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A Safety and Efficacy Study of Tralokinumab in Adults With Asthma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01402986
First Posted: July 27, 2011
Last Update Posted: April 4, 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: May 31, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Other: Placebo Q2W
Biological: Tralokinumab 300 mg, Q2W
Other: Placebo, Q2/4W
Biological: Tralokinumab 300 mg, Q2/4W

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 689 participants were screened, out of which 452 participants were randomized into this study

Reporting Groups
  Description
Placebo, Q2W - Cohort 1 Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Tralokinumab 300 mg, Q2W - Cohort 1 Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Placebo, Q2/4W - Cohort 2 Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Tralokinumab 300 mg, Q2/4W - Cohort 2 Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.

Participant Flow:   Overall Study
    Placebo, Q2W - Cohort 1   Tralokinumab 300 mg, Q2W - Cohort 1   Placebo, Q2/4W - Cohort 2   Tralokinumab 300 mg, Q2/4W - Cohort 2
STARTED   76   150   75   151 
COMPLETED   67   135   67   129 
NOT COMPLETED   9   15   8   22 
Withdrawal by Subject                7                10                7                13 
Death                0                0                0                2 
Lost to Follow-up                0                0                0                1 
Other                2                5                1                6 



  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 intention-to-treat (ITT) population included all participants who were randomized into the study.

Reporting Groups
  Description
Placebo, Q2W - Cohort 1 Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Tralokinumab 300 mg, Q2W - Cohort 1 Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Placebo, Q2/4W - Cohort 2 Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Tralokinumab 300 mg, Q2/4W - Cohort 2 Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Total Total of all reporting groups

Baseline Measures
   Placebo, Q2W - Cohort 1   Tralokinumab 300 mg, Q2W - Cohort 1   Placebo, Q2/4W - Cohort 2   Tralokinumab 300 mg, Q2/4W - Cohort 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 76   150   75   151   452 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.8  (12.1)   49.7  (12.2)   51.7  (13.6)   50.5  (11.8)   50.1  (12.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      51  67.1%      100  66.7%      46  61.3%      100  66.2%      297  65.7% 
Male      25  32.9%      50  33.3%      29  38.7%      51  33.8%      155  34.3% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Annual Asthma Exacerbation Rate (AER)   [ Time Frame: Week 1 up to Week 53 ]

2.  Secondary:   Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53   [ Time Frame: Baseline and Week 53 ]

3.  Secondary:   Mean Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53   [ Time Frame: Baseline and Week 53 ]

4.  Secondary:   Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 53   [ Time Frame: Baseline and Week 53 ]

5.  Secondary:   Mean Change From Baseline in Ratio of Forced Expiratory Volume in 1 Second (FEV1)/Forced Vital Capacity (FVC) at Week 53   [ Time Frame: Baseline and Week 53 ]

6.  Secondary:   Mean Change From Baseline in Inspiratory Capacity (IC) at Week 53   [ Time Frame: Baseline and Week 53 ]

7.  Secondary:   Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home   [ Time Frame: Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53) ]

8.  Secondary:   Mean Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home   [ Time Frame: Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53) ]

9.  Secondary:   Change From Baseline in Mean Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 53   [ Time Frame: Baseline and Week 53 ]

10.  Secondary:   Change From Baseline in Asthma Quality of Life Questionnaire Standardized Version (AQLQ[S]) Score at Week 53   [ Time Frame: Baseline and Week 53 ]

11.  Secondary:   Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53   [ Time Frame: Week 53 ]

12.  Secondary:   Change From Baseline in European Quality of Life 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Week 53   [ Time Frame: Baseline and Week 53 ]

13.  Secondary:   Change From Baseline in Assessing Symptoms of Moderate-to-severe Asthma (ASMA) at Week 53   [ Time Frame: Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53) ]

14.  Secondary:   Change From Baseline in Rescue Medication Use at Week 53   [ Time Frame: Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53) ]

15.  Secondary:   Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs)   [ Time Frame: Baseline and Week 75 ]

16.  Secondary:   Observed Serum Tralokinumab Concentration at Week 53   [ Time Frame: Week 53 ]

17.  Secondary:   Percentage of Participants With Anti-Drug Antibodies (ADA) to Tralokinumab   [ Time Frame: Baseline and Week 75 ]

18.  Secondary:   Severe Annual Asthma Exacerbation Rate (AER)   [ Time Frame: Week 1 up to Week 53 ]

19.  Secondary:   Time to First Exacerbation Through Week 53   [ Time Frame: Week 1 up to Week 53 ]

20.  Secondary:   Time to First Severe Exacerbation Through Week 53   [ Time Frame: Week 1 up to Week 53 ]

21.  Secondary:   Annual Asthma Exacerbation Rate (AER) by Baseline Serum Periostin   [ Time Frame: Week 1 up to Week 53 ]

22.  Secondary:   Annual Asthma Exacerbation Rate (AER) by T-helper-2 (Th2) Status   [ Time Frame: Week 1 up to Week 53 ]

23.  Secondary:   Annual Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count   [ Time Frame: Week 1 up to Week 53 ]

24.  Secondary:   Annual Asthma Exacerbation Rate (AER) by Baseline FEV1 Reversibility   [ Time Frame: Week 1 up to Week 53 ]

25.  Secondary:   Annual Asthma Exacerbation Rate (AER) by Baseline FEV1% Predicted   [ Time Frame: Week 1 up to Week 53 ]

26.  Secondary:   Annual Asthma Exacerbation Rate (AER) by Asthma Exacerbations in the Past Year   [ Time Frame: Week 1 up to Week 53 ]

27.  Secondary:   Severe Asthma Exacerbation Rate (AER) by Baseline Serum Periostin   [ Time Frame: Week 1 up to Week 53 ]

28.  Secondary:   Severe Asthma Exacerbation Rate (AER) by Baseline FEV1 Reversibility   [ Time Frame: Week 1 up to Week 53 ]

29.  Secondary:   Severe Asthma Exacerbation Rate (AER) by T-helper-2 (Th2) Status   [ Time Frame: Week 1 up to Week 53 ]

30.  Secondary:   Severe Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count   [ Time Frame: Week 1 up to Week 53 ]

31.  Secondary:   Percent Change From Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups   [ Time Frame: Week 1 up to Week 53 ]

32.  Secondary:   Change From Baseline in Mean ACQ-6 Scores at Week 53 in Subgroups   [ Time Frame: Week 1 up to Week 53 ]

33.  Secondary:   Change From Baseline in Total AQLQ(S) Scores at Week 53 in Subgroups   [ Time Frame: Week 1 up to Week 53 ]

34.  Secondary:   Annual Asthma Exacerbation Rate (AER) by Atopic Asthma Status   [ Time Frame: Week 1 up to Week 53 ]

35.  Secondary:   Annual Asthma Exacerbation Rate (AER) by Chronic OCS Use   [ Time Frame: Week 1 up to Week 53 ]

36.  Secondary:   Change From Baseline in Percentage of Nighttime Awakening at Week 53   [ Time Frame: Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53) ]

37.  Secondary:   Change From Baseline in Overall Activity Limitations at Week 53   [ Time Frame: Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53) ]

38.  Secondary:   Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53   [ Time Frame: Baseline and Week 53 ]

39.  Secondary:   Percent Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53   [ Time Frame: Baseline and Week 53 ]

40.  Secondary:   Percent Change From Baseline in Forced Vital Capacity (FVC) at Week 53   [ Time Frame: Baseline and Week 53 ]

41.  Secondary:   Percent Change From Baseline in Inspiratory Capacity (IC) at Week 53   [ Time Frame: Baseline and Week 53 ]

42.  Secondary:   Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home   [ Time Frame: Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53) ]

43.  Secondary:   Percent Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home   [ Time Frame: Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53) ]


  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
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  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: Meena Jain, MB BChir, Director, Clinical Development,
Organization: MedImmune, LLC
phone: 301-398-0000
e-mail: JainM@medimmune.com


Publications:

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01402986     History of Changes
Other Study ID Numbers: CD-RI-CAT-354-1049
2011-001360-21 ( EudraCT Number )
First Submitted: July 21, 2011
First Posted: July 27, 2011
Results First Submitted: May 31, 2016
Results First Posted: March 6, 2017
Last Update Posted: April 4, 2017