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Study to Evaluate the Safety and Efficacy of CAT-354

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00873860
First Posted: April 2, 2009
Last Update Posted: March 24, 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: August 26, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Other: Placebo
Biological: CAT-354 150 mg
Biological: CAT-354 300 mg
Biological: CAT-354 600 mg

  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 357 participants were screened in this study, out of which 194 participants me the eligibility criteria and were enrolled and randomized into the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
CAT-354 150 mg CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
CAT-354 300 mg CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
CAT-354 600 mg CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.

Participant Flow:   Overall Study
    Placebo   CAT-354 150 mg   CAT-354 300 mg   CAT-354 600 mg
STARTED   48   47   51   48 
Treated   47   47   51   48 
COMPLETED   44   47   48   47 
NOT COMPLETED   4   0   3   1 
Lost to Follow-up                1                0                0                1 
Withdrawal by Subject                1                0                2                0 
Death                1                0                0                0 
Other                1                0                1                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.
Intent-to-Treat (ITT) population included all participants who were randomized.

Reporting Groups
  Description
Placebo Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
CAT-354 150 mg CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
CAT-354 300 mg CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
CAT-354 600 mg CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
Total Total of all reporting groups

Baseline Measures
   Placebo   CAT-354 150 mg   CAT-354 300 mg   CAT-354 600 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 48   47   51   48   194 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.2  (9.8)   43.4  (11.1)   48.7  (11.0)   49.8  (10.4)   47.3  (10.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      33  68.8%      19  40.4%      36  70.6%      28  58.3%      116  59.8% 
Male      15  31.3%      28  59.6%      15  29.4%      20  41.7%      78  40.2% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92   [ Time Frame: Day 1 and 92 ]

2.  Secondary:   Time to First Observed Asthma Control   [ Time Frame: Day 1 to Day 92 and Day 169 ]

3.  Secondary:   Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169   [ Time Frame: Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 ]

4.  Secondary:   Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169   [ Time Frame: Day -7 to 1 (predose), Day 2 to 169 ]

5.  Secondary:   Number of Puffs of Rescue Beta-2 Agonist Per Week   [ Time Frame: Day -7 to 169 ]

6.  Secondary:   Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores   [ Time Frame: Day 1, 29, 57, 92, 127 and 169 ]

7.  Secondary:   Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169   [ Time Frame: Day 1, 29, 57, 92, 127 and 169 ]

8.  Secondary:   Patient Global Impression of Change (PGIC)   [ Time Frame: Day 92 and 169 ]

9.  Secondary:   Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5   [ Time Frame: Day 92 and 169 ]

10.  Secondary:   Serum Concentration for CAT-354   [ Time Frame: Predose on Day 15, 29, 43, 57, 71 and 85; Day 88, 92, 99, 127, and 169 ]

11.  Secondary:   Number of Participants With Anti-Drug Antibodies to CAT-354 at Any Visit   [ Time Frame: Day 1, 92 and 169 ]

12.  Secondary:   Percentage of Participants With Positive Serum Antibodies to CAT-354 at Any Visit   [ Time Frame: Day 1, 92 and 169 ]

13.  Secondary:   Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)   [ Time Frame: Day 1 to 169 ]

14.  Secondary:   Percentage of Participants With at Least 1 Moderate or Severe Exacerbation   [ Time Frame: Day 92 and 169 ]

15.  Secondary:   Moderate or Severe Asthma Exacerbations Per Person Per Annum   [ Time Frame: Day 1 to Day 92 and Day 169 ]

16.  Secondary:   Time to First Moderate or Severe Asthma Exacerbation   [ Time Frame: Day 1 to Day 92 and Day 169 ]


  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/Associate Medical Director
Organization: MedImmune, LLC
phone: 301-398-0000
e-mail: jainm@medimmune.com


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00873860     History of Changes
Other Study ID Numbers: MI-CP199
2008-007844-33 ( EudraCT Number )
First Submitted: April 1, 2009
First Posted: April 2, 2009
Results First Submitted: August 26, 2016
Results First Posted: February 23, 2017
Last Update Posted: March 24, 2017