Trial Outcomes & Findings for A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary Fibrosis (NCT NCT01629667)

Last Updated: 2017-05-15

Results Overview

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%.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

409 participants

Primary outcome timeframe

Baseline and Week 52

Results posted on

2017-05-15

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.	Tralokinumab 400 Milligram (mg) Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.	Tralokinumab 800 mg Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Overall Study STARTED	59	58	59
Overall Study Randomized and Treated	57	57	59
Overall Study COMPLETED	12	17	14
Overall Study NOT COMPLETED	47	41	45

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.	Tralokinumab 400 Milligram (mg) Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.	Tralokinumab 800 mg Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Overall Study Lost to Follow-up	0	1	1
Overall Study Withdrawal by Subject	31	20	28
Overall Study Death	1	5	3
Overall Study Randomized, not treated	2	1	0
Overall Study Ongoing AE worsening right heart failure	0	1	0
Overall Study Requiring lung transplant	2	1	3
Overall Study Early tretmt termntd, cmpltd safety f-up	9	11	8
Overall Study Started other medicine	1	0	1
Overall Study Site error in safety follow-up	0	0	1
Overall Study Enrolled in another clinical study	0	1	0
Overall Study Code break	1	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=57 Participants Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.	Tralokinumab 400 Milligram (mg) n=57 Participants Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.	Tralokinumab 800 mg n=59 Participants Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.	Total n=173 Participants Total of all reporting groups
Age, Continuous	67.5 Years STANDARD_DEVIATION 6.1 • n=93 Participants	67.3 Years STANDARD_DEVIATION 7.7 • n=4 Participants	67.9 Years STANDARD_DEVIATION 6.7 • n=27 Participants	67.6 Years STANDARD_DEVIATION 6.8 • n=483 Participants
Sex: Female, Male Female	12 Participants n=93 Participants	15 Participants n=4 Participants	13 Participants n=27 Participants	40 Participants n=483 Participants
Sex: Female, Male Male	45 Participants n=93 Participants	42 Participants n=4 Participants	46 Participants n=27 Participants	133 Participants n=483 Participants

PRIMARY outcome

Timeframe: Baseline and Week 52

Population: 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.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.	Tralokinumab 400 Milligram (mg) n=57 Participants Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.	Tralokinumab 800 mg n=59 Participants Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 52 Change at Week 52 (n=36,32,35)	-4.08 Percentage of predicted FVC Standard Deviation 6.85	-6.10 Percentage of predicted FVC Standard Deviation 6.98	-6.07 Percentage of predicted FVC Standard Deviation 5.14
Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 52 Baseline (n=57,57,59)	70.30 Percentage of predicted FVC Standard Deviation 12.04	68.54 Percentage of predicted FVC Standard Deviation 14.26	70.60 Percentage of predicted FVC Standard Deviation 13.37

SECONDARY outcome

Timeframe: From the start of study treatment through Week 88

Population: The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.

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.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.	Tralokinumab 400 Milligram (mg) n=57 Participants Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.	Tralokinumab 800 mg n=59 Participants Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) TEAE	53 Participant	50 Participant	57 Participant
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) TESAE	13 Participant	16 Participant	17 Participant

SECONDARY outcome

Timeframe: From the start of study treatment through Week 88

Population: The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.

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.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.	Tralokinumab 400 Milligram (mg) n=57 Participants Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.	Tralokinumab 800 mg n=59 Participants Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events AST increased	0 Participant	0 Participant	1 Participant
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events Blood glucose increased	0 Participant	0 Participant	1 Participant
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events Gout	0 Participant	1 Participant	1 Participant
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events Anaemia	1 Participant	0 Participant	1 Participant
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events Haemoglobin decreased	0 Participant	1 Participant	0 Participant
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events Hypovolaemia	1 Participant	0 Participant	0 Participant
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events ALT increased	0 Participant	0 Participant	1 Participant
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events Diabetes mellitus	2 Participant	0 Participant	0 Participant
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events Diabetes mellitus inadequate control	0 Participant	1 Participant	0 Participant
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events Type 2 diabetes mellitus	0 Participant	0 Participant	1 Participant
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events Hepatic steatosis	0 Participant	0 Participant	1 Participant
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events Liver function test abnormal	0 Participant	0 Participant	1 Participant
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events GGT increased	0 Participant	0 Participant	1 Participant
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events Hyperlipidaemia	0 Participant	0 Participant	1 Participant
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events Hyperglycaemia	1 Participant	0 Participant	0 Participant
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events Hypokalaemia	1 Participant	0 Participant	0 Participant
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events Hypertriglyceridaemia	1 Participant	0 Participant	0 Participant
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events Hyponatraemia	1 Participant	0 Participant	0 Participant
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events Hypophosphataemia	0 Participant	0 Participant	1 Participant
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events Iron deficiency	1 Participant	0 Participant	0 Participant
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events Vitamin D deficiency	0 Participant	1 Participant	0 Participant
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events Vitamin D decreased	0 Participant	0 Participant	1 Participant

SECONDARY outcome

Timeframe: From the start of study treatment through Week 88

Population: The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.

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.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.	Tralokinumab 400 Milligram (mg) n=57 Participants Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.	Tralokinumab 800 mg n=59 Participants Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events Hypertension	2 Participant	1 Participant	2 Participant
Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events Pulmonary hypertension	2 Participant	1 Participant	2 Participant
Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events Pyrexia	1 Participant	1 Participant	2 Participant
Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events Hypotension	1 Participant	1 Participant	1 Participant
Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events Blood pressure increased	0 Participant	0 Participant	2 Participant
Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events Atrial fibrillation	0 Participant	0 Participant	2 Participant
Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events Atrial flutter	1 Participant	0 Participant	1 Participant
Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events Arrhythmia	0 Participant	0 Participant	1 Participant
Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events Bradycardia	1 Participant	0 Participant	0 Participant
Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events Heart rate increased	0 Participant	0 Participant	1 Participant
Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events Palpitations	0 Participant	0 Participant	1 Participant
Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events Sinus tachycardia	1 Participant	0 Participant	0 Participant
Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events Supraventricular tachycardia	1 Participant	0 Participant	0 Participant
Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events Tachyarrhythmia	0 Participant	0 Participant	1 Participant
Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events Weight decreased	4 Participant	5 Participant	3 Participant

SECONDARY outcome

Timeframe: From the start of study treatment through Week 88

Population: The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.

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.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.	Tralokinumab 400 Milligram (mg) n=57 Participants Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.	Tralokinumab 800 mg n=59 Participants Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Number of Participants With Electrocardiogram Abnormalities Reported as Treatment-emergent Adverse Events	1 Participant	0 Participant	1 Participant

SECONDARY outcome

Timeframe: Week 52 and 72

Population: The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization.

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.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.	Tralokinumab 400 Milligram (mg) n=57 Participants Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.	Tralokinumab 800 mg n=59 Participants Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Percentage of Participants With Disease Progression At Week 72	42.1 Percentage of Participant	42.1 Percentage of Participant	44.1 Percentage of Participant
Percentage of Participants With Disease Progression At Week 52	35.1 Percentage of Participant	35.1 Percentage of Participant	28.8 Percentage of Participant

SECONDARY outcome

Timeframe: Baseline, Week 52 and 72

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.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.	Tralokinumab 400 Milligram (mg) n=57 Participants Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.	Tralokinumab 800 mg n=59 Participants Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Change From Baseline in Haemoglobin (Hb) Corrected Percent-predicted Diffusion Capacity for Carbon Monoxide (DLco) Through Week 72 Baseline (n=57,57,59)	46.962 Percent predicted DLco Standard Deviation 13.796	49.389 Percent predicted DLco Standard Deviation 16.029	47.509 Percent predicted DLco Standard Deviation 12.524
Change From Baseline in Haemoglobin (Hb) Corrected Percent-predicted Diffusion Capacity for Carbon Monoxide (DLco) Through Week 72 Change at Week 52 (n=34,30,32)	-3.963 Percent predicted DLco Standard Deviation 8.777	-5.233 Percent predicted DLco Standard Deviation 9.597	-6.356 Percent predicted DLco Standard Deviation 8.588
Change From Baseline in Haemoglobin (Hb) Corrected Percent-predicted Diffusion Capacity for Carbon Monoxide (DLco) Through Week 72 Change at Week 72 (n=23,21,22)	-8.322 Percent predicted DLco Standard Deviation 9.538	-9.962 Percent predicted DLco Standard Deviation 10.362	-10.382 Percent predicted DLco Standard Deviation 12.372

SECONDARY outcome

Timeframe: Baseline, Week 52 and 72

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.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.	Tralokinumab 400 Milligram (mg) n=57 Participants Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.	Tralokinumab 800 mg n=59 Participants Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Change From Baseline in 6 Minute Walk Test (6MWT) Distance Through Week 72 Baseline (n=55,57,56)	391.07 Meter Standard Deviation 112.06	391.69 Meter Standard Deviation 102.46	383.22 Meter Standard Deviation 93.99
Change From Baseline in 6 Minute Walk Test (6MWT) Distance Through Week 72 Change at Week 52 (n=31,31,29)	19.49 Meter Standard Deviation 71.36	22.96 Meter Standard Deviation 52.38	-12.40 Meter Standard Deviation 55.81
Change From Baseline in 6 Minute Walk Test (6MWT) Distance Through Week 72 Change at Week 72 (n=21,24,19)	18.76 Meter Standard Deviation 54.83	7.85 Meter Standard Deviation 78.12	-30.25 Meter Standard Deviation 78.07

SECONDARY outcome

Timeframe: Baseline and Week 68

Participants transcutaneous oxygen saturation were observed by pulse oximetry.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.	Tralokinumab 400 Milligram (mg) n=57 Participants Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.	Tralokinumab 800 mg n=59 Participants Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Change From Baseline in Oxygen Saturation by Pulse Oximetry at Week 68 Baseline (n=57,57,59)	96.2 Percent of oxygen saturation Standard Deviation 1.9	95.6 Percent of oxygen saturation Standard Deviation 2.0	95.4 Percent of oxygen saturation Standard Deviation 2.9
Change From Baseline in Oxygen Saturation by Pulse Oximetry at Week 68 Change at Week 52 (n=30,28,29)	-0.6 Percent of oxygen saturation Standard Deviation 2.3	0.4 Percent of oxygen saturation Standard Deviation 1.7	-0.7 Percent of oxygen saturation Standard Deviation 2.7
Change From Baseline in Oxygen Saturation by Pulse Oximetry at Week 68 Change at Week 68 (n=23,25,22)	-0.6 Percent of oxygen saturation Standard Deviation 1.8	0.1 Percent of oxygen saturation Standard Deviation 2.4	-1.0 Percent of oxygen saturation Standard Deviation 2.8

SECONDARY outcome

Timeframe: Baseline, Week 52 and 72

Lung volumes were evaluated by total lung capacity (TLC), residual volume (RV), and vital capacity (VC). Lung volumes were determined by body plethysmography.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.	Tralokinumab 400 Milligram (mg) n=57 Participants Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.	Tralokinumab 800 mg n=59 Participants Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Change From Baseline in Lung Volumes Through Week 72 Baseline (n=53,50,53)	4.105 Liter Standard Deviation 0.905	3.870 Liter Standard Deviation 0.905	4.060 Liter Standard Deviation 1.192
Change From Baseline in Lung Volumes Through Week 72 Change at Week 52 (n=32,29,28)	0.891 Liter Standard Deviation 5.150	-0.212 Liter Standard Deviation 0.645	-0.264 Liter Standard Deviation 0.442
Change From Baseline in Lung Volumes Through Week 72 Change at Week 72 (n=24,22,19)	-0.139 Liter Standard Deviation 0.635	-0.274 Liter Standard Deviation 0.705	-0.417 Liter Standard Deviation 0.468

SECONDARY outcome

Timeframe: Week 52 and 72

Population: The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization.

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.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.	Tralokinumab 400 Milligram (mg) n=57 Participants Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.	Tralokinumab 800 mg n=59 Participants Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Percentage of Participants With Idiopathic Pulmonary Fibrosis (IPF) Exacerbations At Week 52	12.3 Percentage of participant	12.3 Percentage of participant	8.5 Percentage of participant
Percentage of Participants With Idiopathic Pulmonary Fibrosis (IPF) Exacerbations At Week 72	12.3 Percentage of participant	17.5 Percentage of participant	11.9 Percentage of participant

SECONDARY outcome

Timeframe: Week 52 and 72

Population: The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization.

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.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.	Tralokinumab 400 Milligram (mg) n=57 Participants Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.	Tralokinumab 800 mg n=59 Participants Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Percentage of Participants With Adjudicated Mortality At Week 52	3.5 Percentage of participant	7.0 Percentage of participant	5.1 Percentage of participant
Percentage of Participants With Adjudicated Mortality At Week 72	3.5 Percentage of participant	8.8 Percentage of participant	5.1 Percentage of participant

SECONDARY outcome

Timeframe: Week 52 and 72

Population: The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization.

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.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.	Tralokinumab 400 Milligram (mg) n=57 Participants Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.	Tralokinumab 800 mg n=59 Participants Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Percentage of Participants With Adjudicated Hospitalization At Week 52	21.1 Percentage of participant	24.6 Percentage of participant	16.9 Percentage of participant
Percentage of Participants With Adjudicated Hospitalization At Week 72	21.1 Percentage of participant	24.6 Percentage of participant	23.7 Percentage of participant

SECONDARY outcome

Timeframe: Baseline, Week 52 and 72

FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.	Tralokinumab 400 Milligram (mg) n=57 Participants Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.	Tralokinumab 800 mg n=59 Participants Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Through Week 72 Baseline (n=57,57,59)	2.199 Liter Standard Deviation 0.500	2.025 Liter Standard Deviation 0.495	2.144 Liter Standard Deviation 0.564
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Through Week 72 Change at Week 52 (n=36,32,35)	-0.120 Liter Standard Deviation 0.259	-0.148 Liter Standard Deviation 0.200	-0.179 Liter Standard Deviation 0.134
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Through Week 72 Change at Week 72 (n=26,26,23)	-0.260 Liter Standard Deviation 0.261	-0.152 Liter Standard Deviation 0.317	-0.222 Liter Standard Deviation 0.166

SECONDARY outcome

Timeframe: Baseline, Week 52 and 72

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%.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.	Tralokinumab 400 Milligram (mg) n=57 Participants Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.	Tralokinumab 800 mg n=59 Participants Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Change From Baseline in Percent-predicted FEV1 Through Week 72 Baseline (n=57,57,59)	78.56 Percent of predicted FEV1 Standard Deviation 13.05	77.88 Percent of predicted FEV1 Standard Deviation 14.88	78.94 Percent of predicted FEV1 Standard Deviation 14.58
Change From Baseline in Percent-predicted FEV1 Through Week 72 Change at Week 52 (n=36,32,35)	-4.16 Percent of predicted FEV1 Standard Deviation 8.50	-5.78 Percent of predicted FEV1 Standard Deviation 8.11	-7.01 Percent of predicted FEV1 Standard Deviation 5.33
Change From Baseline in Percent-predicted FEV1 Through Week 72 Change at Week 72 (n=26,26,23)	-8.77 Percent of predicted FEV1 Standard Deviation 8.99	-6.42 Percent of predicted FEV1 Standard Deviation 11.13	-8.61 Percent of predicted FEV1 Standard Deviation 6.61

SECONDARY outcome

Timeframe: Baseline, Week 52 and 72

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.	Tralokinumab 400 Milligram (mg) n=57 Participants Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.	Tralokinumab 800 mg n=59 Participants Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Change From Baseline in Absolute Forced Vital Capacity (FVC) Through Week 72 Baseline (n=57,57,59)	2.662 Liter Standard Deviation 0.649	2.406 Liter Standard Deviation 0.664	2.593 Liter Standard Deviation 0.711
Change From Baseline in Absolute Forced Vital Capacity (FVC) Through Week 72 Change at Week 52 (n=36,32,35)	-0.162 Liter Standard Deviation 0.278	-0.205 Liter Standard Deviation 0.224	-0.209 Liter Standard Deviation 0.168
Change From Baseline in Absolute Forced Vital Capacity (FVC) Through Week 72 Change at Week 72 (n=26,26,23)	-0.322 Liter Standard Deviation 0.297	-0.186 Liter Standard Deviation 0.325	-0.282 Liter Standard Deviation 0.242

SECONDARY outcome

Timeframe: Week 72

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.	Tralokinumab 400 Milligram (mg) n=24 Participants Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.	Tralokinumab 800 mg n=24 Participants Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Number of Participants With Clinical Global Impression of Severity Scores Very mild	1 Participant	0 Participant	1 Participant
Number of Participants With Clinical Global Impression of Severity Scores Mild	6 Participant	10 Participant	6 Participant
Number of Participants With Clinical Global Impression of Severity Scores Moderate	16 Participant	10 Participant	11 Participant
Number of Participants With Clinical Global Impression of Severity Scores Severe	0 Participant	3 Participant	5 Participant
Number of Participants With Clinical Global Impression of Severity Scores Very severe	2 Participant	1 Participant	1 Participant

SECONDARY outcome

Timeframe: Week 72

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.	Tralokinumab 400 Milligram (mg) n=24 Participants Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.	Tralokinumab 800 mg n=23 Participants Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Number of Participants With Clinical Global Impression of Change Scores Very much improved	0 Participant	0 Participant	0 Participant
Number of Participants With Clinical Global Impression of Change Scores Much improved	1 Participant	0 Participant	3 Participant
Number of Participants With Clinical Global Impression of Change Scores Slightly improved	2 Participant	1 Participant	1 Participant
Number of Participants With Clinical Global Impression of Change Scores No change	12 Participant	13 Participant	8 Participant
Number of Participants With Clinical Global Impression of Change Scores Slightly worse	8 Participant	8 Participant	6 Participant
Number of Participants With Clinical Global Impression of Change Scores Much worse	1 Participant	2 Participant	4 Participant
Number of Participants With Clinical Global Impression of Change Scores Very much worse	1 Participant	0 Participant	1 Participant

SECONDARY outcome

Timeframe: Baseline and Week 72

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.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.	Tralokinumab 400 Milligram (mg) n=57 Participants Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.	Tralokinumab 800 mg n=59 Participants Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Change From Baseline in University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) Total Score at Week 72 Baseline (n=56,55,58)	40.9 Units on a scale Standard Deviation 22.8	36.5 Units on a scale Standard Deviation 21.0	45.9 Units on a scale Standard Deviation 20.4
Change From Baseline in University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) Total Score at Week 72 Change at Week 72 (n=24,21,21)	12.9 Units on a scale Standard Deviation 14.7	-0.4 Units on a scale Standard Deviation 18.0	10.9 Units on a scale Standard Deviation 23.3

SECONDARY outcome

Timeframe: Baseline and Week 72

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.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.	Tralokinumab 400 Milligram (mg) n=57 Participants Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.	Tralokinumab 800 mg n=59 Participants Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 72 Baseline (n=57,57,59)	47.24 Units on a scale Standard Deviation 18.86	44.80 Units on a scale Standard Deviation 18.91	51.39 Units on a scale Standard Deviation 15.64
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 72 Change at Week 72 (n=24,24,23)	2.91 Units on a scale Standard Deviation 14.92	3.16 Units on a scale Standard Deviation 15.11	3.38 Units on a scale Standard Deviation 14.88

SECONDARY outcome

Timeframe: Baseline, Week 52 and 72

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.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.	Tralokinumab 400 Milligram (mg) n=57 Participants Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.	Tralokinumab 800 mg n=59 Participants Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Change From Baseline in Exacerbations of Chronic Pulmonary Disease (EXACT IPF) Total Score Through Week 72 Baseline (n=55,51,56)	16.24 Units on a scale Standard Deviation 9.44	15.87 Units on a scale Standard Deviation 8.38	17.89 Units on a scale Standard Deviation 9.72
Change From Baseline in Exacerbations of Chronic Pulmonary Disease (EXACT IPF) Total Score Through Week 72 Change at Week 52 (n=31,27,30)	1.47 Units on a scale Standard Deviation 5.75	1.61 Units on a scale Standard Deviation 7.21	1.40 Units on a scale Standard Deviation 10.18
Change From Baseline in Exacerbations of Chronic Pulmonary Disease (EXACT IPF) Total Score Through Week 72 Change at Week 72 (n=23,23,20)	1.95 Units on a scale Standard Deviation 7.46	0.63 Units on a scale Standard Deviation 7.50	1.81 Units on a scale Standard Deviation 10.00

SECONDARY outcome

Timeframe: Baseline and Week 72

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.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.	Tralokinumab 400 Milligram (mg) n=57 Participants Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.	Tralokinumab 800 mg n=59 Participants Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Change From Baseline in European Quality of Life-5-Dimension 3 Level Version (EQ-5D-3L) (Including Visual Analog Scale [VAS]) at Week 72 Baseline (n=57,57,59)	70.5 Units on a scale Standard Deviation 19.1	70.5 Units on a scale Standard Deviation 18.1	66.6 Units on a scale Standard Deviation 14.9
Change From Baseline in European Quality of Life-5-Dimension 3 Level Version (EQ-5D-3L) (Including Visual Analog Scale [VAS]) at Week 72 Change at Week 72 (n=24,24,23)	-3.0 Units on a scale Standard Deviation 17.9	2.5 Units on a scale Standard Deviation 20.9	0.6 Units on a scale Standard Deviation 14.3

SECONDARY outcome

Timeframe: Week 72

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Placebo n=23 Participants Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.	Tralokinumab 400 Milligram (mg) n=21 Participants Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.	Tralokinumab 800 mg n=15 Participants Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF) Severe	1 Participant	1 Participant	0 Participant
Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF) Very mild	2 Participant	2 Participant	1 Participant
Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF) Mild	8 Participant	5 Participant	6 Participant
Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF) Moderate	11 Participant	13 Participant	8 Participant
Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF) Very severe	1 Participant	0 Participant	0 Participant

SECONDARY outcome

Timeframe: Week 72

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Placebo n=7 Participants Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.	Tralokinumab 400 Milligram (mg) n=11 Participants Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.	Tralokinumab 800 mg n=14 Participants Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) Slightly worse	3 Participant	2 Participant	3 Participant
Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) Very much improved	0 Participant	0 Participant	0 Participant
Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) Much improved	1 Participant	1 Participant	0 Participant
Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) Slightly improved	1 Participant	4 Participant	4 Participant
Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) No change	1 Participant	3 Participant	5 Participant
Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) Much worse	1 Participant	1 Participant	2 Participant
Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) Very much worse	0 Participant	0 Participant	0 Participant

SECONDARY outcome

Timeframe: Predose, 0 hour, and 2 hour postdose on Week 0; predose on Week 4, 48, 72, 82 and 88

Population: 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.

The mean serum concentration of Tralokinumab were observed.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.	Tralokinumab 400 Milligram (mg) n=59 Participants Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.	Tralokinumab 800 mg Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Mean Serum Concentration of Tralokinumab Week 0: predose (n=50,56)	3.520 microgram per milliliter (mcg/ml) Standard Deviation 23.885	6.151 microgram per milliliter (mcg/ml) Standard Deviation 45.560	—
Mean Serum Concentration of Tralokinumab Week 0: 0 hour postdose (n=53,57)	176.047 microgram per milliliter (mcg/ml) Standard Deviation 125.991	311.105 microgram per milliliter (mcg/ml) Standard Deviation 88.229	—
Mean Serum Concentration of Tralokinumab Week 0: 2 hour postdose (n=53,56)	172.108 microgram per milliliter (mcg/ml) Standard Deviation 46.423	301.321 microgram per milliliter (mcg/ml) Standard Deviation 60.520	—
Mean Serum Concentration of Tralokinumab Week 4 (n=57,57)	30.155 microgram per milliliter (mcg/ml) Standard Deviation 20.164	57.914 microgram per milliliter (mcg/ml) Standard Deviation 45.326	—
Mean Serum Concentration of Tralokinumab Week 48 (n=33,39)	44.653 microgram per milliliter (mcg/ml) Standard Deviation 40.584	80.553 microgram per milliliter (mcg/ml) Standard Deviation 67.187	—
Mean Serum Concentration of Tralokinumab Week 72 (n=24,21)	41.583 microgram per milliliter (mcg/ml) Standard Deviation 24.723	76.224 microgram per milliliter (mcg/ml) Standard Deviation 54.045	—
Mean Serum Concentration of Tralokinumab Week 82 (n=15,12)	3.651 microgram per milliliter (mcg/ml) Standard Deviation 3.547	11.442 microgram per milliliter (mcg/ml) Standard Deviation 13.846	—
Mean Serum Concentration of Tralokinumab Week 88 (n=12,10)	0.493 microgram per milliliter (mcg/ml) Standard Deviation 0.490	10.585 microgram per milliliter (mcg/ml) Standard Deviation 19.084	—

SECONDARY outcome

Timeframe: From the start of study treatment through Week 88

Population: 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.

A participant was considered ADA-positive across the study if they had a positive reading at any time point during the study.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.	Tralokinumab 400 Milligram (mg) n=57 Participants Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.	Tralokinumab 800 mg n=59 Participants Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab Week 88 (n=10,13,11)	20 Percentage of participant	0 Percentage of participant	0 Percentage of participant
Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab Baseline (n=54,54,58)	1.9 Percentage of participant	1.9 Percentage of participant	0 Percentage of participant
Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab Week 0, Day 1 (n=1,3,1)	0 Percentage of participant	0 Percentage of participant	0 Percentage of participant
Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab Week 48 (n=35,32,36)	2.9 Percentage of participant	0 Percentage of participant	0 Percentage of participant
Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab Week 72 (n=2,1,1)	0 Percentage of participant	0 Percentage of participant	0 Percentage of participant
Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab Week 82 (n=13,15,12)	7.7 Percentage of participant	0 Percentage of participant	0 Percentage of participant

Adverse Events

Placebo

Serious events: 13 serious events

Other events: 51 other events

Deaths: 0 deaths

Tralokinumab 400 Milligram (mg)

Serious events: 16 serious events

Other events: 45 other events

Deaths: 0 deaths

Tralokinumab 800 mg

Serious events: 17 serious events

Other events: 50 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

AstraZeneca Clinical Study Information Center

MedImmune, LLC

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

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