 50 51 52
Measure Type: Number
Unit of Measure: Percentage of participants
51.9 54.3 67.3 73.4
8.Secondary Outcome
Title Absolute Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 12
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 maximum total score is 103, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.
Time Frame Baseline (Day 1) and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomized and treated participants, grouped according to assigned treatment. Here, the category "Number Analyzed" is number of participants analyzed for this outcome measure.
Arm/Group Title Placebo Tralokinumab Dose 1 Tralokinumab Dose 2 Tralokinumab Dose 3
Hide Arm/Group Description:
Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Overall Number of Participants Analyzed 51 50 51 52
Mean (Standard Error)
Unit of Measure: units on a scale
-16.67  (2.224) -21.97  (2.204) -26.09  (2.168) -26.50  (2.123)
9.Secondary Outcome
Title Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in SCORAD at Week 12
Hide Description SCORAD 50 responder is defined as a participant who achieves at least a 50% reduction in SCORAD score from baseline. Data from participants who took prohibited medications were excluded from this analysis and a LOCF analysis was used.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomized and treated participants, grouped according to assigned treatment. Here, the category "Number Analyzed" is number of participants analyzed for this outcome measure.
Arm/Group Title Placebo Tralokinumab Dose 1 Tralokinumab Dose 2 Tralokinumab Dose 3
Hide Arm/Group Description:
Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Overall Number of Participants Analyzed 51 50 51 52
Measure Type: Number
Unit of Measure: Percentage of participants
19.5 26.9 44.2 44.1
10.Secondary Outcome
Title Change From Baseline in Pruritus Numeric Rating Scale (NRS) (7-day Mean Score) at Week 12
Hide Description Pruritus assessed using an NRS (0 - 10) with 0= no itch and 10= worst imaginable itch. Daily pruritus assessments were summarized as weekly peak score and a change from baseline in weekly peak score was calculated. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.
Time Frame Baseline (Day 1) and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomized and treated participants, grouped according to assigned treatment. Here, the category "Number Analyzed" is number of participants analyzed for this outcome measure.
Arm/Group Title Placebo Tralokinumab Dose 1 Tralokinumab Dose 2 Tralokinumab Dose 3
Hide Arm/Group Description:
Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Overall Number of Participants Analyzed 51 50 51 52
Mean (Standard Error)
Unit of Measure: units on a scale
-1.03  (0.270) -1.80  (0.266) -1.59  (0.260) -2.17  (0.256)
Time Frame From Study Drug Administration (Day 1) to Week 22
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Tralokinumab Dose 1 Tralokinumab Dose 2 Tralokinumab Dose 3
Hide Arm/Group Description Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks. Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks. Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks. Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
All-Cause Mortality
Placebo Tralokinumab Dose 1 Tralokinumab Dose 2 Tralokinumab Dose 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)      1/50 (2.00%)      0/51 (0.00%)      0/52 (0.00%)    
Hide Serious Adverse Events
Placebo Tralokinumab Dose 1 Tralokinumab Dose 2 Tralokinumab Dose 3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/51 (1.96%)      3/50 (6.00%)      2/51 (3.92%)      0/52 (0.00%)    
Cardiac disorders         
Angina pectoris  1  1/51 (1.96%)  1 0/50 (0.00%)  0 0/51 (0.00%)  0 0/52 (0.00%)  0
Gastrointestinal disorders         
Upper gastrointestinal haemorrhage  1  0/51 (0.00%)  0 1/50 (2.00%)  1 0/51 (0.00%)  0 0/52 (0.00%)  0
General disorders         
Death  1  0/51 (0.00%)  0 1/50 (2.00%)  1 0/51 (0.00%)  0 0/52 (0.00%)  0
Hepatobiliary disorders         
Cholelithiasis  1  0/51 (0.00%)  0 1/50 (2.00%)  1 0/51 (0.00%)  0 0/52 (0.00%)  0
Hepatic function abnormal  1  0/51 (0.00%)  0 1/50 (2.00%)  1 0/51 (0.00%)  0 0/52 (0.00%)  0
Reproductive system and breast disorders         
Ovarian cyst  1  0/51 (0.00%)  0 0/50 (0.00%)  0 1/51 (1.96%)  1 0/52 (0.00%)  0
Uterine polyp  1  0/51 (0.00%)  0 0/50 (0.00%)  0 1/51 (1.96%)  1 0/52 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Asthma  1  0/51 (0.00%)  0 0/50 (0.00%)  0 1/51 (1.96%)  1 0/52 (0.00%)  0
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Placebo Tralokinumab Dose 1 Tralokinumab Dose 2 Tralokinumab Dose 3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/51 (29.41%)      20/50 (40.00%)      21/51 (41.18%)      22/52 (42.31%)    
Infections and infestations         
Nasopharyngitis  1  6/51 (11.76%)  9 11/50 (22.00%)  12 8/51 (15.69%)  9 13/52 (25.00%)  20
Sinusitis  1  1/51 (1.96%)  1 1/50 (2.00%)  1 2/51 (3.92%)  2 3/52 (5.77%)  3
Upper respiratory tract infection  1  5/51 (9.80%)  6 5/50 (10.00%)  7 6/51 (11.76%)  9 4/52 (7.69%)  6
Nervous system disorders         
Headache  1  2/51 (3.92%)  3 3/50 (6.00%)  6 4/51 (7.84%)  4 4/52 (7.69%)  4
Skin and subcutaneous tissue disorders         
Dermatitis atopic  1  4/51 (7.84%)  5 3/50 (6.00%)  3 3/51 (5.88%)  4 3/52 (5.77%)  4
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Rene van der Merwe
Organization: MedImmune, LLC
Phone: 301-398-4095
EMail: information.center@astrazeneca.com
Layout table for additonal information
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02347176    
Other Study ID Numbers: D2213C00001
First Submitted: January 5, 2015
First Posted: January 27, 2015
Results First Submitted: May 11, 2017
Results First Posted: June 7, 2017
Last Update Posted: May 23, 2018