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Study Evaluating the Effect of IMA-638 in Subjects With Persistent Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00425061
First received: January 18, 2007
Last updated: January 12, 2015
Last verified: January 2015
Results First Received: November 6, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Biological: IMA-638
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This study had adaptive study design wherein participants were treated in 3 stages with higher number of participants enrolled in subsequent stages. As the treatment regimen was same for participants who received IMA-638 200 mg or placebo in Stage 2 and 3, participants were summarized together for these arms.

Reporting Groups
  Description
IMA-638 0.2 mg/kg: Stage 1 IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
IMA-638 0.6 mg/kg: Stage 1 IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
IMA-638 2 mg/kg: Stage-1 IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Placebo: Stage 1 Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
IMA-638 200 mg: Stage 2 and 3 IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
IMA-638 75 mg: Stage 3 IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
Placebo: Stage 2 and 3 Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.

Participant Flow:   Overall Study
    IMA-638 0.2 mg/kg: Stage 1     IMA-638 0.6 mg/kg: Stage 1     IMA-638 2 mg/kg: Stage-1     Placebo: Stage 1     IMA-638 200 mg: Stage 2 and 3     IMA-638 75 mg: Stage 3     Placebo: Stage 2 and 3  
STARTED     16     17     16     16     45     4     45  
COMPLETED     14     15     16     14     19     0     26  
NOT COMPLETED     2     2     0     2     26     4     19  
Adverse Event                 1                 0                 0                 2                 2                 0                 0  
Lost to Follow-up                 0                 1                 0                 0                 0                 0                 0  
Protocol Violation                 1                 0                 0                 0                 0                 0                 0  
Withdrawal by Subject                 0                 1                 0                 0                 1                 0                 3  
Sponsor's request                 0                 0                 0                 0                 19                 4                 15  
Physician Decision                 0                 0                 0                 0                 1                 0                 0  
Unspecified                 0                 0                 0                 0                 3                 0                 1  



  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.
Modified intent-to-treat (mITT) population included all randomized participants who received at least 1 dose administration of the test article.

Reporting Groups
  Description
IMA-638 0.2 mg/kg: Stage 1 IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
IMA-638 0.6 mg/kg: Stage 1 IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
IMA-638 2 mg/kg: Stage-1 IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Placebo: Stage 1 Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
IMA-638 200 mg: Stage 2 and 3 IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
IMA-638 75 mg: Stage 3 IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
Placebo: Stage 2 and 3 Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
Total Total of all reporting groups

Baseline Measures
    IMA-638 0.2 mg/kg: Stage 1     IMA-638 0.6 mg/kg: Stage 1     IMA-638 2 mg/kg: Stage-1     Placebo: Stage 1     IMA-638 200 mg: Stage 2 and 3     IMA-638 75 mg: Stage 3     Placebo: Stage 2 and 3     Total  
Number of Participants  
[units: participants]
  16     17     16     16     45     4     45     159  
Age, Customized  
[units: participants]
               
Less than 18 years     0     0     0     0     0     0     0     0  
18 to 71 years     16     17     16     16     45     4     45     159  
Greater than 71 years     0     0     0     0     0     0     0     0  
Gender  
[units: participants]
               
Female     11     10     7     9     25     1     28     91  
Male     5     7     9     7     20     3     17     68  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 1   [ Time Frame: Baseline, Day 112 ]

2.  Primary:   Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 2/3   [ Time Frame: Baseline, Day 112 ]

3.  Secondary:   Change From Baseline in Pre-beta-agonist Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 28, 56, 84 and 112 - Stage 1   [ Time Frame: Baseline, Day 8, 28, 56, 84, 112 ]

4.  Secondary:   Change From Baseline in Pre-beta-agonist Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 28, 56, 84 and 112 - Stage 2/3   [ Time Frame: Baseline, Day 8, 28, 56, 84, 112 ]

5.  Secondary:   Change From Baseline in Airway Hyper-reactivity at Day 28 and 112   [ Time Frame: Baseline, Day 28, 112 ]

6.  Secondary:   Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 1   [ Time Frame: Baseline, Day 8, 28, 56, 84, 112 ]

7.  Secondary:   Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 2/3   [ Time Frame: Baseline, Day 8, 28, 56, 84, 112 ]

8.  Secondary:   Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 1   [ Time Frame: Baseline up to Day 112 ]

9.  Secondary:   Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 2/3   [ Time Frame: Baseline up to Day 112 ]

10.  Secondary:   Mean Number of Puffs of Rescue Medication Used - Stage 1   [ Time Frame: Day 8, 28, 56, 84, 89, 91, 94, 98, 112 ]

11.  Secondary:   Mean Number of Puffs of Rescue Medication Used - Stage 2/3   [ Time Frame: Day 8, 28, 56, 84, 89, 91, 94, 98, 112 ]

12.  Secondary:   Forced Vital Capacity (FVC) - Stage 1   [ Time Frame: Baseline, Day 8, 28, 56, 84, 112 ]

13.  Secondary:   Forced Vital Capacity (FVC) - Stage 2/3   [ Time Frame: Baseline, Day 8, 28, 56, 84, 112 ]

14.  Secondary:   Forced Mid-Expiratory Flow Rate 25 Percent (%) to 75% (FEF25-75) - Stage 1   [ Time Frame: Baseline, Day 8, 28, 56, 84, 112 ]

15.  Secondary:   Forced Mid-Expiratory Flow Rate 25 Percent (%) to 75% (FEF25-75) - Stage 2/3   [ Time Frame: Baseline, Day 8, 28, 56, 84, 112 ]

16.  Secondary:   Blood Eosinophils Levels - Stage 1   [ Time Frame: Baseline, Day 8, 28, 56, 84, 112 ]

17.  Secondary:   Blood Eosinophils Levels - Stage 2/3   [ Time Frame: Baseline, Day 8, 28, 56, 84, 112 ]

18.  Secondary:   Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 1   [ Time Frame: Baseline, Day 28, 56, 84, 112 ]

19.  Secondary:   Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 2/3   [ Time Frame: Baseline, Day 28, 56, 84, 112 ]

20.  Secondary:   Serum Interleukin-13 (IL-13) Level - Stage 1   [ Time Frame: Baseline, Day 8, 28, 56, 84, 112 ]

21.  Secondary:   Serum Interleukin-13 (IL-13) Level - Stage 2/3   [ Time Frame: Baseline, Day 8, 28, 56, 84, 112 ]

22.  Other Pre-specified:   Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance Stage 1   [ Time Frame: Baseline up to Day 112 ]

23.  Other Pre-specified:   Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance - Stage 2/3   [ Time Frame: Baseline up to Day 112 ]

24.  Other Pre-specified:   Number of Participants With Clinically Important Changes in Physical Findings - Stage 1   [ Time Frame: Baseline up to Day 112 ]

25.  Other Pre-specified:   Number of Participants With Clinically Important Changes in Physical Findings - Stage 2/3   [ Time Frame: Baseline up to Day 112 ]

26.  Other Pre-specified:   Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern - Stage 1   [ Time Frame: Baseline up to Day 112 ]

27.  Other Pre-specified:   Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern - Stage 2/3   [ Time Frame: Baseline up to Day 112 ]

28.  Other Pre-specified:   Number of Participants With Injection Site Reaction - Stage 1   [ Time Frame: Baseline up to Day 112 ]

29.  Other Pre-specified:   Number of Participants With Injection Site Reaction - Stage 2/3   [ Time Frame: Baseline up to Day 112 ]

30.  Other Pre-specified:   Number of Participants With Laboratory Test Abnormalities of Potential Clinical Importance - Stage 1   [ Time Frame: Baseline up to Day 112 ]

31.  Other Pre-specified:   Number of Participants With Laboratory Test Abnormalities of Potential Clinical Importance - Stage 2/3   [ Time Frame: Baseline up to Day 112 ]


  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
The study was stopped early due to futility of the interim efficacy analysis results. Hence, only safety results and key efficacy results were presented for this study.


  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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00425061     History of Changes
Other Study ID Numbers: 3174K1-201, B2421007
Study First Received: January 18, 2007
Results First Received: November 6, 2014
Last Updated: January 12, 2015
Health Authority: United States: Food and Drug Administration