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A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary Fibrosis

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ClinicalTrials.gov Identifier: NCT01629667
Recruitment Status : Terminated (Early termination of the study due to lack of efficacy.)
First Posted : June 27, 2012
Results First Posted : May 15, 2017
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Idiopathic Pulmonary Fibrosis
Interventions Biological: Tralokinumab
Other: Placebo
Enrollment 409
Recruitment Details A total of 409 participants participated in the study. Of which, 176 participants were randomized into the study at 48 sites including 17 sites in the USA, 9 sites in Australia, 7 sites in Peru, 6 sites in Israel, 5 sites in Canada, and 4 sites in South Korea.
Pre-assignment Details A total of 176 participants were randomized into the study. Three participants who were randomized did not receive treatment; therefore, 173 participants were randomized and treated.
Arm/Group Title Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
Hide Arm/Group Description Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks. Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks. Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Period Title: Overall Study
Started 59 58 59
Randomized and Treated 57 57 59
Completed 12 17 14
Not Completed 47 41 45
Reason Not Completed
Lost to Follow-up             0             1             1
Withdrawal by Subject             31             20             28
Death             1             5             3
Randomized, not treated             2             1             0
Ongoing AE worsening right heart failure             0             1             0
Requiring lung transplant             2             1             3
Early tretmt termntd, cmpltd safety f-up             9             11             8
Started other medicine             1             0             1
Site error in safety follow-up             0             0             1
Enrolled in another clinical study             0             1             0
Code break             1             0             0
Arm/Group Title Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg Total
Hide Arm/Group Description Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks. Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks. Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks. Total of all reporting groups
Overall Number of Baseline Participants 57 57 59 173
Hide Baseline Analysis Population Description
The intent-to-treat (ITT) population is all randomized participants who receive any study investigational product and participants were analysed according to the randomization.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 57 participants 57 participants 59 participants 173 participants
67.5  (6.1) 67.3  (7.7) 67.9  (6.7) 67.6  (6.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 57 participants 59 participants 173 participants
Female
12
  21.1%
15
  26.3%
13
  22.0%
40
  23.1%
Male
45
  78.9%
42
  73.7%
46
  78.0%
133
  76.9%
1.Primary Outcome
Title Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 52
Hide Description Forced vital capacity (FVC) is a standard pulmonary function test used to monitor disease progression in IPF. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in litres. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%.
Time Frame Baseline and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.
Arm/Group Title Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
Hide Arm/Group Description:
Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Overall Number of Participants Analyzed 57 57 59
Mean (Standard Deviation)
Unit of Measure: Percentage of predicted FVC
Baseline (n=57,57,59) 70.30  (12.04) 68.54  (14.26) 70.60  (13.37)
Change at Week 52 (n=36,32,35) -4.08  (6.85) -6.10  (6.98) -6.07  (5.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tralokinumab 400 Milligram (mg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.140
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -1.77
Confidence Interval (2-Sided) 95%
-4.13 to 0.59
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tralokinumab 800 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.234
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -1.41
Confidence Interval (2-Sided) 95%
-3.73 to 0.91
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Hide Description Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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 were events between administration of investigational product and Week 88 that were absent before treatment or that worsened relative to pretreatment state.
Time Frame From the start of study treatment through Week 88
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.
Arm/Group Title Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
Hide Arm/Group Description:
Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Overall Number of Participants Analyzed 57 57 59
Measure Type: Number
Unit of Measure: Participant
TEAE 53 50 57
TESAE 13 16 17
3.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 were events between administration of investigational product and Week 88 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 the start of study treatment through Week 88
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.
Arm/Group Title Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
Hide Arm/Group Description:
Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Overall Number of Participants Analyzed 57 57 59
Measure Type: Number
Unit of Measure: Participant
Anaemia 1 0 1
Haemoglobin decreased 0 1 0
Hypovolaemia 1 0 0
ALT increased 0 0 1
AST increased 0 0 1
Blood glucose increased 0 0 1
Diabetes mellitus 2 0 0
Diabetes mellitus inadequate control 0 1 0
Type 2 diabetes mellitus 0 0 1
Gout 0 1 1
Hepatic steatosis 0 0 1
Liver function test abnormal 0 0 1
GGT increased 0 0 1
Hyperlipidaemia 0 0 1
Hyperglycaemia 1 0 0
Hypokalaemia 1 0 0
Hypertriglyceridaemia 1 0 0
Hyponatraemia 1 0 0
Hypophosphataemia 0 0 1
Iron deficiency 1 0 0
Vitamin D deficiency 0 1 0
Vitamin D decreased 0 0 1
4.Secondary Outcome
Title Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events
Hide Description Vital signs parameters included heart rate, blood pressure, temperature, weight, pulse oximetry and respiratory rate. Treatment-emergent were events between administration of investigational product and Week 88 that were absent before treatment or that worsened relative to pre-treatment state.
Time Frame From the start of study treatment through Week 88
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.
Arm/Group Title Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
Hide Arm/Group Description:
Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Overall Number of Participants Analyzed 57 57 59
Measure Type: Number
Unit of Measure: Participant
Hypertension 2 1 2
Pulmonary hypertension 2 1 2
Pyrexia 1 1 2
Hypotension 1 1 1
Blood pressure increased 0 0 2
Atrial fibrillation 0 0 2
Atrial flutter 1 0 1
Arrhythmia 0 0 1
Bradycardia 1 0 0
Heart rate increased 0 0 1
Palpitations 0 0 1
Sinus tachycardia 1 0 0
Supraventricular tachycardia 1 0 0
Tachyarrhythmia 0 0 1
Weight decreased 4 5 3
5.Secondary Outcome
Title Number of Participants With Electrocardiogram Abnormalities Reported as Treatment-emergent Adverse Events
Hide Description AEs observed in participants with clinically significant ECG abnormalities were assessed. Tricuspid valve incompetence was the only abnormality reported as TEAE. ECG parameters included heart rate, PR, QRS, QT, and QTc intervals. Treatment-emergent were events between administration of investigational product and Week 88 that were absent before treatment or that worsened relative to pre-treatment state.
Time Frame From the start of study treatment through Week 88
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.
Arm/Group Title Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
Hide Arm/Group Description:
Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Overall Number of Participants Analyzed 57 57 59
Measure Type: Number
Unit of Measure: Participant
1 0 1
6.Secondary Outcome
Title Percentage of Participants With Disease Progression
Hide Description Progression-free Survival (PFS) was used to evaluate disease progression and the percentage of participants with disease progression. A participant was classified as having disease progression if at least one of the following criteria were met:• Adjudicated respiratory-related mortality. •Adjudicated hospitalization due to IPF exacerbation. •Confirmed decline in percent-predicted FVC of greater than or equal to (>=) 10%. •Confirmed decline in 6 minute walk test (6MWT) >= 50 meters.
Time Frame Week 52 and 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization.
Arm/Group Title Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
Hide Arm/Group Description:
Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Overall Number of Participants Analyzed 57 57 59
Measure Type: Number
Unit of Measure: Percentage of Participant
At Week 52 35.1 35.1 28.8
At Week 72 42.1 42.1 44.1
7.Secondary Outcome
Title Change From Baseline in Haemoglobin (Hb) Corrected Percent-predicted Diffusion Capacity for Carbon Monoxide (DLco) Through Week 72
Hide Description The single breath technique was used to determine the DLco. The test was performed by qualified pulmonary function technicians with experience performing this study. Acceptable test criteria included:• An inspiratory volume of more than 85% of vital capacity. • A stable breath hold of 10 seconds (+/- 2 seconds) with no leaks, Valsalva or Mueller maneuvers. • Expiration in less than 4 seconds with appropriate clearance of dead space. The average of the two best acceptable maneuvers was used. There must be a minimum of 4 minutes between the performances of each test.
Time Frame Baseline, Week 52 and 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.
Arm/Group Title Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
Hide Arm/Group Description:
Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Overall Number of Participants Analyzed 57 57 59
Mean (Standard Deviation)
Unit of Measure: Percent predicted DLco
Baseline (n=57,57,59) 46.962  (13.796) 49.389  (16.029) 47.509  (12.524)
Change at Week 52 (n=34,30,32) -3.963  (8.777) -5.233  (9.597) -6.356  (8.588)
Change at Week 72 (n=23,21,22) -8.322  (9.538) -9.962  (10.362) -10.382  (12.372)
8.Secondary Outcome
Title Change From Baseline in 6 Minute Walk Test (6MWT) Distance Through Week 72
Hide Description The 6MWT measures the distance that a participant can walk on a measured, flat hard surface in a period of 6 minutes. The 6MWT evaluates the global and integrated responses of all body systems involved during walking.
Time Frame Baseline, Week 52 and 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.
Arm/Group Title Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
Hide Arm/Group Description:
Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Overall Number of Participants Analyzed 57 57 59
Mean (Standard Deviation)
Unit of Measure: Meter
Baseline (n=55,57,56) 391.07  (112.06) 391.69  (102.46) 383.22  (93.99)
Change at Week 52 (n=31,31,29) 19.49  (71.36) 22.96  (52.38) -12.40  (55.81)
Change at Week 72 (n=21,24,19) 18.76  (54.83) 7.85  (78.12) -30.25  (78.07)
9.Secondary Outcome
Title Change From Baseline in Oxygen Saturation by Pulse Oximetry at Week 68
Hide Description Participants transcutaneous oxygen saturation were observed by pulse oximetry.
Time Frame Baseline and Week 68
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.
Arm/Group Title Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
Hide Arm/Group Description:
Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Overall Number of Participants Analyzed 57 57 59
Mean (Standard Deviation)
Unit of Measure: Percent of oxygen saturation
Baseline (n=57,57,59) 96.2  (1.9) 95.6  (2.0) 95.4  (2.9)
Change at Week 52 (n=30,28,29) -0.6  (2.3) 0.4  (1.7) -0.7  (2.7)
Change at Week 68 (n=23,25,22) -0.6  (1.8) 0.1  (2.4) -1.0  (2.8)
10.Secondary Outcome
Title Change From Baseline in Lung Volumes Through Week 72
Hide Description Lung volumes were evaluated by total lung capacity (TLC), residual volume (RV), and vital capacity (VC). Lung volumes were determined by body plethysmography.
Time Frame Baseline, Week 52 and 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.
Arm/Group Title Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
Hide Arm/Group Description:
Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Overall Number of Participants Analyzed 57 57 59
Mean (Standard Deviation)
Unit of Measure: Liter
Baseline (n=53,50,53) 4.105  (0.905) 3.870  (0.905) 4.060  (1.192)
Change at Week 52 (n=32,29,28) 0.891  (5.150) -0.212  (0.645) -0.264  (0.442)
Change at Week 72 (n=24,22,19) -0.139  (0.635) -0.274  (0.705) -0.417  (0.468)
11.Secondary Outcome
Title Percentage of Participants With Idiopathic Pulmonary Fibrosis (IPF) Exacerbations
Hide Description

The IPF exacerbations is defined as an acute, clinically significant, deterioration of unidentifiable cause in a participant with underlying IPF. Exacerbations of IPF were adjudicated according to the protocol definition by an independent committee as follows:

1. Confirmed acute IPF exacerbation, 2. Suspected acute IPF exacerbation, 3. Not an IPF exacerbation with an alternative diagnosis provided if possible, and 4. Undetermined due to insufficient information.

Time Frame Week 52 and 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization.
Arm/Group Title Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
Hide Arm/Group Description:
Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Overall Number of Participants Analyzed 57 57 59
Measure Type: Number
Unit of Measure: Percentage of participant
At Week 52 12.3 12.3 8.5
At Week 72 12.3 17.5 11.9
12.Secondary Outcome
Title Percentage of Participants With Adjudicated Mortality
Hide Description Participants all cause mortality were observed. Events that resulted in participant death were adjudicated into respiratory-related mortality or all other cause mortality by an independent committee.
Time Frame Week 52 and 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization.
Arm/Group Title Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
Hide Arm/Group Description:
Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Overall Number of Participants Analyzed 57 57 59
Measure Type: Number
Unit of Measure: Percentage of participant
At Week 52 3.5 7.0 5.1
At Week 72 3.5 8.8 5.1
13.Secondary Outcome
Title Percentage of Participants With Adjudicated Hospitalization
Hide Description Participants who were hospitalized due to IPF exacerbation were observed. All events that resulted in the hospitalization of participants were adjudicated by an independent committee to determine if the event was due to an IPF exacerbation as follows: 1. Exacerbation or progression of IPF, 2. Result of a complication of IPF, 3. Not related to IPF (alternative diagnosis provided), and 4. Undetermined due to insufficient information.
Time Frame Week 52 and 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization.
Arm/Group Title Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
Hide Arm/Group Description:
Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Overall Number of Participants Analyzed 57 57 59
Measure Type: Number
Unit of Measure: Percentage of participant
At Week 52 21.1 24.6 16.9
At Week 72 21.1 24.6 23.7
14.Secondary Outcome
Title Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Through Week 72
Hide Description FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.
Time Frame Baseline, Week 52 and 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.
Arm/Group Title Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
Hide Arm/Group Description:
Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Overall Number of Participants Analyzed 57 57 59
Mean (Standard Deviation)
Unit of Measure: Liter
Baseline (n=57,57,59) 2.199  (0.500) 2.025  (0.495) 2.144  (0.564)
Change at Week 52 (n=36,32,35) -0.120  (0.259) -0.148  (0.200) -0.179  (0.134)
Change at Week 72 (n=26,26,23) -0.260  (0.261) -0.152  (0.317) -0.222  (0.166)
15.Secondary Outcome
Title Change From Baseline in Percent-predicted FEV1 Through Week 72
Hide Description FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FEV1 = (observed value)/(predicted value) * 100%.
Time Frame Baseline, Week 52 and 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.
Arm/Group Title Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
Hide Arm/Group Description:
Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Overall Number of Participants Analyzed 57 57 59
Mean (Standard Deviation)
Unit of Measure: Percent of predicted FEV1
Baseline (n=57,57,59) 78.56  (13.05) 77.88  (14.88) 78.94  (14.58)
Change at Week 52 (n=36,32,35) -4.16  (8.50) -5.78  (8.11) -7.01  (5.33)
Change at Week 72 (n=26,26,23) -8.77  (8.99) -6.42  (11.13) -8.61  (6.61)
16.Secondary Outcome
Title Change From Baseline in Absolute Forced Vital Capacity (FVC) Through Week 72
Hide Description Forced vital capacity (FVC) is a standard pulmonary function test used to monitor disease progression in IPF. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in litres.
Time Frame Baseline, Week 52 and 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.
Arm/Group Title Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
Hide Arm/Group Description:
Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Overall Number of Participants Analyzed 57 57 59
Mean (Standard Deviation)
Unit of Measure: Liter
Baseline (n=57,57,59) 2.662  (0.649) 2.406  (0.664) 2.593  (0.711)
Change at Week 52 (n=36,32,35) -0.162  (0.278) -0.205  (0.224) -0.209  (0.168)
Change at Week 72 (n=26,26,23) -0.322  (0.297) -0.186  (0.325) -0.282  (0.242)
17.Secondary Outcome
Title Number of Participants With Clinical Global Impression of Severity Scores
Hide Description The CGI-S is a single, clinician completed, item designed to capture the clinician’s impression of the participants IPF severity. Clinicians were asked to consider their experience in this participant population and rate the overall IPF severity of the participant using a 5-point scale (1 = very mild, 5 = very severe).
Time Frame Week 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "N" is number of participants analysed for this outcome measure.
Arm/Group Title Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
Hide Arm/Group Description:
Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Overall Number of Participants Analyzed 25 24 24
Measure Type: Number
Unit of Measure: Participant
Very mild 1 0 1
Mild 6 10 6
Moderate 16 10 11
Severe 0 3 5
Very severe 2 1 1
18.Secondary Outcome
Title Number of Participants With Clinical Global Impression of Change Scores
Hide Description The CGI-C is a single, clinician completed, item designed to capture the clinicians overall impression of change in IPF severity from the baseline state at Screening. Clinicians were asked to rate the participants IPF severity relative to their state at baseline using a 7-point scale (-3 = very much worse, 0 = no change, about the same, 3 = very much improved).
Time Frame Week 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "N" is number of participants analysed for this outcome measure.
Arm/Group Title Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
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Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Overall Number of Participants Analyzed 25 24 23
Measure Type: Number
Unit of Measure: Participant
Very much improved 0 0 0
Much improved 1 0 3
Slightly improved 2 1 1
No change 12 13 8
Slightly worse 8 8 6
Much worse 1 2 4
Very much worse 1 0 1
19.Secondary Outcome
Title Change From Baseline in University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) Total Score at Week 72
Hide Description The UCSD SOBQ is a 24-item questionnaire designed to capture patient-reported shortness of breath. Respondents were asked to rate their breathlessness during 21 activities of daily living using a 6-point scale (0 = not at all breathless, 5 = maximally breathless or too breathless to do this activity). In addition to the 21 activity items, the UCSD SOBQ includes 3 additional questions about limitations due to shortness of breath, fear of harm from overexertion, and fear of shortness of breath. The UCSD SOBQ was scored by summing responses across all 24 items to form a total score. Scores range from 0-120 with higher scores indicative of greater shortness of breath.
Time Frame Baseline and Week 72
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Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.
Arm/Group Title Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
Hide Arm/Group Description:
Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Overall Number of Participants Analyzed 57 57 59
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=56,55,58) 40.9  (22.8) 36.5  (21.0) 45.9  (20.4)
Change at Week 72 (n=24,21,21) 12.9  (14.7) -0.4  (18.0) 10.9  (23.3)
20.Secondary Outcome
Title Change From Baseline in St. George’s Respiratory Questionnaire (SGRQ) Total Score at Week 72
Hide Description The SGRQ is a 50-item Patient-reported outcome (PRO) instrument developed to measure respiratory-related health status via 76 weighted responses. The SGRQ is divided into two parts. Part 1 asks respondents to consider the last 3 months and report on their respiratory symptoms using 5-point Likert scales. Part 2 asks respondents to consider their current state and respond to a series of dichotomous yes/no items related to their activities (activities that cause or were limited by breathlessness) and impacts (social functioning, psychological disturbances resulting from airways disease). Total scores and domain scores (symptoms, activities, and impact on daily life) were scored from 0-100, where lower scores indicate better health status.
Time Frame Baseline and Week 72
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Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.
Arm/Group Title Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
Hide Arm/Group Description:
Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Overall Number of Participants Analyzed 57 57 59
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=57,57,59) 47.24  (18.86) 44.80  (18.91) 51.39  (15.64)
Change at Week 72 (n=24,24,23) 2.91  (14.92) 3.16  (15.11) 3.38  (14.88)
21.Secondary Outcome
Title Change From Baseline in Exacerbations of Chronic Pulmonary Disease (EXACT IPF) Total Score Through Week 72
Hide Description The EXACT-IPF is a 14-item daily dairy used to capture the IPF related symptoms completed by the participants using an eDiary. The EXACT-IPF total score is the sum of all items ranged from 1 to 14. EXACT-IPF is an interval-level scale ranging from 0 to 100, where the higher scores indicate more severe condition. The EXACT-IPF used Likert scales (with 3 to 6 response options each) to capture participant reported IPF-related symptoms. The scores are the simple sum of item responses for each domain or single item.
Time Frame Baseline, Week 52 and 72
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Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.
Arm/Group Title Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
Hide Arm/Group Description:
Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Overall Number of Participants Analyzed 57 57 59
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=55,51,56) 16.24  (9.44) 15.87  (8.38) 17.89  (9.72)
Change at Week 52 (n=31,27,30) 1.47  (5.75) 1.61  (7.21) 1.40  (10.18)
Change at Week 72 (n=23,23,20) 1.95  (7.46) 0.63  (7.50) 1.81  (10.00)
22.Secondary Outcome
Title Change From Baseline in European Quality of Life-5-Dimension 3 Level Version (EQ-5D-3L) (Including Visual Analog Scale [VAS]) at Week 72
Hide Description The EQ-5D-3L is a standardized PRO used to capture respondent’s general health status. The questionnaire assesses 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 response options (no problem, some or moderate problems, and unable or extreme problems) that reflect increasing levels of difficulty. The questionnaire also includes a visual analog scale, where the participants were asked to rate their current health on a scale of 0-100, with 0 being the worst imaginable health state.
Time Frame Baseline and Week 72
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Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.
Arm/Group Title Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
Hide Arm/Group Description:
Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Overall Number of Participants Analyzed 57 57 59
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=57,57,59) 70.5  (19.1) 70.5  (18.1) 66.6  (14.9)
Change at Week 72 (n=24,24,23) -3.0  (17.9) 2.5  (20.9) 0.6  (14.3)
23.Secondary Outcome
Title Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF)
Hide Description The PGI-S is a single-item, global assessment of participant-perceived IPF severity. The assessment was designed to capture participant perceived IPF-related health status. Participants rate their IPF severity using a 5-point scale (1 = very mild, 5 = very severe).
Time Frame Week 72
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Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "N" is number of participants analysed for this outcome measure.
Arm/Group Title Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
Hide Arm/Group Description:
Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Overall Number of Participants Analyzed 23 21 15
Measure Type: Number
Unit of Measure: Participant
Very mild 2 2 1
Mild 8 5 6
Moderate 11 13 8
Severe 1 1 0
Very severe 1 0 0
24.Secondary Outcome
Title Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF)
Hide Description The PGI-C is a single-item, global assessment designed to capture participant-perceived change in their IPF health condition using a 7-point scale (-3 = very much improved, 0 = no change, about the same, 3 = very much worse).
Time Frame Week 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "N" is number of participants analysed for this outcome measure.
Arm/Group Title Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
Hide Arm/Group Description:
Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Overall Number of Participants Analyzed 7 11 14
Measure Type: Number
Unit of Measure: Participant
Very much improved 0 0 0
Much improved 1 1 0
Slightly improved 1 4 4
No change 1 3 5
Slightly worse 3 2 3
Much worse 1 1 2
Very much worse 0 0 0
25.Secondary Outcome
Title Mean Serum Concentration of Tralokinumab
Hide Description The mean serum concentration of Tralokinumab were observed.
Time Frame Predose, 0 hour, and 2 hour postdose on Week 0; predose on Week 4, 48, 72, 82 and 88
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Hide Analysis Population Description
The Pharmacokinetic population included all participants who received at least one dose of tralokinumab and had at least one detectable trough (Weeks 4, 48 or 72 only) serum concentration measurement. Here, "n" is number of participants analysed at given time point.
Arm/Group Title Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
Hide Arm/Group Description:
Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Overall Number of Participants Analyzed 57 59
Mean (Standard Deviation)
Unit of Measure: microgram per milliliter (mcg/ml)
Week 0: predose (n=50,56) 3.520  (23.885) 6.151  (45.560)
Week 0: 0 hour postdose (n=53,57) 176.047  (125.991) 311.105  (88.229)
Week 0: 2 hour postdose (n=53,56) 172.108  (46.423) 301.321  (60.520)
Week 4 (n=57,57) 30.155  (20.164) 57.914  (45.326)
Week 48 (n=33,39) 44.653  (40.584) 80.553  (67.187)
Week 72 (n=24,21) 41.583  (24.723) 76.224  (54.045)
Week 82 (n=15,12) 3.651  (3.547) 11.442  (13.846)
Week 88 (n=12,10) 0.493  (0.490) 10.585  (19.084)
26.Secondary Outcome
Title Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab
Hide Description A participant was considered ADA-positive across the study if they had a positive reading at any time point during the study.
Time Frame From the start of study treatment through Week 88
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Hide Analysis Population Description
The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received. Here, "n" is number of participants analysed at given time point.
Arm/Group Title Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
Hide Arm/Group Description:
Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Overall Number of Participants Analyzed 57 57 59
Measure Type: Number
Unit of Measure: Percentage of participant
Baseline (n=54,54,58) 1.9 1.9 0
Week 0, Day 1 (n=1,3,1) 0 0 0
Week 48 (n=35,32,36) 2.9 0 0
Week 72 (n=2,1,1) 0 0 0
Week 82 (n=13,15,12) 7.7 0 0
Week 88 (n=10,13,11) 20 0 0
Time Frame From the start of study treatment through Week 88 or at the time of early termination from the study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
Hide Arm/Group Description Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks. Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks. Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
All-Cause Mortality
Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/57 (22.81%)      16/57 (28.07%)      17/59 (28.81%)    
Cardiac disorders       
Angina pectoris  1  0/57 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  2
Atrial flutter  1  0/57 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  1
Cardiac arrest  1  0/57 (0.00%)  0 1/57 (1.75%)  1 0/59 (0.00%)  0
Cardiac failure congestive  1  1/57 (1.75%)  1 0/57 (0.00%)  0 0/59 (0.00%)  0
Right ventricular failure  1  0/57 (0.00%)  0 1/57 (1.75%)  1 0/59 (0.00%)  0
Supraventricular tachycardia  1  1/57 (1.75%)  1 0/57 (0.00%)  0 0/59 (0.00%)  0
Tachyarrhythmia  1  0/57 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  1
Gastrointestinal disorders       
Diarrhoea  1  0/57 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  1
Inguinal hernia  1  1/57 (1.75%)  1 0/57 (0.00%)  0 0/59 (0.00%)  0
Rectal haemorrhage  1  1/57 (1.75%)  1 0/57 (0.00%)  0 0/59 (0.00%)  0
Vomiting  1  0/57 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  1
General disorders       
Chest pain  1  0/57 (0.00%)  0 1/57 (1.75%)  1 0/59 (0.00%)  0
Multi-organ failure  1  1/57 (1.75%)  1 0/57 (0.00%)  0 0/59 (0.00%)  0
Peripheral swelling  1  1/57 (1.75%)  1 0/57 (0.00%)  0 0/59 (0.00%)  0
Infections and infestations       
Appendiceal abscess  1  0/57 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  1
Appendicitis  1  0/57 (0.00%)  0 1/57 (1.75%)  1 0/59 (0.00%)  0
Atypical pneumonia  1  0/57 (0.00%)  0 1/57 (1.75%)  1 0/59 (0.00%)  0
Bronchitis  1  0/57 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  1
Haemophilus infection  1  1/57 (1.75%)  1 0/57 (0.00%)  0 0/59 (0.00%)  0
Pharyngitis  1  0/57 (0.00%)  0 1/57 (1.75%)  1 0/59 (0.00%)  0
Pneumonia  1  2/57 (3.51%)  2 6/57 (10.53%)  7 2/59 (3.39%)  2
Post procedural sepsis  1  0/57 (0.00%)  0 1/57 (1.75%)  1 0/59 (0.00%)  0
Sepsis  1  0/57 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  1
Upper respiratory tract infection  1  0/57 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  1
Urinary tract infection  1  1/57 (1.75%)  1 0/57 (0.00%)  0 0/59 (0.00%)  0
Injury, poisoning and procedural complications       
Concussion  1  0/57 (0.00%)  0 1/57 (1.75%)  1 0/59 (0.00%)  0
Facial bones fracture  1  0/57 (0.00%)  0 1/57 (1.75%)  1 0/59 (0.00%)  0
Joint dislocation  1  0/57 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  2
Metabolism and nutrition disorders       
Dehydration  1  0/57 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  1
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/57 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  1
Osteoarthritis  1  0/57 (0.00%)  0 1/57 (1.75%)  1 0/59 (0.00%)  0
Spinal osteoarthritis  1  0/57 (0.00%)  0 1/57 (1.75%)  1 0/59 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Adenocarcinoma gastric  1  0/57 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  1
Lung adenocarcinoma  1  0/57 (0.00%)  0 1/57 (1.75%)  1 0/59 (0.00%)  0
Malignant melanoma  1  0/57 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  1
Metastases to adrenals  1  0/57 (0.00%)  0 1/57 (1.75%)  1 0/59 (0.00%)  0
Squamous cell carcinoma of skin  1  1/57 (1.75%)  1 0/57 (0.00%)  0 0/59 (0.00%)  0
Nervous system disorders       
Cerebral infarction  1  0/57 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  1
Cerebrovascular accident  1  1/57 (1.75%)  1 0/57 (0.00%)  0 1/59 (1.69%)  1
Syncope  1  2/57 (3.51%)  4 2/57 (3.51%)  2 0/59 (0.00%)  0
Renal and urinary disorders       
Dysuria  1  1/57 (1.75%)  1 0/57 (0.00%)  0 0/59 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  0/57 (0.00%)  0 1/57 (1.75%)  1 0/59 (0.00%)  0
Cough  1  0/57 (0.00%)  0 0/57 (0.00%)  0 2/59 (3.39%)  2
Idiopathic pulmonary fibrosis  1  4/57 (7.02%)  8 7/57 (12.28%)  7 4/59 (6.78%)  4
Pneumothorax  1  0/57 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  2
Pulmonary embolism  1  1/57 (1.75%)  1 1/57 (1.75%)  1 0/59 (0.00%)  0
Pulmonary hypertension  1  1/57 (1.75%)  1 0/57 (0.00%)  0 0/59 (0.00%)  0
Respiratory distress  1  1/57 (1.75%)  1 0/57 (0.00%)  0 0/59 (0.00%)  0
Respiratory failure  1  1/57 (1.75%)  1 0/57 (0.00%)  0 1/59 (1.69%)  1
Skin and subcutaneous tissue disorders       
Drug eruption  1  0/57 (0.00%)  0 1/57 (1.75%)  1 0/59 (0.00%)  0
Pruritus allergic  1  0/57 (0.00%)  0 1/57 (1.75%)  1 0/59 (0.00%)  0
Psoriasis  1  1/57 (1.75%)  1 0/57 (0.00%)  0 0/59 (0.00%)  0
Rash maculo-papular  1  0/57 (0.00%)  0 1/57 (1.75%)  1 0/59 (0.00%)  0
Vascular disorders       
Deep vein thrombosis  1  1/57 (1.75%)  1 0/57 (0.00%)  0 0/59 (0.00%)  0
Haematoma  1  0/57 (0.00%)  0 1/57 (1.75%)  1 0/59 (0.00%)  0
Thrombophlebitis  1  1/57 (1.75%)  1 0/57 (0.00%)  0 0/59 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo Tralokinumab 400 Milligram (mg) Tralokinumab 800 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   51/57 (89.47%)      45/57 (78.95%)      50/59 (84.75%)    
Gastrointestinal disorders       
Constipation  1  4/57 (7.02%)  6 3/57 (5.26%)  6 3/59 (5.08%)  3
Diarrhoea  1  6/57 (10.53%)  10 4/57 (7.02%)  5 9/59 (15.25%)  20
Dry mouth  1  1/57 (1.75%)  1 2/57 (3.51%)  19 1/59 (1.69%)  1
Gastrooesophageal reflux disease  1  1/57 (1.75%)  1 1/57 (1.75%)  1 2/59 (3.39%)  2
Nausea  1  4/57 (7.02%)  4 3/57 (5.26%)  7 6/59 (10.17%)  9
Vomiting  1  3/57 (5.26%)  4 1/57 (1.75%)  1 3/59 (5.08%)  3
General disorders       
Asthenia  1  0/57 (0.00%)  0 0/57 (0.00%)  0 4/59 (6.78%)  4
Fatigue  1  4/57 (7.02%)  4 5/57 (8.77%)  22 11/59 (18.64%)  11
Oedema peripheral  1  4/57 (7.02%)  5 3/57 (5.26%)  3 3/59 (5.08%)  3
Pyrexia  1  1/57 (1.75%)  2 1/57 (1.75%)  1 2/59 (3.39%)  2
Infections and infestations       
Bronchitis  1  5/57 (8.77%)  7 7/57 (12.28%)  9 5/59 (8.47%)  8
Herpes zoster  1  3/57 (5.26%)  3 1/57 (1.75%)  1 2/59 (3.39%)  2
Influenza  1  3/57 (5.26%)  3 0/57 (0.00%)  0 1/59 (1.69%)  1
Lower respiratory tract infection  1  4/57 (7.02%)  5 3/57 (5.26%)  3 5/59 (8.47%)  8
Nasopharyngitis  1  6/57 (10.53%)  6 6/57 (10.53%)  9 5/59 (8.47%)  8
Pharyngitis  1  2/57 (3.51%)  2 6/57 (10.53%)  7 3/59 (5.08%)  3
Respiratory tract infection  1  4/57 (7.02%)  5 1/57 (1.75%)  1 3/59 (5.08%)  7
Sinusitis  1  6/57 (10.53%)  7 1/57 (1.75%)  6 4/59 (6.78%)  5
Upper respiratory tract infection  1  7/57 (12.28%)  16 10/57 (17.54%)  20 11/59 (18.64%)  14
Urinary tract infection  1  3/57 (5.26%)  5 3/57 (5.26%)  3 4/59 (6.78%)  5
Viral upper respiratory tract infection  1  3/57 (5.26%)  4 1/57 (1.75%)  1 1/59 (1.69%)  1
Injury, poisoning and procedural complications       
Infusion related reaction  1  1/57 (1.75%)  1 2/57 (3.51%)  3 4/59 (6.78%)  7
Laceration  1  4/57 (7.02%)  4 0/57 (0.00%)  0 0/59 (0.00%)  0
Investigations       
Weight decreased  1  4/57 (7.02%)  4 5/57 (8.77%)  6 3/59 (5.08%)  4
Metabolism and nutrition disorders       
Decreased appetite  1  3/57 (5.26%)  3 2/57 (3.51%)  2 6/59 (10.17%)  6
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/57 (1.75%)  1 8/57 (14.04%)  9 2/59 (3.39%)  2
Back pain  1  5/57 (8.77%)  5 0/57 (0.00%)  0 2/59 (3.39%)  2
Flank pain  1  2/57 (3.51%)  2 1/57 (1.75%)  1 1/59 (1.69%)  1
Muscle spasms  1  1/57 (1.75%)  1 1/57 (1.75%)  1 3/59 (5.08%)  4
Musculoskeletal chest pain  1  0/57 (0.00%)  0 4/57 (7.02%)  6 4/59 (6.78%)  4
Musculoskeletal pain  1  4/57 (7.02%)  4 3/57 (5.26%)  3 1/59 (1.69%)  1
Myalgia  1  2/57 (3.51%)  2 5/57 (8.77%)  5 4/59 (6.78%)  4
Neck pain  1  2/57 (3.51%)  2 0/57 (0.00%)  0 2/59 (3.39%)  2
Pain in extremity  1  4/57 (7.02%)  4 4/57 (7.02%)  4 2/59 (3.39%)  2
Nervous system disorders       
Dizziness  1  4/57 (7.02%)  4 3/57 (5.26%)  3 6/59 (10.17%)  6
Headache  1  8/57 (14.04%)  12 6/57 (10.53%)  12 5/59 (8.47%)  9
Lethargy  1  2/57 (3.51%)  2 2/57 (3.51%)  3 1/59 (1.69%)  1
Syncope  1  2/57 (3.51%)  3 0/57 (0.00%)  0 2/59 (3.39%)  2
Psychiatric disorders       
Anxiety  1  3/57 (5.26%)  4 0/57 (0.00%)  0 3/59 (5.08%)  3
Depression  1  3/57 (5.26%)  3 0/57 (0.00%)  0 1/59 (1.69%)  1
Insomnia  1  8/57 (14.04%)  9 2/57 (3.51%)  2 4/59 (6.78%)  4
Respiratory, thoracic and mediastinal disorders       
Cough  1  13/57 (22.81%)  15 10/57 (17.54%)  12 17/59 (28.81%)  28
Dyspnoea  1  2/57 (3.51%)  2 4/57 (7.02%)  12 10/59 (16.95%)  14
Dyspnoea exertional  1  1/57 (1.75%)  1 3/57 (5.26%)  3 4/59 (6.78%)  4
Epistaxis  1  2/57 (3.51%)  4 0/57 (0.00%)  0 4/59 (6.78%)  4
Haemoptysis  1  2/57 (3.51%)  2 1/57 (1.75%)  1 1/59 (1.69%)  2
Idiopathic pulmonary fibrosis  1  9/57 (15.79%)  9 8/57 (14.04%)  8 6/59 (10.17%)  6
Oropharyngeal pain  1  3/57 (5.26%)  4 1/57 (1.75%)  1 3/59 (5.08%)  3
Productive cough  1  1/57 (1.75%)  1 1/57 (1.75%)  1 5/59 (8.47%)  9
Pulmonary hypertension  1  1/57 (1.75%)  1 1/57 (1.75%)  1 2/59 (3.39%)  2
Rhinitis allergic  1  3/57 (5.26%)  3 1/57 (1.75%)  1 2/59 (3.39%)  2
Rhinorrhoea  1  1/57 (1.75%)  1 2/57 (3.51%)  2 3/59 (5.08%)  3
Upper-airway cough syndrome  1  2/57 (3.51%)  2 0/57 (0.00%)  0 2/59 (3.39%)  3
Skin and subcutaneous tissue disorders       
Pruritus  1  0/57 (0.00%)  0 3/57 (5.26%)  4 1/59 (1.69%)  1
Rash  1  7/57 (12.28%)  8 3/57 (5.26%)  3 5/59 (8.47%)  5
Vascular disorders       
Haematoma  1  0/57 (0.00%)  0 4/57 (7.02%)  4 0/59 (0.00%)  0
Hypertension  1  2/57 (3.51%)  2 1/57 (1.75%)  2 2/59 (3.39%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Study was early terminated due to lack of efficacy.
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 ongoing 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: AstraZeneca Clinical Study Information Center
Organization: MedImmune, LLC
Phone: 1-877-240-9479
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01629667     History of Changes
Other Study ID Numbers: CD-RI-CAT-354-1066
First Submitted: June 12, 2012
First Posted: June 27, 2012
Results First Submitted: January 19, 2017
Results First Posted: May 15, 2017
Last Update Posted: May 15, 2017