A Phase 2 interventional study of Tralokinumab and Tralokinumab in Idiopathic Pulmonary Fibrosis, sponsored by MedImmune LLC. Terminated at 45 sites in 6 countries. Open to participants aged 50 Years to 79 Years. Per ClinicalTrials.gov, last updated 2017-05-15.
Sponsored by MedImmune LLC · Phase 2, Interventional, and Treatment
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.
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
680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.
This study's enrollment of 409 is above the median of 50 across 419 interventional studies indexed under Pulmonary Fibrosis.
Browse Pulmonary Fibrosis studies →MedImmune LLC is the lead sponsor of 265 studies on the registry; none are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 28 (56%) have results posted.
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Key Inclusion Criteria:
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:
Key Exclusion Criteria:
Use of the following medications:
Participants will receive Tralokinumab 400 mg intravenous (IV) infusion Q4W for 68 Weeks.
Biological: Tralokinumab
Participants will receive Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Biological: Tralokinumab
Participants will receive placebo IV once every 4 Weeks (Q4W) for 68 Weeks.
Other: Placebo
Participants will receive Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Participants will receive Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Participants will receive placebo IV once every 4 Weeks (Q4W) for 68 Weeks.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
| Milestone | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg |
|---|---|---|---|
| Started | 59 | 58 | 59 |
| Randomized and treated | 57 | 57 | 59 |
| Completed | 12 | 17 | 14 |
| Not completed | 47 | 41 | 45 |
| Withdrew: Lost to follow-up | 0 | 1 | 1 |
| Withdrew: Withdrawal by subject | 31 | 20 | 28 |
| Withdrew: Death | 1 | 5 | 3 |
| Withdrew: Randomized, not treated | 2 | 1 | 0 |
| Withdrew: Ongoing ae worsening right heart failure | 0 | 1 | 0 |
| Withdrew: Requiring lung transplant | 2 | 1 | 3 |
| Withdrew: Early tretmt termntd, cmpltd safety f-up | 9 | 11 | 8 |
| Withdrew: Started other medicine | 1 | 0 | 1 |
| Withdrew: Site error in safety follow-up | 0 | 0 | 1 |
| Withdrew: Enrolled in another clinical study | 0 | 1 | 0 |
| Withdrew: Code break | 1 | 0 | 0 |
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%.
| Percentage of predicted FVC | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg |
|---|---|---|---|
| Baseline (n=57,57,59) | 70.30 ± 12.04 | 68.54 ± 14.26 | 70.60 ± 13.37 |
| Change at Week 52 (n=36,32,35) | -4.08 ± 6.85 | -6.10 ± 6.98 | -6.07 ± 5.14 |
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.
| Participant | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg |
|---|---|---|---|
| TEAE | 53 | 50 | 57 |
| TESAE | 13 | 16 | 17 |
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.
| Participant | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg |
|---|---|---|---|
| Anaemia | 1 | 0 | 1 |
| Haemoglobin decreased | 0 | 1 | 0 |
| Hypovolaemia | 1 | 0 | 0 |
| ALT increased | 0 | 0 | 1 |
| AST increased | 0 | 0 | 1 |
| Blood glucose increased | 0 | 0 | 1 |
| Diabetes mellitus | 2 | 0 | 0 |
| Diabetes mellitus inadequate control | 0 | 1 | 0 |
| Type 2 diabetes mellitus | 0 | 0 | 1 |
| Gout | 0 | 1 | 1 |
| Hepatic steatosis | 0 | 0 | 1 |
| Liver function test abnormal | 0 | 0 | 1 |
| GGT increased | 0 | 0 | 1 |
| Hyperlipidaemia | 0 | 0 | 1 |
| Hyperglycaemia | 1 | 0 | 0 |
| Hypokalaemia | 1 | 0 | 0 |
| Hypertriglyceridaemia | 1 | 0 | 0 |
| Hyponatraemia | 1 | 0 | 0 |
| Hypophosphataemia | 0 | 0 | 1 |
| Iron deficiency | 1 | 0 | 0 |
| Vitamin D deficiency | 0 | 1 | 0 |
| Vitamin D decreased | 0 | 0 | 1 |
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.
| Participant | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg |
|---|---|---|---|
| Hypertension | 2 | 1 | 2 |
| Pulmonary hypertension | 2 | 1 | 2 |
| Pyrexia | 1 | 1 | 2 |
| Hypotension | 1 | 1 | 1 |
| Blood pressure increased | 0 | 0 | 2 |
| Atrial fibrillation | 0 | 0 | 2 |
| Atrial flutter | 1 | 0 | 1 |
| Arrhythmia | 0 | 0 | 1 |
| Bradycardia | 1 | 0 | 0 |
| Heart rate increased | 0 | 0 | 1 |
| Palpitations | 0 | 0 | 1 |
| Sinus tachycardia | 1 | 0 | 0 |
| Supraventricular tachycardia | 1 | 0 | 0 |
| Tachyarrhythmia | 0 | 0 | 1 |
| Weight decreased | 4 | 5 | 3 |
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.
| Participant | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg |
|---|---|---|---|
| Number of Participants With Electrocardiogram Abnormalities Reported as Treatment-emergent Adverse Events | 1 | 0 | 1 |
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.
| Percentage of Participant | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg |
|---|---|---|---|
| At Week 52 | 35.1 | 35.1 | 28.8 |
| At Week 72 | 42.1 | 42.1 | 44.1 |
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.
| Percent predicted DLco | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg |
|---|---|---|---|
| Baseline (n=57,57,59) | 46.962 ± 13.796 | 49.389 ± 16.029 | 47.509 ± 12.524 |
| Change at Week 52 (n=34,30,32) | -3.963 ± 8.777 | -5.233 ± 9.597 | -6.356 ± 8.588 |
| Change at Week 72 (n=23,21,22) | -8.322 ± 9.538 | -9.962 ± 10.362 | -10.382 ± 12.372 |
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.
| Meter | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg |
|---|---|---|---|
| Baseline (n=55,57,56) | 391.07 ± 112.06 | 391.69 ± 102.46 | 383.22 ± 93.99 |
| Change at Week 52 (n=31,31,29) | 19.49 ± 71.36 | 22.96 ± 52.38 | -12.40 ± 55.81 |
| Change at Week 72 (n=21,24,19) | 18.76 ± 54.83 | 7.85 ± 78.12 | -30.25 ± 78.07 |
Participants transcutaneous oxygen saturation were observed by pulse oximetry.
| Percent of oxygen saturation | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg |
|---|---|---|---|
| Baseline (n=57,57,59) | 96.2 ± 1.9 | 95.6 ± 2.0 | 95.4 ± 2.9 |
| Change at Week 52 (n=30,28,29) | -0.6 ± 2.3 | 0.4 ± 1.7 | -0.7 ± 2.7 |
| Change at Week 68 (n=23,25,22) | -0.6 ± 1.8 | 0.1 ± 2.4 | -1.0 ± 2.8 |
Lung volumes were evaluated by total lung capacity (TLC), residual volume (RV), and vital capacity (VC). Lung volumes were determined by body plethysmography.
| Liter | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg |
|---|---|---|---|
| Baseline (n=53,50,53) | 4.105 ± 0.905 | 3.870 ± 0.905 | 4.060 ± 1.192 |
| Change at Week 52 (n=32,29,28) | 0.891 ± 5.150 | -0.212 ± 0.645 | -0.264 ± 0.442 |
| Change at Week 72 (n=24,22,19) | -0.139 ± 0.635 | -0.274 ± 0.705 | -0.417 ± 0.468 |
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 participant | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg |
|---|---|---|---|
| At Week 52 | 12.3 | 12.3 | 8.5 |
| At Week 72 | 12.3 | 17.5 | 11.9 |
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 participant | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg |
|---|---|---|---|
| At Week 52 | 3.5 | 7.0 | 5.1 |
| At Week 72 | 3.5 | 8.8 | 5.1 |
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.
| Percentage of participant | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg |
|---|---|---|---|
| At Week 52 | 21.1 | 24.6 | 16.9 |
| At Week 72 | 21.1 | 24.6 | 23.7 |
FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.
| Liter | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg |
|---|---|---|---|
| Baseline (n=57,57,59) | 2.199 ± 0.500 | 2.025 ± 0.495 | 2.144 ± 0.564 |
| Change at Week 52 (n=36,32,35) | -0.120 ± 0.259 | -0.148 ± 0.200 | -0.179 ± 0.134 |
| Change at Week 72 (n=26,26,23) | -0.260 ± 0.261 | -0.152 ± 0.317 | -0.222 ± 0.166 |
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%.
| Percent of predicted FEV1 | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg |
|---|---|---|---|
| Baseline (n=57,57,59) | 78.56 ± 13.05 | 77.88 ± 14.88 | 78.94 ± 14.58 |
| Change at Week 52 (n=36,32,35) | -4.16 ± 8.50 | -5.78 ± 8.11 | -7.01 ± 5.33 |
| Change at Week 72 (n=26,26,23) | -8.77 ± 8.99 | -6.42 ± 11.13 | -8.61 ± 6.61 |
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.
| Liter | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg |
|---|---|---|---|
| Baseline (n=57,57,59) | 2.662 ± 0.649 | 2.406 ± 0.664 | 2.593 ± 0.711 |
| Change at Week 52 (n=36,32,35) | -0.162 ± 0.278 | -0.205 ± 0.224 | -0.209 ± 0.168 |
| Change at Week 72 (n=26,26,23) | -0.322 ± 0.297 | -0.186 ± 0.325 | -0.282 ± 0.242 |
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).
| Participant | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg |
|---|---|---|---|
| Very mild | 1 | 0 | 1 |
| Mild | 6 | 10 | 6 |
| Moderate | 16 | 10 | 11 |
| Severe | 0 | 3 | 5 |
| Very severe | 2 | 1 | 1 |
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).
| Participant | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg |
|---|---|---|---|
| Very much improved | 0 | 0 | 0 |
| Much improved | 1 | 0 | 3 |
| Slightly improved | 2 | 1 | 1 |
| No change | 12 | 13 | 8 |
| Slightly worse | 8 | 8 | 6 |
| Much worse | 1 | 2 | 4 |
| Very much worse | 1 | 0 | 1 |
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.
| Units on a scale | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg |
|---|---|---|---|
| Baseline (n=56,55,58) | 40.9 ± 22.8 | 36.5 ± 21.0 | 45.9 ± 20.4 |
| Change at Week 72 (n=24,21,21) | 12.9 ± 14.7 | -0.4 ± 18.0 | 10.9 ± 23.3 |
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.
| Units on a scale | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg |
|---|---|---|---|
| Baseline (n=57,57,59) | 47.24 ± 18.86 | 44.80 ± 18.91 | 51.39 ± 15.64 |
| Change at Week 72 (n=24,24,23) | 2.91 ± 14.92 | 3.16 ± 15.11 | 3.38 ± 14.88 |
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.
| Units on a scale | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg |
|---|---|---|---|
| Baseline (n=55,51,56) | 16.24 ± 9.44 | 15.87 ± 8.38 | 17.89 ± 9.72 |
| Change at Week 52 (n=31,27,30) | 1.47 ± 5.75 | 1.61 ± 7.21 | 1.40 ± 10.18 |
| Change at Week 72 (n=23,23,20) | 1.95 ± 7.46 | 0.63 ± 7.50 | 1.81 ± 10.00 |
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.
| Units on a scale | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg |
|---|---|---|---|
| Baseline (n=57,57,59) | 70.5 ± 19.1 | 70.5 ± 18.1 | 66.6 ± 14.9 |
| Change at Week 72 (n=24,24,23) | -3.0 ± 17.9 | 2.5 ± 20.9 | 0.6 ± 14.3 |
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).
| Participant | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg |
|---|---|---|---|
| Very mild | 2 | 2 | 1 |
| Mild | 8 | 5 | 6 |
| Moderate | 11 | 13 | 8 |
| Severe | 1 | 1 | 0 |
| Very severe | 1 | 0 | 0 |
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).
| Participant | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg |
|---|---|---|---|
| Very much improved | 0 | 0 | 0 |
| Much improved | 1 | 1 | 0 |
| Slightly improved | 1 | 4 | 4 |
| No change | 1 | 3 | 5 |
| Slightly worse | 3 | 2 | 3 |
| Much worse | 1 | 1 | 2 |
| Very much worse | 0 | 0 | 0 |
The mean serum concentration of Tralokinumab were observed.
| microgram per milliliter (mcg/ml) | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg |
|---|---|---|
| Week 0: predose (n=50,56) | 3.520 ± 23.885 | 6.151 ± 45.560 |
| Week 0: 0 hour postdose (n=53,57) | 176.047 ± 125.991 | 311.105 ± 88.229 |
| Week 0: 2 hour postdose (n=53,56) | 172.108 ± 46.423 | 301.321 ± 60.520 |
| Week 4 (n=57,57) | 30.155 ± 20.164 | 57.914 ± 45.326 |
| Week 48 (n=33,39) | 44.653 ± 40.584 | 80.553 ± 67.187 |
| Week 72 (n=24,21) | 41.583 ± 24.723 | 76.224 ± 54.045 |
| Week 82 (n=15,12) | 3.651 ± 3.547 | 11.442 ± 13.846 |
| Week 88 (n=12,10) | 0.493 ± 0.490 | 10.585 ± 19.084 |
A participant was considered ADA-positive across the study if they had a positive reading at any time point during the study.
| Percentage of participant | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg |
|---|---|---|---|
| Baseline (n=54,54,58) | 1.9 | 1.9 | 0 |
| Week 0, Day 1 (n=1,3,1) | 0 | 0 | 0 |
| Week 48 (n=35,32,36) | 2.9 | 0 | 0 |
| Week 72 (n=2,1,1) | 0 | 0 | 0 |
| Week 82 (n=13,15,12) | 7.7 | 0 | 0 |
| Week 88 (n=10,13,11) | 20 | 0 | 0 |
Collected over From the start of study treatment through Week 88 or at the time of early termination from the study. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 13/57 (22.8%) | 51/57 (89.5%) |
| Tralokinumab 400 Milligram (mg) | — | 16/57 (28.1%) | 45/57 (78.9%) |
| Tralokinumab 800 mg | — | 17/59 (28.8%) | 50/59 (84.7%) |
| Event | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg |
|---|---|---|---|
| Idiopathic pulmonary fibrosisRespiratory, thoracic and mediastinal disorders | 4/57 | 7/57 | 4/59 |
| PneumoniaInfections and infestations | 2/57 | 6/57 | 2/59 |
| SyncopeNervous system disorders | 2/57 | 2/57 | 0/59 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/57 | 0/57 | 2/59 |
| Cardiac arrestCardiac disorders | 0/57 | 1/57 | 0/59 |
| Cardiac failure congestiveCardiac disorders | 1/57 | 0/57 | 0/59 |
| Right ventricular failureCardiac disorders | 0/57 | 1/57 | 0/59 |
| Supraventricular tachycardiaCardiac disorders | 1/57 | 0/57 | 0/59 |
| Inguinal herniaGastrointestinal disorders | 1/57 | 0/57 | 0/59 |
| Rectal haemorrhageGastrointestinal disorders | 1/57 | 0/57 | 0/59 |
| Event | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg |
|---|---|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | 13/57 | 10/57 | 17/59 |
| FatigueGeneral disorders | 4/57 | 5/57 | 11/59 |
| Upper respiratory tract infectionInfections and infestations | 7/57 | 10/57 | 11/59 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 2/57 | 4/57 | 10/59 |
| Idiopathic pulmonary fibrosisRespiratory, thoracic and mediastinal disorders | 9/57 | 8/57 | 6/59 |
| DiarrhoeaGastrointestinal disorders | 6/57 | 4/57 | 9/59 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/57 | 8/57 | 2/59 |
| HeadacheNervous system disorders | 8/57 | 6/57 | 5/59 |
| InsomniaPsychiatric disorders | 8/57 | 2/57 | 4/59 |
| BronchitisInfections and infestations | 5/57 | 7/57 | 5/59 |
The intent-to-treat (ITT) population is all randomized participants who receive any study investigational product and participants were analysed according to the randomization.
| Age, Continuous(Years) | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg | Total |
|---|---|---|---|---|
| Mean | 67.5 ± 6.1 | 67.3 ± 7.7 | 67.9 ± 6.7 | 67.6 ± 6.8 |
| Sex: Female, Male(Participants) | Placebo | Tralokinumab 400 Milligram (mg) | Tralokinumab 800 mg | Total |
|---|---|---|---|---|
| Female | 12 | 15 | 13 | 40 |
| Male | 45 | 42 | 46 | 133 |
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