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| ID | Type | Description | Link |
|---|---|---|---|
| B2421001 | Other Identifier | Alias Study Number |
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Primary purpose of the protocol is to determine if IMA-638 prevents a mild asthma attack by a subject with mild asthma inhaling an allergen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMA-638 is a biologic | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Screening | 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. | Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Screening (Day -14) |
| Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 14 | 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. | Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 14 |
| Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 35 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. |
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Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia | Vancouver | British Columbia | V5Z 1M9 | Canada | ||
| University of British Columbia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21057005 | Derived | Gauvreau GM, Boulet LP, Cockcroft DW, Fitzgerald JM, Carlsten C, Davis BE, Deschesnes F, Duong M, Durn BL, Howie KJ, Hui L, Kasaian MT, Killian KJ, Strinich TX, Watson RM, Y N, Zhou S, Raible D, O'Byrne PM. Effects of interleukin-13 blockade on allergen-induced airway responses in mild atopic asthma. Am J Respir Crit Care Med. 2011 Apr 15;183(8):1007-14. doi: 10.1164/rccm.201008-1210OC. Epub 2010 Nov 5. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | IMA-638 2mg/kg | IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8. |
| FG001 | Placebo | Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intent-to-treat population (ITT) included all randomized participants who received at least 1 dose administration of the test article.
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| ID | Title | Description |
|---|---|---|
| BG000 | IMA-638 2mg/kg | IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8. |
| BG001 | Placebo | Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Screening | 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. | ITT population included all randomized participants who received at least 1 dose administration of the test article. | Posted | Mean | Standard Deviation | percent drop | Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Screening (Day -14) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IMA-638 2mg/kg | IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 35 |
| Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Screening (Day -14), Day 14, 35 |
| 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 | 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. | Pre-allergen baseline, 10, 20, 30, 45, 60, 90, 120, 180 minutes post-allergen inhalation Screening, Day 14, 35 |
| 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) | 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. | Pre-allergen baseline, 10, 20, 30, 45, 60, 90, 120, 180 minutes post-allergen inhalation Screening, Day 14, 35 |
| 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 | 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). | Day -15, -13 for Screening (Day -14) challenge; Day 13, 15 for Day 14 challenge; Day 34, 36 for Day 35 challenge |
| Change From Baseline in Total and Differential Sputum Cell Counts at Day 14 and 35 | 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. | Baseline, Day 14, 35 |
| Allergen Specific and Total Immunoglobulin E (IgE) Count at Baseline | 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. | Baseline |
| Change From Baseline in Allergen Specific and Total Immunoglobulin E (IgE) Count at Day 13, 34, 56, 112 and 168 | 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. | Baseline, Day 13, 34, 56, 112, 168 |
| Total Blood Eosinophil Counts at Baseline | 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). | Baseline |
| Change From Baseline in Total Blood Eosinophil Counts at Day 8, 13, 21, 34, 56, 84 and 168 | 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). | Baseline, Day 8, 13, 21, 34, 56, 84, 168 |
| Blood Levels of Interleukin-13 (IL-13) | Screening, baseline, Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168 |
| Messenger Ribonucleic Acid (mRNA) Gene Expression in Sputum and Blood | 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. | Screening (Day-13, -14, -15), Day 1, 13, 14, 15, 34, 35, 36, 112 |
| Protein Expression in Sputum and Blood | 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. | Screening (Day-13, -14, -15), Day 1, 13, 14, 15, 34, 35, 36, 112 |
| Maximum Observed Serum Concentration (Cmax) for IMA-638 | Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168 |
| Time to Reach Maximum Observed Serum Concentration (Tmax) for IMA-638 | Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168 |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] for IMA-638 | Area under the plasma concentration time-curve from zero to the last measured concentration (AUC0-t). | Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168 |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for IMA-638 | 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 - ∞). | Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168 |
| Serum Decay Half-Life (t1/2) for IMA-638 | Serum decay half-life is the time measured for the serum concentration to decrease by one half. | Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168 |
| Number of Participants With Antibodies to IMA-638 | Baseline up to Day 168 |
| Vancouver |
| British Columbia |
| V5Z 3J5 |
| Canada |
| McMaster University Medical | Hamilton | Ontario | L8N 3Z5 | Canada |
| Hopital Laval | Ste-Foy | Quebec | G1V 4G5 | Canada |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| IMA-638 2mg/kg |
IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8. |
| OG001 | Placebo | Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8. |
|
|
| Primary | Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 14 | 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. | ITT population included all randomized participants who received at least 1 dose administration of the test article. | Posted | Mean | Standard Deviation | percent drop | Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 14 |
|
|
|
|
| Primary | Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 35 | 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. | ITT population included all randomized participants who received at least 1 dose administration of the test article. | Posted | Mean | Standard Deviation | percent drop | Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 35 |
|
|
|
|
| Secondary | 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) | 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. | ITT population included all randomized participants who received at least 1 dose administration of the test article. | Posted | Mean | Standard Deviation | Percent drop*hour | Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Screening (Day -14), Day 14, 35 |
|
|
|
|
| Secondary | 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 | 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. | ITT population included all randomized participants who received at least 1 dose administration of the test article. | Posted | Mean | Standard Deviation | percent drop | Pre-allergen baseline, 10, 20, 30, 45, 60, 90, 120, 180 minutes post-allergen inhalation Screening, Day 14, 35 |
|
|
|
|
| Secondary | 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) | 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. | ITT population included all randomized participants who received at least 1 dose administration of the test article. | Posted | Mean | Standard Deviation | percent drop*hour | Pre-allergen baseline, 10, 20, 30, 45, 60, 90, 120, 180 minutes post-allergen inhalation Screening, Day 14, 35 |
|
|
|
|
| Secondary | 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 | 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). | ITT population included all randomized participants who received at least 1 dose administration of the test article. | Posted | Mean | Standard Deviation | Log2 milligram/milliliter (log2 mg/mL) | Day -15, -13 for Screening (Day -14) challenge; Day 13, 15 for Day 14 challenge; Day 34, 36 for Day 35 challenge |
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| Secondary | Change From Baseline in Total and Differential Sputum Cell Counts at Day 14 and 35 | 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. | Data was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed. | Posted | Baseline, Day 14, 35 |
|
|
| Secondary | Allergen Specific and Total Immunoglobulin E (IgE) Count at Baseline | 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. | 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. | Posted | Mean | Standard Deviation | kilo unit/liter (kU/L) | Baseline |
|
|
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| Secondary | Change From Baseline in Allergen Specific and Total Immunoglobulin E (IgE) Count at Day 13, 34, 56, 112 and 168 | 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. | 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. | Posted | Mean | Standard Error | kU/L | Baseline, Day 13, 34, 56, 112, 168 |
|
|
|
| Secondary | Total Blood Eosinophil Counts at Baseline | 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). | ITT population included all randomized participants who received at least 1 dose administration of the test article. | Posted | Mean | Standard Deviation | 10^9 cells/Liter | Baseline |
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| Secondary | Change From Baseline in Total Blood Eosinophil Counts at Day 8, 13, 21, 34, 56, 84 and 168 | 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). | 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. | Posted | Mean | Standard Error | 10^9 cells/Liter | Baseline, Day 8, 13, 21, 34, 56, 84, 168 |
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| Secondary | Blood Levels of Interleukin-13 (IL-13) | 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. | Posted | Screening, baseline, Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168 |
|
|
| Secondary | Messenger Ribonucleic Acid (mRNA) Gene Expression in Sputum and Blood | 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. | 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. | Posted | Screening (Day-13, -14, -15), Day 1, 13, 14, 15, 34, 35, 36, 112 |
|
|
| Secondary | Protein Expression in Sputum and Blood | 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. | 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. | Posted | Screening (Day-13, -14, -15), Day 1, 13, 14, 15, 34, 35, 36, 112 |
|
|
| Secondary | Maximum Observed Serum Concentration (Cmax) for IMA-638 | Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data. | Posted | Mean | Standard Deviation | microgram/milliliter(mcg/mL) | Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168 |
|
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| Secondary | Time to Reach Maximum Observed Serum Concentration (Tmax) for IMA-638 | Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data. | Posted | Mean | Standard Deviation | days | Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168 |
|
|
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| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] for IMA-638 | Area under the plasma concentration time-curve from zero to the last measured concentration (AUC0-t). | Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data. | Posted | Mean | Standard Deviation | microgram*hour/milliliter (mcg*hr/mL) | Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168 |
|
|
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| Secondary | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for IMA-638 | 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 - ∞). | Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data. | Posted | Mean | Standard Deviation | mcg*hr/mL | Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168 |
|
|
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| Secondary | Serum Decay Half-Life (t1/2) for IMA-638 | Serum decay half-life is the time measured for the serum concentration to decrease by one half. | Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data. | Posted | Mean | Standard Deviation | days | Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168 |
|
|
|
| Secondary | Number of Participants With Antibodies to IMA-638 | ITT population included all randomized participants who received at least 1 dose administration of the test article. | Posted | Number | participants | Baseline up to Day 168 |
|
|
|
| 0 |
| 14 |
| 7 |
| 14 |
| EG001 | Placebo | Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8. | 0 | 13 | 8 | 13 |
| Conjunctivitis | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA | Non-systematic Assessment |
|
| Injection site paresthesia | General disorders | MedDRA | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Neck injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Syncope vasovagal | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
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.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Day 35 |
|
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. |
| ANOVA |
| 0.1326 |
| Mean Difference (Final Values) |
| -17.17 |
| 2-Sided |
| 95 |
| -39.72 |
| 5.39 |
| No |
| Superiority or Other |
| Day 35 |
|
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. |
| ANOVA |
| 0.3902 |
| Mean Difference (Final Values) |
| -4.06 |
| 2-Sided |
| 95 |
| -13.46 |
| 5.35 |
| No |
| Superiority or Other |
| Day 35 |
|
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. |
| ANOVA |
| 0.1289 |
| Mean Difference (Final Values) |
| -13.19 |
| 2-Sided |
| 95 |
| -30.34 |
| 3.97 |
| No |
| Superiority or Other |
| Day 35 |
|
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. |
| Mixed Models Analysis |
| 0.9995 |
| Mean Difference (Final Values) |
| -0.00 |
| 2-Sided |
| 95 |
| -0.86 |
| 0.86 |
| No |
| Superiority or Other |
| 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. | Mixed Models Analysis | 0.5280 | Mean Difference (Final Values) | -0.28 | 2-Sided | 95 | -1.14 | 0.59 | No | Superiority or Other |
| Change at Day 56 (n=13, 13) |
|
| Change at Day 112 (n=13, 13) |
|
| Change at Day 168 (n=14, 13) |
|
| Change at Day 21(n=14, 13) |
|
| Change at Day 34 (n=14, 13) |
|
| Change at Day 56 (n=12, 13) |
|
| Change at Day 84 (n=0, 1) |
|
| Change at Day 168 (n=14, 13) |
|