Study Evaluating the Effect of IMA-638 in Subjects With Persistent Asthma

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00425061

Collaborator

(none)

159

Enrollment

Locations

Arms

Duration (Months)

1.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary purpose is to assess if IMA-638 is safe and improves asthma in subjects with persistent asthma.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Biological: IMA-638 Biological: IMA-638 Other: placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

159 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study Conducted Sequentially With 3 Doses Of Ima-638 Administered Sc.

Study Start Date :

Feb 1, 2007

Actual Primary Completion Date :

Aug 1, 2008

Actual Study Completion Date :

Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Biological: IMA-638 SC Injection, 12 weeks
Experimental: 2	Biological: IMA-638 SC Injection, 12 weeks
Placebo Comparator: 3	Other: placebo placebo

Arm

Intervention/Treatment

Experimental: 1

Biological: IMA-638

SC Injection, 12 weeks

Experimental: 2

Biological: IMA-638

SC Injection, 12 weeks

Placebo Comparator: 3

Other: placebo

placebo

Outcome Measures

Primary Outcome Measures

Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 1 [Baseline, Day 112]
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.
Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 2/3 [Baseline, Day 112]
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.

Secondary Outcome Measures

Change From Baseline in Pre-beta-agonist Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 28, 56, 84 and 112 - Stage 1 [Baseline, Day 8, 28, 56, 84, 112]
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.
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 [Baseline, Day 8, 28, 56, 84, 112]
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.
Change From Baseline in Airway Hyper-reactivity at Day 28 and 112 [Baseline, Day 28, 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.
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 1 [Baseline, Day 8, 28, 56, 84, 112]
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.
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 2/3 [Baseline, Day 8, 28, 56, 84, 112]
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.
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 [Day 8, 28, 56, 84, 89, 91, 94, 98, 112]
The rescue medication taken for needed symptoms was a short acting beta agonist (SABA) inhaler. Albuterol, 90 microgram (mcg)/puff, was recommended for use.
Mean Number of Puffs of Rescue Medication Used - Stage 2/3 [Day 8, 28, 56, 84, 89, 91, 94, 98, 112]
The rescue medication taken for needed symptoms was a SABA inhaler. Albuterol, 90 mcg/puff, was recommended for use.
Forced Vital Capacity (FVC) - Stage 1 [Baseline, Day 8, 28, 56, 84, 112]
FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Forced Vital Capacity (FVC) - Stage 2/3 [Baseline, Day 8, 28, 56, 84, 112]
FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Forced Mid-Expiratory Flow Rate 25 Percent (%) to 75% (FEF25-75) - Stage 1 [Baseline, Day 8, 28, 56, 84, 112]
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.
Forced Mid-Expiratory Flow Rate 25 Percent (%) to 75% (FEF25-75) - Stage 2/3 [Baseline, Day 8, 28, 56, 84, 112]
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.
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 [Baseline, Day 28, 56, 84, 112]
Log 10-transformed serum total IgE levels were expressed in Log-10 International units/milliliter (IU/mL).
Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 2/3 [Baseline, Day 28, 56, 84, 112]
Log 10-transformed serum total IgE levels were expressed in Log-10 International units/milliliter (IU/mL).
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]

Other Outcome Measures

Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance Stage 1 [Baseline up to Day 112]
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.
Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance - Stage 2/3 [Baseline up to Day 112]
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.
Number of Participants With Clinically Important Changes in Physical Findings - Stage 1 [Baseline up to Day 112]
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.
Number of Participants With Clinically Important Changes in Physical Findings - Stage 2/3 [Baseline up to Day 112]
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.
Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern - Stage 1 [Baseline up to Day 112]
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.
Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern - Stage 2/3 [Baseline up to Day 112]
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.
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 [Baseline up to Day 112]
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.
Number of Participants With Laboratory Test Abnormalities of Potential Clinical Importance - Stage 2/3 [Baseline up to Day 112]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alabama Allergy and Asthma Center	Birmingham	Alabama	United States	35209
2	Alabama Allergy & Asthma Clinic	Montgomery	Alabama	United States	36106
3	Little Rock Allergy & Asthma	Little Rock	Arkansas	United States	72205
4	Pacific Coast Allergy	Crescent City	California	United States	95531
5	ABM Research Center	Fresno	California	United States	93720
6	Allergy and Asthma Care Center of Southern California	Long Beach	California	United States	90808
7	Allergy Medical Clinic	Los Angeles	California	United States	90025
8	Advances in Medicine	Rancho Mirage	California	United States	92270
9	Penisula Research Associates	Rolling Hills Estates	California	United States	90274
10	Sharp Rees-Stealy Medical Group	San Diego	California	United States	92101
11	Allergy Associates Medical Group, Inc.	San Diego	California	United States	92120
12	Allergy & Asthma Assoc of Santa Clara Valley Research Ctr	San Jose	California	United States	95117
13	San Jose Clinical Research, Inc.	San Jose	California	United States	95128
14	Bensch Research Associates	Stockton	California	United States	95207
15	Allergy and Immunology Medical Group	Vista	California	United States	92083
16	Allergy & Asthma Clinical Research, Inc.	Walnut Creek	California	United States	94598
17	National Jewish Medical & Research Center	Denver	Colorado	United States	80206
18	Colorado Allergy and Asthma Centers	Denver	Colorado	United States	80230
19	Waterbury Pulmonary Associates	Waterbury	Connecticut	United States	06708
20	Brandon-Valico Center for Allergy & Asthma Research, LLC	Valrico	Florida	United States	33594
21	Roberson Allergy & Asthma	West Palm Beach	Florida	United States	33401
22	Georgia Pollens CRC, Inc.	Albany	Georgia	United States	31707
23	DataQuest Medical Research	Lawrenceville	Georgia	United States	30045
24	Aero Allergy Research Labs of Savannah, Inc. 505 Eisenhower	Savannah	Georgia	United States	31406
25	Allergy and Asthma Center of Chicago	River Forest	Illinois	United States	60305
26	Fort Wayne Medical Institute	Fort Wayne	Indiana	United States	46815
27	South Bend Clinic	South Bend	Indiana	United States	46617
28	College Park Family Care Center	Overland Park	Kansas	United States	66210
29	Kansas City Allergy & Asthma	Overland Park	Kansas	United States	66210
30	Abraham Research, PLLC	Crescent Springs	Kentucky	United States	41017
31	Clinical Research Specialists	Metairie	Louisiana	United States	70006
32	Allergy and Arthritis Family	Gardner	Massachusetts	United States	01440
33	Center for Clinical Research	Taunton	Massachusetts	United States	02780
34	Clinical Research Institute	Minneapolis	Minnesota	United States	55402
35	Mississippi Asthma and Allergy Clinic, P.A.	Jackson	Mississippi	United States	39202
36	The Clinical Research Center LLC	St Louis	Missouri	United States	63141
37	Midwest Clinical Research LLC	St. Louis	Missouri	United States	63141
38	Montana Medical Research, Inc	Missoula	Montana	United States	59808
39	Midwest Allergy and Asthma Clinic	Omaha	Nebraska	United States	68130
40	Allergy and Asthma Assoc	Las Vegas	Nevada	United States	89102
41	Princeton Center for Clinical Research	Skillman	New Jersey	United States	08558
42	Pulmonary and Allergy Associates	Summit	New Jersey	United States	07901
43	Pulmonary & Critical Care Services, P.C.5 Palisades Dr., Su	Albany	New York	United States	12205
44	Montefiore Medical Center	Bronx	New York	United States	10461
45	AAIR Research Center	Rochester	New York	United States	14618
46	Regional Allergy and Asthma Consultants, P.A.	Asheville	North Carolina	United States	28801
47	AAC Research, PC	Mount Pleasant	North Carolina	United States	29464
48	North Carolina Clinical Research	Raleigh	North Carolina	United States	27607
49	Allergy & Respiratory Center	Canton	Ohio	United States	44718
50	New Horizons Clinical Research	Cincinnati	Ohio	United States	45242
51	Toledo Center for Clinial Researcch	Sylvania	Ohio	United States	43560
52	Allergy, Asthma & Clinical Research Center	Oklahoma City	Oklahoma	United States	73120
53	Allergy and Asthma Research Group	Eugene	Oregon	United States	97401
54	Allergy, Asthma and Dermatology Research Center, LLC 3975 Me	Lake Oswego	Oregon	United States	97035
55	Clinical Research Institute of Southern Oregon	Medford	Oregon	United States	97504
56	Allergy Associates Research Center	Portland	Oregon	United States	97213
57	Valley Clinical Research Center	Bethlehem	Pennsylvania	United States	18020
58	Allergy & Asthma Research of New Jersey	Philadelphia	Pennsylvania	United States	19115
59	Allergy and Clinical Immunology	Pittsburgh	Pennsylvania	United States	15241
60	Pulmonary and Allergy Associates	Sellersville	Pennsylvania	United States	18960
61	AAPRI Clinical Research Institute	Lincoln	Rhode Island	United States	02865
62	Allergic Disease and Asthma Center Research, PA	Greenville	South Carolina	United States	29607
63	AAC Research, PC	Mount Pleasant	South Carolina	United States	29464
64	East Tennessee Center for Clinical Research	Knoxville	Tennessee	United States	37909
65	Lovelace Scientific Resources	Austin	Texas	United States	78759
66	Allergy and Asthma Research Center of El Paso	El Paso	Texas	United States	79925
67	Family Center for Asthma & Allergic Diseases	Friendswood	Texas	United States	77546
68	Allergy and Asthma Associates	Houston	Texas	United States	77054
69	Clinical Trials North Houston	Houston	Texas	United States	77070
70	Clinical Trial Network	Houston	Texas	United States	77074
71	The Allergy and Asthma Clinic of Central Texas	Killeen	Texas	United States	76542
72	Allergy Asthma and Immunology	San Antonio	Texas	United States	78229
73	Timber Lane Allergy and Asthma Research LLC	South Burlington	Vermont	United States	05403
74	Virginia Adult & Pediatric Allergy & Asthma, P.C.	Richmond	Virginia	United States	23229
75	University of Wisconsin Medical School	Madison	Wisconsin	United States	53792
76	Auroroa Health Care, Inc.	Milwaukee	Wisconsin	United States	53209
77	Alpha Medical Research Inc.	Mississauga	Ontario	Canada	L5A 3V4
78	Alexander Medical Innovations Inc.	Niagara Falls	Ontario	Canada	L2G 1J4
79	Allergy and Asthma Research Centre	Ottawa	Ontario	Canada	K1Y 4G2
80	Recherche Invascor Inc	Longueuil	Quebec	Canada	J4N 1E1
81	Hopital du Sacre-Coeur de Montreal	Montreal	Quebec	Canada	H4J 1C5
82	CIC Mauricie Inc.	Trois-Rivieres	Quebec	Canada	G8T 7A1

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT00425061

Other Study ID Numbers:

3174K1-201
B2421007

First Posted:

Jan 22, 2007

Last Update Posted:

Jan 14, 2015

Last Verified:

Jan 1, 2015

Additional relevant MeSH terms:

Asthma

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail	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.

Arm/Group Title	IMA-638 0.2 mg/kg: Stage 1	IMA-638 0.6 mg/kg: Stage 1	IMA-638 2 mg/kg: Stage-1	Placebo: Stage 1	IMA-638 200 mg: Stage 2 and 3	IMA-638 75 mg: Stage 3	Placebo: Stage 2 and 3
Arm/Group Description	IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.	IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
Period Title: Overall Study
STARTED	16	17	16	16	45	4	45
COMPLETED	14	15	16	14	19	0	26
NOT COMPLETED	2	2	0	2	26	4	19

Baseline Characteristics

Arm/Group Title	IMA-638 0.2 mg/kg: Stage 1	IMA-638 0.6 mg/kg: Stage 1	IMA-638 2 mg/kg: Stage-1	Placebo: Stage 1	IMA-638 200 mg: Stage 2 and 3	IMA-638 75 mg: Stage 3	Placebo: Stage 2 and 3	Total
Arm/Group Description	IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.	IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.	Total of all reporting groups
Overall Participants	16	17	16	16	45	4	45	159
Age, Customized (participants) [Number]
Less than 18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
18 to 71 years	16 100%	17 100%	16 100%	16 100%	45 100%	4 100%	45 100%	159 100%
Greater than 71 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	11 68.8%	10 58.8%	7 43.8%	9 56.3%	25 55.6%	1 25%	28 62.2%	91 57.2%
Male	5 31.3%	7 41.2%	9 56.3%	7 43.8%	20 44.4%	3 75%	17 37.8%	68 42.8%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 1
Description	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.
Time Frame	Baseline, Day 112

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	IMA-638 0.2 mg/kg: Stage 1	IMA-638 0.6 mg/kg: Stage 1	IMA-638 2 mg/kg: Stage-1	Placebo: Stage 1
Arm/Group Description	IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Measure Participants	16	17	16	16
Baseline	286.4 (67.6)	297.6 (55.4)	343.5 (91.8)	291.5 (64.7)
Change at Day 112	21.1 (40.9)	3.4 (53.6)	7.6 (38.1)	11.8 (37.5)

2. Primary Outcome

Title	Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 2/3
Description	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.
Time Frame	Baseline, Day 112

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	IMA-638 200 mg: Stage 2 and 3	IMA-638 75 mg: Stage 3	Placebo: Stage 2 and 3
Arm/Group Description	IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.	IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
Measure Participants	45	4	45
Baseline (n=42, 4, 45)	329.3 (81.7)	348.6 (39.9)	330.4 (89.5)
Change at Day 112 (n=45, 4, 45)	6.8 (42.9)	18.8 (30.7)	7.6 (48.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	IMA-638 0.2 mg/kg: Stage 1, IMA-638 2 mg/kg: Stage-1
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.612
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares (LS) mean difference
	Estimated Value	-5.2
	Confidence Interval	(2-Sided) 95% -25.6 to 15.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Change From Baseline in Pre-beta-agonist Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 28, 56, 84 and 112 - Stage 1
Description	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.
Time Frame	Baseline, Day 8, 28, 56, 84, 112

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	IMA-638 0.2 mg/kg: Stage 1	IMA-638 0.6 mg/kg: Stage 1	IMA-638 2 mg/kg: Stage-1	Placebo: Stage 1
Arm/Group Description	IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Measure Participants	16	17	16	16
Baseline	2.1 (0.4)	2.0 (0.4)	2.3 (0.5)	2.0 (0.5)
Change at Day 8	0.1 (0.2)	0.0 (0.1)	0.0 (0.3)	-0.0 (0.2)
Change at Day 28	0.1 (0.2)	0.1 (0.1)	0.0 (0.4)	0.0 (0.2)
Change at Day 56	0.0 (0.2)	0.1 (0.2)	0.1 (0.3)	0.1 (0.2)
Change at Day 84	0.1 (0.2)	0.0 (0.2)	0.0 (0.4)	0.1 (0.2)
Change at Day 112	0.2 (0.3)	0.1 (0.2)	0.1 (0.4)	0.1 (0.3)

4. Secondary Outcome

Title	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
Description	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.
Time Frame	Baseline, Day 8, 28, 56, 84, 112

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	IMA-638 200 mg: Stage 2 and 3	IMA-638 75 mg: Stage 3	Placebo: Stage 2 and 3
Arm/Group Description	IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.	IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
Measure Participants	45	4	45
Baseline	2.2 (0.6)	2.3 (0.7)	2.1 (0.6)
Change at Day 8	-0.0 (0.2)	0.2 (0.2)	0.0 (0.3)
Change at Day 28	0.0 (0.3)	0.2 (0.2)	0.1 (0.3)
Change at Day 56	0.0 (0.3)	0.2 (0.2)	0.1 (0.3)
Change at Day 84	0.1 (0.3)	0.2 (0.2)	0.1 (0.3)
Change at Day 112	0.1 (0.3)	0.2 (0.2)	0.1 (0.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	IMA-638 0.2 mg/kg: Stage 1, IMA-638 2 mg/kg: Stage-1
	Comments	Day 8: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.482
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS mean Difference
	Estimated Value	-0.0
	Confidence Interval	(2-Sided) 95% -0.2 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	IMA-638 0.2 mg/kg: Stage 1, IMA-638 2 mg/kg: Stage-1
	Comments	Day 28: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.492
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.0
	Confidence Interval	(2-Sided) 95% -0.2 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	IMA-638 0.2 mg/kg: Stage 1, IMA-638 2 mg/kg: Stage-1
	Comments	Day 56: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.323
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95% -0.2 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	IMA-638 0.2 mg/kg: Stage 1, IMA-638 2 mg/kg: Stage-1
	Comments	Day 84: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.226
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95% -0.2 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	IMA-638 0.2 mg/kg: Stage 1, IMA-638 2 mg/kg: Stage-1
	Comments	Day 112: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.256
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95% -0.2 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Change From Baseline in Airway Hyper-reactivity at Day 28 and 112
Description	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.
Time Frame	Baseline, Day 28, 112

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	IMA-638	Placebo
Arm/Group Description	Included participants who received any dose of IMA-638 subcutaneous injection during Stage 1, 2 or 3.	Included all participants who received placebo matched to IMA-638 subcutaneous injection during Stage 1, 2 or 3.
Measure Participants	33	11
Baseline	1.1 (13.8)	0.3 (38.9)
Change at Day 28	1.2 (9.8)	0.6 (11.4)
Change at Day 112	1.0 (28.9)	0.5 (22.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	IMA-638 0.2 mg/kg: Stage 1, IMA-638 0.6 mg/kg: Stage 1
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.090
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	1.8
	Confidence Interval	(2-Sided) 95% -0.3 to 3.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	IMA-638 0.2 mg/kg: Stage 1, IMA-638 0.6 mg/kg: Stage 1
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.144
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	2.1
	Confidence Interval	(2-Sided) 95% -0.8 to 5.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 1
Description	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.
Time Frame	Baseline, Day 8, 28, 56, 84, 112

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	IMA-638 0.2 mg/kg: Stage 1	IMA-638 0.6 mg/kg: Stage 1	IMA-638 2 mg/kg: Stage-1	Placebo: Stage 1
Arm/Group Description	IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Measure Participants	16	17	16	16
Baseline	2.7 (0.6)	2.6 (0.8)	2.8 (0.6)	2.7 (0.7)
Change at Day 8	-0.6 (1.1)	-0.2 (0.7)	-0.6 (0.7)	-0.3 (0.6)
Change at Day 28	-0.7 (1.1)	-0.5 (0.7)	-0.8 (0.9)	-0.7 (0.6)
Change at Day 56	-0.8 (1.1)	-0.6 (0.8)	-1.1 (1.1)	-0.7 (0.7)
Change at Day 84	-1.1 (1.2)	-0.8 (0.9)	-1.1 (1.1)	-0.8 (0.8)
Change at Day 112	-0.9 (1.2)	-0.7 (0.9)	-1.2 (1.0)	-0.8 (0.8)

7. Secondary Outcome

Title	Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 2/3
Description	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.
Time Frame	Baseline, Day 8, 28, 56, 84, 112

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	IMA-638 200 mg: Stage 2 and 3	IMA-638 75 mg: Stage 3	Placebo: Stage 2 and 3
Arm/Group Description	IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.	IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
Measure Participants	45	4	45
Baseline	2.7 (0.6)	2.3 (0.6)	2.8 (0.6)
Change at Day 8	-0.6 (0.7)	-0.4 (0.8)	-0.5 (0.7)
Change at Day 28	-0.7 (1.0)	-0.4 (0.9)	-0.7 (0.8)
Change at Day 56	-0.8 (1.1)	-0.4 (0.9)	-0.8 (0.9)
Change at Day 84	-0.8 (1.1)	-0.4 (0.9)	-1.0 (0.9)
Change at Day 112	-0.8 (1.1)	-0.4 (0.9)	-1.0 (0.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	IMA-638 0.2 mg/kg: Stage 1, IMA-638 2 mg/kg: Stage-1
	Comments	Day 8: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.354
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95% -0.4 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	IMA-638 0.2 mg/kg: Stage 1, IMA-638 2 mg/kg: Stage-1
	Comments	Day 28: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.900
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95% -0.4 to 0.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	IMA-638 0.2 mg/kg: Stage 1, IMA-638 2 mg/kg: Stage-1
	Comments	Day 56: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.921
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95% -0.4 to 0.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	IMA-638 0.2 mg/kg: Stage 1, IMA-638 2 mg/kg: Stage-1
	Comments	Day 84: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.388
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95% -0.2 to 0.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	IMA-638 0.2 mg/kg: Stage 1, IMA-638 2 mg/kg: Stage-1
	Comments	Day 112: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.249
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95% -0.2 to 0.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 1
Description
Time Frame	Baseline up to Day 112

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	IMA-638 0.2 mg/kg: Stage 1	IMA-638 0.6 mg/kg: Stage 1	IMA-638 2 mg/kg: Stage-1	Placebo: Stage 1
Arm/Group Description	IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Measure Participants	16	17	16	16
Number [percentage of participants]	0.00 0%	0.00 0%	6.25 39.1%	12.50 78.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	IMA-638 0.2 mg/kg: Stage 1, IMA-638 0.6 mg/kg: Stage 1, IMA-638 2 mg/kg: Stage-1, Placebo: Stage 1
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.267
	Comments
	Method	Chi-squared
	Comments

9. Secondary Outcome

Title	Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 2/3
Description
Time Frame	Baseline up to Day 112

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	IMA-638 200 mg: Stage 2 and 3	IMA-638 75 mg: Stage 3	Placebo: Stage 2 and 3
Arm/Group Description	IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.	IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
Measure Participants	45	4	45
Number [percentage of participant]	11.11	25.00	0.00

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	IMA-638 0.2 mg/kg: Stage 1, IMA-638 0.6 mg/kg: Stage 1, IMA-638 2 mg/kg: Stage-1
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.029
	Comments
	Method	Chi-squared
	Comments

10. Secondary Outcome

Title	Mean Number of Puffs of Rescue Medication Used - Stage 1
Description	The rescue medication taken for needed symptoms was a short acting beta agonist (SABA) inhaler. Albuterol, 90 microgram (mcg)/puff, was recommended for use.
Time Frame	Day 8, 28, 56, 84, 89, 91, 94, 98, 112

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	IMA-638 0.2 mg/kg: Stage 1	IMA-638 0.6 mg/kg: Stage 1	IMA-638 2 mg/kg: Stage-1	Placebo: Stage 1
Arm/Group Description	IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Measure Participants	0	0	0	0

11. Secondary Outcome

Title	Mean Number of Puffs of Rescue Medication Used - Stage 2/3
Description	The rescue medication taken for needed symptoms was a SABA inhaler. Albuterol, 90 mcg/puff, was recommended for use.
Time Frame	Day 8, 28, 56, 84, 89, 91, 94, 98, 112

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	IMA-638 200 mg: Stage 2 and 3	IMA-638 75 mg: Stage 3	Placebo: Stage 2 and 3
Arm/Group Description	IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.	IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
Measure Participants	0	0	0

12. Secondary Outcome

Title	Forced Vital Capacity (FVC) - Stage 1
Description	FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Time Frame	Baseline, Day 8, 28, 56, 84, 112

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	IMA-638 0.2 mg/kg: Stage 1	IMA-638 0.6 mg/kg: Stage 1	IMA-638 2 mg/kg: Stage-1	Placebo: Stage 1
Arm/Group Description	IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Measure Participants	0	0	0	0

13. Secondary Outcome

Title	Forced Vital Capacity (FVC) - Stage 2/3
Description	FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Time Frame	Baseline, Day 8, 28, 56, 84, 112

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	IMA-638 200 mg: Stage 2 and 3	IMA-638 75 mg: Stage 3	Placebo: Stage 2 and 3
Arm/Group Description	IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.	IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
Measure Participants	0	0	0

14. Secondary Outcome

Title	Forced Mid-Expiratory Flow Rate 25 Percent (%) to 75% (FEF25-75) - Stage 1
Description	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.
Time Frame	Baseline, Day 8, 28, 56, 84, 112

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	IMA-638 0.2 mg/kg: Stage 1	IMA-638 0.6 mg/kg: Stage 1	IMA-638 2 mg/kg: Stage-1	Placebo: Stage 1
Arm/Group Description	IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Measure Participants	0	0	0	0

15. Secondary Outcome

Title	Forced Mid-Expiratory Flow Rate 25 Percent (%) to 75% (FEF25-75) - Stage 2/3
Description	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.
Time Frame	Baseline, Day 8, 28, 56, 84, 112

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	IMA-638 200 mg: Stage 2 and 3	IMA-638 75 mg: Stage 3	Placebo: Stage 2 and 3
Arm/Group Description	IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.	IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
Measure Participants	0	0	0

16. Secondary Outcome

Title	Blood Eosinophils Levels - Stage 1
Description
Time Frame	Baseline, Day 8, 28, 56, 84, 112

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	IMA-638 0.2 mg/kg: Stage 1	IMA-638 0.6 mg/kg: Stage 1	IMA-638 2 mg/kg: Stage-1	Placebo: Stage 1
Arm/Group Description	IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Measure Participants	16	17	16	16
Baseline	0.3 (0.2)	0.3 (0.2)	0.3 (0.2)	0.3 (0.2)
Day 8	0.3 (0.2)	0.3 (0.2)	0.3 (0.2)	0.3 (0.2)
Day 28	0.3 (0.3)	0.3 (0.4)	0.3 (0.2)	0.3 (0.1)
Day 56	0.3 (0.2)	0.3 (0.3)	0.3 (0.2)	0.3 (0.1)
Day 84	0.3 (0.2)	0.3 (0.3)	0.3 (0.2)	0.3 (0.2)
Day 112	0.3 (0.2)	0.4 (0.3)	0.3 (0.2)	0.2 (0.2)

17. Secondary Outcome

Title	Blood Eosinophils Levels - Stage 2/3
Description
Time Frame	Baseline, Day 8, 28, 56, 84, 112

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	IMA-638 200 mg: Stage 2 and 3	IMA-638 75 mg: Stage 3	Placebo: Stage 2 and 3
Arm/Group Description	IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.	IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
Measure Participants	45	4	45
Baseline	0.3 (0.2)	0.7 (1.0)	0.3 (0.2)
Day 8	0.3 (0.2)	0.7 (1.0)	0.3 (0.2)
Day 28	0.3 (0.3)	0.8 (0.9)	0.3 (0.2)
Day 56	0.3 (0.3)	0.8 (0.9)	0.3 (0.1)
Day 84	0.3 (0.3)	0.8 (0.9)	0.2 (0.1)
Day 112	0.3 (0.4)	0.8 (0.9)	0.2 (0.2)

18. Secondary Outcome

Title	Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 1
Description	Log 10-transformed serum total IgE levels were expressed in Log-10 International units/milliliter (IU/mL).
Time Frame	Baseline, Day 28, 56, 84, 112

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	IMA-638 0.2 mg/kg: Stage 1	IMA-638 0.6 mg/kg: Stage 1	IMA-638 2 mg/kg: Stage-1	Placebo: Stage 1
Arm/Group Description	IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Measure Participants	16	17	16	16
Baseline (n=16, 16, 14, 14)	3.8 (1.6)	4.5 (1.9)	4.4 (1.4)	4.9 (1.4)
Day 28 (n=16, 17, 16, 16)	3.8 (1.5)	4.3 (1.9)	4.5 (1.4)	4.5 (1.7)
Day 56 (n=16, 17, 16, 16)	3.7 (1.7)	4.2 (1.9)	4.3 (1.5)	4.6 (1.7)
Day 84 (n=16, 17, 16, 16)	3.8 (1.6)	4.2 (1.9)	4.4 (1.5)	4.6 (1.7)
Day 112 (n=16, 17, 16, 16)	3.8 (1.6)	4.1 (1.7)	4.3 (1.5)	4.6 (1.7)

19. Secondary Outcome

Title	Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 2/3
Description	Log 10-transformed serum total IgE levels were expressed in Log-10 International units/milliliter (IU/mL).
Time Frame	Baseline, Day 28, 56, 84, 112

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	IMA-638 200 mg: Stage 2 and 3	IMA-638 75 mg: Stage 3	Placebo: Stage 2 and 3
Arm/Group Description	IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.	IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
Measure Participants	45	4	45
Baseline (n=43, 4, 43)	4.5 (1.5)	5.1 (1.7)	4.9 (1.2)
Day 28 (n=44, 4, 45)	4.6 (1.5)	5.1 (1.8)	4.9 (1.3)
Day 56 (n=45, 4, 45)	4.6 (1.5)	5.1 (1.8)	4.9 (1.2)
Day 84 (n=45, 4, 45)	4.6 (1.5)	5.1 (1.8)	4.9 (1.2)
Day 112 (n=45, 4, 45)	4.6 (1.5)	5.1 (1.8)	5.0 (1.2)

20. Secondary Outcome

Title	Serum Interleukin-13 (IL-13) Level - Stage 1
Description
Time Frame	Baseline, Day 8, 28, 56, 84, 112

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	IMA-638 0.2 mg/kg: Stage 1	IMA-638 0.6 mg/kg: Stage 1	IMA-638 2 mg/kg: Stage-1	Placebo: Stage 1
Arm/Group Description	IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Measure Participants	0	0	0	0

21. Secondary Outcome

Title	Serum Interleukin-13 (IL-13) Level - Stage 2/3
Description
Time Frame	Baseline, Day 8, 28, 56, 84, 112

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	IMA-638 200 mg: Stage 2 and 3	IMA-638 75 mg: Stage 3	Placebo: Stage 2 and 3
Arm/Group Description	IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.	IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
Measure Participants	0	0	0

22. Other Pre-specified Outcome

Title	Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance Stage 1
Description	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.
Time Frame	Baseline up to Day 112

Outcome Measure Data

Analysis Population Description
mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1.

Arm/Group Title	IMA-638 0.2 mg/kg: Stage 1	IMA-638 0.6 mg/kg: Stage 1	IMA-638 2 mg/kg: Stage-1	Placebo: Stage 1
Arm/Group Description	IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Measure Participants	16	17	16	16
Number [participants]	1 6.3%	2 11.8%	1 6.3%	1 6.3%

23. Other Pre-specified Outcome

Title	Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance - Stage 2/3
Description	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.
Time Frame	Baseline up to Day 112

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	IMA-638 200 mg: Stage 2 and 3	IMA-638 75 mg: Stage 3	Placebo: Stage 2 and 3
Arm/Group Description	IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.	IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
Measure Participants	45	4	45
Number [participants]	3 18.8%	0 0%	1 6.3%

24. Other Pre-specified Outcome

Title	Number of Participants With Clinically Important Changes in Physical Findings - Stage 1
Description	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.
Time Frame	Baseline up to Day 112

Outcome Measure Data

Analysis Population Description
mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1.

Arm/Group Title	IMA-638 0.2 mg/kg: Stage 1	IMA-638 0.6 mg/kg: Stage 1	IMA-638 2 mg/kg: Stage-1	Placebo: Stage 1
Arm/Group Description	IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Measure Participants	16	17	16	16
Number [participants]	0 0%	0 0%	0 0%	0 0%

25. Other Pre-specified Outcome

Title	Number of Participants With Clinically Important Changes in Physical Findings - Stage 2/3
Description	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.
Time Frame	Baseline up to Day 112

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	IMA-638 200 mg: Stage 2 and 3	IMA-638 75 mg: Stage 3	Placebo: Stage 2 and 3
Arm/Group Description	IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.	IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
Measure Participants	45	4	45
Number [participants]	0 0%	0 0%	0 0%

26. Other Pre-specified Outcome

Title	Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern - Stage 1
Description	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.
Time Frame	Baseline up to Day 112

Outcome Measure Data

Analysis Population Description
mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1.

Arm/Group Title	IMA-638 0.2 mg/kg: Stage 1	IMA-638 0.6 mg/kg: Stage 1	IMA-638 2 mg/kg: Stage-1	Placebo: Stage 1
Arm/Group Description	IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Measure Participants	16	17	16	16
Number [participants]	1 6.3%	0 0%	1 6.3%	1 6.3%

27. Other Pre-specified Outcome

Title	Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern - Stage 2/3
Description	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.
Time Frame	Baseline up to Day 112

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	IMA-638 200 mg: Stage 2 and 3	IMA-638 75 mg: Stage 3	Placebo: Stage 2 and 3
Arm/Group Description	IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.	IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
Measure Participants	45	4	45
Number [participants]	3 18.8%	0 0%	1 6.3%

28. Other Pre-specified Outcome

Title	Number of Participants With Injection Site Reaction - Stage 1
Description
Time Frame	Baseline up to Day 112

Outcome Measure Data

Analysis Population Description
mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1.

Arm/Group Title	IMA-638 0.2 mg/kg: Stage 1	IMA-638 0.6 mg/kg: Stage 1	IMA-638 2 mg/kg: Stage-1	Placebo: Stage 1
Arm/Group Description	IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Measure Participants	16	17	16	16
Injection site bruising	1 6.3%	0 0%	0 0%	0 0%
Injection site erythema	0 0%	1 5.9%	0 0%	0 0%
Injection site swelling	0 0%	1 5.9%	0 0%	0 0%
Injection site urticaria	0 0%	1 5.9%	0 0%	0 0%

29. Other Pre-specified Outcome

Title	Number of Participants With Injection Site Reaction - Stage 2/3
Description
Time Frame	Baseline up to Day 112

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	IMA-638 200 mg: Stage 2 and 3	IMA-638 75 mg: Stage 3	Placebo: Stage 2 and 3
Arm/Group Description	IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.	IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
Measure Participants	45	4	45
Injection site bruising	1 6.3%	0 0%	0 0%
Injection site erythema	2 12.5%	0 0%	1 6.3%
Injection site induration	0 0%	0 0%	1 6.3%
Injection site swelling	0 0%	0 0%	1 6.3%
Injection site urticaria	0 0%	0 0%	1 6.3%

30. Other Pre-specified Outcome

Title	Number of Participants With Laboratory Test Abnormalities of Potential Clinical Importance - Stage 1
Description	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.
Time Frame	Baseline up to Day 112

Outcome Measure Data

Analysis Population Description
mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1.

Arm/Group Title	IMA-638 0.2 mg/kg: Stage 1	IMA-638 0.6 mg/kg: Stage 1	IMA-638 2 mg/kg: Stage-1	Placebo: Stage 1
Arm/Group Description	IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
Measure Participants	16	17	16	16
Number [participants]	5 31.3%	11 64.7%	12 75%	9 56.3%

31. Other Pre-specified Outcome

Title	Number of Participants With Laboratory Test Abnormalities of Potential Clinical Importance - Stage 2/3
Description	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.
Time Frame	Baseline up to Day 112

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	IMA-638 200 mg: Stage 2 and 3	IMA-638 75 mg: Stage 3	Placebo: Stage 2 and 3
Arm/Group Description	IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.	IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.	Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
Measure Participants	45	4	45
Number [participants]	30 187.5%	1 5.9%	21 131.3%

Adverse Events

	IMA-638 0.2 mg/kg: Stage 1		IMA-638 0.6 mg/kg: Stage 1		IMA-638 2 mg/kg: Stage-1		Placebo: Stage 1		IMA-638 200 mg: Stage 2 and 3		IMA-638 75 mg: Stage 3		Placebo: Stage 2 and 3
Time Frame
Adverse Event Reporting 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.

Arm/Group Title	IMA-638 0.2 mg/kg: Stage 1		IMA-638 0.6 mg/kg: Stage 1		IMA-638 2 mg/kg: Stage-1		Placebo: Stage 1		IMA-638 200 mg: Stage 2 and 3		IMA-638 75 mg: Stage 3		Placebo: Stage 2 and 3
Arm/Group Description	IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.		IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.		IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.		Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.		IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.		IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.		Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	IMA-638 0.2 mg/kg: Stage 1		IMA-638 0.6 mg/kg: Stage 1		IMA-638 2 mg/kg: Stage-1		Placebo: Stage 1		IMA-638 200 mg: Stage 2 and 3		IMA-638 75 mg: Stage 3		Placebo: Stage 2 and 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		1/17 (5.9%)		2/16 (12.5%)		1/16 (6.3%)		2/45 (4.4%)		0/4 (0%)		0/45 (0%)
Ear and labyrinth disorders
Deafness unilateral	0/16 (0%)		0/17 (0%)		0/16 (0%)		1/16 (6.3%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Infections and infestations
Staphylococcal sepsis	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		0/45 (0%)
Injury, poisoning and procedural complications
Injury	0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Pregnancy, puerperium and perinatal conditions
Pregnancy	0/16 (0%)		0/17 (0%)		1/16 (6.3%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Psychiatric disorders
Depression	0/16 (0%)		0/17 (0%)		1/16 (6.3%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		0/45 (0%)
Other (Not Including Serious) Adverse Events
	IMA-638 0.2 mg/kg: Stage 1		IMA-638 0.6 mg/kg: Stage 1		IMA-638 2 mg/kg: Stage-1		Placebo: Stage 1		IMA-638 200 mg: Stage 2 and 3		IMA-638 75 mg: Stage 3		Placebo: Stage 2 and 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/16 (81.3%)		12/17 (70.6%)		11/16 (68.8%)		10/16 (62.5%)		27/45 (60%)		1/4 (25%)		26/45 (57.8%)
Blood and lymphatic system disorders
Lymphadenopathy	0/16 (0%)		0/17 (0%)		1/16 (6.3%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Ear and labyrinth disorders
Deafness unilateral	0/16 (0%)		0/17 (0%)		0/16 (0%)		1/16 (6.3%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Ear congestion	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		0/45 (0%)
Ear discomfort	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Ear pain	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		2/45 (4.4%)		0/4 (0%)		0/45 (0%)
Tinnitus	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Tympanic membrane scarring	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Eye disorders
Conjunctivitis	0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Eyelids pruritus	1/16 (6.3%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Ocular hyperaemia	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		0/45 (0%)
Visual disturbance	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		0/45 (0%)
Gastrointestinal disorders
Abdominal discomfort	1/16 (6.3%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Abdominal distension	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		0/45 (0%)
Abdominal pain	0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Constipation	0/16 (0%)		0/17 (0%)		1/16 (6.3%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Diarrhoea	0/16 (0%)		1/17 (5.9%)		1/16 (6.3%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Food poisoning	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		0/45 (0%)
Gastric ulcer	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Gastrooesophageal reflux disease	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		1/4 (25%)		1/45 (2.2%)
Nausea	0/16 (0%)		1/17 (5.9%)		1/16 (6.3%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Toothache	0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Vomiting	0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
General disorders
Chest pain	0/16 (0%)		0/17 (0%)		1/16 (6.3%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Fatigue	0/16 (0%)		0/17 (0%)		0/16 (0%)		1/16 (6.3%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Injection site bruising	1/16 (6.3%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		0/45 (0%)
Injection site erythema	0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)		2/45 (4.4%)		0/4 (0%)		1/45 (2.2%)
Injection site induration	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Injection site swelling	0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Injection site urticaria	0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Oedema peripheral	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Pitting oedema	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Pyrexia	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		0/45 (0%)
Immune system disorders
Drug hypersensitivity	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		0/45 (0%)
Seasonal allergy	0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Infections and infestations
Abdominal abscess	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		0/45 (0%)
Acute sinusitis	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		0/45 (0%)
Bronchitis	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Candidiasis	0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Conjunctivitis viral	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Ear infection	1/16 (6.3%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Gastroenteritis viral	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Helicobacter infection	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Influenza	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		2/45 (4.4%)
Laryngitis	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		0/45 (0%)
Nasopharyngitis	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		4/45 (8.9%)		0/4 (0%)		2/45 (4.4%)
Oral candidiasis	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		2/45 (4.4%)		0/4 (0%)		3/45 (6.7%)
Oral herpes	0/16 (0%)		0/17 (0%)		1/16 (6.3%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		0/45 (0%)
Oropharyngeal candidiasis	0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Pharyngitis	0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Rhinitis	1/16 (6.3%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Sinusitis	0/16 (0%)		0/17 (0%)		0/16 (0%)		1/16 (6.3%)		2/45 (4.4%)		0/4 (0%)		5/45 (11.1%)
Skin infection	0/16 (0%)		0/17 (0%)		1/16 (6.3%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Upper respiratory tract infection	1/16 (6.3%)		2/17 (11.8%)		0/16 (0%)		3/16 (18.8%)		13/45 (28.9%)		0/4 (0%)		3/45 (6.7%)
Urinary tract infection	1/16 (6.3%)		3/17 (17.6%)		1/16 (6.3%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		1/45 (2.2%)
Viral infection	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		3/45 (6.7%)		0/4 (0%)		0/45 (0%)
Viral upper respiratory tract infection	0/16 (0%)		0/17 (0%)		1/16 (6.3%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		3/45 (6.7%)
Rash pustular	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		0/45 (0%)
Injury, poisoning and procedural complications
Ankle fracture	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Back injury	0/16 (0%)		1/17 (5.9%)		1/16 (6.3%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Contusion	1/16 (6.3%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Epicondylitis	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Excoriation	1/16 (6.3%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Fall	0/16 (0%)		0/17 (0%)		0/16 (0%)		1/16 (6.3%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Joint dislocation	0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Joint injury	0/16 (0%)		0/17 (0%)		1/16 (6.3%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		0/45 (0%)
Ligament rupture	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		0/45 (0%)
Limb injury	1/16 (6.3%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Muscle strain	1/16 (6.3%)		0/17 (0%)		2/16 (12.5%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Post procedural complication	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		0/45 (0%)
Procedural pain	0/16 (0%)		0/17 (0%)		0/16 (0%)		1/16 (6.3%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Skeletal injury	0/16 (0%)		0/17 (0%)		0/16 (0%)		1/16 (6.3%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Wound	0/16 (0%)		0/17 (0%)		1/16 (6.3%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Investigations
Alanine aminotransferase increased	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Blood amylase increased	0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Blood creatine phosphokinase increased	1/16 (6.3%)		1/17 (5.9%)		2/16 (12.5%)		1/16 (6.3%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Blood pressure increased	0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Lipase increased	1/16 (6.3%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Metabolism and nutrition disorders
Gout	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Hyperkalaemia	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		0/45 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/16 (6.3%)		0/17 (0%)		1/16 (6.3%)		2/16 (12.5%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Arthritis	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		0/45 (0%)
Back pain	0/16 (0%)		0/17 (0%)		0/16 (0%)		1/16 (6.3%)		1/45 (2.2%)		0/4 (0%)		2/45 (4.4%)
Joint range of motion decreased	0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Musculoskeletal chest pain	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		1/4 (25%)		0/45 (0%)
Myalgia	0/16 (0%)		3/17 (17.6%)		1/16 (6.3%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Pain in extremity	0/16 (0%)		1/17 (5.9%)		0/16 (0%)		1/16 (6.3%)		0/45 (0%)		0/4 (0%)		2/45 (4.4%)
Plantar fasciitis	1/16 (6.3%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Rhabdomyolysis	0/16 (0%)		0/17 (0%)		1/16 (6.3%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Rotator cuff syndrome	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		0/45 (0%)
Tendonitis	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Nervous system disorders
Dizziness	0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		0/45 (0%)
Headache	0/16 (0%)		1/17 (5.9%)		1/16 (6.3%)		1/16 (6.3%)		4/45 (8.9%)		0/4 (0%)		2/45 (4.4%)
Migraine	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		1/45 (2.2%)
Sinus headache	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		1/45 (2.2%)		1/4 (25%)		0/45 (0%)
Tension headache	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Psychiatric disorders
Alcohol abuse	0/16 (0%)		0/17 (0%)		1/16 (6.3%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Anxiety	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Nicotine dependence	0/16 (0%)		0/17 (0%)		1/16 (6.3%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Renal and urinary disorders
Nephrolithiasis	0/16 (0%)		0/17 (0%)		1/16 (6.3%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Reproductive system and breast disorders
Amenorrhoea	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		0/45 (0%)
Menorrhagia	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Respiratory, thoracic and mediastinal disorders
Asthma	1/16 (6.3%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Cough	1/16 (6.3%)		0/17 (0%)		1/16 (6.3%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		2/45 (4.4%)
Foreign body aspiration	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Nasal congestion	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		2/45 (4.4%)		0/4 (0%)		0/45 (0%)
Nasal oedema	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Nasal polyps	0/16 (0%)		0/17 (0%)		1/16 (6.3%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		2/45 (4.4%)
Pharyngeal leukoplakia	1/16 (6.3%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Pharyngolaryngeal pain	1/16 (6.3%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		2/45 (4.4%)		0/4 (0%)		0/45 (0%)
Pulmonary congestion	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		1/45 (2.2%)
Rhinitis seasonal	0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Throat irritation	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		0/45 (0%)
Skin and subcutaneous tissue disorders
Acne	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Cold sweat	0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Dermatitis contact	0/16 (0%)		0/17 (0%)		1/16 (6.3%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Ingrowing nail	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		0/45 (0%)
Pruritus	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Rash	1/16 (6.3%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		2/45 (4.4%)		0/4 (0%)		1/45 (2.2%)
Rosacea	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		0/45 (0%)
Scar	0/16 (0%)		0/17 (0%)		0/16 (0%)		1/16 (6.3%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Swelling face	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		1/45 (2.2%)		0/4 (0%)		0/45 (0%)
Urticaria	1/16 (6.3%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)
Rash papular	0/16 (0%)		1/17 (5.9%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Vascular disorders
Diastolic hypertension	0/16 (0%)		0/17 (0%)		0/16 (0%)		1/16 (6.3%)		0/45 (0%)		0/4 (0%)		0/45 (0%)
Hypertension	0/16 (0%)		0/17 (0%)		0/16 (0%)		0/16 (0%)		0/45 (0%)		0/4 (0%)		1/45 (2.2%)

Limitations/Caveats

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.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.

Results Point of Contact

Name/Title	Pfizer ClinicalTrials.gov Call Center
Organization	Pfizer, Inc.
Phone	1-800-718-1021
Email	ClinicalTrials.gov_Inquiries@pfizer.com

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT00425061

Other Study ID Numbers:

3174K1-201
B2421007

First Posted:

Jan 22, 2007

Last Update Posted:

Jan 14, 2015

Last Verified:

Jan 1, 2015

Study Evaluating the Effect of IMA-638 in Subjects With Persistent Asthma

Study Details

Study Description

Brief Summary

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Other Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

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Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

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Additional Information:

Publications

Study Results

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Baseline Characteristics

Outcome Measures

Outcome Measure Data

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Statistical Analysis 3

Statistical Analysis 4

Statistical Analysis 5

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Outcome Measure Data

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Statistical Analysis 3

Statistical Analysis 4

Statistical Analysis 5

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

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Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

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Outcome Measure Data

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Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

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