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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 has been terminated.
(Early termination of the study due to lack of efficacy.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01629667
First Posted: June 27, 2012
Last Update Posted: May 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
MedImmune LLC
Results First Submitted: January 19, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Idiopathic Pulmonary Fibrosis
Interventions: Biological: Tralokinumab
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 409 participants participated in the study. Of which, 176 participants were randomized into the study at 48 sites including 17 sites in the USA, 9 sites in Australia, 7 sites in Peru, 6 sites in Israel, 5 sites in Canada, and 4 sites in South Korea.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 176 participants were randomized into the study. Three participants who were randomized did not receive treatment; therefore, 173 participants were randomized and treated.

Reporting Groups
  Description
Placebo Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 Milligram (mg) Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

Participant Flow:   Overall Study
    Placebo   Tralokinumab 400 Milligram (mg)   Tralokinumab 800 mg
STARTED   59   58   59 
Randomized and Treated   57   57   59 
COMPLETED   12   17   14 
NOT COMPLETED   47   41   45 
Lost to Follow-up                0                1                1 
Withdrawal by Subject                31                20                28 
Death                1                5                3 
Randomized, not treated                2                1                0 
Ongoing AE worsening right heart failure                0                1                0 
Requiring lung transplant                2                1                3 
Early tretmt termntd, cmpltd safety f-up                9                11                8 
Started other medicine                1                0                1 
Site error in safety follow-up                0                0                1 
Enrolled in another clinical study                0                1                0 
Code break                1                0                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat (ITT) population is all randomized participants who receive any study investigational product and participants were analysed according to the randomization.

Reporting Groups
  Description
Placebo Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
Tralokinumab 400 Milligram (mg) Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo   Tralokinumab 400 Milligram (mg)   Tralokinumab 800 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 57   57   59   173 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.5  (6.1)   67.3  (7.7)   67.9  (6.7)   67.6  (6.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      12  21.1%      15  26.3%      13  22.0%      40  23.1% 
Male      45  78.9%      42  73.7%      46  78.0%      133  76.9% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 52   [ Time Frame: Baseline and Week 52 ]

2.  Secondary:   Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)   [ Time Frame: From the start of study treatment through Week 88 ]

3.  Secondary:   Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events   [ Time Frame: From the start of study treatment through Week 88 ]

4.  Secondary:   Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events   [ Time Frame: From the start of study treatment through Week 88 ]

5.  Secondary:   Number of Participants With Electrocardiogram Abnormalities Reported as Treatment-emergent Adverse Events   [ Time Frame: From the start of study treatment through Week 88 ]

6.  Secondary:   Percentage of Participants With Disease Progression   [ Time Frame: Week 52 and 72 ]

7.  Secondary:   Change From Baseline in Haemoglobin (Hb) Corrected Percent-predicted Diffusion Capacity for Carbon Monoxide (DLco) Through Week 72   [ Time Frame: Baseline, Week 52 and 72 ]

8.  Secondary:   Change From Baseline in 6 Minute Walk Test (6MWT) Distance Through Week 72   [ Time Frame: Baseline, Week 52 and 72 ]

9.  Secondary:   Change From Baseline in Oxygen Saturation by Pulse Oximetry at Week 68   [ Time Frame: Baseline and Week 68 ]

10.  Secondary:   Change From Baseline in Lung Volumes Through Week 72   [ Time Frame: Baseline, Week 52 and 72 ]

11.  Secondary:   Percentage of Participants With Idiopathic Pulmonary Fibrosis (IPF) Exacerbations   [ Time Frame: Week 52 and 72 ]

12.  Secondary:   Percentage of Participants With Adjudicated Mortality   [ Time Frame: Week 52 and 72 ]

13.  Secondary:   Percentage of Participants With Adjudicated Hospitalization   [ Time Frame: Week 52 and 72 ]

14.  Secondary:   Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Through Week 72   [ Time Frame: Baseline, Week 52 and 72 ]

15.  Secondary:   Change From Baseline in Percent-predicted FEV1 Through Week 72   [ Time Frame: Baseline, Week 52 and 72 ]

16.  Secondary:   Change From Baseline in Absolute Forced Vital Capacity (FVC) Through Week 72   [ Time Frame: Baseline, Week 52 and 72 ]

17.  Secondary:   Number of Participants With Clinical Global Impression of Severity Scores   [ Time Frame: Week 72 ]

18.  Secondary:   Number of Participants With Clinical Global Impression of Change Scores   [ Time Frame: Week 72 ]

19.  Secondary:   Change From Baseline in University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) Total Score at Week 72   [ Time Frame: Baseline and Week 72 ]

20.  Secondary:   Change From Baseline in St. George’s Respiratory Questionnaire (SGRQ) Total Score at Week 72   [ Time Frame: Baseline and Week 72 ]

21.  Secondary:   Change From Baseline in Exacerbations of Chronic Pulmonary Disease (EXACT IPF) Total Score Through Week 72   [ Time Frame: Baseline, Week 52 and 72 ]

22.  Secondary:   Change From Baseline in European Quality of Life-5-Dimension 3 Level Version (EQ-5D-3L) (Including Visual Analog Scale [VAS]) at Week 72   [ Time Frame: Baseline and Week 72 ]

23.  Secondary:   Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF)   [ Time Frame: Week 72 ]

24.  Secondary:   Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF)   [ Time Frame: Week 72 ]

25.  Secondary:   Mean Serum Concentration of Tralokinumab   [ Time Frame: Predose, 0 hour, and 2 hour postdose on Week 0; predose on Week 4, 48, 72, 82 and 88 ]

26.  Secondary:   Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab   [ Time Frame: From the start of study treatment through Week 88 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study was early terminated due to lack of efficacy.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: AstraZeneca Clinical Study Information Center
Organization: MedImmune, LLC
phone: 1-877-240-9479
e-mail: information.center@astrazeneca.com



Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01629667     History of Changes
Other Study ID Numbers: CD-RI-CAT-354-1066
First Submitted: June 12, 2012
First Posted: June 27, 2012
Results First Submitted: January 19, 2017
Results First Posted: May 15, 2017
Last Update Posted: May 15, 2017