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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01629667




Registration number
NCT01629667
Ethics application status
Date submitted
12/06/2012
Date registered
27/06/2012
Date last updated
15/05/2017

Titles & IDs
Public title
A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary Fibrosis
Scientific title
A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary Fibrosis
Secondary ID [1] 0 0
CD-RI-CAT-354-1066
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Tralokinumab
Treatment: Other - Tralokinumab
Other interventions - Placebo

Experimental: Tralokinumab 400 milligram (mg) - Participants will receive Tralokinumab 400 mg intravenous (IV) infusion Q4W for 68 Weeks.

Experimental: Tralokinumab 800 mg - Participants will receive Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Placebo comparator: Placebo - Participants will receive placebo IV once every 4 Weeks (Q4W) for 68 Weeks.


Treatment: Other: Tralokinumab
Participants will receive Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.

Treatment: Other: Tralokinumab
Participants will receive Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Other interventions: Placebo
Participants will receive placebo IV once every 4 Weeks (Q4W) for 68 Weeks.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 52
Assessment method [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%.
Timepoint [1] 0 0
Baseline and Week 52
Secondary outcome [1] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
From the start of study treatment through Week 88
Secondary outcome [2] 0 0
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
From the start of study treatment through Week 88
Secondary outcome [3] 0 0
Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
From the start of study treatment through Week 88
Secondary outcome [4] 0 0
Number of Participants With Electrocardiogram Abnormalities Reported as Treatment-emergent Adverse Events
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
From the start of study treatment through Week 88
Secondary outcome [5] 0 0
Percentage of Participants With Disease Progression
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
Week 52 and 72
Secondary outcome [6] 0 0
Change From Baseline in Haemoglobin (Hb) Corrected Percent-predicted Diffusion Capacity for Carbon Monoxide (DLco) Through Week 72
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
Baseline, Week 52 and 72
Secondary outcome [7] 0 0
Change From Baseline in 6 Minute Walk Test (6MWT) Distance Through Week 72
Assessment method [7] 0 0
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.
Timepoint [7] 0 0
Baseline, Week 52 and 72
Secondary outcome [8] 0 0
Change From Baseline in Oxygen Saturation by Pulse Oximetry at Week 68
Assessment method [8] 0 0
Participants transcutaneous oxygen saturation were observed by pulse oximetry.
Timepoint [8] 0 0
Baseline and Week 68
Secondary outcome [9] 0 0
Change From Baseline in Lung Volumes Through Week 72
Assessment method [9] 0 0
Lung volumes were evaluated by total lung capacity (TLC), residual volume (RV), and vital capacity (VC). Lung volumes were determined by body plethysmography.
Timepoint [9] 0 0
Baseline, Week 52 and 72
Secondary outcome [10] 0 0
Percentage of Participants With Idiopathic Pulmonary Fibrosis (IPF) Exacerbations
Assessment method [10] 0 0
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.
Timepoint [10] 0 0
Week 52 and 72
Secondary outcome [11] 0 0
Percentage of Participants With Adjudicated Mortality
Assessment method [11] 0 0
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.
Timepoint [11] 0 0
Week 52 and 72
Secondary outcome [12] 0 0
Percentage of Participants With Adjudicated Hospitalization
Assessment method [12] 0 0
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.
Timepoint [12] 0 0
Week 52 and 72
Secondary outcome [13] 0 0
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Through Week 72
Assessment method [13] 0 0
FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.
Timepoint [13] 0 0
Baseline, Week 52 and 72
Secondary outcome [14] 0 0
Change From Baseline in Percent-predicted FEV1 Through Week 72
Assessment method [14] 0 0
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%.
Timepoint [14] 0 0
Baseline, Week 52 and 72
Secondary outcome [15] 0 0
Change From Baseline in Absolute Forced Vital Capacity (FVC) Through Week 72
Assessment method [15] 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.
Timepoint [15] 0 0
Baseline, Week 52 and 72
Secondary outcome [16] 0 0
Number of Participants With Clinical Global Impression of Severity Scores
Assessment method [16] 0 0
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).
Timepoint [16] 0 0
Week 72
Secondary outcome [17] 0 0
Number of Participants With Clinical Global Impression of Change Scores
Assessment method [17] 0 0
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).
Timepoint [17] 0 0
Week 72
Secondary outcome [18] 0 0
Change From Baseline in University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) Total Score at Week 72
Assessment method [18] 0 0
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.
Timepoint [18] 0 0
Baseline and Week 72
Secondary outcome [19] 0 0
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 72
Assessment method [19] 0 0
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.
Timepoint [19] 0 0
Baseline and Week 72
Secondary outcome [20] 0 0
Change From Baseline in Exacerbations of Chronic Pulmonary Disease (EXACT IPF) Total Score Through Week 72
Assessment method [20] 0 0
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.
Timepoint [20] 0 0
Baseline, Week 52 and 72
Secondary outcome [21] 0 0
Change From Baseline in European Quality of Life-5-Dimension 3 Level Version (EQ-5D-3L) (Including Visual Analog Scale [VAS]) at Week 72
Assessment method [21] 0 0
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.
Timepoint [21] 0 0
Baseline and Week 72
Secondary outcome [22] 0 0
Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF)
Assessment method [22] 0 0
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).
Timepoint [22] 0 0
Week 72
Secondary outcome [23] 0 0
Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF)
Assessment method [23] 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).
Timepoint [23] 0 0
Week 72
Secondary outcome [24] 0 0
Mean Serum Concentration of Tralokinumab
Assessment method [24] 0 0
The mean serum concentration of Tralokinumab were observed.
Timepoint [24] 0 0
Predose, 0 hour, and 2 hour postdose on Week 0; predose on Week 4, 48, 72, 82 and 88
Secondary outcome [25] 0 0
Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab
Assessment method [25] 0 0
A participant was considered ADA-positive across the study if they had a positive reading at any time point during the study.
Timepoint [25] 0 0
From the start of study treatment through Week 88

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
50 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2016
Sample size
Target
Accrual to date
Final
409
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Box Hill
Recruitment hospital [2] 0 0
Research Site - Camperdown
Recruitment hospital [3] 0 0
Research Site - Concord
Recruitment hospital [4] 0 0
Research Site - Darlinghurst
Recruitment hospital [5] 0 0
Research Site - Frankston
Recruitment hospital [6] 0 0
Research Site - Glen Osmond
Recruitment hospital [7] 0 0
Research Site - New Lambton
Recruitment hospital [8] 0 0
Research Site - Parkville
Recruitment hospital [9] 0 0
Research Site - Prahran
Recruitment hospital [10] 0 0
Research Site - Woodville South
Recruitment postcode(s) [1] 0 0
- Box Hill
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Concord
Recruitment postcode(s) [4] 0 0
- Darlinghurst
Recruitment postcode(s) [5] 0 0
- Frankston
Recruitment postcode(s) [6] 0 0
- Glen Osmond
Recruitment postcode(s) [7] 0 0
- New Lambton
Recruitment postcode(s) [8] 0 0
- Parkville
Recruitment postcode(s) [9] 0 0
- Prahran
Recruitment postcode(s) [10] 0 0
- Woodville South
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Hawaii
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Utah
Country [18] 0 0
Canada
State/province [18] 0 0
Alberta
Country [19] 0 0
Canada
State/province [19] 0 0
British Columbia
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Israel
State/province [22] 0 0
Ashkelon
Country [23] 0 0
Israel
State/province [23] 0 0
Haifa
Country [24] 0 0
Israel
State/province [24] 0 0
Jerusalem
Country [25] 0 0
Israel
State/province [25] 0 0
Petach Tikva
Country [26] 0 0
Israel
State/province [26] 0 0
Rehovot
Country [27] 0 0
Israel
State/province [27] 0 0
Tel Aviv
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Seoul
Country [29] 0 0
Peru
State/province [29] 0 0
Cercado de Lima
Country [30] 0 0
Peru
State/province [30] 0 0
Lima

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
MedImmune LLC
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joseph Parker, MD
Address 0 0
MedImmune LLC
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01629667