A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary Fibrosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01629667
• Other study ID #: CD-RI-CAT-354-1066
• Status: Terminated
• Phase: Phase 2
• First received: June 12, 2012
• Last updated: February 29, 2016
• Start date: October 2012
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 409
• Est. completion date: January 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 79 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Biological:
• Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody (MAb)) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor
• Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody (MAb)) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor

Other:
• Placebo

Locations

Country	Name	City	State
Australia	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
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Quebec
Canada	Research Site	Vancouver	British Columbia
Canada	Research Site	Windsor	Ontario
Israel	Research Site	Ashkelon
Israel	Research Site	Haifa
Israel	Research Site	Jerusalem
Israel	Research Site	Petach Tikva
Israel	Research Site	Rehovot
Israel	Research Site	Tel Aviv
Korea, Republic of	Research Site	Seoul
Peru	Research Site	Cercado de Lima
Peru	Research Site	Lima
United States	Research Site	Ann Arbor	Michigan
United States	Research Site	Atlanta	Georgia
United States	Research Site	Charleston	South Carolina
United States	Research Site	Chesterfield	Missouri
United States	Research Site	Chicago	Illinois
United States	Research Site	Durham	North Carolina
United States	Research Site	Hershey	Pennsylvania
United States	Research Site	Honolulu	Hawaii
United States	Research Site	La Jolla	California
United States	Research Site	Louisville	Kentucky
United States	Research Site	McAllen	Texas
United States	Research Site	McKinney	Texas
United States	Research Site	Nashville	Tennessee
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Phoenix	Arizona
United States	Research Site	Rochester	Minnesota
United States	Research Site	Sacramento	California
United States	Research Site	Salt Lake City	Utah
United States	Research Site	Summit	New Jersey
United States	Research Site	Tampa	Florida
United States	Research Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Israel,  Korea, Republic of,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Percent-Predicted Forced Vital Capacity at Week 52	Mean change from baseline in percent-predicted forced vital capacity	Week 52	No
Secondary	Number of Participants with Adverse Events	Number and percent of subjects with at least one treatment-emergent adverse event	Day 1 - Week 88	Yes
Secondary	Number of Participants with Disease Progression	Number and percent of subjects who have documented disease progression	Day 1 - Week 88	No
Secondary	Mean Tralokinumab Serum Concentration	Mean serum concentration of tralokinumab	Day 1 - Week 88	No
Secondary	Number of Participants with Serious Adverse Events	Number and percent of subjects with at least one treatment-emergent serious adverse event	Day 1 - Week 88	Yes
Secondary	Number of Participants with Clinically Significant Electrocardiogram Abnormalities	Number and percent of subjects with at least one clinically significant electrocardiogram abnormality	Day 1 - Week 88	Yes
Secondary	Number of Participants with Clinically Significant Vital Sign Abnormalities	Number and percent of subjects with at least one clinically significant vital sign abnormality	Day 1 - Week 88	Yes
Secondary	Number of Participants with Clinically Significant Laboratory Abnormalities	Number and percent of subjects with at least one clinically significant laboratory abnormality	Day 1 - Week 88	Yes
Secondary	Change from Baseline in Diffusion Capacity for Carbon Monoxide at Weeks 36, 52, and 72	Mean change from baseline in percent-predicted diffusion capacity for carbon monoxide at Weeks 36, 52, and 72	Weeks 36, 52, and 72	No
Secondary	Change from Baseline in Lung Volumes at Weeks 36, 52, and 72	Mean change from baseline in lung volumes (total lung capacity, residual volume, vital capacity, functional residual capacity, and inspiratory capacity) at Weeks 36, 52, and 72	Weeks 36, 52, and 72	No
Secondary	Number of Participants with a Decline in the 6 Minute Walk Test	Number and percent of subjects with a decline in the 6 Minute Walk Test greater than or equal to 50 meters	Day 1 - Week 88	No
Secondary	Change from Baseline in Oxygen Saturation by Pulse Oximetry During the Study	Mean change from baseline in oxygen saturation by pulse oximetry	Day 1 - Week 88	No
Secondary	Number of Participants with Exacerbations of Idiopathic Pulmonary Fibrosis	Number and percent of subjects with at least one exacerbation of idiopathic pulmonary fibrosis	Day 1 - Week 88	No
Secondary	Change from Baseline in Lung Function During the Study	Mean change from baseline in lung function (forced expiratory volume in 1 second and forced vital capacity).	Day 1 - Week 88	No
Secondary	Mean Clinical Global Impression of Severity Scores	Mean Clinical Global Impression of Severity scores	Day 1 - Week 88	No
Secondary	Mean Clinical Global Impression of Change Scores	Mean Clinical Global Impression of Change score	Day 1 - Week 88	No
Secondary	Number of Participants with Positive Antibodies to Tralokinumab	Number and percent of subjects with positive antibodies to tralokinumab	Day 1 - Week 88	Yes