Moderate-to-Severe Asthma
Conditions
Keywords
Asthma, GM-CSF, Moderate-to-Severe Asthma
Brief summary
This study will evaluate the safety, tolerability and efficacy of a single dose level of KB003 in subjects with inadequately controlled asthma.
Interventions
BIOLOGICALAnti-GM-CSF Monoclonal Antibody 400mg
Anti-GM-CSF Monoclonal Antibody 400mg
OTHERPlacebo
Normal Saline
Sponsors
Humanigen, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * A diagnosis of asthma established for at least 2 years * Symptomatic asthma as defined by the Juniper Asthma Control Questionnaire * Symptomatic asthma despite stable treatment with inhaled corticosteroids fluticasone or budesonide, or other corticosteroids, for at least 12 weeks * Currently receiving inhaled long-acting beta agonist (LABA) or previously documented LABA intolerability or lack of responsiveness * At least 2 exacerbations (no more than 6) in the previous 12 months that required systemic corticosteroids or at least a doubling of daily oral dose Key
Exclusion criteria
* Acute asthma worsening (requiring emergency room visit, hospitalization, urgent care, physician visit, or change in asthma medications) or lower respiratory tract infection requiring the use of antibiotics, within 4 weeks prior to Screening Visit. * History of life-threatening asthma with admission to the intensive care unit requiring the use of mechanical ventilation within the past 12 months * Use of any immunosuppressive or immunomodulatory agents within 12 weeks or an investigational agent within 4 weeks prior to Screening Visit * History of any cardiovascular, neurological, hepatic, or renal condition * History of smoking within the past 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Percent Predicted FEV1 at Week 24 | Baseline to Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| To Evaluate the Efficacy of KB003 as Measured by Asthma Exacerbation Rate | Week 24 |
| To Evaluate the Effect of KB003 on Peak Expiratory Flow (PEF) | Week 24 |
| To Evaluate the Safety and Tolerability of KB003 as Measured by Frequency and Severity of AEs, Clinical Safety, Laboratory Abnormalities and Chest Radiographic Assessments | Week 24 |
Countries
Australia, France, Poland, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
25 July 2012 - 09 June 2013
Participants by arm
| Arm | Count |
|---|---|
| Anti-GM-CSF Monoclonal Antibody 400mg Anti-GM-CSF Monoclonal Antibody 400mg: Anti-GM-CSF Monoclonal Antibody 400mg | 78 |
| Normal Saline Placebo: Normal Saline | 82 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Non-Compliance | 2 | 1 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Protocol Violation | 6 | 10 |
| Overall Study | Withdrawal by Subject | 5 | 4 |
Baseline characteristics
| Characteristic | Total | Anti-GM-CSF Monoclonal Antibody 400mg | Normal Saline |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 25 Participants | 16 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 135 Participants | 62 Participants | 73 Participants |
| Age, Continuous | 52.9 Years STANDARD_DEVIATION 11.1 | 52.9 Years STANDARD_DEVIATION 11.95 | 53.1 Years STANDARD_DEVIATION 10.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 4 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 149 Participants | 74 Participants | 75 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 7 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 138 Participants | 69 Participants | 69 Participants |
| Region of Enrollment Australia | 13 participants | 6 participants | 7 participants |
| Region of Enrollment France | 5 participants | 1 participants | 4 participants |
| Region of Enrollment Poland | 45 participants | 26 participants | 19 participants |
| Region of Enrollment Ukraine | 34 participants | 17 participants | 17 participants |
| Region of Enrollment United Kingdom | 4 participants | 0 participants | 4 participants |
| Region of Enrollment United States | 59 participants | 28 participants | 31 participants |
| Sex: Female, Male Female | 92 Participants | 44 Participants | 48 Participants |
| Sex: Female, Male Male | 68 Participants | 34 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 78 | 15 / 82 |
| serious Total, serious adverse events | 5 / 78 | 2 / 82 |
Outcome results
Primary
Change in Percent Predicted FEV1 at Week 24
Time frame: Baseline to Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-GM-CSF Monoclonal Antibody 400mg | Change in Percent Predicted FEV1 at Week 24 | 3.631 Percent | Standard Deviation 12.6174 |
| Normal Saline | Change in Percent Predicted FEV1 at Week 24 | 2.000 Percent | Standard Deviation 8.5251 |
Secondary
To Evaluate the Effect of KB003 on Peak Expiratory Flow (PEF)
Time frame: Week 24
Secondary
To Evaluate the Efficacy of KB003 as Measured by Asthma Exacerbation Rate
Time frame: Week 24
Secondary
To Evaluate the Safety and Tolerability of KB003 as Measured by Frequency and Severity of AEs, Clinical Safety, Laboratory Abnormalities and Chest Radiographic Assessments
Time frame: Week 24