Study Stopped
Early termination of the study due to lack of efficacy.
A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary Fibrosis
1 other identifier
interventional
409
6 countries
45
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2012
Typical duration for phase_2
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2012
CompletedFirst Posted
Study publicly available on registry
June 27, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
May 15, 2017
CompletedMay 15, 2017
April 1, 2017
2.6 years
June 12, 2012
January 19, 2017
April 28, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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%.
Baseline and Week 52
Secondary Outcomes (25)
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
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events
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
From the start of study treatment through Week 88
Number of Participants With Electrocardiogram Abnormalities Reported as Treatment-emergent Adverse Events
From the start of study treatment through Week 88
Percentage of Participants With Disease Progression
Week 52 and 72
- +20 more secondary outcomes
Study Arms (3)
Tralokinumab 400 milligram (mg)
EXPERIMENTALParticipants will receive Tralokinumab 400 mg intravenous (IV) infusion Q4W for 68 Weeks.
Tralokinumab 800 mg
EXPERIMENTALParticipants will receive Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Placebo
PLACEBO COMPARATORParticipants will receive placebo IV once every 4 Weeks (Q4W) for 68 Weeks.
Interventions
Participants will receive Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Eligibility Criteria
You may qualify if:
- FVC \>= 50% predicted normal
- 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
- Hemoglobin-corrected diffusion capacity for carbon monoxide (DLCO) \>= 30% predicted normal 4) Be able to walk \>= 100 meters unassisted
You may not qualify if:
- A FEV1/FVC ratio less than 0.70 at the time of screening (postbronchodilator)
- The extent of emphysema on the HRCT is greater than the extent of fibrosis.
- Currently listed for lung transplantation
- Use of the following medications:
- 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)
- Pirfenidone within 4 weeks prior to Visit 1 (screening)
- N-acetylcysteine within 4 weeks prior to Visit 1 (screening)
- Live attenuated vaccines within 4 weeks prior to Visit 1 (screening)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (45)
Research Site
Phoenix, Arizona, United States
Research Site
La Jolla, California, United States
Research Site
Sacramento, California, United States
Research Site
Tampa, Florida, United States
Research Site
Winter Park, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Honolulu, Hawaii, United States
Research Site
Chicago, Illinois, United States
Research Site
Louisville, Kentucky, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Rochester, Minnesota, United States
Research Site
Chesterfield, Missouri, United States
Research Site
Summit, New Jersey, United States
Research Site
Durham, North Carolina, United States
Research Site
Hershey, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Charleston, South Carolina, United States
Research Site
Nashville, Tennessee, United States
Research Site
McAllen, Texas, United States
Research Site
McKinney, Texas, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Box Hill, Australia
Research Site
Camperdown, Australia
Research Site
Concord, Australia
Research Site
Darlinghurst, Australia
Research Site
Frankston, Australia
Research Site
Glen Osmond, Australia
Research Site
New Lambton, Australia
Research Site
Parkville, Australia
Research Site
Prahran, Australia
Research Site
Woodville South, Australia
Research Site
Edmonton, Alberta, Canada
Research Site
Vancouver, British Columbia, Canada
Research Site
Windsor, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Ashkelon, Israel
Research Site
Haifa, Israel
Research Site
Jerusalem, Israel
Research Site
Petah Tikva, Israel
Research Site
Rehovot, Israel
Research Site
Tel Aviv, Israel
Research Site
Lima, Peru
Research Site
Lima Cercado, Peru
Research Site
Seoul, South Korea
Related Publications (1)
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.
PMID: 28787186DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Study was early terminated due to lack of efficacy.
Results Point of Contact
- Title
- AstraZeneca Clinical Study Information Center
- Organization
- MedImmune, LLC
Study Officials
- STUDY DIRECTOR
Joseph Parker, MD
MedImmune LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2012
First Posted
June 27, 2012
Study Start
October 1, 2012
Primary Completion
May 1, 2015
Study Completion
January 1, 2016
Last Updated
May 15, 2017
Results First Posted
May 15, 2017
Record last verified: 2017-04