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Study Evaluating the Effects of IMA-638 on Allergen-Induced Airway Responses in Subjects With Mild Atopic Asthma

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.
 
ClinicalTrials.gov Identifier: NCT00410280
Recruitment Status : Completed
First Posted : December 12, 2006
Results First Posted : November 18, 2014
Last Update Posted : November 18, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Asthma
Intervention Biological: IMA-638 is a biologic
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IMA-638 2mg/kg Placebo
Hide Arm/Group Description IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8. Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Period Title: Overall Study
Started 14 13
Completed 14 13
Not Completed 0 0
Arm/Group Title IMA-638 2mg/kg Placebo Total
Hide Arm/Group Description IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8. Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8. Total of all reporting groups
Overall Number of Baseline Participants 14 13 27
Hide Baseline Analysis Population Description
Intent-to-treat population (ITT) included all randomized participants who received at least 1 dose administration of the test article.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 13 participants 27 participants
26.14  (6.25) 32.31  (11.66) 29.11  (9.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 27 participants
Female
7
  50.0%
8
  61.5%
15
  55.6%
Male
7
  50.0%
5
  38.5%
12
  44.4%
1.Primary Outcome
Title Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Screening
Hide Description Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. LAR was characterized by a fall in FEV1 of more than or equal to (>=) 15 percent (%) at 3 to 7 hours post-allergen inhalation. Maximum drop in FEV1 relative to the pre-allergen baseline FEV1 between 3 to 7 hours at Screening was reported. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.
Time Frame Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Screening (Day -14)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 dose administration of the test article.
Arm/Group Title IMA-638 2mg/kg Placebo
Hide Arm/Group Description:
IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: percent drop
27.19  (9.75) 20.47  (8.12)
2.Primary Outcome
Title Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 14
Hide Description Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. LAR was characterized by a fall in FEV1 of more than or equal to (>=) 15 percent (%) at 3 to 7 hours post-allergen inhalation. Maximum drop in FEV1 relative to the pre-allergen baseline FEV1 between 3 to 7 hours on Day 14 was reported. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.
Time Frame Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 dose administration of the test article.
Arm/Group Title IMA-638 2mg/kg Placebo
Hide Arm/Group Description:
IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: percent drop
12.84  (10.29) 19.28  (10.69)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IMA-638 2mg/kg, Placebo
Comments Repeated measures analysis of variance (ANOVA) model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95 % confidence interval (CI) and p-value were derived from the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0947
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.44
Confidence Interval (2-Sided) 95%
-14.04 to 1.15
Estimation Comments [Not Specified]
3.Primary Outcome
Title Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 35
Hide Description Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. LAR was characterized by a fall in FEV1 of more than or equal to (>=) 15 percent (%) at 3 to 7 hours post-allergen inhalation. Maximum drop in FEV1 relative to the pre-allergen baseline FEV1 between 3 to 7 hours on Day 35 was reported. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.
Time Frame Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 35
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 dose administration of the test article.
Arm/Group Title IMA-638 2mg/kg Placebo
Hide Arm/Group Description:
IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: percent drop
11.32  (9.39) 15.56  (10.45)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IMA-638 2mg/kg, Placebo
Comments Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2673
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.24
Confidence Interval (2-Sided) 95%
-11.84 to 3.35
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Area Under the Percent Drop in Forced Expiratory Volume in 1 Second Curve (AUC FEV1) From Time 3 to 7 Hours for Late-Phase Asthma Response (LAR)
Hide Description Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. LAR was characterized by a fall in FEV1 of >=15% at 3 to 7 hours post-allergen inhalation. Area under the percent drop in FEV1 relative to the pre-allergen baseline FEV1 from 3 to 7 hours was computed using the linear trapezoidal rule. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.
Time Frame Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Screening (Day -14), Day 14, 35
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 dose administration of the test article.
Arm/Group Title IMA-638 2mg/kg Placebo
Hide Arm/Group Description:
IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: Percent drop*hour
Screening 57.57  (24.26) 55.64  (27.78)
Day 14 25.48  (29.49) 49.28  (32.66)
Day 35 21.94  (21.27) 39.11  (37.46)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IMA-638 2mg/kg, Placebo
Comments Day 14: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0391
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -23.80
Confidence Interval (2-Sided) 95%
-46.35 to -1.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IMA-638 2mg/kg, Placebo
Comments Day 35: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1326
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -17.17
Confidence Interval (2-Sided) 95%
-39.72 to 5.39
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Early-Phase Asthma Response (EAR) at Screening, Day 14 and 35
Hide Description Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. EAR was characterized by a fall in FEV1 >=20% at 0 to 3 hours post-allergen inhalation. Maximum drop in FEV1 relative to the pre-allergen baseline FEV1 between 0 to 3 hours was reported. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.
Time Frame Pre-allergen baseline, 10, 20, 30, 45, 60, 90, 120, 180 minutes post-allergen inhalation Screening, Day 14, 35
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 dose administration of the test article.
Arm/Group Title IMA-638 2mg/kg Placebo
Hide Arm/Group Description:
IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: percent drop
Screening 33.23  (6.26) 34.40  (8.51)
Day 14 20.40  (14.98) 30.15  (13.57)
Day 35 22.76  (13.51) 26.82  (13.56)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IMA-638 2mg/kg, Placebo
Comments Day 14: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0423
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.76
Confidence Interval (2-Sided) 95%
-19.16 to -0.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IMA-638 2mg/kg, Placebo
Comments Day 35: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3902
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.06
Confidence Interval (2-Sided) 95%
-13.46 to 5.35
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Area Under the Percent Drop in Forced Expiratory Volume in 1 Second Curve (AUC FEV1) From Time 0 to 3 Hours for Early-Phase Asthma Response (EAR)
Hide Description Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. EAR was characterized by a fall in FEV1 >=20% at 0 to 3 hours post-allergen inhalation. Area under the percent drop in FEV1 relative to the pre-allergen baseline FEV1 from 0 to 3 hours at each visit was computed using the linear trapezoidal rule. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.
Time Frame Pre-allergen baseline, 10, 20, 30, 45, 60, 90, 120, 180 minutes post-allergen inhalation Screening, Day 14, 35
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 dose administration of the test article.
Arm/Group Title IMA-638 2mg/kg Placebo
Hide Arm/Group Description:
IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: percent drop*hour
Screening 45.37  (15.03) 50.39  (24.09)
Day 14 21.51  (23.20) 40.56  (26.62)
Day 35 25.75  (18.21) 38.94  (24.42)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IMA-638 2mg/kg, Placebo
Comments Day 14: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0302
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -19.05
Confidence Interval (2-Sided) 95%
-36.21 to -1.90
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IMA-638 2mg/kg, Placebo
Comments Day 35: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1289
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.19
Confidence Interval (2-Sided) 95%
-30.34 to 3.97
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Pre-allergen Challenge in Provocative Concentration of Methacholine Causing a 20% Fall in FEV1 (PC20) to Post-allergen Challenge For Screening, Day 14 and 35 Challenge
Hide Description Methacholine inhalation test was performed to determine airway hyper-reactivity using provocative concentration 20 (PC20). PC20 was the lowest concentration of methacholine at which participant had 20% decrease from baseline in FEV1. Pre-allergen challenge methacholine inhalation test was performed 1 day prior to the allergen challenge and post-allergen challenge methacholine inhalation test was performed 1 day after to the allergen challenge (that is, pre- and post-allergen methacholine inhalation test was conducted on Day -15 and -13 for Screening allergen challenge, Day 13 and 15 for Day 14 allergen challenge and Day 34 and 36 for Day 35 allergen challenge, respectively). For each methacholine inhalation test, baseline FEV1 was defined as the lowest value among the triplicate readings taken after administration of the diluent (saline administration). Difference between post-allergen challenge and pre-allergen challenge was expressed as log2 (post-allergen PC20 - pre-allergen PC20).
Time Frame Day -15, -13 for Screening (Day -14) challenge; Day 13, 15 for Day 14 challenge; Day 34, 36 for Day 35 challenge
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 dose administration of the test article.
Arm/Group Title IMA-638 2mg/kg Placebo
Hide Arm/Group Description:
IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: Log2 milligram/milliliter (log2 mg/mL)
Screening -1.37  (0.74) -1.47  (1.72)
Day 14 -0.63  (1.20) -0.63  (1.28)
Day 35 -0.71  (0.97) -0.43  (0.72)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IMA-638 2mg/kg, Placebo
Comments Screening: Mixed model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participants was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-values were derived from the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8469
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.09
Confidence Interval (2-Sided) 95%
-0.79 to 0.96
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IMA-638 2mg/kg, Placebo
Comments Day 14: Mixed model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participants was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-values were derived from the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9995
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.00
Confidence Interval (2-Sided) 95%
-0.86 to 0.86
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection IMA-638 2mg/kg, Placebo
Comments Day 35: Mixed model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participants was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-values were derived from the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5280
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-1.14 to 0.59
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Total and Differential Sputum Cell Counts at Day 14 and 35
Hide Description The collected sputum was planned to be analyzed for epithelial cells, eosinophils, lymphocytes, neutrophils, metachromatic cells, or macrophages counts. Sputum induction was to be performed after each methacholine challenge and at 7 hours after each allergen inhalation challenge.
Time Frame Baseline, Day 14, 35
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed.
Arm/Group Title IMA-638 2mg/kg Placebo
Hide Arm/Group Description:
IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Allergen Specific and Total Immunoglobulin E (IgE) Count at Baseline
Hide Description The baseline for the outcome measure was defined as the last post-dose measurement obtained prior to the allergen challenge within a given challenge triad (planned on day 13 and 34). The challenge triad included pre-allergen methacholine inhalation challenge, allergen inhalation challenge, and post-allergen methacholine inhalation challenge. Results are reported for total IgE count.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 dose administration of the test article. Allergen-specific IgE was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed.
Arm/Group Title IMA-638 2mg/kg Placebo
Hide Arm/Group Description:
IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: kilo unit/liter (kU/L)
259.7  (395.8) 179.8  (204.7)
10.Secondary Outcome
Title Change From Baseline in Allergen Specific and Total Immunoglobulin E (IgE) Count at Day 13, 34, 56, 112 and 168
Hide Description The baseline for the outcome measure was defined as the last post-dose measurement obtained prior to the allergen challenge (planned on Day 13 and 34). Results are reported for total IgE count.
Time Frame Baseline, Day 13, 34, 56, 112, 168
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here, "n" signifies participants evaluated for this measure at the specified time point for each arm. Allergen-specific IgE was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed.
Arm/Group Title IMA-638 2mg/kg Placebo
Hide Arm/Group Description:
IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Overall Number of Participants Analyzed 14 13
Mean (Standard Error)
Unit of Measure: kU/L
Change at Day 13 (n=14, 13) 29.1  (23.1) -4.4  (10.9)
Change at Day 34 (n=14, 13) 37.4  (43.9) 1.5  (8.4)
Change at Day 56 (n=13, 13) 4.2  (8.6) -14.2  (13.8)
Change at Day 112 (n=13, 13) -9.2  (21.9) -32.0  (16.3)
Change at Day 168 (n=14, 13) -40.0  (55.6) -12.2  (31.6)
11.Secondary Outcome
Title Total Blood Eosinophil Counts at Baseline
Hide Description The baseline for the outcome measure was defined as the last post-dose measurement obtained prior to the allergen challenge (planned on day 13 and 34).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 dose administration of the test article.
Arm/Group Title IMA-638 2mg/kg Placebo
Hide Arm/Group Description:
IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/Liter
0.276  (0.140) 0.315  (0.469)
12.Secondary Outcome
Title Change From Baseline in Total Blood Eosinophil Counts at Day 8, 13, 21, 34, 56, 84 and 168
Hide Description The baseline for the outcome measure was defined as the last post-dose measurement obtained prior to the allergen challenge (planned on Day 13 and 34).
Time Frame Baseline, Day 8, 13, 21, 34, 56, 84, 168
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 dose administration of the test article. Here, "n" signifies participants evaluated for this measure at the specified time point for each arm.
Arm/Group Title IMA-638 2mg/kg Placebo
Hide Arm/Group Description:
IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Overall Number of Participants Analyzed 14 13
Mean (Standard Error)
Unit of Measure: 10^9 cells/Liter
Change at Day 8 (n=14,13) 0.051  (0.039) -0.112  (0.090)
Change at Day 13 (n=14, 13) 0.089  (0.044) -0.056  (0.091)
Change at Day 21(n=14, 13) 0.060  (0.062) -0.008  (0.035)
Change at Day 34 (n=14, 13) 0.026  (0.042) -0.022  (0.039)
Change at Day 56 (n=12, 13) 0.023  (0.051) -0.128  (0.072)
Change at Day 84 (n=0, 1) NA [1]   (NA) 0.030 [2]   (NA)
Change at Day 168 (n=14, 13) -0.007  (0.051) -0.141  (0.138)
[1]
Data was not presented because none of the participants were evaluable at Day 84 for this reporting arm.
[2]
Standard Error could not been estimated as single participant was evaluable for this reporting arm.
13.Secondary Outcome
Title Blood Levels of Interleukin-13 (IL-13)
Hide Description [Not Specified]
Time Frame Screening, baseline, Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed.
Arm/Group Title IMA-638 2mg/kg Placebo
Hide Arm/Group Description:
IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Messenger Ribonucleic Acid (mRNA) Gene Expression in Sputum and Blood
Hide Description Sputum induction was performed after each methacholine challenge and at hour 7 after each allergen inhalation challenge. The baseline for this outcome measure was defined as the last value prior to dosing.
Time Frame Screening (Day-13, -14, -15), Day 1, 13, 14, 15, 34, 35, 36, 112
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed.
Arm/Group Title IMA-638 2mg/kg Placebo
Hide Arm/Group Description:
IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Protein Expression in Sputum and Blood
Hide Description Sputum induction was performed after each methacholine challenge and at hour 7 after each allergen inhalation challenge. The baseline for this outcome measure was defined as the last value prior to dosing.
Time Frame Screening (Day-13, -14, -15), Day 1, 13, 14, 15, 34, 35, 36, 112
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure w as not analyzed because the study w as stopped early after interim analysis and only safety and key efficacy analyses w ere performed.
Arm/Group Title IMA-638 2mg/kg Placebo
Hide Arm/Group Description:
IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Maximum Observed Serum Concentration (Cmax) for IMA-638
Hide Description [Not Specified]
Time Frame Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data.
Arm/Group Title IMA-638 2mg/kg
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IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: microgram/milliliter(mcg/mL)
30.5  (6.4)
17.Secondary Outcome
Title Time to Reach Maximum Observed Serum Concentration (Tmax) for IMA-638
Hide Description [Not Specified]
Time Frame Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data.
Arm/Group Title IMA-638 2mg/kg
Hide Arm/Group Description:
IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: days
8.5  (4.4)
18.Secondary Outcome
Title Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] for IMA-638
Hide Description Area under the plasma concentration time-curve from zero to the last measured concentration (AUC0-t).
Time Frame Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data.
Arm/Group Title IMA-638 2mg/kg
Hide Arm/Group Description:
IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: microgram*hour/milliliter (mcg*hr/mL)
32259.13  (6255.88)
19.Secondary Outcome
Title Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for IMA-638
Hide Description AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Time Frame Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data.
Arm/Group Title IMA-638 2mg/kg
Hide Arm/Group Description:
IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: mcg*hr/mL
32609.32  (6369.46)
20.Secondary Outcome
Title Serum Decay Half-Life (t1/2) for IMA-638
Hide Description Serum decay half-life is the time measured for the serum concentration to decrease by one half.
Time Frame Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data.
Arm/Group Title IMA-638 2mg/kg
Hide Arm/Group Description:
IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: days
25.1  (4.7)
21.Secondary Outcome
Title Number of Participants With Antibodies to IMA-638
Hide Description [Not Specified]
Time Frame Baseline up to Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 dose administration of the test article.
Arm/Group Title IMA-638 2mg/kg Placebo
Hide Arm/Group Description:
IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Overall Number of Participants Analyzed 14 13
Measure Type: Number
Unit of Measure: participants
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IMA-638 2mg/kg Placebo
Hide Arm/Group Description IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8. Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
All-Cause Mortality
IMA-638 2mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
IMA-638 2mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/13 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IMA-638 2mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   7/14 (50.00%)   8/13 (61.54%) 
Blood and lymphatic system disorders     
Lymphadenopathy * 1  1/14 (7.14%)  0/13 (0.00%) 
Eye disorders     
Conjunctivitis * 1  1/14 (7.14%)  0/13 (0.00%) 
Gastrointestinal disorders     
Abdominal pain * 1  0/14 (0.00%)  1/13 (7.69%) 
Haematochezia * 1  0/14 (0.00%)  1/13 (7.69%) 
Nausea * 1  1/14 (7.14%)  0/13 (0.00%) 
General disorders     
Injection site bruising * 1  0/14 (0.00%)  1/13 (7.69%) 
Injection site erythema * 1  1/14 (7.14%)  0/13 (0.00%) 
Injection site paresthesia * 1  0/14 (0.00%)  1/13 (7.69%) 
Injection site swelling * 1  1/14 (7.14%)  1/13 (7.69%) 
Infections and infestations     
Gastroenteritis * 1  0/14 (0.00%)  2/13 (15.38%) 
Nasopharyngitis * 1  2/14 (14.29%)  1/13 (7.69%) 
Pharyngitis * 1  0/14 (0.00%)  1/13 (7.69%) 
Sinusitis * 1  0/14 (0.00%)  1/13 (7.69%) 
Urinary tract infection * 1  0/14 (0.00%)  2/13 (15.38%) 
Viral upper respiratory tract infection * 1  1/14 (7.14%)  1/13 (7.69%) 
Injury, poisoning and procedural complications     
Neck injury * 1  0/14 (0.00%)  1/13 (7.69%) 
Procedural dizziness * 1  1/14 (7.14%)  0/13 (0.00%) 
Procedural pain * 1  1/14 (7.14%)  0/13 (0.00%) 
Investigations     
Lymphocyte count decreased * 1  0/14 (0.00%)  1/13 (7.69%) 
White blood cell count decreased * 1  0/14 (0.00%)  1/13 (7.69%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/14 (7.14%)  0/13 (0.00%) 
Nervous system disorders     
Headache * 1  0/14 (0.00%)  1/13 (7.69%) 
Syncope * 1  1/14 (7.14%)  0/13 (0.00%) 
Syncope vasovagal * 1  1/14 (7.14%)  0/13 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  2/14 (14.29%)  0/13 (0.00%) 
Pharyngolaryngeal pain * 1  3/14 (21.43%)  2/13 (15.38%) 
Skin and subcutaneous tissue disorders     
Rash * 1  0/14 (0.00%)  1/13 (7.69%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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.
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00410280    
Other Study ID Numbers: 3174K1-200
B2421001 ( Other Identifier: Alias Study Number )
First Submitted: December 8, 2006
First Posted: December 12, 2006
Results First Submitted: November 7, 2014
Results First Posted: November 18, 2014
Last Update Posted: November 18, 2014