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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
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)
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
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
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
Timepoint [4] 0 0
From the start of study treatment through Week 88
Secondary outcome [5] 0 0
Percentage of Participants With Disease Progression
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
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
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
Timepoint [8] 0 0
Baseline and Week 68
Secondary outcome [9] 0 0
Change From Baseline in Lung Volumes Through Week 72
Timepoint [9] 0 0
Baseline, Week 52 and 72
Secondary outcome [10] 0 0
Percentage of Participants With Idiopathic Pulmonary Fibrosis (IPF) Exacerbations
Timepoint [10] 0 0
Week 52 and 72
Secondary outcome [11] 0 0
Percentage of Participants With Adjudicated Mortality
Timepoint [11] 0 0
Week 52 and 72
Secondary outcome [12] 0 0
Percentage of Participants With Adjudicated Hospitalization
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
Timepoint [13] 0 0
Baseline, Week 52 and 72
Secondary outcome [14] 0 0
Change From Baseline in Percent-predicted FEV1 Through Week 72
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
Timepoint [15] 0 0
Baseline, Week 52 and 72
Secondary outcome [16] 0 0
Number of Participants With Clinical Global Impression of Severity Scores
Timepoint [16] 0 0
Week 72
Secondary outcome [17] 0 0
Number of Participants With Clinical Global Impression of Change Scores
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
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
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
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
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)
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)
Timepoint [23] 0 0
Week 72
Secondary outcome [24] 0 0
Mean Serum Concentration of Tralokinumab
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
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
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01629667
Trial related presentations / publications
Parker JM, Glaspole IN, Lancaster LH, Haddad TJ, She D, Roseti SL, Fiening JP, Grant EP, Kell CM, Flaherty KR. A Phase 2 Randomized Controlled Study of Tralokinumab in Subjects with Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2018 Jan 1;197(1):94-103. doi: 10.1164/rccm.201704-0784OC.
Public notes

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01629667