Idiopathic Pulmonary Fibrosis
Conditions
Brief summary
To study the safety and effectiveness of multiple-doses of tralokinumab on pulmonary function in adults with mild to moderate idiopathic pulmonary fibrosis (IPF). IPF is a chronic, progressive, irreversible, and usually fatal lung disease of unknown cause.
Detailed description
The primary objective of this study is to determine the effect of multiple doses of tralokinumab on pulmonary function in adults with mild to moderate IPF
Interventions
BIOLOGICALTralokinumab
Participants will receive Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
OTHERPlacebo
Participants will receive placebo IV once every 4 Weeks (Q4W) for 68 Weeks.
Sponsors
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 1\) IPF diagnosis for \<= 5 years prior to Visit 1 (screening). Confirmation of diagnosis of IPF in accordance is required for subject inclusion 2) Confirmed diagnosis of IPF by clinical characteristics, HRCT and surgical lung biopsy (if required) 3)Mild to moderate IPF to include all of the following at screening: 1. FVC \>= 50% predicted normal 2. Partial pressure of oxygen in arterial blood (PaO2) of \>= 55 mmHg on room air or 50 mmHg at high altitude (\> 1500 meters), or oxygen saturation by pulse oximetry (SpO2) of \>= 90%on room air at rest 3. Hemoglobin-corrected diffusion capacity for carbon monoxide (DLCO) \>= 30% predicted normal 4) Be able to walk \>= 100 meters unassisted Key
Exclusion criteria
1. A FEV1/FVC ratio less than 0.70 at the time of screening (postbronchodilator) 2. The extent of emphysema on the HRCT is greater than the extent of fibrosis. 3. Currently listed for lung transplantation 4. Use of the following medications: 1. Immunosuppressive medications (eg, methotrexate, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroid) within 3 months prior to Visit 1 (screening). Oral prednisone \<= 15 mg/day (or equivalent oral corticosteroid) is allowed for chronic use if subject was on a stable dose at least 30 days prior to Visit 1 (screening) 2. Pirfenidone within 4 weeks prior to Visit 1 (screening) 3. N-acetylcysteine within 4 weeks prior to Visit 1 (screening) 4. Live attenuated vaccines within 4 weeks prior to Visit 1 (screening)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 52 | Baseline and Week 52 | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | From the start of study treatment through Week 88 | 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. |
| Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | From the start of study treatment through Week 88 | 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. |
| Number of Participants With Electrocardiogram Abnormalities Reported as Treatment-emergent Adverse Events | From the start of study treatment through Week 88 | 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. |
| Percentage of Participants With Disease Progression | Week 52 and 72 | 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. |
| Change From Baseline in Haemoglobin (Hb) Corrected Percent-predicted Diffusion Capacity for Carbon Monoxide (DLco) Through Week 72 | 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. |
| Change From Baseline in 6 Minute Walk Test (6MWT) Distance Through Week 72 | 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. |
| Change From Baseline in Oxygen Saturation by Pulse Oximetry at Week 68 | Baseline and Week 68 | Participants transcutaneous oxygen saturation were observed by pulse oximetry. |
| Change From Baseline in Lung Volumes Through Week 72 | 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. |
| Percentage of Participants With Idiopathic Pulmonary Fibrosis (IPF) Exacerbations | Week 52 and 72 | 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. |
| Percentage of Participants With Adjudicated Mortality | Week 52 and 72 | 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. |
| Percentage of Participants With Adjudicated Hospitalization | Week 52 and 72 | 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. |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Through Week 72 | 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. |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From the start of study treatment through Week 88 | 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. |
| Change From Baseline in Absolute Forced Vital Capacity (FVC) Through Week 72 | Baseline, Week 52 and 72 | 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. |
| Number of Participants With Clinical Global Impression of Severity Scores | Week 72 | 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). |
| Number of Participants With Clinical Global Impression of Change Scores | Week 72 | 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). |
| Change From Baseline in University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) Total Score at Week 72 | 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. |
| Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 72 | 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. |
| Change From Baseline in Exacerbations of Chronic Pulmonary Disease (EXACT IPF) Total Score Through Week 72 | 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. |
| 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 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. |
| Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF) | Week 72 | 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). |
| Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) | Week 72 | 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). |
| Mean Serum Concentration of Tralokinumab | Predose, 0 hour, and 2 hour postdose on Week 0; predose on Week 4, 48, 72, 82 and 88 | The mean serum concentration of Tralokinumab were observed. |
| Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab | From the start of study treatment through Week 88 | A participant was considered ADA-positive across the study if they had a positive reading at any time point during the study. |
| Change From Baseline in Percent-predicted FEV1 Through Week 72 | 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%. |
Countries
Australia, Canada, Israel, Peru, South Korea, United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks. | 57 |
| Tralokinumab 400 Milligram (mg) Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks. | 57 |
| Tralokinumab 800 mg Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks. | 59 |
| Total | 173 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Code break | 1 | 0 | 0 |
| Overall Study | Death | 1 | 5 | 3 |
| Overall Study | Early tretmt termntd, cmpltd safety f-up | 9 | 11 | 8 |
| Overall Study | Enrolled in another clinical study | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 1 |
| Overall Study | Ongoing AE worsening right heart failure | 0 | 1 | 0 |
| Overall Study | Randomized, not treated | 2 | 1 | 0 |
| Overall Study | Requiring lung transplant | 2 | 1 | 3 |
| Overall Study | Site error in safety follow-up | 0 | 0 | 1 |
| Overall Study | Started other medicine | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 31 | 20 | 28 |
Baseline characteristics
| Characteristic | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 67.5 Years STANDARD_DEVIATION 6.1 | 67.3 Years STANDARD_DEVIATION 7.7 | 67.9 Years STANDARD_DEVIATION 6.7 | 67.6 Years STANDARD_DEVIATION 6.8 |
| Sex: Female, Male Female | 12 Participants | 15 Participants | 13 Participants | 40 Participants |
| Sex: Female, Male Male | 45 Participants | 42 Participants | 46 Participants | 133 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 51 / 57 | 45 / 57 | 50 / 59 |
| serious Total, serious adverse events | 13 / 57 | 16 / 57 | 17 / 59 |
Outcome results
Primary
Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 52
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Tralokinumab 400 Milligram (mg) | Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 52 | Baseline (n=57,57,59) | 68.54 Percentage of predicted FVC | Standard Deviation 14.26 |
| Tralokinumab 400 Milligram (mg) | Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 52 | Change at Week 52 (n=36,32,35) | -6.10 Percentage of predicted FVC | Standard Deviation 6.98 |
| Tralokinumab 800 mg | Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 52 | Baseline (n=57,57,59) | 70.60 Percentage of predicted FVC | Standard Deviation 13.37 |
| Tralokinumab 800 mg | Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 52 | Change at Week 52 (n=36,32,35) | -6.07 Percentage of predicted FVC | Standard Deviation 5.14 |
p-value: 0.1495% CI: [-4.13, 0.59]ANCOVA
p-value: 0.23495% CI: [-3.73, 0.91]ANCOVA
Secondary
Change From Baseline in 6 Minute Walk Test (6MWT) Distance Through Week 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.
Time frame: Baseline, 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. Here, n is number of participants analysed at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Tralokinumab 400 Milligram (mg) | Change From Baseline in 6 Minute Walk Test (6MWT) Distance Through Week 72 | Change at Week 52 (n=31,31,29) | 22.96 Meter | Standard Deviation 52.38 |
| Tralokinumab 400 Milligram (mg) | Change From Baseline in 6 Minute Walk Test (6MWT) Distance Through Week 72 | Baseline (n=55,57,56) | 391.69 Meter | Standard Deviation 102.46 |
| Tralokinumab 400 Milligram (mg) | Change From Baseline in 6 Minute Walk Test (6MWT) Distance Through Week 72 | Change at Week 72 (n=21,24,19) | 7.85 Meter | Standard Deviation 78.12 |
| Tralokinumab 800 mg | Change From Baseline in 6 Minute Walk Test (6MWT) Distance Through Week 72 | Baseline (n=55,57,56) | 383.22 Meter | Standard Deviation 93.99 |
| Tralokinumab 800 mg | Change From Baseline in 6 Minute Walk Test (6MWT) Distance Through Week 72 | Change at Week 72 (n=21,24,19) | -30.25 Meter | Standard Deviation 78.07 |
| Tralokinumab 800 mg | Change From Baseline in 6 Minute Walk Test (6MWT) Distance Through Week 72 | Change at Week 52 (n=31,31,29) | -12.40 Meter | Standard Deviation 55.81 |
Secondary
Change From Baseline in Absolute Forced Vital Capacity (FVC) Through Week 72
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | Change From Baseline in Absolute Forced Vital Capacity (FVC) Through Week 72 | Baseline (n=57,57,59) | 2.662 Liter | Standard Deviation 0.649 |
| Placebo | 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 |
| Tralokinumab 400 Milligram (mg) | Change From Baseline in Absolute Forced Vital Capacity (FVC) Through Week 72 | Change at Week 52 (n=36,32,35) | -0.205 Liter | Standard Deviation 0.224 |
| Tralokinumab 400 Milligram (mg) | Change From Baseline in Absolute Forced Vital Capacity (FVC) Through Week 72 | Baseline (n=57,57,59) | 2.406 Liter | Standard Deviation 0.664 |
| Tralokinumab 400 Milligram (mg) | Change From Baseline in Absolute Forced Vital Capacity (FVC) Through Week 72 | Change at Week 72 (n=26,26,23) | -0.186 Liter | Standard Deviation 0.325 |
| Tralokinumab 800 mg | Change From Baseline in Absolute Forced Vital Capacity (FVC) Through Week 72 | Baseline (n=57,57,59) | 2.593 Liter | Standard Deviation 0.711 |
| Tralokinumab 800 mg | Change From Baseline in Absolute Forced Vital Capacity (FVC) Through Week 72 | Change at Week 72 (n=26,26,23) | -0.282 Liter | Standard Deviation 0.242 |
| Tralokinumab 800 mg | Change From Baseline in Absolute Forced Vital Capacity (FVC) Through Week 72 | Change at Week 52 (n=36,32,35) | -0.209 Liter | Standard Deviation 0.168 |
Secondary
Change From Baseline in European Quality of Life-5-Dimension 3 Level Version (EQ-5D-3L) (Including Visual Analog Scale [VAS]) at 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.
Time frame: Baseline and 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 at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Tralokinumab 400 Milligram (mg) | 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 18.1 |
| Tralokinumab 400 Milligram (mg) | 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) | 2.5 Units on a scale | Standard Deviation 20.9 |
| Tralokinumab 800 mg | 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) | 66.6 Units on a scale | Standard Deviation 14.9 |
| Tralokinumab 800 mg | 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) | 0.6 Units on a scale | Standard Deviation 14.3 |
Secondary
Change From Baseline in Exacerbations of Chronic Pulmonary Disease (EXACT IPF) Total Score Through Week 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.
Time frame: Baseline, 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. Here, n is number of participants analysed at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Tralokinumab 400 Milligram (mg) | Change From Baseline in Exacerbations of Chronic Pulmonary Disease (EXACT IPF) Total Score Through Week 72 | Change at Week 72 (n=23,23,20) | 0.63 Units on a scale | Standard Deviation 7.5 |
| Tralokinumab 400 Milligram (mg) | Change From Baseline in Exacerbations of Chronic Pulmonary Disease (EXACT IPF) Total Score Through Week 72 | Baseline (n=55,51,56) | 15.87 Units on a scale | Standard Deviation 8.38 |
| Tralokinumab 400 Milligram (mg) | Change From Baseline in Exacerbations of Chronic Pulmonary Disease (EXACT IPF) Total Score Through Week 72 | Change at Week 52 (n=31,27,30) | 1.61 Units on a scale | Standard Deviation 7.21 |
| Tralokinumab 800 mg | Change From Baseline in Exacerbations of Chronic Pulmonary Disease (EXACT IPF) Total Score Through Week 72 | Change at Week 52 (n=31,27,30) | 1.40 Units on a scale | Standard Deviation 10.18 |
| Tralokinumab 800 mg | Change From Baseline in Exacerbations of Chronic Pulmonary Disease (EXACT IPF) Total Score Through Week 72 | Baseline (n=55,51,56) | 17.89 Units on a scale | Standard Deviation 9.72 |
| Tralokinumab 800 mg | Change From Baseline in Exacerbations of Chronic Pulmonary Disease (EXACT IPF) Total Score Through Week 72 | Change at Week 72 (n=23,23,20) | 1.81 Units on a scale | Standard Deviation 10 |
Secondary
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Through Week 72
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Through Week 72 | Baseline (n=57,57,59) | 2.199 Liter | Standard Deviation 0.5 |
| Placebo | 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 |
| Tralokinumab 400 Milligram (mg) | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Through Week 72 | Change at Week 52 (n=36,32,35) | -0.148 Liter | Standard Deviation 0.2 |
| Tralokinumab 400 Milligram (mg) | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Through Week 72 | Baseline (n=57,57,59) | 2.025 Liter | Standard Deviation 0.495 |
| Tralokinumab 400 Milligram (mg) | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Through Week 72 | Change at Week 72 (n=26,26,23) | -0.152 Liter | Standard Deviation 0.317 |
| Tralokinumab 800 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Through Week 72 | Baseline (n=57,57,59) | 2.144 Liter | Standard Deviation 0.564 |
| Tralokinumab 800 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Through Week 72 | Change at Week 72 (n=26,26,23) | -0.222 Liter | Standard Deviation 0.166 |
| Tralokinumab 800 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Through Week 72 | Change at Week 52 (n=36,32,35) | -0.179 Liter | Standard Deviation 0.134 |
Secondary
Change From Baseline in Haemoglobin (Hb) Corrected Percent-predicted Diffusion Capacity for Carbon Monoxide (DLco) Through Week 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.
Time frame: Baseline, 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. Here, n is number of participants analysed at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Tralokinumab 400 Milligram (mg) | 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) | -5.233 Percent predicted DLco | Standard Deviation 9.597 |
| Tralokinumab 400 Milligram (mg) | Change From Baseline in Haemoglobin (Hb) Corrected Percent-predicted Diffusion Capacity for Carbon Monoxide (DLco) Through Week 72 | Baseline (n=57,57,59) | 49.389 Percent predicted DLco | Standard Deviation 16.029 |
| Tralokinumab 400 Milligram (mg) | 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) | -9.962 Percent predicted DLco | Standard Deviation 10.362 |
| Tralokinumab 800 mg | Change From Baseline in Haemoglobin (Hb) Corrected Percent-predicted Diffusion Capacity for Carbon Monoxide (DLco) Through Week 72 | Baseline (n=57,57,59) | 47.509 Percent predicted DLco | Standard Deviation 12.524 |
| Tralokinumab 800 mg | 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) | -10.382 Percent predicted DLco | Standard Deviation 12.372 |
| Tralokinumab 800 mg | 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) | -6.356 Percent predicted DLco | Standard Deviation 8.588 |
Secondary
Change From Baseline in Lung Volumes Through Week 72
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Lung Volumes Through Week 72 | Change at Week 52 (n=32,29,28) | 0.891 Liter | Standard Deviation 5.15 |
| Placebo | Change From Baseline in Lung Volumes Through Week 72 | Baseline (n=53,50,53) | 4.105 Liter | Standard Deviation 0.905 |
| Placebo | Change From Baseline in Lung Volumes Through Week 72 | Change at Week 72 (n=24,22,19) | -0.139 Liter | Standard Deviation 0.635 |
| Tralokinumab 400 Milligram (mg) | Change From Baseline in Lung Volumes Through Week 72 | Baseline (n=53,50,53) | 3.870 Liter | Standard Deviation 0.905 |
| Tralokinumab 400 Milligram (mg) | Change From Baseline in Lung Volumes Through Week 72 | Change at Week 52 (n=32,29,28) | -0.212 Liter | Standard Deviation 0.645 |
| Tralokinumab 400 Milligram (mg) | Change From Baseline in Lung Volumes Through Week 72 | Change at Week 72 (n=24,22,19) | -0.274 Liter | Standard Deviation 0.705 |
| Tralokinumab 800 mg | Change From Baseline in Lung Volumes Through Week 72 | Baseline (n=53,50,53) | 4.060 Liter | Standard Deviation 1.192 |
| Tralokinumab 800 mg | Change From Baseline in Lung Volumes Through Week 72 | Change at Week 72 (n=24,22,19) | -0.417 Liter | Standard Deviation 0.468 |
| Tralokinumab 800 mg | Change From Baseline in Lung Volumes Through Week 72 | Change at Week 52 (n=32,29,28) | -0.264 Liter | Standard Deviation 0.442 |
Secondary
Change From Baseline in Oxygen Saturation by Pulse Oximetry at Week 68
Participants transcutaneous oxygen saturation were observed by pulse oximetry.
Time frame: Baseline and Week 68
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Tralokinumab 400 Milligram (mg) | Change From Baseline in Oxygen Saturation by Pulse Oximetry at Week 68 | Change at Week 68 (n=23,25,22) | 0.1 Percent of oxygen saturation | Standard Deviation 2.4 |
| Tralokinumab 400 Milligram (mg) | Change From Baseline in Oxygen Saturation by Pulse Oximetry at Week 68 | Baseline (n=57,57,59) | 95.6 Percent of oxygen saturation | Standard Deviation 2 |
| Tralokinumab 400 Milligram (mg) | Change From Baseline in Oxygen Saturation by Pulse Oximetry at Week 68 | Change at Week 52 (n=30,28,29) | 0.4 Percent of oxygen saturation | Standard Deviation 1.7 |
| Tralokinumab 800 mg | Change From Baseline in Oxygen Saturation by Pulse Oximetry at Week 68 | Change at Week 68 (n=23,25,22) | -1.0 Percent of oxygen saturation | Standard Deviation 2.8 |
| Tralokinumab 800 mg | Change From Baseline in Oxygen Saturation by Pulse Oximetry at Week 68 | Change at Week 52 (n=30,28,29) | -0.7 Percent of oxygen saturation | Standard Deviation 2.7 |
| Tralokinumab 800 mg | Change From Baseline in Oxygen Saturation by Pulse Oximetry at Week 68 | Baseline (n=57,57,59) | 95.4 Percent of oxygen saturation | Standard Deviation 2.9 |
Secondary
Change From Baseline in Percent-predicted FEV1 Through Week 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%.
Time frame: Baseline, 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. Here, n is number of participants analysed at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 8.5 |
| Placebo | 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 |
| Placebo | 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 |
| Tralokinumab 400 Milligram (mg) | Change From Baseline in Percent-predicted FEV1 Through Week 72 | Change at Week 52 (n=36,32,35) | -5.78 Percent of predicted FEV1 | Standard Deviation 8.11 |
| Tralokinumab 400 Milligram (mg) | Change From Baseline in Percent-predicted FEV1 Through Week 72 | Baseline (n=57,57,59) | 77.88 Percent of predicted FEV1 | Standard Deviation 14.88 |
| Tralokinumab 400 Milligram (mg) | Change From Baseline in Percent-predicted FEV1 Through Week 72 | Change at Week 72 (n=26,26,23) | -6.42 Percent of predicted FEV1 | Standard Deviation 11.13 |
| Tralokinumab 800 mg | Change From Baseline in Percent-predicted FEV1 Through Week 72 | Baseline (n=57,57,59) | 78.94 Percent of predicted FEV1 | Standard Deviation 14.58 |
| Tralokinumab 800 mg | Change From Baseline in Percent-predicted FEV1 Through Week 72 | Change at Week 72 (n=26,26,23) | -8.61 Percent of predicted FEV1 | Standard Deviation 6.61 |
| Tralokinumab 800 mg | Change From Baseline in Percent-predicted FEV1 Through Week 72 | Change at Week 52 (n=36,32,35) | -7.01 Percent of predicted FEV1 | Standard Deviation 5.33 |
Secondary
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at 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.
Time frame: Baseline and 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 at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Tralokinumab 400 Milligram (mg) | Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 72 | Baseline (n=57,57,59) | 44.80 Units on a scale | Standard Deviation 18.91 |
| Tralokinumab 400 Milligram (mg) | Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 72 | Change at Week 72 (n=24,24,23) | 3.16 Units on a scale | Standard Deviation 15.11 |
| Tralokinumab 800 mg | Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 72 | Baseline (n=57,57,59) | 51.39 Units on a scale | Standard Deviation 15.64 |
| Tralokinumab 800 mg | Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 72 | Change at Week 72 (n=24,24,23) | 3.38 Units on a scale | Standard Deviation 14.88 |
Secondary
Change From Baseline in University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) Total Score at 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.
Time frame: Baseline and 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 at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Tralokinumab 400 Milligram (mg) | 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) | 36.5 Units on a scale | Standard Deviation 21 |
| Tralokinumab 400 Milligram (mg) | 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) | -0.4 Units on a scale | Standard Deviation 18 |
| Tralokinumab 800 mg | 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) | 45.9 Units on a scale | Standard Deviation 20.4 |
| Tralokinumab 800 mg | 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) | 10.9 Units on a scale | Standard Deviation 23.3 |
Secondary
Mean Serum Concentration of Tralokinumab
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Serum Concentration of Tralokinumab | Week 0: predose (n=50,56) | 3.520 microgram per milliliter (mcg/ml) | Standard Deviation 23.885 |
| Placebo | Mean Serum Concentration of Tralokinumab | Week 0: 0 hour postdose (n=53,57) | 176.047 microgram per milliliter (mcg/ml) | Standard Deviation 125.991 |
| Placebo | Mean Serum Concentration of Tralokinumab | Week 0: 2 hour postdose (n=53,56) | 172.108 microgram per milliliter (mcg/ml) | Standard Deviation 46.423 |
| Placebo | Mean Serum Concentration of Tralokinumab | Week 4 (n=57,57) | 30.155 microgram per milliliter (mcg/ml) | Standard Deviation 20.164 |
| Placebo | Mean Serum Concentration of Tralokinumab | Week 48 (n=33,39) | 44.653 microgram per milliliter (mcg/ml) | Standard Deviation 40.584 |
| Placebo | Mean Serum Concentration of Tralokinumab | Week 72 (n=24,21) | 41.583 microgram per milliliter (mcg/ml) | Standard Deviation 24.723 |
| Placebo | Mean Serum Concentration of Tralokinumab | Week 82 (n=15,12) | 3.651 microgram per milliliter (mcg/ml) | Standard Deviation 3.547 |
| Placebo | Mean Serum Concentration of Tralokinumab | Week 88 (n=12,10) | 0.493 microgram per milliliter (mcg/ml) | Standard Deviation 0.49 |
| Tralokinumab 400 Milligram (mg) | Mean Serum Concentration of Tralokinumab | Week 88 (n=12,10) | 10.585 microgram per milliliter (mcg/ml) | Standard Deviation 19.084 |
| Tralokinumab 400 Milligram (mg) | Mean Serum Concentration of Tralokinumab | Week 0: predose (n=50,56) | 6.151 microgram per milliliter (mcg/ml) | Standard Deviation 45.56 |
| Tralokinumab 400 Milligram (mg) | Mean Serum Concentration of Tralokinumab | Week 48 (n=33,39) | 80.553 microgram per milliliter (mcg/ml) | Standard Deviation 67.187 |
| Tralokinumab 400 Milligram (mg) | Mean Serum Concentration of Tralokinumab | Week 0: 0 hour postdose (n=53,57) | 311.105 microgram per milliliter (mcg/ml) | Standard Deviation 88.229 |
| Tralokinumab 400 Milligram (mg) | Mean Serum Concentration of Tralokinumab | Week 82 (n=15,12) | 11.442 microgram per milliliter (mcg/ml) | Standard Deviation 13.846 |
| Tralokinumab 400 Milligram (mg) | Mean Serum Concentration of Tralokinumab | Week 0: 2 hour postdose (n=53,56) | 301.321 microgram per milliliter (mcg/ml) | Standard Deviation 60.52 |
| Tralokinumab 400 Milligram (mg) | Mean Serum Concentration of Tralokinumab | Week 72 (n=24,21) | 76.224 microgram per milliliter (mcg/ml) | Standard Deviation 54.045 |
| Tralokinumab 400 Milligram (mg) | Mean Serum Concentration of Tralokinumab | Week 4 (n=57,57) | 57.914 microgram per milliliter (mcg/ml) | Standard Deviation 45.326 |
Secondary
Number of Participants With Clinical Global Impression of Change Scores
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Clinical Global Impression of Change Scores | Much improved | 1 Participant |
| Placebo | Number of Participants With Clinical Global Impression of Change Scores | Slightly worse | 8 Participant |
| Placebo | Number of Participants With Clinical Global Impression of Change Scores | No change | 12 Participant |
| Placebo | Number of Participants With Clinical Global Impression of Change Scores | Very much improved | 0 Participant |
| Placebo | Number of Participants With Clinical Global Impression of Change Scores | Very much worse | 1 Participant |
| Placebo | Number of Participants With Clinical Global Impression of Change Scores | Much worse | 1 Participant |
| Placebo | Number of Participants With Clinical Global Impression of Change Scores | Slightly improved | 2 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Global Impression of Change Scores | No change | 13 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Global Impression of Change Scores | Very much improved | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Global Impression of Change Scores | Much improved | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Global Impression of Change Scores | Slightly improved | 1 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Global Impression of Change Scores | Slightly worse | 8 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Global Impression of Change Scores | Much worse | 2 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Global Impression of Change Scores | Very much worse | 0 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Global Impression of Change Scores | Slightly worse | 6 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Global Impression of Change Scores | Much improved | 3 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Global Impression of Change Scores | Very much worse | 1 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Global Impression of Change Scores | Much worse | 4 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Global Impression of Change Scores | No change | 8 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Global Impression of Change Scores | Slightly improved | 1 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Global Impression of Change Scores | Very much improved | 0 Participant |
Secondary
Number of Participants With Clinical Global Impression of Severity Scores
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Clinical Global Impression of Severity Scores | Severe | 0 Participant |
| Placebo | Number of Participants With Clinical Global Impression of Severity Scores | Moderate | 16 Participant |
| Placebo | Number of Participants With Clinical Global Impression of Severity Scores | Very mild | 1 Participant |
| Placebo | Number of Participants With Clinical Global Impression of Severity Scores | Mild | 6 Participant |
| Placebo | Number of Participants With Clinical Global Impression of Severity Scores | Very severe | 2 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Global Impression of Severity Scores | Moderate | 10 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Global Impression of Severity Scores | Very mild | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Global Impression of Severity Scores | Mild | 10 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Global Impression of Severity Scores | Severe | 3 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Global Impression of Severity Scores | Very severe | 1 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Global Impression of Severity Scores | Very severe | 1 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Global Impression of Severity Scores | Severe | 5 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Global Impression of Severity Scores | Very mild | 1 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Global Impression of Severity Scores | Moderate | 11 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Global Impression of Severity Scores | Mild | 6 Participant |
Secondary
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events
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
Population: The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Iron deficiency | 1 Participant |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Hypokalaemia | 1 Participant |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Type 2 diabetes mellitus | 0 Participant |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | ALT increased | 0 Participant |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Hyperglycaemia | 1 Participant |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Gout | 0 Participant |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Vitamin D decreased | 0 Participant |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Hyperlipidaemia | 0 Participant |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Hepatic steatosis | 0 Participant |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Hypophosphataemia | 0 Participant |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | GGT increased | 0 Participant |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Liver function test abnormal | 0 Participant |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | AST increased | 0 Participant |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Vitamin D deficiency | 0 Participant |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Hyponatraemia | 1 Participant |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Blood glucose increased | 0 Participant |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Hypovolaemia | 1 Participant |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Anaemia | 1 Participant |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Diabetes mellitus | 2 Participant |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Haemoglobin decreased | 0 Participant |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Hypertriglyceridaemia | 1 Participant |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Diabetes mellitus inadequate control | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Hypertriglyceridaemia | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Anaemia | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Haemoglobin decreased | 1 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Hypovolaemia | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | ALT increased | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | AST increased | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Blood glucose increased | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Diabetes mellitus | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Diabetes mellitus inadequate control | 1 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Type 2 diabetes mellitus | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Gout | 1 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Hepatic steatosis | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Liver function test abnormal | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | GGT increased | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Hyperlipidaemia | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Hyperglycaemia | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Hypokalaemia | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Hyponatraemia | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Hypophosphataemia | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Iron deficiency | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Vitamin D deficiency | 1 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Vitamin D decreased | 0 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Hyperglycaemia | 0 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Diabetes mellitus inadequate control | 0 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Haemoglobin decreased | 0 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Hypokalaemia | 0 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Diabetes mellitus | 0 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Blood glucose increased | 1 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Hypertriglyceridaemia | 0 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | AST increased | 1 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Vitamin D decreased | 1 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Hyponatraemia | 0 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | ALT increased | 1 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Vitamin D deficiency | 0 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Hypophosphataemia | 1 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Liver function test abnormal | 1 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Hepatic steatosis | 1 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Hypovolaemia | 0 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | GGT increased | 1 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Gout | 1 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Anaemia | 1 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Hyperlipidaemia | 1 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Type 2 diabetes mellitus | 1 Participant |
| Tralokinumab 800 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events | Iron deficiency | 0 Participant |
Secondary
Number of Participants With Electrocardiogram Abnormalities Reported as Treatment-emergent Adverse Events
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
Population: The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Electrocardiogram Abnormalities Reported as Treatment-emergent Adverse Events | 1 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Electrocardiogram Abnormalities Reported as Treatment-emergent Adverse Events | 0 Participant |
| Tralokinumab 800 mg | Number of Participants With Electrocardiogram Abnormalities Reported as Treatment-emergent Adverse Events | 1 Participant |
Secondary
Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF)
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) | Much improved | 1 Participant |
| Placebo | Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) | Slightly worse | 3 Participant |
| Placebo | Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) | No change | 1 Participant |
| Placebo | Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) | Very much improved | 0 Participant |
| Placebo | Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) | Very much worse | 0 Participant |
| Placebo | Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) | Much worse | 1 Participant |
| Placebo | Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) | Slightly improved | 1 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) | No change | 3 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) | Very much improved | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) | Much improved | 1 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) | Slightly improved | 4 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) | Slightly worse | 2 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) | Much worse | 1 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) | Very much worse | 0 Participant |
| Tralokinumab 800 mg | Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) | Slightly worse | 3 Participant |
| Tralokinumab 800 mg | Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) | Much improved | 0 Participant |
| Tralokinumab 800 mg | Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) | Very much worse | 0 Participant |
| Tralokinumab 800 mg | Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) | Much worse | 2 Participant |
| Tralokinumab 800 mg | Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) | No change | 5 Participant |
| Tralokinumab 800 mg | Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) | Slightly improved | 4 Participant |
| Tralokinumab 800 mg | Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF) | Very much improved | 0 Participant |
Secondary
Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF)
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF) | Mild | 8 Participant |
| Placebo | Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF) | Very severe | 1 Participant |
| Placebo | Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF) | Very mild | 2 Participant |
| Placebo | Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF) | Moderate | 11 Participant |
| Placebo | Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF) | Severe | 1 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF) | Moderate | 13 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF) | Very mild | 2 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF) | Very severe | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF) | Mild | 5 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF) | Severe | 1 Participant |
| Tralokinumab 800 mg | Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF) | Very severe | 0 Participant |
| Tralokinumab 800 mg | Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF) | Very mild | 1 Participant |
| Tralokinumab 800 mg | Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF) | Mild | 6 Participant |
| Tralokinumab 800 mg | Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF) | Severe | 0 Participant |
| Tralokinumab 800 mg | Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF) | Moderate | 8 Participant |
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
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
Population: The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TEAE | 53 Participant |
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TESAE | 13 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TEAE | 50 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TESAE | 16 Participant |
| Tralokinumab 800 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TEAE | 57 Participant |
| Tralokinumab 800 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TESAE | 17 Participant |
Secondary
Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events
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
Population: The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Atrial fibrillation | 0 Participant |
| Placebo | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Pyrexia | 1 Participant |
| Placebo | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Palpitations | 0 Participant |
| Placebo | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Atrial flutter | 1 Participant |
| Placebo | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Pulmonary hypertension | 2 Participant |
| Placebo | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Heart rate increased | 0 Participant |
| Placebo | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Arrhythmia | 0 Participant |
| Placebo | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Supraventricular tachycardia | 1 Participant |
| Placebo | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Bradycardia | 1 Participant |
| Placebo | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Hypotension | 1 Participant |
| Placebo | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Weight decreased | 4 Participant |
| Placebo | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Hypertension | 2 Participant |
| Placebo | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Blood pressure increased | 0 Participant |
| Placebo | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Tachyarrhythmia | 0 Participant |
| Placebo | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Sinus tachycardia | 1 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Sinus tachycardia | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Hypertension | 1 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Pulmonary hypertension | 1 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Pyrexia | 1 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Hypotension | 1 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Blood pressure increased | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Atrial fibrillation | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Atrial flutter | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Arrhythmia | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Bradycardia | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Heart rate increased | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Palpitations | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Supraventricular tachycardia | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Tachyarrhythmia | 0 Participant |
| Tralokinumab 400 Milligram (mg) | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Weight decreased | 5 Participant |
| Tralokinumab 800 mg | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Atrial fibrillation | 2 Participant |
| Tralokinumab 800 mg | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Tachyarrhythmia | 1 Participant |
| Tralokinumab 800 mg | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Palpitations | 1 Participant |
| Tralokinumab 800 mg | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Blood pressure increased | 2 Participant |
| Tralokinumab 800 mg | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Hypotension | 1 Participant |
| Tralokinumab 800 mg | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Sinus tachycardia | 0 Participant |
| Tralokinumab 800 mg | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Pyrexia | 2 Participant |
| Tralokinumab 800 mg | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Hypertension | 2 Participant |
| Tralokinumab 800 mg | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Supraventricular tachycardia | 0 Participant |
| Tralokinumab 800 mg | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Arrhythmia | 1 Participant |
| Tralokinumab 800 mg | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Pulmonary hypertension | 2 Participant |
| Tralokinumab 800 mg | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Bradycardia | 0 Participant |
| Tralokinumab 800 mg | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Atrial flutter | 1 Participant |
| Tralokinumab 800 mg | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Weight decreased | 3 Participant |
| Tralokinumab 800 mg | Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events | Heart rate increased | 1 Participant |
Secondary
Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab | Baseline (n=54,54,58) | 1.9 Percentage of participant |
| Placebo | Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab | Week 0, Day 1 (n=1,3,1) | 0 Percentage of participant |
| Placebo | Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab | Week 48 (n=35,32,36) | 2.9 Percentage of participant |
| Placebo | Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab | Week 72 (n=2,1,1) | 0 Percentage of participant |
| Placebo | Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab | Week 82 (n=13,15,12) | 7.7 Percentage of participant |
| Placebo | Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab | Week 88 (n=10,13,11) | 20 Percentage of participant |
| Tralokinumab 400 Milligram (mg) | Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab | Week 88 (n=10,13,11) | 0 Percentage of participant |
| Tralokinumab 400 Milligram (mg) | Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab | Baseline (n=54,54,58) | 1.9 Percentage of participant |
| Tralokinumab 400 Milligram (mg) | Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab | Week 72 (n=2,1,1) | 0 Percentage of participant |
| Tralokinumab 400 Milligram (mg) | Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab | Week 82 (n=13,15,12) | 0 Percentage of participant |
| Tralokinumab 400 Milligram (mg) | Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab | Week 0, Day 1 (n=1,3,1) | 0 Percentage of participant |
| Tralokinumab 400 Milligram (mg) | Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab | Week 48 (n=35,32,36) | 0 Percentage of participant |
| Tralokinumab 800 mg | Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab | Week 0, Day 1 (n=1,3,1) | 0 Percentage of participant |
| Tralokinumab 800 mg | Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab | Week 48 (n=35,32,36) | 0 Percentage of participant |
| Tralokinumab 800 mg | Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab | Week 88 (n=10,13,11) | 0 Percentage of participant |
| Tralokinumab 800 mg | Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab | Week 72 (n=2,1,1) | 0 Percentage of participant |
| Tralokinumab 800 mg | Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab | Baseline (n=54,54,58) | 0 Percentage of participant |
| Tralokinumab 800 mg | Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab | Week 82 (n=13,15,12) | 0 Percentage of participant |
Secondary
Percentage of Participants With Adjudicated Hospitalization
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Adjudicated Hospitalization | At Week 52 | 21.1 Percentage of participant |
| Placebo | Percentage of Participants With Adjudicated Hospitalization | At Week 72 | 21.1 Percentage of participant |
| Tralokinumab 400 Milligram (mg) | Percentage of Participants With Adjudicated Hospitalization | At Week 52 | 24.6 Percentage of participant |
| Tralokinumab 400 Milligram (mg) | Percentage of Participants With Adjudicated Hospitalization | At Week 72 | 24.6 Percentage of participant |
| Tralokinumab 800 mg | Percentage of Participants With Adjudicated Hospitalization | At Week 52 | 16.9 Percentage of participant |
| Tralokinumab 800 mg | Percentage of Participants With Adjudicated Hospitalization | At Week 72 | 23.7 Percentage of participant |
Secondary
Percentage of Participants With Adjudicated Mortality
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Adjudicated Mortality | At Week 52 | 3.5 Percentage of participant |
| Placebo | Percentage of Participants With Adjudicated Mortality | At Week 72 | 3.5 Percentage of participant |
| Tralokinumab 400 Milligram (mg) | Percentage of Participants With Adjudicated Mortality | At Week 52 | 7.0 Percentage of participant |
| Tralokinumab 400 Milligram (mg) | Percentage of Participants With Adjudicated Mortality | At Week 72 | 8.8 Percentage of participant |
| Tralokinumab 800 mg | Percentage of Participants With Adjudicated Mortality | At Week 52 | 5.1 Percentage of participant |
| Tralokinumab 800 mg | Percentage of Participants With Adjudicated Mortality | At Week 72 | 5.1 Percentage of participant |
Secondary
Percentage of Participants With Disease Progression
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Disease Progression | At Week 52 | 35.1 Percentage of Participant |
| Placebo | Percentage of Participants With Disease Progression | At Week 72 | 42.1 Percentage of Participant |
| Tralokinumab 400 Milligram (mg) | Percentage of Participants With Disease Progression | At Week 52 | 35.1 Percentage of Participant |
| Tralokinumab 400 Milligram (mg) | Percentage of Participants With Disease Progression | At Week 72 | 42.1 Percentage of Participant |
| Tralokinumab 800 mg | Percentage of Participants With Disease Progression | At Week 52 | 28.8 Percentage of Participant |
| Tralokinumab 800 mg | Percentage of Participants With Disease Progression | At Week 72 | 44.1 Percentage of Participant |
Secondary
Percentage of Participants With Idiopathic Pulmonary Fibrosis (IPF) Exacerbations
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Idiopathic Pulmonary Fibrosis (IPF) Exacerbations | At Week 52 | 12.3 Percentage of participant |
| Placebo | Percentage of Participants With Idiopathic Pulmonary Fibrosis (IPF) Exacerbations | At Week 72 | 12.3 Percentage of participant |
| Tralokinumab 400 Milligram (mg) | Percentage of Participants With Idiopathic Pulmonary Fibrosis (IPF) Exacerbations | At Week 52 | 12.3 Percentage of participant |
| Tralokinumab 400 Milligram (mg) | Percentage of Participants With Idiopathic Pulmonary Fibrosis (IPF) Exacerbations | At Week 72 | 17.5 Percentage of participant |
| Tralokinumab 800 mg | Percentage of Participants With Idiopathic Pulmonary Fibrosis (IPF) Exacerbations | At Week 52 | 8.5 Percentage of participant |
| Tralokinumab 800 mg | Percentage of Participants With Idiopathic Pulmonary Fibrosis (IPF) Exacerbations | At Week 72 | 11.9 Percentage of participant |