Trial Outcomes & Findings for A Study to Evaluate the Effectiveness and Safety of MEDI-528 in Adults (NCT NCT00968669)

NCT ID: NCT00968669

Last Updated: 2014-06-04

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 329 participants
• Primary outcome timeframe: Day 92
• Results posted on: 2014-06-04

Participant Flow

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.

Participant milestones

Measure	Placebo Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 30 mg MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 100 mg MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 300 mg MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Overall Study STARTED	82	81	83	81
Overall Study COMPLETED	64	63	72	72
Overall Study NOT COMPLETED	18	18	11	9

Reasons for withdrawal

Measure	Placebo Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 30 mg MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 100 mg MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 300 mg MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Overall Study Lost to Follow-up	5	2	1	4
Overall Study Withdrawal by Subject	9	7	5	3
Overall Study Pregnancy	0	0	2	0
Overall Study AE	1	0	0	0
Overall Study AE-TRANSITIONAL CELL TUMOR IN BLADDER	0	0	0	1
Overall Study DID NOT MEET EXCLUSION CRITERIA	1	0	0	0
Overall Study DUE TO REPEATED ASTHMA EXACERBATIONS	1	0	0	0
Overall Study EARLY DISCONTINUED ON 10-DEC-2010	0	0	1	0
Overall Study EARLY WITHDRAWAL	0	1	0	0
Overall Study ERROR IN HADS ADMINISTRATION	0	0	1	0
Overall Study INEGIBILITY TO PERFORM VISIT	1	0	0	0
Overall Study PATIENT RECEIVE ORAL PREDNISONE	0	1	0	0
Overall Study PATIENT WAS ENROLLED BY MISTAKE	0	1	0	0
Overall Study PATIENT WAS RANDOMIZED BY MISTAKE	0	1	0	0
Overall Study PATIENT WILL BE WORKING ABROAD	0	1	0	0
Overall Study SPONSOR DECISION	0	1	0	0
Overall Study SUBJECT COMPLETED SAFETY FOLLOW-UP	0	0	1	0
Overall Study SUBJECT DID NOT MEET ACQ REQUIREMENT	0	1	0	0
Overall Study SUBJECT INCARCERATED	0	1	0	0
Overall Study SUBJECT WAS RANDOMIZED IN ERROR	0	1	0	0
Overall Study WITHDRAWN DUE TO PREDNISONE USE	0	0	0	1

Baseline Characteristics

A Study to Evaluate the Effectiveness and Safety of MEDI-528 in Adults

Baseline characteristics by cohort

Measure	Placebo n=82 Participants Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 30 mg n=81 Participants MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 100 mg n=83 Participants MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 300 mg n=81 Participants MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	Total n=327 Participants Total of all reporting groups
Age, Continuous	43.6 Years STANDARD_DEVIATION 11.6 • n=5 Participants	41.8 Years STANDARD_DEVIATION 11.1 • n=7 Participants	45.1 Years STANDARD_DEVIATION 11.6 • n=5 Participants	41.5 Years STANDARD_DEVIATION 12.3 • n=4 Participants	43.0 Years STANDARD_DEVIATION 11.7 • n=21 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	55 Participants n=7 Participants	62 Participants n=5 Participants	55 Participants n=4 Participants	225 Participants n=21 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	26 Participants n=7 Participants	21 Participants n=5 Participants	26 Participants n=4 Participants	102 Participants n=21 Participants

PRIMARY outcome

Timeframe: Day 92

Population: All participants randomized into the 30, 100, or 300 mg MEDI-528 (n=81, 83, or 81, respectively) or placebo (n=82) groups.

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.

Outcome measures

Measure	Placebo n=82 Participants Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 30 mg n=81 Participants MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 100 mg n=83 Participants MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 300 mg n=81 Participants MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Change at Day 92 From Baseline in Mean Asthma Control Questionnaire (ACQ) Scores (Intent-toTreat Analysis)	-1.23 Scores on a scale Standard Deviation 0.95	-1.10 Scores on a scale Standard Deviation 1.11	-1.26 Scores on a scale Standard Deviation 1.02	-1.31 Scores on a scale Standard Deviation 1.07

SECONDARY outcome

Timeframe: Days 1 - 92

Population: All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)

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.

Outcome measures

Measure	Placebo n=82 Participants Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 30 mg n=81 Participants MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 100 mg n=83 Participants MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 300 mg n=81 Participants MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Weighted Asthma Exacerbation Rate Through Day 92 (Intent-to-Treat Analysis)	0.53 Exacerbations per participant year 95% Confidence Interval 0.96 • Interval 0.27 to 0.96	0.82 Exacerbations per participant year 95% Confidence Interval 1.15 • Interval 0.47 to 1.33	0.33 Exacerbations per participant year Interval 0.13 to 0.68	0.39 Exacerbations per participant year Interval 0.17 to 0.77

SECONDARY outcome

Timeframe: Days 1 - 176

Population: All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)

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.

Outcome measures

Measure	Placebo n=82 Participants Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 30 mg n=81 Participants MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 100 mg n=83 Participants MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 300 mg n=81 Participants MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Weighted Asthma Exacerbation Rate Through Day 176 (Intent-to-Treat Analysis)	0.58 Exacerbations per participant year 95% Confidence Interval 0.96 • Interval 0.36 to 0.88	0.64 Exacerbations per participant year 95% Confidence Interval 1.15 • Interval 0.4 to 0.96	0.28 Exacerbations per participant year Interval 0.14 to 0.5	0.58 Exacerbations per participant year Interval 0.36 to 0.88

SECONDARY outcome

Timeframe: Days 1 - 92

Population: All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)

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.

Outcome measures

Measure	Placebo n=82 Participants Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 30 mg n=81 Participants MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 100 mg n=83 Participants MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 300 mg n=81 Participants MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Proportion of Participants Experiencing at Least One Asthma Exacerbation Through Day 92 (Intent-to-Treat Analysis)	8 Participants 0.15 • Interval 0.36 to 0.88	14 Participants 0.14 • Interval 0.36 to 0.88	5 Participants	7 Participants

SECONDARY outcome

Timeframe: Days 1 - 176

Population: All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)

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.

Outcome measures

Measure	Placebo n=82 Participants Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 30 mg n=81 Participants MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 100 mg n=83 Participants MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 300 mg n=81 Participants MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Proportion of Participants Experiencing at Least One Asthma Exacerbation Through Day 176 (Intent-to-Treat Analysis)	16 Participants 0.15 • Interval 0.36 to 0.88	17 Participants 0.14 • Interval 0.36 to 0.88	8 Participants	15 Participants

SECONDARY outcome

Timeframe: Days 1 - 92

Population: All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)

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.

Outcome measures

Measure	Placebo n=82 Participants Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 30 mg n=81 Participants MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 100 mg n=83 Participants MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 300 mg n=81 Participants MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Time to First Asthma Exacerbation Through Day 92 (Intent-to-Treat Analysis)	NA Day 95% Confidence Interval 2.10 Too few events; time to median time to first asthma exacerbation was not reached.	NA Day 95% Confidence Interval 3.38 Too few events; time to median time to first asthma exacerbation was not reached.	NA Day 95% Confidence Interval 2.14 Too few events; time to median time to first asthma exacerbation was not reached.	NA Day 95% Confidence Interval 2.27 Too few events; time to median time to first asthma exacerbation was not reached.

SECONDARY outcome

Timeframe: Days 1 - 176

Population: All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)

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.

Outcome measures

Measure	Placebo n=82 Participants Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 30 mg n=81 Participants MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 100 mg n=83 Participants MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 300 mg n=81 Participants MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Time to First Asthma Exacerbation Through Day 176 (Intent-to-Treat Analysis)	NA Day 95% Confidence Interval 5.30 Too few events; time to median time to first asthma exacerbation was not reached.	NA Day 95% Confidence Interval 7.15 Too few events; time to median time to first asthma exacerbation was not reached.	NA Day 95% Confidence Interval 4.70 Too few events; time to median time to first asthma exacerbation was not reached.	NA Day 95% Confidence Interval 5.40 Too few events; time to median time to first asthma exacerbation was not reached.

SECONDARY outcome

Timeframe: Day 176

Population: 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.

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.

Outcome measures

Measure	Placebo n=82 Participants Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 30 mg n=81 Participants MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 100 mg n=83 Participants MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 300 mg n=81 Participants MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Change at Day 176 From Baseline in Mean Asthma Control Questionnaire Scores (Intent-to-Treat Analysis)	-1.27 Scores on a scale Standard Deviation 1.17	-1.32 Scores on a scale Standard Deviation 1.23	-1.46 Scores on a scale Standard Deviation 1.07	-1.45 Scores on a scale Standard Deviation 1.08

SECONDARY outcome

Timeframe: Day 92

Population: 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.

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.

Outcome measures

Measure	Placebo n=82 Participants Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 30 mg n=81 Participants MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 100 mg n=83 Participants MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 300 mg n=81 Participants MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
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) < or = 0.75	17 Participants	17 Participants	17 Participants	22 Participants
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) > 0.75 and < 1.5	23 Participants	21 Participants	22 Participants	16 Participants
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) > or = 1.5	42 Participants	43 Participants	44 Participants	43 Participants

SECONDARY outcome

Timeframe: Day 176

Population: 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.

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.

Outcome measures

Measure	Placebo n=82 Participants Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 30 mg n=81 Participants MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 100 mg n=83 Participants MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 300 mg n=81 Participants MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
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) < or = 0.75	25 Participants	29 Participants	24 Participants	25 Participants
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) > 0.75 and < 1.5	19 Participants	18 Participants	18 Participants	20 Participants
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) > or = 1.5	38 Participants	34 Participants	41 Participants	36 Participants

SECONDARY outcome

Timeframe: Days 1 - 92

Population: 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.

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.

Outcome measures

Measure	Placebo n=82 Participants Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 30 mg n=81 Participants MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 100 mg n=83 Participants MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 300 mg n=81 Participants MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Time to First Observed Mean Asthma Control Questionnaire (ACQ) Change From Baseline > or = 0.5 Through Day 92 (Intent-to-Treat Analysis)	15.0 Day 95% Confidence Interval 2.62 • Interval 15.0 to 22.0	17.0 Day 95% Confidence Interval 2.93 • Interval 15.0 to 21.0	20.0 Day 95% Confidence Interval 2.67 • Interval 15.0 to 23.0	20.0 Day 95% Confidence Interval 2.89 • Interval 15.0 to 27.0

SECONDARY outcome

Timeframe: Days 1 - 176

Population: 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.

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.

Outcome measures

Measure	Placebo n=82 Participants Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 30 mg n=81 Participants MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 100 mg n=83 Participants MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 300 mg n=81 Participants MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Time to First Observed Mean Asthma Control Questionnaire (ACQ) Change From Baseline > or = 0.5 Through Day 176 (Intent-to-Treat Analysis)	15.0 Day 95% Confidence Interval 4.07 • Interval 15.0 to 22.0	17.0 Day 95% Confidence Interval 4.57 • Interval 15.0 to 21.0	20.0 Day 95% Confidence Interval 3.63 • Interval 15.0 to 23.0	20.0 Day 95% Confidence Interval 4.70 • Interval 15.0 to 27.0

SECONDARY outcome

Timeframe: Day 92

Population: 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).

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.

Outcome measures

Measure	Placebo n=67 Participants Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 30 mg n=62 Participants MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 100 mg n=73 Participants MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 300 mg n=72 Participants MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Change at Day 92 From Baseline in Forced Expiratory Volume in One Second (FEV1) (Intent-to-Treat Analysis)	0.033 Liters Standard Deviation 0.326	0.045 Liters Standard Deviation 0.327	0.048 Liters Standard Deviation 0.230	0.097 Liters Standard Deviation 0.290

SECONDARY outcome

Timeframe: Day 176

Population: 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).

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

Outcome measures

Measure	Placebo n=69 Participants Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 30 mg n=67 Participants MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 100 mg n=75 Participants MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 300 mg n=73 Participants MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Change at Day 176 From Baseline in Forced Expiratory Volume in One Second (FEV1) (Intent-to-Treat Analysis)	0.044 Liters Standard Deviation 0.367	-0.005 Liters Standard Deviation 0.324	0.055 Liters Standard Deviation 0.299	0.047 Liters Standard Deviation 0.290

SECONDARY outcome

Timeframe: Day 85

Population: 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).

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.

Outcome measures

Measure	Placebo n=69 Participants Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 30 mg n=63 Participants MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 100 mg n=76 Participants MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 300 mg n=68 Participants MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Proportion of Participants Who Had a Asthma Quality of Life Questionnaire - Standard (AQLQ[S]) Assessment Response at Day 85 (Intent-to-Treat Analysis)	53 Participants 57.871	43 Participants 60.584	52 Participants 53.110	49 Participants 55.339

SECONDARY outcome

Timeframe: Day 176

Population: 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).

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.

Outcome measures

Measure	Placebo n=62 Participants Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 30 mg n=58 Participants MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 100 mg n=64 Participants MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 300 mg n=60 Participants MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Proportion of Participants Who Had a Asthma Quality of Life Questionnaire - Standard (AQLQ[S]) Assessment Response at Day 176 (Intent-to-Treat Analysis)	50 Participants 57.871	42 Participants 60.584	48 Participants 53.110	46 Participants 55.339

SECONDARY outcome

Timeframe: Days 1, 29, 57, 85, 127, 169, 176, 204,260, and 323

Population: 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.

Proportion of participants with detectable anti-drug antibodies to MEDI-528 in subjects receiving 30, 100, or 300 mg MEDI-528 and placebo

Outcome measures

Measure	Placebo n=82 Participants Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 30 mg n=81 Participants MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 100 mg n=83 Participants MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 300 mg n=81 Participants MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Proportion of Participants With Detectable Anti-drug Antibodies to MEDI-528	4 Participants	15 Participants 1.53	4 Participants 1.83	3 Participants 1.99

SECONDARY outcome

Timeframe: Day 15

Population: All participants randomized into the 30, 100, or 300 mg MEDI-528 group (n=81, 83, or 81, respectively).

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.

Outcome measures

Measure	Placebo Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 30 mg n=81 Participants MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 100 mg n=83 Participants MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 300 mg n=81 Participants MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
First Dose Trough Concentration of MEDI-528	—	2.15 Microgram per milliliter Standard Deviation 0.81	5.91 Microgram per milliliter Standard Deviation 2.97	15.80 Microgram per milliliter Standard Deviation 5.68

SECONDARY outcome

Timeframe: Day 169

Population: All participants randomized into the 30, 100, or 300 mg MEDI-528 group (n=81, 83, or 81, respectively).

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.

Outcome measures

Measure	Placebo Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 30 mg n=81 Participants MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 100 mg n=83 Participants MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 300 mg n=81 Participants MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Day 169 Steady State Trough Concentration of MEDI-528	—	5.99 Microgram per milliliter Standard Deviation 3.37	21.68 Microgram per milliliter Standard Deviation 9.49	61.57 Microgram per milliliter Standard Deviation 26.85

SECONDARY outcome

Timeframe: Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323

Population: All participants randomized into the 30, 100, or 300 mg MEDI-528 group (n=81, 83, or 81, respectively).

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.

Outcome measures

Measure	Placebo Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 30 mg n=81 Participants MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 100 mg n=83 Participants MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 300 mg n=81 Participants MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Half Life of MEDI-528	—	39.0 Days Standard Deviation 8.14	32.6 Days Standard Deviation 5.89	32.2 Days Standard Deviation 6.41

SECONDARY outcome

Timeframe: Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323

Population: 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.

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.

Outcome measures

Measure	Placebo Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 30 mg n=81 Participants MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 100 mg n=83 Participants MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 300 mg n=81 Participants MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Accumulation Ratio of Trough Concentrations of MEDI-528	—	3.46 Ratio Standard Deviation 1.53	4.18 Ratio Standard Deviation 1.83	4.11 Ratio Standard Deviation 1.99

Adverse Events

Placebo

Serious events: 4 serious events

Other events: 67 other events

Deaths: 0 deaths

MEDI528 30 mg

Serious events: 9 serious events

Other events: 62 other events

Deaths: 0 deaths

MEDI528 100 mg

Serious events: 4 serious events

Other events: 68 other events

Deaths: 0 deaths

MEDI528 300 mg

Serious events: 2 serious events

Other events: 69 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=82 participants at risk Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 30 mg n=81 participants at risk MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 100 mg n=83 participants at risk MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 300 mg n=81 participants at risk MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Gastrointestinal disorders Pancreatitis	1.2% 1/82 • Number of events 1 • Day 1 to Day 323	0.00% 0/81 • Day 1 to Day 323	0.00% 0/83 • Day 1 to Day 323	0.00% 0/81 • Day 1 to Day 323
Hepatobiliary disorders Cholelithiasis	1.2% 1/82 • Number of events 1 • Day 1 to Day 323	0.00% 0/81 • Day 1 to Day 323	0.00% 0/83 • Day 1 to Day 323	0.00% 0/81 • Day 1 to Day 323
Hepatobiliary disorders Hydrocholecystis	1.2% 1/82 • Number of events 1 • Day 1 to Day 323	0.00% 0/81 • Day 1 to Day 323	0.00% 0/83 • Day 1 to Day 323	0.00% 0/81 • Day 1 to Day 323
Immune system disorders Food allergy	0.00% 0/82 • Day 1 to Day 323	1.2% 1/81 • Number of events 1 • Day 1 to Day 323	0.00% 0/83 • Day 1 to Day 323	0.00% 0/81 • Day 1 to Day 323
Infections and infestations Appendicitis	1.2% 1/82 • Number of events 1 • Day 1 to Day 323	0.00% 0/81 • Day 1 to Day 323	0.00% 0/83 • Day 1 to Day 323	0.00% 0/81 • Day 1 to Day 323
Infections and infestations Bronchitis	0.00% 0/82 • Day 1 to Day 323	1.2% 1/81 • Number of events 1 • Day 1 to Day 323	0.00% 0/83 • Day 1 to Day 323	0.00% 0/81 • Day 1 to Day 323
Infections and infestations Lobar pneumonia	0.00% 0/82 • Day 1 to Day 323	0.00% 0/81 • Day 1 to Day 323	1.2% 1/83 • Number of events 1 • Day 1 to Day 323	0.00% 0/81 • Day 1 to Day 323
Infections and infestations Pneumonia	0.00% 0/82 • Day 1 to Day 323	3.7% 3/81 • Number of events 3 • Day 1 to Day 323	0.00% 0/83 • Day 1 to Day 323	0.00% 0/81 • Day 1 to Day 323
Injury, poisoning and procedural complications Limb traumatic amputation	0.00% 0/82 • Day 1 to Day 323	1.2% 1/81 • Number of events 1 • Day 1 to Day 323	0.00% 0/83 • Day 1 to Day 323	0.00% 0/81 • Day 1 to Day 323
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/82 • Day 1 to Day 323	0.00% 0/81 • Day 1 to Day 323	1.2% 1/83 • Number of events 1 • Day 1 to Day 323	0.00% 0/81 • Day 1 to Day 323
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/82 • Day 1 to Day 323	0.00% 0/81 • Day 1 to Day 323	1.2% 1/83 • Number of events 1 • Day 1 to Day 323	0.00% 0/81 • Day 1 to Day 323
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/82 • Day 1 to Day 323	0.00% 0/81 • Day 1 to Day 323	1.2% 1/83 • Number of events 1 • Day 1 to Day 323	0.00% 0/81 • Day 1 to Day 323
Nervous system disorders Complicated migraine	0.00% 0/82 • Day 1 to Day 323	1.2% 1/81 • Number of events 1 • Day 1 to Day 323	0.00% 0/83 • Day 1 to Day 323	0.00% 0/81 • Day 1 to Day 323
Nervous system disorders Ischaemic stroke	0.00% 0/82 • Day 1 to Day 323	1.2% 1/81 • Number of events 1 • Day 1 to Day 323	0.00% 0/83 • Day 1 to Day 323	0.00% 0/81 • Day 1 to Day 323
Renal and urinary disorders Nephrolithiasis	1.2% 1/82 • Number of events 1 • Day 1 to Day 323	0.00% 0/81 • Day 1 to Day 323	0.00% 0/83 • Day 1 to Day 323	0.00% 0/81 • Day 1 to Day 323
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/82 • Day 1 to Day 323	0.00% 0/81 • Day 1 to Day 323	1.2% 1/83 • Number of events 1 • Day 1 to Day 323	0.00% 0/81 • Day 1 to Day 323
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/82 • Day 1 to Day 323	7.4% 6/81 • Number of events 6 • Day 1 to Day 323	1.2% 1/83 • Number of events 1 • Day 1 to Day 323	2.5% 2/81 • Number of events 2 • Day 1 to Day 323

Other adverse events

Measure	Placebo n=82 participants at risk Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 30 mg n=81 participants at risk MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 100 mg n=83 participants at risk MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks	MEDI528 300 mg n=81 participants at risk MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Gastrointestinal disorders Diarrhoea	2.4% 2/82 • Number of events 2 • Day 1 to Day 323	3.7% 3/81 • Number of events 3 • Day 1 to Day 323	3.6% 3/83 • Number of events 4 • Day 1 to Day 323	3.7% 3/81 • Number of events 3 • Day 1 to Day 323
Gastrointestinal disorders Toothache	1.2% 1/82 • Number of events 1 • Day 1 to Day 323	2.5% 2/81 • Number of events 2 • Day 1 to Day 323	4.8% 4/83 • Number of events 4 • Day 1 to Day 323	0.00% 0/81 • Day 1 to Day 323
General disorders Asthenia	2.4% 2/82 • Number of events 3 • Day 1 to Day 323	3.7% 3/81 • Number of events 3 • Day 1 to Day 323	1.2% 1/83 • Number of events 1 • Day 1 to Day 323	1.2% 1/81 • Number of events 1 • Day 1 to Day 323
General disorders Injection site erythema	2.4% 2/82 • Number of events 3 • Day 1 to Day 323	1.2% 1/81 • Number of events 2 • Day 1 to Day 323	4.8% 4/83 • Number of events 10 • Day 1 to Day 323	6.2% 5/81 • Number of events 9 • Day 1 to Day 323
General disorders Injection site pain	6.1% 5/82 • Number of events 6 • Day 1 to Day 323	1.2% 1/81 • Number of events 1 • Day 1 to Day 323	4.8% 4/83 • Number of events 5 • Day 1 to Day 323	2.5% 2/81 • Number of events 14 • Day 1 to Day 323
General disorders Pyrexia	0.00% 0/82 • Day 1 to Day 323	0.00% 0/81 • Day 1 to Day 323	4.8% 4/83 • Number of events 4 • Day 1 to Day 323	3.7% 3/81 • Number of events 3 • Day 1 to Day 323
Infections and infestations Acute sinusitis	2.4% 2/82 • Number of events 2 • Day 1 to Day 323	3.7% 3/81 • Number of events 4 • Day 1 to Day 323	2.4% 2/83 • Number of events 2 • Day 1 to Day 323	2.5% 2/81 • Number of events 4 • Day 1 to Day 323
Infections and infestations Bronchitis	9.8% 8/82 • Number of events 8 • Day 1 to Day 323	4.9% 4/81 • Number of events 5 • Day 1 to Day 323	2.4% 2/83 • Number of events 3 • Day 1 to Day 323	6.2% 5/81 • Number of events 7 • Day 1 to Day 323
Infections and infestations Gastroenteritis	3.7% 3/82 • Number of events 3 • Day 1 to Day 323	2.5% 2/81 • Number of events 2 • Day 1 to Day 323	6.0% 5/83 • Number of events 5 • Day 1 to Day 323	2.5% 2/81 • Number of events 2 • Day 1 to Day 323
Infections and infestations Influenza	7.3% 6/82 • Number of events 8 • Day 1 to Day 323	12.3% 10/81 • Number of events 11 • Day 1 to Day 323	6.0% 5/83 • Number of events 5 • Day 1 to Day 323	2.5% 2/81 • Number of events 2 • Day 1 to Day 323
Infections and infestations Nasopharyngitis	14.6% 12/82 • Number of events 15 • Day 1 to Day 323	13.6% 11/81 • Number of events 15 • Day 1 to Day 323	6.0% 5/83 • Number of events 9 • Day 1 to Day 323	8.6% 7/81 • Number of events 11 • Day 1 to Day 323
Infections and infestations Pharyngitis	2.4% 2/82 • Number of events 2 • Day 1 to Day 323	4.9% 4/81 • Number of events 4 • Day 1 to Day 323	9.6% 8/83 • Number of events 13 • Day 1 to Day 323	4.9% 4/81 • Number of events 5 • Day 1 to Day 323
Infections and infestations Rhinitis	6.1% 5/82 • Number of events 5 • Day 1 to Day 323	3.7% 3/81 • Number of events 3 • Day 1 to Day 323	3.6% 3/83 • Number of events 3 • Day 1 to Day 323	2.5% 2/81 • Number of events 2 • Day 1 to Day 323
Infections and infestations Sinusitis	4.9% 4/82 • Number of events 5 • Day 1 to Day 323	12.3% 10/81 • Number of events 11 • Day 1 to Day 323	4.8% 4/83 • Number of events 4 • Day 1 to Day 323	7.4% 6/81 • Number of events 10 • Day 1 to Day 323
Infections and infestations Upper respiratory tract infection	14.6% 12/82 • Number of events 19 • Day 1 to Day 323	7.4% 6/81 • Number of events 6 • Day 1 to Day 323	19.3% 16/83 • Number of events 23 • Day 1 to Day 323	24.7% 20/81 • Number of events 32 • Day 1 to Day 323
Infections and infestations Urinary tract infection	7.3% 6/82 • Number of events 6 • Day 1 to Day 323	8.6% 7/81 • Number of events 9 • Day 1 to Day 323	8.4% 7/83 • Number of events 7 • Day 1 to Day 323	2.5% 2/81 • Number of events 3 • Day 1 to Day 323
Infections and infestations Viral upper respiratory tract infection	6.1% 5/82 • Number of events 7 • Day 1 to Day 323	1.2% 1/81 • Number of events 4 • Day 1 to Day 323	0.00% 0/83 • Day 1 to Day 323	3.7% 3/81 • Number of events 3 • Day 1 to Day 323
Musculoskeletal and connective tissue disorders Back pain	2.4% 2/82 • Number of events 2 • Day 1 to Day 323	3.7% 3/81 • Number of events 3 • Day 1 to Day 323	3.6% 3/83 • Number of events 3 • Day 1 to Day 323	2.5% 2/81 • Number of events 3 • Day 1 to Day 323
Musculoskeletal and connective tissue disorders Pain in extremity	2.4% 2/82 • Number of events 2 • Day 1 to Day 323	1.2% 1/81 • Number of events 1 • Day 1 to Day 323	3.6% 3/83 • Number of events 3 • Day 1 to Day 323	3.7% 3/81 • Number of events 4 • Day 1 to Day 323
Nervous system disorders Dizziness	6.1% 5/82 • Number of events 5 • Day 1 to Day 323	2.5% 2/81 • Number of events 2 • Day 1 to Day 323	6.0% 5/83 • Number of events 15 • Day 1 to Day 323	0.00% 0/81 • Day 1 to Day 323
Nervous system disorders Headache	9.8% 8/82 • Number of events 11 • Day 1 to Day 323	16.0% 13/81 • Number of events 20 • Day 1 to Day 323	6.0% 5/83 • Number of events 9 • Day 1 to Day 323	7.4% 6/81 • Number of events 7 • Day 1 to Day 323
Nervous system disorders Migraine	1.2% 1/82 • Number of events 1 • Day 1 to Day 323	4.9% 4/81 • Number of events 5 • Day 1 to Day 323	1.2% 1/83 • Number of events 1 • Day 1 to Day 323	1.2% 1/81 • Number of events 1 • Day 1 to Day 323
Respiratory, thoracic and mediastinal disorders Asthma	30.5% 25/82 • Number of events 41 • Day 1 to Day 323	34.6% 28/81 • Number of events 53 • Day 1 to Day 323	24.1% 20/83 • Number of events 29 • Day 1 to Day 323	38.3% 31/81 • Number of events 64 • Day 1 to Day 323
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/82 • Day 1 to Day 323	2.5% 2/81 • Number of events 2 • Day 1 to Day 323	2.4% 2/83 • Number of events 2 • Day 1 to Day 323	3.7% 3/81 • Number of events 3 • Day 1 to Day 323
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/82 • Day 1 to Day 323	2.5% 2/81 • Number of events 2 • Day 1 to Day 323	3.6% 3/83 • Number of events 3 • Day 1 to Day 323	2.5% 2/81 • Number of events 2 • Day 1 to Day 323
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	8.5% 7/82 • Number of events 7 • Day 1 to Day 323	6.2% 5/81 • Number of events 5 • Day 1 to Day 323	1.2% 1/83 • Number of events 1 • Day 1 to Day 323	3.7% 3/81 • Number of events 4 • Day 1 to Day 323
Skin and subcutaneous tissue disorders Pruritus	1.2% 1/82 • Number of events 1 • Day 1 to Day 323	1.2% 1/81 • Number of events 1 • Day 1 to Day 323	2.4% 2/83 • Number of events 3 • Day 1 to Day 323	3.7% 3/81 • Number of events 3 • Day 1 to Day 323
Skin and subcutaneous tissue disorders Rash	3.7% 3/82 • Number of events 4 • Day 1 to Day 323	2.5% 2/81 • Number of events 2 • Day 1 to Day 323	1.2% 1/83 • Number of events 2 • Day 1 to Day 323	4.9% 4/81 • Number of events 5 • Day 1 to Day 323
Vascular disorders Hypertension	2.4% 2/82 • Number of events 3 • Day 1 to Day 323	4.9% 4/81 • Number of events 4 • Day 1 to Day 323	3.6% 3/83 • Number of events 3 • Day 1 to Day 323	0.00% 0/81 • Day 1 to Day 323

Additional Information

Joe Parker, MD

MedImmune

Phone: 301-398-0000

Email: parkerJ@medimmune.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER