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Study is replaced by MI-CP198 per CPM.
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To evaluate the effect of MEDI-528 in adults with atopic asthma.
To evaluate the effect of MEDI-528 on the change in biologically active IL-9 levels in BAL fluid following segmental allergen challenge in adults with atopic asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEDI528 9 mg/kg | Experimental | MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion |
|
| PLACEBO | Placebo Comparator | Placebo administered as a single intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PLACEBO | Other | Placebo administered as a single intravenous infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Listing of Total Interleukin-9 (IL-9) Counts by Enzyme-linked Immunosorbent Assay in Bronchoalveolar Lavage Fluid (BAL) | The response of biologically active IL-9 in BAL fluid to the segmental allergen challenge, 1-2 days after the applying the allergen, prior to and 2 weeks after investigational product administration. | Baseline (2 to 4 weeks prior to Day 0) and Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Number of participants experiencing adverse events (includes both adverse events and serious adverse events) | Days 0 - 126 |
| Incidence of Serious Adverse Events | Number of participants experiencing serious adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Parker, M.D. | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham & Women's Hospital Asthma Research | Boston | Massachusetts | 02115-6106 | United States | ||
| Washington Univeristy School of Medicine, Division of Pulmonary and Critical Care Medicine |
Treatment assignments were determined using a block randomization procedure with a 1:1 ratio through an interactive voice response system. Only participants who had detectable levels of interleukin-9 in the Baseline Visit 2' bronchioalveolar lavage sample will be randomized.
A total of 11 adult participants participated in the study between 19Jul2007 and 15Oct2008 at 2 sites in the United States of America.
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| ID | Title | Description |
|---|---|---|
| FG000 | PLACEBO | Placebo administered as a single intravenous dose |
| FG001 | MEDI528 9 mg | MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PLACEBO | Placebo administered as a single intravenous dose |
| BG001 | MEDI528 9 mg | MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion |
| 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 | Listing of Total Interleukin-9 (IL-9) Counts by Enzyme-linked Immunosorbent Assay in Bronchoalveolar Lavage Fluid (BAL) | The response of biologically active IL-9 in BAL fluid to the segmental allergen challenge, 1-2 days after the applying the allergen, prior to and 2 weeks after investigational product administration. | All subjects who were randomized (n=11), received at least one dose of investigational product (MEDI-528 or placebo; n=10), and completed the 2-day BAL and segmental allergen challenge procedures at baseline (2-4 weeks prior to Day 0) and on Days 14 and 15 (n=2; 1 subject in each treatment group). | Posted | Number | Picograms per milliliter | Baseline (2 to 4 weeks prior to Day 0) and Day 15 |
|
Not provided
Not provided
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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 | PLACEBO | Placebo administered as a single intravenous dose |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph Parker, MD | MedImmune | 301-398-0000 | parkerj@medimmune.com |
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C542276 | enokizumab |
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| MEDI528 9 mg/kg |
| Biological |
MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion |
|
| Days 0 - 126 |
| Incidence of Anti-drug Antibodies (ADA) to MEDI-528 | Number of participants with ADA to MEDI-528 | Days 0, 28, 56, 84, and 126 |
| Time to Peak Concentration (Tmax) | Tmax of MEDI-528 | Days 0, 1, 7, 14, 15, 28, 56, 84, and 126 |
| Peak Concentration (Cmax) | Cmax of MEDI-528 | Days 0, 1, 7, 14, 15, 28, 56, 84, and 126 |
| Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)] | AUC(0-t) of MEDI-528 | Days 0, 1, 7, 14, 15, 28, 56, 84, and 126 |
| Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)] | AUC(0-infinity) of MEDI-528 | Days 0, 1, 7, 14, 15, 28, 56, 84, and 126 |
| Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)] | AUC(ext) of MEDI-528 | Days 0, 1, 7, 14, 15, 28, 56, 84, and 126 |
| Clearance (CL) | CL of MEDI-528 | Days 0, 1, 7, 14, 15, 28, 56, 84, and 126 |
| Terminal Half-life (T1/2) | T1/2 of MEDI-528 | Days 0, 1, 7, 14, 15, 28, 56, 84, and 126 |
| Volume at Steady State (Vss) | Vss of MEDI-528 | Days 0, 1, 7, 14, 15, 28, 56, 84, and 126 |
| Volume at Distribution (Vz) | Vz of MEDI-528 | Days 0, 1, 7, 14, 15, 28, 56, 84, and 126 |
| St Louis |
| Missouri |
| 63110 |
| United States |
| Wake Forest University, Baptist Medicial Center | Winston-Salem | North Carolina | 27157 | United States |
| University of Wisconsin, Section of Allergy, Pulmonary & Critical Care | Madison | Wisconsin | 53792 | United States |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| MEDI528 9 mg/kg |
MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion |
|
|
| Secondary | Incidence of Adverse Events | Number of participants experiencing adverse events (includes both adverse events and serious adverse events) | All participants who were randomized (n=11) and received at least one dose of investigational product (MEDI-528 or placebo; n=10). | Posted | Number | Participants | Days 0 - 126 |
|
|
|
| Secondary | Incidence of Serious Adverse Events | Number of participants experiencing serious adverse events | All participants who were randomized (n=11) and received at least one dose of investigational product (MEDI-528 or placebo; n=10). | Posted | Number | Participants | Days 0 - 126 |
|
|
|
| Secondary | Incidence of Anti-drug Antibodies (ADA) to MEDI-528 | Number of participants with ADA to MEDI-528 | All participants who were randomized (n=11) and received at least one dose of investigational product (MEDI-528 or placebo; n=10). One subject in the 9 mg/kg group had no sample collected on Day 126. | Posted | Number | Participants | Days 0, 28, 56, 84, and 126 |
|
|
|
| Secondary | Time to Peak Concentration (Tmax) | Tmax of MEDI-528 | All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4) | Posted | Geometric Mean | Geometric Coefficient of Variation | Day | Days 0, 1, 7, 14, 15, 28, 56, 84, and 126 |
|
|
|
| Secondary | Peak Concentration (Cmax) | Cmax of MEDI-528 | All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4) | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | Days 0, 1, 7, 14, 15, 28, 56, 84, and 126 |
|
|
|
| Secondary | Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)] | AUC(0-t) of MEDI-528 | All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4) | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram times day per milliliter | Days 0, 1, 7, 14, 15, 28, 56, 84, and 126 |
|
|
|
| Secondary | Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)] | AUC(0-infinity) of MEDI-528 | All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4) | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram times day per milliliter | Days 0, 1, 7, 14, 15, 28, 56, 84, and 126 |
|
|
|
| Secondary | Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)] | AUC(ext) of MEDI-528 | All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4) | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage of Total Area | Days 0, 1, 7, 14, 15, 28, 56, 84, and 126 |
|
|
|
| Secondary | Clearance (CL) | CL of MEDI-528 | All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4) | Posted | Geometric Mean | Geometric Coefficient of Variation | Milliliters per day | Days 0, 1, 7, 14, 15, 28, 56, 84, and 126 |
|
|
|
| Secondary | Terminal Half-life (T1/2) | T1/2 of MEDI-528 | All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4) | Posted | Geometric Mean | Geometric Coefficient of Variation | Day | Days 0, 1, 7, 14, 15, 28, 56, 84, and 126 |
|
|
|
| Secondary | Volume at Steady State (Vss) | Vss of MEDI-528 | All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4) | Posted | Geometric Mean | Geometric Coefficient of Variation | Milliliter | Days 0, 1, 7, 14, 15, 28, 56, 84, and 126 |
|
|
|
| Secondary | Volume at Distribution (Vz) | Vz of MEDI-528 | All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4) | Posted | Geometric Mean | Geometric Coefficient of Variation | Milliliter | Days 0, 1, 7, 14, 15, 28, 56, 84, and 126 |
|
|
|
| 0 |
| 5 |
| 5 |
| 5 |
| EG001 | MEDI528 9 mg | MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion | 0 | 5 | 5 | 5 |
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Allergy to animal | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Post procedural swelling | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Procedural headache | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Breath sounds abnormal | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Migraine with aura | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nasal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |