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

This study is currently recruiting participants.
Verified April 2013 by MedImmune LLC
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01629667
First received: June 12, 2012
Last updated: April 19, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
 Biological: Tralokinumab
Other: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Change from Baseline in Percent-Predicted Forced Vital Capacity at Week 72 [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
    Mean change from baseline in percent-predicted forced vital capacity


Secondary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: Day 1 - Week 84 ] [ Designated as safety issue: Yes ]
    Number and percent of subjects with at least one treatment-emergent adverse event

  • Number of Participants with Disease Progression [ Time Frame: Day 1 - Week 84 ] [ Designated as safety issue: No ]
    Number and percent of subjects who have documented disease progression

  • Mean Tralokinumab Serum Concentration [ Time Frame: Day 1 - Week 84 ] [ Designated as safety issue: No ]
    Mean serum concentration of tralokinumab

  • Number of Participants with Serious Adverse Events [ Time Frame: Day 1 - Week 84 ] [ Designated as safety issue: Yes ]
    Number and percent of subjects with at least one treatment-emergent serious adverse event

  • Number of Participants with Clinically Significant Electrocardiogram Abnormalities [ Time Frame: Day 1 - Week 84 ] [ Designated as safety issue: Yes ]
    Number and percent of subjects with at least one clinically significant electrocardiogram abnormality

  • Number of Participants with Clinically Significant Vital Sign Abnormalities [ Time Frame: Day 1 - Week 84 ] [ Designated as safety issue: Yes ]
    Number and percent of subjects with at least one clinically significant vital sign abnormality

  • Number of Participants with Clinically Significant Laboratory Abnormallities [ Time Frame: Day 1 - Week 84 ] [ Designated as safety issue: Yes ]
    Number and percent of subjects with at least one clinically significant laboratory abnormality

  • Change from Baseline in Diffusion Capacity for Carbon Monoxide at Weeks 36, 52, and 72 [ Time Frame: Weeks 36, 52, and 72 ] [ Designated as safety issue: No ]
    Mean change from baseline in percent-predicted diffusion capacity for carbon monoxide at Weeks 36, 52, and 72

  • Change from Baseline in Lung Volumes at Weeks 36, 52, and 72 [ Time Frame: Weeks 36, 52, and 72 ] [ Designated as safety issue: No ]
    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

  • Number of Participants with a Decline in the 6 Minute Walk Test [ Time Frame: Day 1 - Week 84 ] [ Designated as safety issue: No ]
    Number and percent of subjects with a decline in the 6 Minute Walk Test greater than or equal to 50 meters

  • Change from Baseline in Oxygen Saturation by Pulse Oximetry During the Study [ Time Frame: Day 1 - Week 84 ] [ Designated as safety issue: No ]
    Mean change from baseline in oxygen saturation by pulse oximetry

  • Number of Participants with Exacerbations of Idiopathic Pulmonary Fibrosis [ Time Frame: Day 1 - Week 84 ] [ Designated as safety issue: No ]
    Number and percent of subjects with at least one exacerbation of idiopathic pulmonary fibrosis

  • Change from Baseline in Lung Function During the Study [ Time Frame: Day 1 - Week 84 ] [ Designated as safety issue: No ]
    Mean change from baseline in lung function (forced expiratory volume in 1 second and forced vital capacity).

  • Mean Clinical Global Impression of Severity Scores [ Time Frame: Day 1 - Week 84 ] [ Designated as safety issue: No ]
    Mean Clinical Global Impression of Severity scores

  • Mean Clinical Global Impression of Change Scores [ Time Frame: Day 1 - Week 84 ] [ Designated as safety issue: No ]
    Mean Clinical Global Impression of Change score

  • Number of Participants with Positive Antibodies to Tralokinumab [ Time Frame: Day 1 - Week 84 ] [ Designated as safety issue: Yes ]
    Number and percent of subjects with positive antibodies to tralokinumab


Estimated Enrollment: 186
Study Start Date: October 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose
Investigational product tralokinumab
 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
Experimental: High dose
Investigational product tralokinumab
 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
Placebo Comparator: Placebo
Placebo
 Other: Placebo

Detailed 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

  Eligibility

Ages Eligible for Study:   50 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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% and ≤ 90% 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% and ≤ 90% 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01629667

Contacts
Contact: Jon P Fiening clinicaltrialenquiries@medimmune.com

  Show 31 Study Locations
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Joseph Parker, MD MedImmune LLC
  More Information

No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01629667     History of Changes
Other Study ID Numbers: CD-RI-CAT-354-1066
Study First Received: June 12, 2012
Last Updated: April 19, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
 Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on May 16, 2013