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To study the effectiveness and safety of multiple-doses of MEDI-528 on asthma control in adult participants with uncontrolled, moderate-to-severe, persistent asthma.
The primary objective of this study is to evaluate the effect of multiple-dose subcutaneous (SC) administration of MEDI-528 on asthma control in adults with uncontrolled, moderate-to-severe, persistent asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEDI528 30 mg | Experimental | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
|
| MEDI528 100 mg | Experimental | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
|
| MEDI528 300 mg | Experimental | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
|
| Placebo | Experimental | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI528 30 mg | Biological | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change at Day 92 From Baseline in Mean Asthma Control Questionnaire (ACQ) Scores (Intent-toTreat Analysis) | Change at Day 92 from baseline (Day 1, prior to dosing) in mean ACQ scores in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful. | Day 92 |
| Measure | Description | Time Frame |
|---|---|---|
| Weighted Asthma Exacerbation Rate Through Day 92 (Intent-to-Treat Analysis) | Weighted asthma exacerbation rate (total number of exacerbation rate in each group per total duration of participant-year follow-up in each group) between Day 1 and Day 92 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject's asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy. |
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Inclusion Criteria
Subjects must meet all of the following criteria:
Male or female
Age 18 through 65 years at the time of screening
Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
Female subjects of childbearing potential who are sexually active with non-sterilized male partner must use adequate contraception from screening through the end of the study. An acceptable method of contraception is defined as one that has no higher than a 1% failure rate. Sustained abstinence is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception
Weight ≥ 45 kg but ≤ 120 kg and body mass index (BMI) between 18 and 35 kg/m2
Physician-diagnosed asthma by medical chart
Currently taking inhaled corticosteroids (ICS) or is a candidate to receive ICS per Expert Panel Report (EPR)-3
Pre-bronchodilator forced expiratory volume in 1 second (FEV1) value ≥ 40% at Day -28 and Day 1
A post-bronchodilator increase in FEV1 and/or FVC ≥ 12% and ≥ 200 mL at Day -28 OR meeting any one of the following criteria:
Uncontrolled asthma consistent with EPR-3. In the 28 days before screening, subjects should have a history of one or more of the following:
An Asthma Control Questionnaire (ACQ) score ≥ 1.5 at Day -28 and at Day 1.
At least one asthma exacerbation in the 12 months before screening that required intake of systemic corticosteroids after an unscheduled medical encounter or as agreed with a physician based on an asthma action plan that defines when oral steroids can be taken by the subject
Ability and willingness to complete the follow-up period through Day 323 as required by the protocol.
Exclusion Criteria
Any of the following would exclude the subject from participation in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Chad Oh, M.D. | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Pell City | Alabama | 35128 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24050312 | Derived | Oh CK, Leigh R, McLaurin KK, Kim K, Hultquist M, Molfino NA. A randomized, controlled trial to evaluate the effect of an anti-interleukin-9 monoclonal antibody in adults with uncontrolled asthma. Respir Res. 2013 Sep 19;14(1):93. doi: 10.1186/1465-9921-14-93. | |
| 21060320 | Derived | Lloyd CM, Hessel EM. Functions of T cells in asthma: more than just T(H)2 cells. Nat Rev Immunol. 2010 Dec;10(12):838-48. doi: 10.1038/nri2870. Epub 2010 Nov 9. |
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A total of 329 participants was randomized into the study, but 2 participants (1 in the MEDI-528 30 mg arm and 1 in the MEDI-528 300 mg arm) were randomized by mistake as they were screen failures. Therefore, a total of 327 participants were correctly randomized into the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks |
| FG001 | MEDI528 30 mg | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| MEDI528 100 mg | Biological | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
|
| MEDI528 300 mg | Biological | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
|
| Placebo | Other | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks |
|
| Days 1 - 92 |
| Weighted Asthma Exacerbation Rate Through Day 176 (Intent-to-Treat Analysis) | Weighted asthma exacerbation rate (total number of exacerbation rate in each group per total duration of participant-year follow-up in each group) between Day 1 and Day 176 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject's asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy. | Days 1 - 176 |
| Proportion of Participants Experiencing at Least One Asthma Exacerbation Through Day 92 (Intent-to-Treat Analysis) | The proportion of participants that experienced at least one asthma exacerbation between Day 1 and Day 92 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject's asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy. | Days 1 - 92 |
| Proportion of Participants Experiencing at Least One Asthma Exacerbation Through Day 176 (Intent-to-Treat Analysis) | The proportion of participants that experienced at least one asthma exacerbation between Day 1 and Day 176 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject's asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy. | Days 1 - 176 |
| Time to First Asthma Exacerbation Through Day 92 (Intent-to-Treat Analysis) | Time to first asthma exacerbation between Day 1 and Day 92 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject's asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy. | Days 1 - 92 |
| Time to First Asthma Exacerbation Through Day 176 (Intent-to-Treat Analysis) | Time to first asthma exacerbation between Day 1 and Day 176 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject's asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy. | Days 1 - 176 |
| Change at Day 176 From Baseline in Mean Asthma Control Questionnaire Scores (Intent-to-Treat Analysis) | Change at Day 176 from baseline (Day 1, prior to dosing) in mean ACQ scores in participants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful. | Day 176 |
| Proportion of Participants Achieving Mean Asthma Control Questionnaire (ACQ) Scores at Day 92 of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 (Intent-to-Treat Analysis) | Proportion of participants achieving mean ACQ scores of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 at Day 92 in participants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful. | Day 92 |
| Proportion of Participants Achieving Mean Asthma Control Questionnaire (ACQ) Scores at Day 176 of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 (Intent-to-Treat Analysis) | Proportion of participants achieving mean ACQ scores of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 at Day 176 in participants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful. | Day 176 |
| Time to First Observed Mean Asthma Control Questionnaire (ACQ) Change From Baseline > or = 0.5 Through Day 92 (Intent-to-Treat Analysis) | Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the time to first observed mean ACQ change from baseline (Day 1, prior to dosing) > or = 0.5 through Day 92 (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful. | Days 1 - 92 |
| Time to First Observed Mean Asthma Control Questionnaire (ACQ) Change From Baseline > or = 0.5 Through Day 176 (Intent-to-Treat Analysis) | Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the time to first observed mean ACQ change from baseline (Day 1, prior to dosing) > or = 1.5 Through Day 176 (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful. | Days 1 - 176 |
| Change at Day 92 From Baseline in Forced Expiratory Volume in One Second (FEV1) (Intent-to-Treat Analysis) | Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the mean change at Day 92 from baseline (Day 1, prior to dosing) in FEV1. | Day 92 |
| Change at Day 176 From Baseline in Forced Expiratory Volume in One Second (FEV1) (Intent-to-Treat Analysis) | Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the mean change from baseline (Day 1, prior to dosing) in FEV1 at Day 176 | Day 176 |
| Proportion of Participants Who Had a Asthma Quality of Life Questionnaire - Standard (AQLQ[S]) Assessment Response at Day 85 (Intent-to-Treat Analysis) | Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the proportion of participants who had an AQLQ(S) assessment response (defined as an improvement of at least 0.5 score in AQLQ[S]) at Day 85 (Intent-to-Treat Analysis). The AQLQ(S) is a 32-item questionnaire that measures the health related quality of life experienced by asthma patients. In the study, participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions. Individual improvement in the overall score of 0.5 has been identified as the minimally important difference, with score changes > 1.5 identified to be large meaningful differences. | Day 85 |
| Proportion of Participants Who Had a Asthma Quality of Life Questionnaire - Standard (AQLQ[S]) Assessment Response at Day 176 (Intent-to-Treat Analysis) | Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the proportion of participants who had an AQLQ(S) assessment response at Day 176 (Intent-to-Treat Analysis). The AQLQ(S) is a 32-item questionnaire that measures the health related quality of life experienced by asthma patients. In the study, participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions. Individual improvement in the overall score of 0.5 has been identified as the minimally important difference, with score changes > 1.5 identified to be large meaningful differences. | Day 176 |
| Proportion of Participants With Detectable Anti-drug Antibodies to MEDI-528 | Proportion of participants with detectable anti-drug antibodies to MEDI-528 in subjects receiving 30, 100, or 300 mg MEDI-528 and placebo | Days 1, 29, 57, 85, 127, 169, 176, 204,260, and 323 |
| First Dose Trough Concentration of MEDI-528 | First dose trough concentration of MEDI-528 measured on Day 15 prior to administration of the second dose of MEDI-528 (30, 100, or 300 mg). Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323. The first dose trough concentration of MEDI-528 was measured on Day 15 prior to the Day 15 dose. | Day 15 |
| Day 169 Steady State Trough Concentration of MEDI-528 | Trough concentration of MEDI-528 measured on Day 169 prior to administration of the last dose of MEDI-528 (30, 100, or 300 mg). Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323. Steady state trough concentration of MEDI-528 was measured on Day 169. | Day 169 |
| Half Life of MEDI-528 | Half life of MEDI-528 in subjects receiving 30, 100, or 300 mg MEDI-528. Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323. | Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323 |
| Accumulation Ratio of Trough Concentrations of MEDI-528 | Accumulation ratio of trough concentrations of MEDI-528 in subjects receiving 30, 100, or 300 mg MEDI-528. Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323. | Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323 |
| Los Angeles |
| California |
| 90025 |
| United States |
| Research Site | Sacramento | California | 95819 | United States |
| Research Site | San Diego | California | 92123 | United States |
| Research Site | Centennial | Colorado | 80112 | United States |
| Research Site | Colarado Springs | Colorado | 80907 | United States |
| Research Site | Thornton | Colorado | 80233 | United States |
| Research Site | Waterbury | Connecticut | 06708 | United States |
| Research Site | Kissimmee | Florida | 34741 | United States |
| Research Site | Normal | Illinois | 61761 | United States |
| Research Site | Overland Park | Kansas | 66210 | United States |
| Research Site | Louisville | Kentucky | 40215 | United States |
| Research Site | Baltimore | Maryland | 21236 | United States |
| Research Site | Silver Spring | Maryland | 20902 | United States |
| Research Site | North Dartmouth | Massachusetts | 02747 | United States |
| Research Site | Minneapolis | Minnesota | 55402 | United States |
| Research Site | Omaha | Nebraska | 68131 | United States |
| Research Site | Mount Laurel | New Jersey | 08054 | United States |
| Research Site | Sylvania | Ohio | 43560 | United States |
| Research Site | Medford | Oregon | 97504 | United States |
| Research Site | Lincoln | Rhode Island | 02865 | United States |
| Research Site | Greenville | South Carolina | 29607 | United States |
| Research Site | El Paso | Texas | 79903 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | Buenos Aire | Buenos Aires F.D. | 1425 | Argentina |
| Research Site | Ciudad Autonoma Bs As | Buenos Aires F.D. | 1405 | Argentina |
| Research Site | Rosario | Santa Fe Province | 2000 | Argentina |
| Research Site | San Miguel de Tucumán | Tucumán Province | T4000IAR | Argentina |
| Research Site | Buenos Aires | C1424BSF | Argentina |
| Research Site | Ciudad de Buenos Aire | 1425 | Argentina |
| Research Site | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Research Site | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Research Site | Florianópolis | Santa Catarina | 88040-970 | Brazil |
| Research Site | Santo André | 09060-870 | Brazil |
| Research Site | São Paulo | 05403-000 | Brazil |
| Research Site | Calgary | Alberta | T2N 4Z6 | Canada |
| Research Site | Edmonton | Alberta | T6G 2B7 | Canada |
| Research Site | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Research Site | Mississauga | Ontario | L5A 3V4 | Canada |
| Research Site | Ottawa | Ontario | K1Y 4G2 | Canada |
| Research Site | Montreal | Quebec | H2X 2P4 | Canada |
| Research Site | Québec | Quebec | G1V 4M6 | Canada |
| Research Site | Québec | Quebec | Canada |
| Research Site | Bogota DC | Cundinamarca | Colombia |
| Research Site | Bogota | Cundinamarca | Colombia |
| Research Site | Bogotá D.C. | Cundinamarca | Colombia |
| Research Site | San Francisco de Dos Ríos | Provincia de San José | Costa Rica |
| Research Site | Panama City | Panama |
| Research Site | Lima | Lima Province | Lima 27 | Peru |
| Research Site | Lima | Lima Province | LIMA 33 | Peru |
| Research Site | Lima | Lima Province | Peru |
| Research Site | Jesus Maria | Lima region | Lima 11 | Peru |
| Research Site | Lipa City | Batangas | Philippines |
| Research Site | Iloilo City | Iloilo | 5000 | Philippines |
| Research Site | Quezon City | National Capital Region | 870 | Philippines |
| Research Site | Kaohsiung City | Taiwan |
| Research Site | Taoyuan | Taiwan |
| FG002 | MEDI528 100 mg | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| FG003 | MEDI528 300 mg | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| COMPLETED |
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| NOT COMPLETED |
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|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks |
| BG001 | MEDI528 30 mg | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| BG002 | MEDI528 100 mg | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| BG003 | MEDI528 300 mg | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Change at Day 92 From Baseline in Mean Asthma Control Questionnaire (ACQ) Scores (Intent-toTreat Analysis) | Change at Day 92 from baseline (Day 1, prior to dosing) in mean ACQ scores in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful. | All participants randomized into the 30, 100, or 300 mg MEDI-528 (n=81, 83, or 81, respectively) or placebo (n=82) groups. | Posted | Mean | Standard Deviation | Scores on a scale | Day 92 |
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| Secondary | Weighted Asthma Exacerbation Rate Through Day 92 (Intent-to-Treat Analysis) | Weighted asthma exacerbation rate (total number of exacerbation rate in each group per total duration of participant-year follow-up in each group) between Day 1 and Day 92 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject's asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy. | All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo) | Posted | Number | 95% Confidence Interval | Exacerbations per participant year | Days 1 - 92 |
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| Secondary | Weighted Asthma Exacerbation Rate Through Day 176 (Intent-to-Treat Analysis) | Weighted asthma exacerbation rate (total number of exacerbation rate in each group per total duration of participant-year follow-up in each group) between Day 1 and Day 176 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject's asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy. | All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo) | Posted | Number | 95% Confidence Interval | Exacerbations per participant year | Days 1 - 176 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants Experiencing at Least One Asthma Exacerbation Through Day 92 (Intent-to-Treat Analysis) | The proportion of participants that experienced at least one asthma exacerbation between Day 1 and Day 92 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject's asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy. | All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo) | Posted | Number | Participants | Days 1 - 92 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants Experiencing at Least One Asthma Exacerbation Through Day 176 (Intent-to-Treat Analysis) | The proportion of participants that experienced at least one asthma exacerbation between Day 1 and Day 176 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject's asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy. | All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo) | Posted | Number | Participants | Days 1 - 176 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Asthma Exacerbation Through Day 92 (Intent-to-Treat Analysis) | Time to first asthma exacerbation between Day 1 and Day 92 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject's asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy. | All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo) | Posted | Median | 95% Confidence Interval | Day | Days 1 - 92 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Asthma Exacerbation Through Day 176 (Intent-to-Treat Analysis) | Time to first asthma exacerbation between Day 1 and Day 176 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject's asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy. | All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo) | Posted | Median | 95% Confidence Interval | Day | Days 1 - 176 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change at Day 176 From Baseline in Mean Asthma Control Questionnaire Scores (Intent-to-Treat Analysis) | Change at Day 176 from baseline (Day 1, prior to dosing) in mean ACQ scores in participants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful. | All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data available on Day 176. | Posted | Mean | Standard Deviation | Scores on a scale | Day 176 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants Achieving Mean Asthma Control Questionnaire (ACQ) Scores at Day 92 of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 (Intent-to-Treat Analysis) | Proportion of participants achieving mean ACQ scores of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 at Day 92 in participants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful. | All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data available on Day 92. | Posted | Number | Participants | Day 92 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants Achieving Mean Asthma Control Questionnaire (ACQ) Scores at Day 176 of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 (Intent-to-Treat Analysis) | Proportion of participants achieving mean ACQ scores of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 at Day 176 in participants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful. | All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data available on Day 176. | Posted | Number | Participants | Day 176 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Observed Mean Asthma Control Questionnaire (ACQ) Change From Baseline > or = 0.5 Through Day 92 (Intent-to-Treat Analysis) | Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the time to first observed mean ACQ change from baseline (Day 1, prior to dosing) > or = 0.5 through Day 92 (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful. | All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data through Day 92. | Posted | Median | 95% Confidence Interval | Day | Days 1 - 92 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Observed Mean Asthma Control Questionnaire (ACQ) Change From Baseline > or = 0.5 Through Day 176 (Intent-to-Treat Analysis) | Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the time to first observed mean ACQ change from baseline (Day 1, prior to dosing) > or = 1.5 Through Day 176 (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful. | All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data through Day 176. | Posted | Median | 95% Confidence Interval | Day | Days 1 - 176 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change at Day 92 From Baseline in Forced Expiratory Volume in One Second (FEV1) (Intent-to-Treat Analysis) | Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the mean change at Day 92 from baseline (Day 1, prior to dosing) in FEV1. | All participants randomized into the 30, 100, or 300 mg MEDI-528 (n=81, 83, or 81, respectively) or placebo (n=82) groups who had FEV1 data available at Day 92 (n=62, 73, or 72 for 30, 100, or 300 mg MEDI-528, respectively, and n=67 for placebo). | Posted | Mean | Standard Deviation | Liters | Day 92 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change at Day 176 From Baseline in Forced Expiratory Volume in One Second (FEV1) (Intent-to-Treat Analysis) | Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the mean change from baseline (Day 1, prior to dosing) in FEV1 at Day 176 | All participants randomized into the 30, 100, or 300 mg MEDI-528 (n=81, 83, or 81, respectively) or placebo (n=82) groups who had FEV1 data available at Day 176 (n=67, 75, or 73 for 30, 100, or 300 mg MEDI-528, respectively, and n=69 for placebo). | Posted | Mean | Standard Deviation | Liters | Day 176 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants Who Had a Asthma Quality of Life Questionnaire - Standard (AQLQ[S]) Assessment Response at Day 85 (Intent-to-Treat Analysis) | Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the proportion of participants who had an AQLQ(S) assessment response (defined as an improvement of at least 0.5 score in AQLQ[S]) at Day 85 (Intent-to-Treat Analysis). The AQLQ(S) is a 32-item questionnaire that measures the health related quality of life experienced by asthma patients. In the study, participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions. Individual improvement in the overall score of 0.5 has been identified as the minimally important difference, with score changes > 1.5 identified to be large meaningful differences. | All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had AQLQ(S) data at Day 85 (n=69, 63, 76, and 68 for placebo, 30, 100, and 300 mg MEDI-528, respectively). | Posted | Number | Participants | Day 85 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants Who Had a Asthma Quality of Life Questionnaire - Standard (AQLQ[S]) Assessment Response at Day 176 (Intent-to-Treat Analysis) | Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the proportion of participants who had an AQLQ(S) assessment response at Day 176 (Intent-to-Treat Analysis). The AQLQ(S) is a 32-item questionnaire that measures the health related quality of life experienced by asthma patients. In the study, participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions. Individual improvement in the overall score of 0.5 has been identified as the minimally important difference, with score changes > 1.5 identified to be large meaningful differences. | All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had AQLQ(S) data at Day 176 (n=62, 58, 64, and 60 for placebo, 30, 100, and 300 mg MEDI-528, respectively). | Posted | Number | Participants | Day 176 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Detectable Anti-drug Antibodies to MEDI-528 | Proportion of participants with detectable anti-drug antibodies to MEDI-528 in subjects receiving 30, 100, or 300 mg MEDI-528 and placebo | All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo (n=82) group and received at least one dose of investigational product. | Posted | Number | Participants | Days 1, 29, 57, 85, 127, 169, 176, 204,260, and 323 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | First Dose Trough Concentration of MEDI-528 | First dose trough concentration of MEDI-528 measured on Day 15 prior to administration of the second dose of MEDI-528 (30, 100, or 300 mg). Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323. The first dose trough concentration of MEDI-528 was measured on Day 15 prior to the Day 15 dose. | All participants randomized into the 30, 100, or 300 mg MEDI-528 group (n=81, 83, or 81, respectively). | Posted | Mean | Standard Deviation | Microgram per milliliter | Day 15 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Day 169 Steady State Trough Concentration of MEDI-528 | Trough concentration of MEDI-528 measured on Day 169 prior to administration of the last dose of MEDI-528 (30, 100, or 300 mg). Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323. Steady state trough concentration of MEDI-528 was measured on Day 169. | All participants randomized into the 30, 100, or 300 mg MEDI-528 group (n=81, 83, or 81, respectively). | Posted | Mean | Standard Deviation | Microgram per milliliter | Day 169 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Half Life of MEDI-528 | Half life of MEDI-528 in subjects receiving 30, 100, or 300 mg MEDI-528. Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323. | All participants randomized into the 30, 100, or 300 mg MEDI-528 group (n=81, 83, or 81, respectively). | Posted | Mean | Standard Deviation | Days | Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Accumulation Ratio of Trough Concentrations of MEDI-528 | Accumulation ratio of trough concentrations of MEDI-528 in subjects receiving 30, 100, or 300 mg MEDI-528. Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323. | All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81) and received at least one dose of investigational product. | Posted | Mean | Standard Deviation | Ratio | Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323 |
|
Day 1 to Day 323
Not provided
Not provided
| 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 subcutaneous injection every 2 weeks for 24 weeks | 4 | 82 | 67 | 82 | ||
| EG001 | MEDI528 30 mg | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | 9 | 81 | 62 | 81 | ||
| EG002 | MEDI528 100 mg | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | 4 | 83 | 68 | 83 | ||
| EG003 | MEDI528 300 mg | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | 2 | 81 | 69 | 81 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hydrocholecystis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Limb traumatic amputation | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Complicated migraine | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.0 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joe Parker, MD | MedImmune | 301-398-0000 | parkerJ@medimmune.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C542276 | enokizumab |
Not provided
Not provided
Not provided
| Male |
|
| 0.828 |
| No |
| Superiority or Other |
| ANOVA | Missing mean ACQ scores at Day 92 was imputed by last observation carried forward | 0.628 | No | Superiority or Other |
| OG002 | MEDI528 100 mg | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| OG003 | MEDI528 300 mg | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
|
|
|
| OG002 | MEDI528 100 mg | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| OG003 | MEDI528 300 mg | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
|
|
|
| OG002 | MEDI528 100 mg | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| OG003 | MEDI528 300 mg | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
|
|
|
| OG002 | MEDI528 100 mg | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| OG003 | MEDI528 300 mg | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
|
|
|
| OG002 |
| MEDI528 100 mg |
MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| OG003 | MEDI528 300 mg | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
|
|
|
| OG002 |
| MEDI528 100 mg |
MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| OG003 | MEDI528 300 mg | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
|
|
|
| OG002 | MEDI528 100 mg | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| OG003 | MEDI528 300 mg | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
|
|
|
| OG002 | MEDI528 100 mg | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| OG003 | MEDI528 300 mg | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
|
|
|
| OG002 | MEDI528 100 mg | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| OG003 | MEDI528 300 mg | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
|
|
|
| OG002 | MEDI528 100 mg | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| OG003 | MEDI528 300 mg | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
|
|
|
| OG002 | MEDI528 100 mg | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| OG003 | MEDI528 300 mg | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
|
|
|
|
|
|
|
|
|
| OG002 | MEDI528 100 mg | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| OG003 | MEDI528 300 mg | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
|
|
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| OG002 | MEDI528 100 mg | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| OG003 | MEDI528 300 mg | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
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MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
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MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
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