Trial Outcomes & Findings for Effect of KB003 in Subjects With Asthma Inadequately Controlled by Corticosteroids (NCT NCT01603277)
NCT ID: NCT01603277
Last Updated: 2015-02-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
160 participants
Primary outcome timeframe
Baseline to Week 24
Results posted on
2015-02-02
Participant Flow
25 July 2012 - 09 June 2013
Participant milestones
| Measure |
Anti-GM-CSF Monoclonal Antibody 400mg
Anti-GM-CSF Monoclonal Antibody 400mg: Anti-GM-CSF Monoclonal Antibody 400mg
|
Normal Saline
Placebo: Normal Saline
|
|---|---|---|
|
Overall Study
STARTED
|
78
|
82
|
|
Overall Study
COMPLETED
|
64
|
64
|
|
Overall Study
NOT COMPLETED
|
14
|
18
|
Reasons for withdrawal
| Measure |
Anti-GM-CSF Monoclonal Antibody 400mg
Anti-GM-CSF Monoclonal Antibody 400mg: Anti-GM-CSF Monoclonal Antibody 400mg
|
Normal Saline
Placebo: Normal Saline
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Protocol Violation
|
6
|
10
|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
|
Overall Study
Non-Compliance
|
2
|
1
|
Baseline Characteristics
Effect of KB003 in Subjects With Asthma Inadequately Controlled by Corticosteroids
Baseline characteristics by cohort
| Measure |
Anti-GM-CSF Monoclonal Antibody 400mg
n=78 Participants
Anti-GM-CSF Monoclonal Antibody 400mg: Anti-GM-CSF Monoclonal Antibody 400mg
|
Normal Saline
n=82 Participants
Placebo: Normal Saline
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.9 Years
STANDARD_DEVIATION 11.95 • n=5 Participants
|
53.1 Years
STANDARD_DEVIATION 10.30 • n=7 Participants
|
52.9 Years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
62 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
69 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
31 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
26 participants
n=5 Participants
|
19 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Region of Enrollment
France
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Outcome measures
| Measure |
Anti-GM-CSF Monoclonal Antibody 400mg
n=78 Participants
Anti-GM-CSF Monoclonal Antibody 400mg: Anti-GM-CSF Monoclonal Antibody 400mg
|
Normal Saline
n=82 Participants
Placebo: Normal Saline
|
|---|---|---|
|
Change in Percent Predicted FEV1 at Week 24
|
3.631 Percent
Standard Deviation 12.6174
|
2.000 Percent
Standard Deviation 8.5251
|
SECONDARY outcome
Timeframe: Week 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24Outcome measures
Outcome data not reported
Adverse Events
Anti-GM-CSF Monoclonal Antibody 400mg
Serious events: 5 serious events
Other events: 10 other events
Deaths: 0 deaths
Normal Saline
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Anti-GM-CSF Monoclonal Antibody 400mg
n=78 participants at risk
Anti-GM-CSF Monoclonal Antibody 400mg: Anti-GM-CSF Monoclonal Antibody 400mg
|
Normal Saline
n=82 participants at risk
Placebo: Normal Saline
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
1.3%
1/78
Adverse Event Greater than or Equal to 5%
|
0.00%
0/82
Adverse Event Greater than or Equal to 5%
|
|
General disorders
Thrombosis in device
|
0.00%
0/78
Adverse Event Greater than or Equal to 5%
|
1.2%
1/82
Adverse Event Greater than or Equal to 5%
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/78
Adverse Event Greater than or Equal to 5%
|
1.2%
1/82
Adverse Event Greater than or Equal to 5%
|
|
Infections and infestations
Pneumonia
|
2.6%
2/78
Adverse Event Greater than or Equal to 5%
|
0.00%
0/82
Adverse Event Greater than or Equal to 5%
|
|
Infections and infestations
Appendicitis
|
1.3%
1/78
Adverse Event Greater than or Equal to 5%
|
0.00%
0/82
Adverse Event Greater than or Equal to 5%
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/78
Adverse Event Greater than or Equal to 5%
|
1.2%
1/82
Adverse Event Greater than or Equal to 5%
|
|
Psychiatric disorders
Suicide attempt
|
1.3%
1/78
Adverse Event Greater than or Equal to 5%
|
0.00%
0/82
Adverse Event Greater than or Equal to 5%
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.3%
1/78
Adverse Event Greater than or Equal to 5%
|
0.00%
0/82
Adverse Event Greater than or Equal to 5%
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/78
Adverse Event Greater than or Equal to 5%
|
1.2%
1/82
Adverse Event Greater than or Equal to 5%
|
Other adverse events
| Measure |
Anti-GM-CSF Monoclonal Antibody 400mg
n=78 participants at risk
Anti-GM-CSF Monoclonal Antibody 400mg: Anti-GM-CSF Monoclonal Antibody 400mg
|
Normal Saline
n=82 participants at risk
Placebo: Normal Saline
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.4%
5/78
Adverse Event Greater than or Equal to 5%
|
4.9%
4/82
Adverse Event Greater than or Equal to 5%
|
|
Infections and infestations
Upper respiratory tract infection
|
3.8%
3/78
Adverse Event Greater than or Equal to 5%
|
7.3%
6/82
Adverse Event Greater than or Equal to 5%
|
|
Nervous system disorders
Headache
|
3.8%
3/78
Adverse Event Greater than or Equal to 5%
|
6.1%
5/82
Adverse Event Greater than or Equal to 5%
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place