Study Evaluating the Effect of IMA-638 in Subjects With P... | NCT00425061 | Trialant
NCT00425061
Sponsor
Pfizer
Status
Completed
Last Update Posted
Jan 14, 2015Estimated
Enrollment
159Actual
Phase
Phase 2
Conditions
Asthma
Interventions
IMA-638
IMA-638
placebo
Countries
United States
Canada
Protocol Section
Identification Module
NCT ID
NCT00425061
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
3174K1-201
Secondary IDs
ID
Type
Description
Link
B2421007
Other Identifier
Alias Study Number
Brief Title
Study Evaluating the Effect of IMA-638 in Subjects With Persistent Asthma
Official Title
Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study Conducted Sequentially With 3 Doses Of Ima-638 Administered Sc.
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Jan 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 2007
Primary Completion Date
Aug 2008Actual
Completion Date
Aug 2008Actual
First Submitted Date
Jan 18, 2007
First Submission Date that Met QC Criteria
Jan 19, 2007
First Posted Date
Jan 22, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 6, 2014
Results First Submitted that Met QC Criteria
Jan 12, 2015
Results First Posted Date
Jan 14, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Apr 11, 2014
Certification/Extension First Submitted that Passed QC Review
Apr 11, 2014
Certification/Extension First Posted Date
May 6, 2014Estimated
Last Update Submitted Date
Jan 12, 2015
Last Update Posted Date
Jan 14, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Primary purpose is to assess if IMA-638 is safe and improves asthma in subjects with persistent asthma.
Detailed Description
Not provided
Conditions Module
Conditions
Asthma
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
159Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1
Experimental
Biological: IMA-638
2
Experimental
Biological: IMA-638
3
Placebo Comparator
Other: placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
IMA-638
Biological
SC Injection, 12 weeks
1
IMA-638
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 1
The PEFR is a participant's maximum speed of expiration, as measured with a peak flow meter. All participants were issued with the peak flow meter and instructed to perform the activity in triplicate in the morning prior to taking bronchodilator. The best among the 3 readings was selected.
Baseline, Day 112
Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 2/3
The PEFR is a participant's maximum speed of expiration, as measured with a peak flow meter. All participants were issued with the peak flow meter and instructed to perform the activity in triplicate in the morning prior to taking bronchodilator. The best among the 3 readings was selected.
Baseline, Day 112
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Pre-beta-agonist Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 28, 56, 84 and 112 - Stage 1
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 was obtained from spirometry, performed before study treatment administration. Participants performed the test in triplicate at each visit and the best of the 3 values was selected.
Other Outcomes
Measure
Description
Time Frame
Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance Stage 1
Criteria for potentially clinically important (PCI) vital sign abnormalities- heart rate: greater than (>) 15 beats per minute (bpm) increase from baseline and greater than or equal to (>=) 120 bpm, >15 bpm decrease from baseline and less than or equal to (<=) 45 bpm: systolic blood pressure (SBP): >=20 millimeter of mercury (mmHg) increase from baseline and >=160 mmHg, >=20 mmHg decrease from baseline and <=90 mmHg: diastolic blood pressure (DBP): of >=15 mmHg increase from baseline and >=100 mmHg, >=15 mmHg decrease from baseline and <=50 mmHg, oral temperature <35 or >38.3 degrees centigrade: respiratory rate: <10 or >25 breaths/minute: body weight: >=7% increase or decrease from baseline.
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Generally healthy men and women with persistent asthma, 18 to 70 years of age, with body weight between 50 kg and 115 kg.
History of treatment with a medium to high dose of inhaled corticosteroids (ICS), with or without long-acting beta-agonists (LABA), for at least 2 months prior to the screening visit and must remain constant during the study.
FEV1 ≥ 55% to ≤ 80% predicted and demonstrated improvement in FEV1 (L) with inhaled albuterol (salbutamol) (reversibility) of ≥ 12%.
Exclusion Criteria:
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
80 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Alabama Allergy and Asthma Center
Birmingham
Alabama
35209
United States
Alabama Allergy & Asthma Clinic
References Module
Citations
Not provided
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
This study had adaptive study design wherein participants were treated in 3 stages with higher number of participants enrolled in subsequent stages. As the treatment regimen was same for participants who received IMA-638 200 mg or placebo in Stage 2 and 3, participants were summarized together for these arms.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
IMA-638 0.2 mg/kg: Stage 1
IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
FG001
IMA-638 0.6 mg/kg: Stage 1
IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Biological
SC Injection, 12 weeks
2
placebo
Other
placebo
3
Baseline, Day 8, 28, 56, 84, 112
Change From Baseline in Pre-beta-agonist Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 28, 56, 84 and 112 - Stage 2/3
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 was obtained from spirometry, performed before study treatment administration. Participants performed the test in triplicate at each visit and the best of the 3 values was selected.
Baseline, Day 8, 28, 56, 84, 112
Change From Baseline in Airway Hyper-reactivity at Day 28 and 112
Airway hyper-reactivity was assessed using provocative concentration 20 (PC20). PC20 was the concentration of methacholine at which participants had 20 percent (%) decrease in FEV1. Results for PC20 were summarized together for all participants who received any dose of IMA-638 and for all participants who received placebo during any stage of the study as per investigator's discretion.
Baseline, Day 28, 112
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 1
ACQ-5 was a 5-item participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing). 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 was the mean of the responses. Mean scores of less than or equal to (=<) 0.75 indicate well-controlled asthma, scores between 0.76 and less than (<) 1.5 indicate partly controlled asthma, and a score greater than or equal to (>=) 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.
Baseline, Day 8, 28, 56, 84, 112
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 2/3
ACQ-5 was a 5-item participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing). 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 was 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.
Baseline, Day 8, 28, 56, 84, 112
Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 1
Baseline up to Day 112
Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 2/3
Baseline up to Day 112
Mean Number of Puffs of Rescue Medication Used - Stage 1
The rescue medication taken for needed symptoms was a short acting beta agonist (SABA) inhaler. Albuterol, 90 microgram (mcg)/puff, was recommended for use.
Day 8, 28, 56, 84, 89, 91, 94, 98, 112
Mean Number of Puffs of Rescue Medication Used - Stage 2/3
The rescue medication taken for needed symptoms was a SABA inhaler. Albuterol, 90 mcg/puff, was recommended for use.
Day 8, 28, 56, 84, 89, 91, 94, 98, 112
Forced Vital Capacity (FVC) - Stage 1
FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Baseline, Day 8, 28, 56, 84, 112
Forced Vital Capacity (FVC) - Stage 2/3
FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
FEF25-75 is the average expiratory flow over the middle half of the FVC. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
FEF25-75 is the average expiratory flow over the middle half of the FVC. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Baseline, Day 8, 28, 56, 84, 112
Blood Eosinophils Levels - Stage 1
Baseline, Day 8, 28, 56, 84, 112
Blood Eosinophils Levels - Stage 2/3
Baseline, Day 8, 28, 56, 84, 112
Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 1
Log 10-transformed serum total IgE levels were expressed in Log-10 International units/milliliter (IU/mL).
Baseline, Day 28, 56, 84, 112
Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 2/3
Log 10-transformed serum total IgE levels were expressed in Log-10 International units/milliliter (IU/mL).
Baseline, Day 28, 56, 84, 112
Serum Interleukin-13 (IL-13) Level - Stage 1
Baseline, Day 8, 28, 56, 84, 112
Serum Interleukin-13 (IL-13) Level - Stage 2/3
Baseline, Day 8, 28, 56, 84, 112
Baseline up to Day 112
Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance - Stage 2/3
Criteria for PCI vital sign abnormalities- heart rate: >15 bpm increase from baseline and >=120 bpm, >15 bpm decrease from baseline and <=45 bpm: SBP: >=20 mmHg increase from baseline and >=160 mmHg, >=20 mmHg decrease from baseline and <=90 mmHg: DBP: of >=15 mmHg increase from baseline and >=100 mmHg, >=15 mmHg decrease from baseline and <=50 mmHg, oral temperature <35 or >38.3 degrees centigrade: respiratory rate: <10 or >25 breaths/minute: body weight: >=7% increase or decrease from baseline.
Baseline up to Day 112
Number of Participants With Clinically Important Changes in Physical Findings - Stage 1
Physical examination included examination of general appearance, skin, head, ears, eyes, nose, throat, heart, lungs, breasts, abdomen, external genitalia, extremities, neurological exam, back/spine and lymph nodes.
Baseline up to Day 112
Number of Participants With Clinically Important Changes in Physical Findings - Stage 2/3
Physical examination included examination of general appearance, skin, head, ears, eyes, nose, throat, heart, lungs, breasts, abdomen, external genitalia, extremities, neurological exam, back/spine and lymph nodes.
Baseline up to Day 112
Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern - Stage 1
Clinically significant ECG findings included - heart rate: >15 bpm increase from baseline and >=120 bpm, PR interval: >=20 millisecond (msec) change from baseline and >=220 msec: QRS interval: >=120 msec: corrected QT (QTc) interval: >450 msec for males and >470 msec for females.
Baseline up to Day 112
Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern - Stage 2/3
Clinically significant ECG findings included - heart rate: >15 bpm increase from baseline and >=120 bpm, PR interval: >=20 msec change from baseline and >=220 msec: QRS interval: >=120 msec: QTc interval: >450 msec for males and >470 msec for females.
Baseline up to Day 112
Number of Participants With Injection Site Reaction - Stage 1
Baseline up to Day 112
Number of Participants With Injection Site Reaction - Stage 2/3
Baseline up to Day 112
Number of Participants With Laboratory Test Abnormalities of Potential Clinical Importance - Stage 1
Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, total neutrophils, eosinophils); hepatobiliary biochemistry: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, total bilirubin, gamma glutamyl transferase (GGT), total lactate dehydrogenase (LDH); renal function tests: blood urea nitrogen (BUN), creatinine, creatinine kinase, uric acid, albumin; electrolytes: sodium, potassium, calcium, magnesium, phosphorus; coagulation: prothrombin time and partial thromboplastin time; glucose: fasting, non-fasting; lipid profile: total cholesterol, triglycerides.
Baseline up to Day 112
Number of Participants With Laboratory Test Abnormalities of Potential Clinical Importance - Stage 2/3
Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, total neutrophils, eosinophils); hepatobiliary biochemistry: ALT, AST, alkaline phosphatase, total bilirubin, GGT, total LDH; renal function tests: BUN, creatinine, creatinine kinase, uric acid, albumin; electrolytes: sodium, potassium, calcium, magnesium, phosphorus; coagulation: prothrombin time and partial thromboplastin time; glucose: fasting, non-fasting; lipid profile: total cholesterol, triglycerides.
Baseline up to Day 112
Montgomery
Alabama
36106
United States
Little Rock Allergy & Asthma
Little Rock
Arkansas
72205
United States
Pacific Coast Allergy
Crescent City
California
95531
United States
ABM Research Center
Fresno
California
93720
United States
Allergy and Asthma Care Center of Southern California
Long Beach
California
90808
United States
Allergy Medical Clinic
Los Angeles
California
90025
United States
Advances in Medicine
Rancho Mirage
California
92270
United States
Penisula Research Associates
Rolling Hills Estates
California
90274
United States
Sharp Rees-Stealy Medical Group
San Diego
California
92101
United States
Allergy Associates Medical Group, Inc.
San Diego
California
92120
United States
Allergy & Asthma Assoc of Santa Clara Valley Research Ctr
San Jose
California
95117
United States
San Jose Clinical Research, Inc.
San Jose
California
95128
United States
Bensch Research Associates
Stockton
California
95207
United States
Allergy and Immunology Medical Group
Vista
California
92083
United States
Allergy & Asthma Clinical Research, Inc.
Walnut Creek
California
94598
United States
National Jewish Medical & Research Center
Denver
Colorado
80206
United States
Colorado Allergy and Asthma Centers
Denver
Colorado
80230
United States
Waterbury Pulmonary Associates
Waterbury
Connecticut
06708
United States
Brandon-Valico Center for Allergy & Asthma Research, LLC
Valrico
Florida
33594
United States
Roberson Allergy & Asthma
West Palm Beach
Florida
33401
United States
Georgia Pollens CRC, Inc.
Albany
Georgia
31707
United States
DataQuest Medical Research
Lawrenceville
Georgia
30045
United States
Aero Allergy Research Labs of Savannah, Inc. 505 Eisenhower
Savannah
Georgia
31406
United States
Allergy and Asthma Center of Chicago
River Forest
Illinois
60305
United States
Fort Wayne Medical Institute
Fort Wayne
Indiana
46815
United States
South Bend Clinic
South Bend
Indiana
46617
United States
College Park Family Care Center
Overland Park
Kansas
66210
United States
Kansas City Allergy & Asthma
Overland Park
Kansas
66210
United States
Abraham Research, PLLC
Crescent Springs
Kentucky
41017
United States
Clinical Research Specialists
Metairie
Louisiana
70006
United States
Allergy and Arthritis Family
Gardner
Massachusetts
01440
United States
Center for Clinical Research
Taunton
Massachusetts
02780
United States
Clinical Research Institute
Minneapolis
Minnesota
55402
United States
Mississippi Asthma and Allergy Clinic, P.A.
Jackson
Mississippi
39202
United States
Midwest Clinical Research LLC
St Louis
Missouri
63141
United States
The Clinical Research Center LLC
St Louis
Missouri
63141
United States
Montana Medical Research, Inc
Missoula
Montana
59808
United States
Midwest Allergy and Asthma Clinic
Omaha
Nebraska
68130
United States
Allergy and Asthma Assoc
Las Vegas
Nevada
89102
United States
Princeton Center for Clinical Research
Skillman
New Jersey
08558
United States
Pulmonary and Allergy Associates
Summit
New Jersey
07901
United States
Pulmonary & Critical Care Services, P.C.5 Palisades Dr., Su
Albany
New York
12205
United States
AAIR Research Center
Rochester
New York
14618
United States
Montefiore Medical Center
The Bronx
New York
10461
United States
Regional Allergy and Asthma Consultants, P.A.
Asheville
North Carolina
28801
United States
AAC Research, PC
Mt Pleasant
North Carolina
29464
United States
North Carolina Clinical Research
Raleigh
North Carolina
27607
United States
Allergy & Respiratory Center
Canton
Ohio
44718
United States
New Horizons Clinical Research
Cincinnati
Ohio
45242
United States
Toledo Center for Clinial Researcch
Sylvania
Ohio
43560
United States
Allergy, Asthma & Clinical Research Center
Oklahoma City
Oklahoma
73120
United States
Allergy and Asthma Research Group
Eugene
Oregon
97401
United States
Allergy, Asthma and Dermatology Research Center, LLC 3975 Me
Lake Oswego
Oregon
97035
United States
Clinical Research Institute of Southern Oregon
Medford
Oregon
97504
United States
Allergy Associates Research Center
Portland
Oregon
97213
United States
Valley Clinical Research Center
Bethlehem
Pennsylvania
18020
United States
Allergy & Asthma Research of New Jersey
Philadelphia
Pennsylvania
19115
United States
Allergy and Clinical Immunology
Pittsburgh
Pennsylvania
15241
United States
Pulmonary and Allergy Associates
Sellersville
Pennsylvania
18960
United States
AAPRI Clinical Research Institute
Lincoln
Rhode Island
02865
United States
Allergic Disease and Asthma Center Research, PA
Greenville
South Carolina
29607
United States
AAC Research, PC
Mt. Pleasant
South Carolina
29464
United States
East Tennessee Center for Clinical Research
Knoxville
Tennessee
37909
United States
Lovelace Scientific Resources
Austin
Texas
78759
United States
Allergy and Asthma Research Center of El Paso
El Paso
Texas
79925
United States
Family Center for Asthma & Allergic Diseases
Friendswood
Texas
77546
United States
Allergy and Asthma Associates
Houston
Texas
77054
United States
Clinical Trials North Houston
Houston
Texas
77070
United States
Clinical Trial Network
Houston
Texas
77074
United States
The Allergy and Asthma Clinic of Central Texas
Killeen
Texas
76542
United States
Allergy Asthma and Immunology
San Antonio
Texas
78229
United States
Timber Lane Allergy and Asthma Research LLC
South Burlington
Vermont
05403
United States
Virginia Adult & Pediatric Allergy & Asthma, P.C.
Richmond
Virginia
23229
United States
University of Wisconsin Medical School
Madison
Wisconsin
53792
United States
Auroroa Health Care, Inc.
Milwaukee
Wisconsin
53209
United States
Alpha Medical Research Inc.
Mississauga
Ontario
L5A 3V4
Canada
Alexander Medical Innovations Inc.
Niagara Falls
Ontario
L2G 1J4
Canada
Allergy and Asthma Research Centre
Ottawa
Ontario
K1Y 4G2
Canada
Recherche Invascor Inc
Longueuil
Quebec
J4N 1E1
Canada
Hopital du Sacre-Coeur de Montreal
Montreal
Quebec
H4J 1C5
Canada
CIC Mauricie Inc.
Trois-Rivières
Quebec
G8T 7A1
Canada
FG002
IMA-638 2 mg/kg: Stage-1
IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
FG003
Placebo: Stage 1
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
FG004
IMA-638 200 mg: Stage 2 and 3
IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
FG005
IMA-638 75 mg: Stage 3
IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
FG006
Placebo: Stage 2 and 3
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
FG00016 subjects
FG00117 subjects
FG00216 subjects
FG00316 subjects
FG00445 subjects
FG0054 subjects
FG00645 subjects
COMPLETED
FG00014 subjects
FG00115 subjects
FG00216 subjects
FG00314 subjects
FG00419 subjects
FG0050 subjects
FG00626 subjects
NOT COMPLETED
FG0002 subjects
FG0012 subjects
FG0020 subjects
FG0032 subjects
FG00426 subjects
FG0054 subjects
FG00619 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG0042 subjects
FG0050 subjects
FG0060 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Sponsor's request
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Modified intent-to-treat (mITT) population included all randomized participants who received at least 1 dose administration of the test article.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
IMA-638 0.2 mg/kg: Stage 1
IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
BG001
IMA-638 0.6 mg/kg: Stage 1
IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
BG002
IMA-638 2 mg/kg: Stage-1
IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
BG003
Placebo: Stage 1
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
BG004
IMA-638 200 mg: Stage 2 and 3
IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
BG005
IMA-638 75 mg: Stage 3
IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
BG006
Placebo: Stage 2 and 3
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00016
BG00117
BG00216
BG00316
BG00445
BG0054
BG00645
BG007159
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
participants
Title
Denominators
Categories
Less than 18 years
Title
Measurements
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00011
BG00110
BG002
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 From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 1
The PEFR is a participant's maximum speed of expiration, as measured with a peak flow meter. All participants were issued with the peak flow meter and instructed to perform the activity in triplicate in the morning prior to taking bronchodilator. The best among the 3 readings was selected.
mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1. Last observation carried forward (LOCF) method was used to impute missing values.
Posted
Mean
Standard Deviation
liter per minute (L/min)
Baseline, Day 112
ID
Title
Description
OG000
IMA-638 0.2 mg/kg: Stage 1
IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG001
IMA-638 0.6 mg/kg: Stage 1
IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG002
IMA-638 2 mg/kg: Stage-1
IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG003
Placebo: Stage 1
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Units
Counts
Participants
OG00016
OG00117
OG00216
OG003
Title
Denominators
Categories
Baseline
Title
Measurements
OG000286.4± 67.6
OG001297.6± 55.4
OG002343.5± 91.8
OG003
Primary
Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 2/3
The PEFR is a participant's maximum speed of expiration, as measured with a peak flow meter. All participants were issued with the peak flow meter and instructed to perform the activity in triplicate in the morning prior to taking bronchodilator. The best among the 3 readings was selected.
mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values. "n" signifies those participants who were evaluated for this measure at the specified time point for each arm.
Posted
Mean
Standard Deviation
L/min
Baseline, Day 112
ID
Title
Description
OG000
IMA-638 200 mg: Stage 2 and 3
IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
OG001
IMA-638 75 mg: Stage 3
IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
OG002
Placebo: Stage 2 and 3
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
Secondary
Change From Baseline in Pre-beta-agonist Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 28, 56, 84 and 112 - Stage 1
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 was obtained from spirometry, performed before study treatment administration. Participants performed the test in triplicate at each visit and the best of the 3 values was selected.
mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1. LOCF method was used to impute missing values.
Posted
Mean
Standard Deviation
liter
Baseline, Day 8, 28, 56, 84, 112
ID
Title
Description
OG000
IMA-638 0.2 mg/kg: Stage 1
IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG001
IMA-638 0.6 mg/kg: Stage 1
IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG002
IMA-638 2 mg/kg: Stage-1
IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG003
Secondary
Change From Baseline in Pre-beta-agonist Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 28, 56, 84 and 112 - Stage 2/3
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 was obtained from spirometry, performed before study treatment administration. Participants performed the test in triplicate at each visit and the best of the 3 values was selected.
mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values.
Posted
Mean
Standard Deviation
liter
Baseline, Day 8, 28, 56, 84, 112
ID
Title
Description
OG000
IMA-638 200 mg: Stage 2 and 3
IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
OG001
IMA-638 75 mg: Stage 3
IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
OG002
Placebo: Stage 2 and 3
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
Secondary
Change From Baseline in Airway Hyper-reactivity at Day 28 and 112
Airway hyper-reactivity was assessed using provocative concentration 20 (PC20). PC20 was the concentration of methacholine at which participants had 20 percent (%) decrease in FEV1. Results for PC20 were summarized together for all participants who received any dose of IMA-638 and for all participants who received placebo during any stage of the study as per investigator's discretion.
mITT population included all randomized participants who received at least 1 dose administration of the test article. LOCF method was used to impute missing values. 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Posted
Geometric Mean
Standard Deviation
milligram per milliliter (mg/mL)
Baseline, Day 28, 112
ID
Title
Description
OG000
IMA-638
Included participants who received any dose of IMA-638 subcutaneous injection during Stage 1, 2 or 3.
OG001
Placebo
Included all participants who received placebo matched to IMA-638 subcutaneous injection during Stage 1, 2 or 3.
Units
Counts
Participants
Secondary
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 1
ACQ-5 was a 5-item participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing). 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 was the mean of the responses. Mean scores of less than or equal to (=<) 0.75 indicate well-controlled asthma, scores between 0.76 and less than (<) 1.5 indicate partly controlled asthma, and a score greater than or equal to (>=) 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.
mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1. LOCF method was used to impute missing values.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Day 8, 28, 56, 84, 112
ID
Title
Description
OG000
IMA-638 0.2 mg/kg: Stage 1
IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG001
IMA-638 0.6 mg/kg: Stage 1
IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Secondary
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 2/3
ACQ-5 was a 5-item participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing). 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 was 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.
mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Day 8, 28, 56, 84, 112
ID
Title
Description
OG000
IMA-638 200 mg: Stage 2 and 3
IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
OG001
IMA-638 75 mg: Stage 3
IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
OG002
Secondary
Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 1
mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1. LOCF method was used to impute missing values.
Posted
Number
percentage of participants
Baseline up to Day 112
ID
Title
Description
OG000
IMA-638 0.2 mg/kg: Stage 1
IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG001
IMA-638 0.6 mg/kg: Stage 1
IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG002
IMA-638 2 mg/kg: Stage-1
IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG003
Placebo: Stage 1
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Secondary
Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 2/3
mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values.
Posted
Number
percentage of participant
Baseline up to Day 112
ID
Title
Description
OG000
IMA-638 200 mg: Stage 2 and 3
IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
OG001
IMA-638 75 mg: Stage 3
IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
OG002
Placebo: Stage 2 and 3
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
Units
Counts
Participants
Secondary
Mean Number of Puffs of Rescue Medication Used - Stage 1
The rescue medication taken for needed symptoms was a short acting beta agonist (SABA) inhaler. Albuterol, 90 microgram (mcg)/puff, was recommended for use.
Data for this outcome measure was not analyzed as the study was stopped early and sponsor's decision to analyze only safety and key efficacy outcomes.
Posted
Day 8, 28, 56, 84, 89, 91, 94, 98, 112
ID
Title
Description
OG000
IMA-638 0.2 mg/kg: Stage 1
IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG001
IMA-638 0.6 mg/kg: Stage 1
IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG002
IMA-638 2 mg/kg: Stage-1
IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG003
Placebo: Stage 1
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Secondary
Mean Number of Puffs of Rescue Medication Used - Stage 2/3
The rescue medication taken for needed symptoms was a SABA inhaler. Albuterol, 90 mcg/puff, was recommended for use.
Data for this outcome measure was not analyzed as the study was stopped early and sponsor's decision to analyze only safety and key efficacy outcomes.
Posted
Day 8, 28, 56, 84, 89, 91, 94, 98, 112
ID
Title
Description
OG000
IMA-638 200 mg: Stage 2 and 3
IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
OG001
IMA-638 75 mg: Stage 3
IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
OG002
Placebo: Stage 2 and 3
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
Units
Counts
Participants
Secondary
Forced Vital Capacity (FVC) - Stage 1
FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Data for this outcome measure was not analyzed as the study was stopped early and sponsor's decision to analyze only safety and key efficacy outcomes.
Posted
Baseline, Day 8, 28, 56, 84, 112
ID
Title
Description
OG000
IMA-638 0.2 mg/kg: Stage 1
IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG001
IMA-638 0.6 mg/kg: Stage 1
IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG002
IMA-638 2 mg/kg: Stage-1
IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG003
Placebo: Stage 1
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Secondary
Forced Vital Capacity (FVC) - Stage 2/3
FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Data for this outcome measure was not analyzed as the study was stopped early and sponsor's decision to analyze only safety and key efficacy outcomes.
Posted
Baseline, Day 8, 28, 56, 84, 112
ID
Title
Description
OG000
IMA-638 200 mg: Stage 2 and 3
IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
OG001
IMA-638 75 mg: Stage 3
IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
OG002
Placebo: Stage 2 and 3
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
FEF25-75 is the average expiratory flow over the middle half of the FVC. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Data for this outcome measure was not analyzed as the study was stopped early and sponsor's decision to analyze only safety and key efficacy outcomes.
Posted
Baseline, Day 8, 28, 56, 84, 112
ID
Title
Description
OG000
IMA-638 0.2 mg/kg: Stage 1
IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG001
IMA-638 0.6 mg/kg: Stage 1
IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG002
IMA-638 2 mg/kg: Stage-1
IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG003
Placebo: Stage 1
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
FEF25-75 is the average expiratory flow over the middle half of the FVC. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Data for this outcome measure was not analyzed as the study was stopped early and sponsor's decision to analyze only safety and key efficacy outcomes.
Posted
Baseline, Day 8, 28, 56, 84, 112
ID
Title
Description
OG000
IMA-638 200 mg: Stage 2 and 3
IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
OG001
IMA-638 75 mg: Stage 3
IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
OG002
Placebo: Stage 2 and 3
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
Units
Counts
Secondary
Blood Eosinophils Levels - Stage 1
mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1. LOCF method was used to impute missing values.
Posted
Mean
Standard Deviation
10^9 cells per liter (cells/L)
Baseline, Day 8, 28, 56, 84, 112
ID
Title
Description
OG000
IMA-638 0.2 mg/kg: Stage 1
IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG001
IMA-638 0.6 mg/kg: Stage 1
IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG002
IMA-638 2 mg/kg: Stage-1
IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG003
Placebo: Stage 1
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Secondary
Blood Eosinophils Levels - Stage 2/3
mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values.
Posted
Mean
Standard Deviation
10^9 cells/L
Baseline, Day 8, 28, 56, 84, 112
ID
Title
Description
OG000
IMA-638 200 mg: Stage 2 and 3
IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
OG001
IMA-638 75 mg: Stage 3
IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
OG002
Placebo: Stage 2 and 3
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
Units
Counts
Participants
Secondary
Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 1
Log 10-transformed serum total IgE levels were expressed in Log-10 International units/milliliter (IU/mL).
mITT population (Stage 1) included all randomized participants who received at least 1 dose of test article in Stage 1. LOCF method was used to impute missing values.'N' (Number of Participants Analyzed) signifies participants evaluable for this measure."n" signifies participants evaluated for this measure at the specified time point for each arm.
Posted
Mean
Standard Deviation
log-10 IU/mL
Baseline, Day 28, 56, 84, 112
ID
Title
Description
OG000
IMA-638 0.2 mg/kg: Stage 1
IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG001
IMA-638 0.6 mg/kg: Stage 1
IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG002
IMA-638 2 mg/kg: Stage-1
IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG003
Placebo: Stage 1
Secondary
Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 2/3
Log 10-transformed serum total IgE levels were expressed in Log-10 International units/milliliter (IU/mL).
mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values. "n" signifies participants evaluated for this measure at the specified time point for each arm.
Posted
Mean
Standard Deviation
log-10 IU/mL
Baseline, Day 28, 56, 84, 112
ID
Title
Description
OG000
IMA-638 200 mg: Stage 2 and 3
IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
OG001
IMA-638 75 mg: Stage 3
IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
OG002
Placebo: Stage 2 and 3
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
Secondary
Serum Interleukin-13 (IL-13) Level - Stage 1
Data for this outcome measure was not analyzed as the study was stopped early and sponsor's decision to analyze only safety and key efficacy outcomes.
Posted
Baseline, Day 8, 28, 56, 84, 112
ID
Title
Description
OG000
IMA-638 0.2 mg/kg: Stage 1
IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG001
IMA-638 0.6 mg/kg: Stage 1
IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG002
IMA-638 2 mg/kg: Stage-1
IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG003
Placebo: Stage 1
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Units
Secondary
Serum Interleukin-13 (IL-13) Level - Stage 2/3
Data for this outcome measure was not analyzed as the study was stopped early and sponsor's decision to analyze only safety and key efficacy outcomes.
Posted
Baseline, Day 8, 28, 56, 84, 112
ID
Title
Description
OG000
IMA-638 200 mg: Stage 2 and 3
IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
OG001
IMA-638 75 mg: Stage 3
IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
OG002
Placebo: Stage 2 and 3
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
Units
Counts
Participants
OG000
Other Pre-specified
Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance Stage 1
Criteria for potentially clinically important (PCI) vital sign abnormalities- heart rate: greater than (>) 15 beats per minute (bpm) increase from baseline and greater than or equal to (>=) 120 bpm, >15 bpm decrease from baseline and less than or equal to (<=) 45 bpm: systolic blood pressure (SBP): >=20 millimeter of mercury (mmHg) increase from baseline and >=160 mmHg, >=20 mmHg decrease from baseline and <=90 mmHg: diastolic blood pressure (DBP): of >=15 mmHg increase from baseline and >=100 mmHg, >=15 mmHg decrease from baseline and <=50 mmHg, oral temperature <35 or >38.3 degrees centigrade: respiratory rate: <10 or >25 breaths/minute: body weight: >=7% increase or decrease from baseline.
mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1.
Posted
Number
participants
Baseline up to Day 112
ID
Title
Description
OG000
IMA-638 0.2 mg/kg: Stage 1
IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG001
IMA-638 0.6 mg/kg: Stage 1
IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG002
IMA-638 2 mg/kg: Stage-1
Other Pre-specified
Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance - Stage 2/3
Criteria for PCI vital sign abnormalities- heart rate: >15 bpm increase from baseline and >=120 bpm, >15 bpm decrease from baseline and <=45 bpm: SBP: >=20 mmHg increase from baseline and >=160 mmHg, >=20 mmHg decrease from baseline and <=90 mmHg: DBP: of >=15 mmHg increase from baseline and >=100 mmHg, >=15 mmHg decrease from baseline and <=50 mmHg, oral temperature <35 or >38.3 degrees centigrade: respiratory rate: <10 or >25 breaths/minute: body weight: >=7% increase or decrease from baseline.
mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3.
Posted
Number
participants
Baseline up to Day 112
ID
Title
Description
OG000
IMA-638 200 mg: Stage 2 and 3
IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
OG001
IMA-638 75 mg: Stage 3
IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
OG002
Placebo: Stage 2 and 3
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
Other Pre-specified
Number of Participants With Clinically Important Changes in Physical Findings - Stage 1
Physical examination included examination of general appearance, skin, head, ears, eyes, nose, throat, heart, lungs, breasts, abdomen, external genitalia, extremities, neurological exam, back/spine and lymph nodes.
mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1.
Posted
Number
participants
Baseline up to Day 112
ID
Title
Description
OG000
IMA-638 0.2 mg/kg: Stage 1
IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG001
IMA-638 0.6 mg/kg: Stage 1
IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG002
IMA-638 2 mg/kg: Stage-1
IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG003
Placebo: Stage 1
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Other Pre-specified
Number of Participants With Clinically Important Changes in Physical Findings - Stage 2/3
Physical examination included examination of general appearance, skin, head, ears, eyes, nose, throat, heart, lungs, breasts, abdomen, external genitalia, extremities, neurological exam, back/spine and lymph nodes.
mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3.
Posted
Number
participants
Baseline up to Day 112
ID
Title
Description
OG000
IMA-638 200 mg: Stage 2 and 3
IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
OG001
IMA-638 75 mg: Stage 3
IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
OG002
Placebo: Stage 2 and 3
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
Other Pre-specified
Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern - Stage 1
Clinically significant ECG findings included - heart rate: >15 bpm increase from baseline and >=120 bpm, PR interval: >=20 millisecond (msec) change from baseline and >=220 msec: QRS interval: >=120 msec: corrected QT (QTc) interval: >450 msec for males and >470 msec for females.
mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1.
Posted
Number
participants
Baseline up to Day 112
ID
Title
Description
OG000
IMA-638 0.2 mg/kg: Stage 1
IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG001
IMA-638 0.6 mg/kg: Stage 1
IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG002
IMA-638 2 mg/kg: Stage-1
IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG003
Placebo: Stage 1
Other Pre-specified
Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern - Stage 2/3
Clinically significant ECG findings included - heart rate: >15 bpm increase from baseline and >=120 bpm, PR interval: >=20 msec change from baseline and >=220 msec: QRS interval: >=120 msec: QTc interval: >450 msec for males and >470 msec for females.
mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3.
Posted
Number
participants
Baseline up to Day 112
ID
Title
Description
OG000
IMA-638 200 mg: Stage 2 and 3
IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
OG001
IMA-638 75 mg: Stage 3
IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
OG002
Placebo: Stage 2 and 3
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
Other Pre-specified
Number of Participants With Injection Site Reaction - Stage 1
mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1.
Posted
Number
participants
Baseline up to Day 112
ID
Title
Description
OG000
IMA-638 0.2 mg/kg: Stage 1
IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG001
IMA-638 0.6 mg/kg: Stage 1
IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG002
IMA-638 2 mg/kg: Stage-1
IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG003
Placebo: Stage 1
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Other Pre-specified
Number of Participants With Injection Site Reaction - Stage 2/3
mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3.
Posted
Number
participants
Baseline up to Day 112
ID
Title
Description
OG000
IMA-638 200 mg: Stage 2 and 3
IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
OG001
IMA-638 75 mg: Stage 3
IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
OG002
Placebo: Stage 2 and 3
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
Units
Counts
Participants
Other Pre-specified
Number of Participants With Laboratory Test Abnormalities of Potential Clinical Importance - Stage 1
Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, total neutrophils, eosinophils); hepatobiliary biochemistry: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, total bilirubin, gamma glutamyl transferase (GGT), total lactate dehydrogenase (LDH); renal function tests: blood urea nitrogen (BUN), creatinine, creatinine kinase, uric acid, albumin; electrolytes: sodium, potassium, calcium, magnesium, phosphorus; coagulation: prothrombin time and partial thromboplastin time; glucose: fasting, non-fasting; lipid profile: total cholesterol, triglycerides.
mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1.
Posted
Number
participants
Baseline up to Day 112
ID
Title
Description
OG000
IMA-638 0.2 mg/kg: Stage 1
IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG001
IMA-638 0.6 mg/kg: Stage 1
IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG002
IMA-638 2 mg/kg: Stage-1
Other Pre-specified
Number of Participants With Laboratory Test Abnormalities of Potential Clinical Importance - Stage 2/3
Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, total neutrophils, eosinophils); hepatobiliary biochemistry: ALT, AST, alkaline phosphatase, total bilirubin, GGT, total LDH; renal function tests: BUN, creatinine, creatinine kinase, uric acid, albumin; electrolytes: sodium, potassium, calcium, magnesium, phosphorus; coagulation: prothrombin time and partial thromboplastin time; glucose: fasting, non-fasting; lipid profile: total cholesterol, triglycerides.
mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values.
Posted
Number
participants
Baseline up to Day 112
ID
Title
Description
OG000
IMA-638 200 mg: Stage 2 and 3
IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
OG001
IMA-638 75 mg: Stage 3
IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
OG002
Placebo: Stage 2 and 3
Time Frame
Not provided
Description
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
IMA-638 0.2 mg/kg: Stage 1
IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
0
16
13
16
EG001
IMA-638 0.6 mg/kg: Stage 1
IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1
17
12
17
EG002
IMA-638 2 mg/kg: Stage-1
IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
2
16
11
16
EG003
Placebo: Stage 1
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1
16
10
16
EG004
IMA-638 200 mg: Stage 2 and 3
IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
2
45
27
45
EG005
IMA-638 75 mg: Stage 3
IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
0
4
1
4
EG006
Placebo: Stage 2 and 3
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
0
45
26
45
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Deafness unilateral
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG0031 affected16 at risk
EG0040 affected45 at risk
EG0050 affected4 at risk
EG0060 affected45 at risk
Injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected17 at risk
EG0020 affected16 at risk
EG003
Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0021 affected16 at risk
EG003
Depression
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0021 affected16 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0021 affected16 at risk
EG0030 affected16 at risk
EG0040 affected45 at risk
EG0050 affected4 at risk
EG0061 affected45 at risk
Deafness unilateral
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Ear congestion
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Tympanic membrane scarring
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected17 at risk
EG0020 affected16 at risk
EG003
Eyelids pruritus
Eye disorders
MedDRA
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Visual disturbance
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected17 at risk
EG0020 affected16 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0021 affected16 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected17 at risk
EG0021 affected16 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected17 at risk
EG0021 affected16 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected17 at risk
EG0020 affected16 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected17 at risk
EG0020 affected16 at risk
EG003
Chest pain
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0021 affected16 at risk
EG003
Fatigue
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Injection site bruising
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Injection site erythema
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected17 at risk
EG0020 affected16 at risk
EG003
Injection site induration
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Injection site swelling
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected17 at risk
EG0020 affected16 at risk
EG003
Injection site urticaria
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected17 at risk
EG0020 affected16 at risk
EG003
Oedema peripheral
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Pitting oedema
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Pyrexia
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected17 at risk
EG0020 affected16 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Candidiasis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected17 at risk
EG0020 affected16 at risk
EG003
Conjunctivitis viral
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Ear infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Helicobacter infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Influenza
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Laryngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Oral herpes
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0021 affected16 at risk
EG003
Oropharyngeal candidiasis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected17 at risk
EG0020 affected16 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected17 at risk
EG0020 affected16 at risk
EG003
Rhinitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Sinusitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Skin infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0021 affected16 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected16 at risk
EG0012 affected17 at risk
EG0020 affected16 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected16 at risk
EG0013 affected17 at risk
EG0021 affected16 at risk
EG003
Viral infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0021 affected16 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Back injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected17 at risk
EG0021 affected16 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0001 affected16 at risk
EG0011 affected17 at risk
EG0020 affected16 at risk
EG003
Epicondylitis
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected17 at risk
EG0020 affected16 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0021 affected16 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0001 affected16 at risk
EG0011 affected17 at risk
EG0020 affected16 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected17 at risk
EG0022 affected16 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Skeletal injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0021 affected16 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Blood amylase increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected17 at risk
EG0020 affected16 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA
Non-systematic Assessment
EG0001 affected16 at risk
EG0011 affected17 at risk
EG0022 affected16 at risk
EG003
Blood pressure increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected17 at risk
EG0020 affected16 at risk
EG003
Lipase increased
Investigations
MedDRA
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected17 at risk
EG0021 affected16 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected17 at risk
EG0020 affected16 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0013 affected17 at risk
EG0021 affected16 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected17 at risk
EG0020 affected16 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0021 affected16 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Dizziness
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected17 at risk
EG0020 affected16 at risk
EG003
Headache
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected17 at risk
EG0021 affected16 at risk
EG003
Migraine
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Tension headache
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Alcohol abuse
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0021 affected16 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Nicotine dependence
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0021 affected16 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0021 affected16 at risk
EG003
Amenorrhoea
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected17 at risk
EG0021 affected16 at risk
EG003
Foreign body aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Nasal oedema
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Nasal polyps
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0021 affected16 at risk
EG003
Pharyngeal leukoplakia
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Pulmonary congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Rhinitis seasonal
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected17 at risk
EG0020 affected16 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Cold sweat
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected17 at risk
EG0020 affected16 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0021 affected16 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Rosacea
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Scar
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Diastolic hypertension
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Hypertension
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected17 at risk
EG0020 affected16 at risk
EG003
Rash pustular
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected17 at risk
EG0020 affected16 at risk
EG003
The study was stopped early due to futility of the interim efficacy analysis results. Hence, only safety results and key efficacy results were presented for this study.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D001249
Asthma
Ancestor Terms
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
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000599521
anrukinzumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
1 subjects
FG0050 subjects
FG0063 subjects
19 subjects
FG0054 subjects
FG00615 subjects
1 subjects
FG0050 subjects
FG0060 subjects
3 subjects
FG0050 subjects
FG0061 subjects
0
BG0040
BG0050
BG0060
BG0070
18 to 71 years
Title
Measurements
BG00016
BG00117
BG00216
BG00316
BG00445
BG0054
BG00645
BG007159
Greater than 71 years
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
7
BG0039
BG00425
BG0051
BG00628
BG00791
Male
BG0005
BG0017
BG0029
BG0037
BG00420
BG0053
BG00617
BG00768
16
291.5
± 64.7
Change at Day 112
Title
Measurements
OG00021.1± 40.9
OG0013.4± 53.6
OG0027.6± 38.1
OG00311.8± 37.5
Units
Counts
Participants
OG00045
OG0014
OG00245
Title
Denominators
Categories
Baseline (n=42, 4, 45)
Title
Measurements
OG000329.3± 81.7
OG001348.6± 39.9
OG002330.4± 89.5
Change at Day 112 (n=45, 4, 45)
Title
Measurements
OG0006.8± 42.9
OG00118.8± 30.7
OG0027.6± 48.9
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Day 112: Analysis of co-variance (ANCOVA) model was used with baseline as a covariate, long-acting beta-agonist (LABA) use (Inhaled Corticosteroid [ICS] only or ICS plus LABA) and treatment as two factors.
ANCOVA
0.612
Least squares (LS) mean difference
-5.2
2-Sided
95
-25.6
15.2
No
Superiority or Other
Placebo: Stage 1
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Units
Counts
Participants
OG00016
OG00117
OG00216
OG00316
Title
Denominators
Categories
Baseline
Title
Measurements
OG0002.1± 0.4
OG0012.0± 0.4
OG0022.3± 0.5
OG0032.0± 0.5
Change at Day 8
Title
Measurements
OG0000.1± 0.2
OG0010.0± 0.1
OG0020.0± 0.3
OG003
Change at Day 28
Title
Measurements
OG0000.1± 0.2
OG0010.1± 0.1
OG0020.0± 0.4
OG003
Change at Day 56
Title
Measurements
OG0000.0± 0.2
OG0010.1± 0.2
OG0020.1± 0.3
OG003
Change at Day 84
Title
Measurements
OG0000.1± 0.2
OG0010.0± 0.2
OG0020.0± 0.4
OG003
Change at Day 112
Title
Measurements
OG0000.2± 0.3
OG0010.1± 0.2
OG0020.1± 0.4
OG003
Units
Counts
Participants
OG00045
OG0014
OG00245
Title
Denominators
Categories
Baseline
Title
Measurements
OG0002.2± 0.6
OG0012.3± 0.7
OG0022.1± 0.6
Change at Day 8
Title
Measurements
OG000-0.0± 0.2
OG0010.2± 0.2
OG0020.0± 0.3
Change at Day 28
Title
Measurements
OG0000.0± 0.3
OG0010.2± 0.2
OG0020.1± 0.3
Change at Day 56
Title
Measurements
OG0000.0± 0.3
OG0010.2± 0.2
OG0020.1± 0.3
Change at Day 84
Title
Measurements
OG0000.1± 0.3
OG0010.2± 0.2
OG0020.1± 0.3
Change at Day 112
Title
Measurements
OG0000.1± 0.3
OG0010.2± 0.2
OG0020.1± 0.3
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Day 8: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.
ANCOVA
0.482
LS mean Difference
-0.0
2-Sided
95
-0.2
0.1
No
Superiority or Other
OG000
OG002
Day 28: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.
ANCOVA
0.492
LS mean difference
-0.0
2-Sided
95
-0.2
0.1
No
Superiority or Other
OG000
OG002
Day 56: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.
ANCOVA
0.323
LS mean difference
-0.1
2-Sided
95
-0.2
0.1
No
Superiority or Other
OG000
OG002
Day 84: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.
ANCOVA
0.226
LS mean difference
-0.1
2-Sided
95
-0.2
0.1
No
Superiority or Other
OG000
OG002
Day 112: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.
ANCOVA
0.256
LS mean difference
-0.1
2-Sided
95
-0.2
0.1
No
Superiority or Other
OG00033
OG00111
Title
Denominators
Categories
Baseline
Title
Measurements
OG0001.1± 13.8
OG0010.3± 38.9
Change at Day 28
Title
Measurements
OG0001.2± 9.8
OG0010.6± 11.4
Change at Day 112
Title
Measurements
OG0001.0± 28.9
OG0010.5± 22.7
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Day 28: ANCOVA model was based on the log 2 transformed methacholine challenge test values with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.
ANCOVA
0.090
LS mean difference
1.8
2-Sided
95
-0.3
3.9
No
Superiority or Other
OG000
OG001
Day 112: ANCOVA model was based on the log 2 transformed methacholine challenge test values with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.
ANCOVA
0.144
LS mean difference
2.1
2-Sided
95
-0.8
5.0
No
Superiority or Other
OG002
IMA-638 2 mg/kg: Stage-1
IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG003
Placebo: Stage 1
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Units
Counts
Participants
OG00016
OG00117
OG00216
OG00316
Title
Denominators
Categories
Baseline
Title
Measurements
OG0002.7± 0.6
OG0012.6± 0.8
OG0022.8± 0.6
OG0032.7± 0.7
Change at Day 8
Title
Measurements
OG000-0.6± 1.1
OG001-0.2± 0.7
OG002-0.6± 0.7
OG003
Change at Day 28
Title
Measurements
OG000-0.7± 1.1
OG001-0.5± 0.7
OG002-0.8± 0.9
OG003
Change at Day 56
Title
Measurements
OG000-0.8± 1.1
OG001-0.6± 0.8
OG002-1.1± 1.1
OG003
Change at Day 84
Title
Measurements
OG000-1.1± 1.2
OG001-0.8± 0.9
OG002-1.1± 1.1
OG003
Change at Day 112
Title
Measurements
OG000-0.9± 1.2
OG001-0.7± 0.9
OG002-1.2± 1.0
OG003
Placebo: Stage 2 and 3
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
Units
Counts
Participants
OG00045
OG0014
OG00245
Title
Denominators
Categories
Baseline
Title
Measurements
OG0002.7± 0.6
OG0012.3± 0.6
OG0022.8± 0.6
Change at Day 8
Title
Measurements
OG000-0.6± 0.7
OG001-0.4± 0.8
OG002-0.5± 0.7
Change at Day 28
Title
Measurements
OG000-0.7± 1.0
OG001-0.4± 0.9
OG002-0.7± 0.8
Change at Day 56
Title
Measurements
OG000-0.8± 1.1
OG001-0.4± 0.9
OG002-0.8± 0.9
Change at Day 84
Title
Measurements
OG000-0.8± 1.1
OG001-0.4± 0.9
OG002-1.0± 0.9
Change at Day 112
Title
Measurements
OG000-0.8± 1.1
OG001-0.4± 0.9
OG002-1.0± 0.9
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Day 8: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.
ANCOVA
0.354
LS mean difference
-0.1
2-Sided
95
-0.4
0.1
No
Superiority or Other
OG000
OG002
Day 28: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.
ANCOVA
0.900
LS mean difference
0.0
2-Sided
95
-0.4
0.4
No
Superiority or Other
OG000
OG002
Day 56: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.
ANCOVA
0.921
LS mean difference
0.0
2-Sided
95
-0.4
0.4
No
Superiority or Other
OG000
OG002
Day 84: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.
ANCOVA
0.388
LS mean difference
0.2
2-Sided
95
-0.2
0.6
No
Superiority or Other
OG000
OG002
Day 112: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.
ANCOVA
0.249
LS mean difference
0.2
2-Sided
95
-0.2
0.7
No
Superiority or Other
Units
Counts
Participants
OG00016
OG00117
OG00216
OG00316
Title
Denominators
Categories
Title
Measurements
OG0000.00
OG0010.00
OG0026.25
OG00312.50
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
Chi-squared
0.267
2-Sided
No
Superiority or Other
OG00045
OG0014
OG00245
Title
Denominators
Categories
Title
Measurements
OG00011.11
OG00125.00
OG0020.00
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
Chi-squared
0.029
2-Sided
No
Superiority or Other
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0000
OG0010
OG0020
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0000
OG0010
OG0020
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
Participants
OG0000
OG0010
OG0020
Units
Counts
Participants
OG00016
OG00117
OG00216
OG00316
Title
Denominators
Categories
Baseline
Title
Measurements
OG0000.3± 0.2
OG0010.3± 0.2
OG0020.3± 0.2
OG0030.3± 0.2
Day 8
Title
Measurements
OG0000.3± 0.2
OG0010.3± 0.2
OG0020.3± 0.2
OG003
Day 28
Title
Measurements
OG0000.3± 0.3
OG0010.3± 0.4
OG0020.3± 0.2
OG003
Day 56
Title
Measurements
OG0000.3± 0.2
OG0010.3± 0.3
OG0020.3± 0.2
OG003
Day 84
Title
Measurements
OG0000.3± 0.2
OG0010.3± 0.3
OG0020.3± 0.2
OG003
Day 112
Title
Measurements
OG0000.3± 0.2
OG0010.4± 0.3
OG0020.3± 0.2
OG003
OG00045
OG0014
OG00245
Title
Denominators
Categories
Baseline
Title
Measurements
OG0000.3± 0.2
OG0010.7± 1.0
OG0020.3± 0.2
Day 8
Title
Measurements
OG0000.3± 0.2
OG0010.7± 1.0
OG0020.3± 0.2
Day 28
Title
Measurements
OG0000.3± 0.3
OG0010.8± 0.9
OG0020.3± 0.2
Day 56
Title
Measurements
OG0000.3± 0.3
OG0010.8± 0.9
OG0020.3± 0.1
Day 84
Title
Measurements
OG0000.3± 0.3
OG0010.8± 0.9
OG0020.2± 0.1
Day 112
Title
Measurements
OG0000.3± 0.4
OG0010.8± 0.9
OG0020.2± 0.2
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Units
Counts
Participants
OG00016
OG00117
OG00216
OG00316
Title
Denominators
Categories
Baseline (n=16, 16, 14, 14)
Title
Measurements
OG0003.8± 1.6
OG0014.5± 1.9
OG0024.4± 1.4
OG0034.9± 1.4
Day 28 (n=16, 17, 16, 16)
Title
Measurements
OG0003.8± 1.5
OG0014.3± 1.9
OG0024.5± 1.4
OG003
Day 56 (n=16, 17, 16, 16)
Title
Measurements
OG0003.7± 1.7
OG0014.2± 1.9
OG0024.3± 1.5
OG003
Day 84 (n=16, 17, 16, 16)
Title
Measurements
OG0003.8± 1.6
OG0014.2± 1.9
OG0024.4± 1.5
OG003
Day 112 (n=16, 17, 16, 16)
Title
Measurements
OG0003.8± 1.6
OG0014.1± 1.7
OG0024.3± 1.5
OG003
Units
Counts
Participants
OG00045
OG0014
OG00245
Title
Denominators
Categories
Baseline (n=43, 4, 43)
Title
Measurements
OG0004.5± 1.5
OG0015.1± 1.7
OG0024.9± 1.2
Day 28 (n=44, 4, 45)
Title
Measurements
OG0004.6± 1.5
OG0015.1± 1.8
OG0024.9± 1.3
Day 56 (n=45, 4, 45)
Title
Measurements
OG0004.6± 1.5
OG0015.1± 1.8
OG0024.9± 1.2
Day 84 (n=45, 4, 45)
Title
Measurements
OG0004.6± 1.5
OG0015.1± 1.8
OG0024.9± 1.2
Day 112 (n=45, 4, 45)
Title
Measurements
OG0004.6± 1.5
OG0015.1± 1.8
OG0025.0± 1.2
Counts
Participants
OG0000
OG0010
OG0020
OG0030
0
OG0010
OG0020
IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG003
Placebo: Stage 1
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Units
Counts
Participants
OG00016
OG00117
OG00216
OG00316
Title
Denominators
Categories
Title
Measurements
OG0001
OG0012
OG0021
OG0031
Units
Counts
Participants
OG00045
OG0014
OG00245
Title
Denominators
Categories
Title
Measurements
OG0003
OG0010
OG0021
Units
Counts
Participants
OG00016
OG00117
OG00216
OG00316
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Units
Counts
Participants
OG00045
OG0014
OG00245
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Units
Counts
Participants
OG00016
OG00117
OG00216
OG00316
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0021
OG0031
Units
Counts
Participants
OG00045
OG0014
OG00245
Title
Denominators
Categories
Title
Measurements
OG0003
OG0010
OG0021
Units
Counts
Participants
OG00016
OG00117
OG00216
OG00316
Title
Denominators
Categories
Injection site bruising
Title
Measurements
OG0001
OG0010
OG0020
OG0030
Injection site erythema
Title
Measurements
OG0000
OG0011
OG0020
OG003
Injection site swelling
Title
Measurements
OG0000
OG0011
OG0020
OG003
Injection site urticaria
Title
Measurements
OG0000
OG0011
OG0020
OG003
OG000
45
OG0014
OG00245
Title
Denominators
Categories
Injection site bruising
Title
Measurements
OG0001
OG0010
OG0020
Injection site erythema
Title
Measurements
OG0002
OG0010
OG0021
Injection site induration
Title
Measurements
OG0000
OG0010
OG0021
Injection site swelling
Title
Measurements
OG0000
OG0010
OG0021
Injection site urticaria
Title
Measurements
OG0000
OG0010
OG0021
IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
OG003
Placebo: Stage 1
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Units
Counts
Participants
OG00016
OG00117
OG00216
OG00316
Title
Denominators
Categories
Title
Measurements
OG0005
OG00111
OG00212
OG0039
Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.