Asthma
Conditions
Keywords
Asthma, Secukinumab, Therapeutic Uses, Respiratory, Lung, Pulmonary, inhaled, corticosteroids
Brief summary
This study is a preliminary proof of efficacy study of AIN457 in patients with bronchial asthma that is poorly controlled with the current standard of care.
Interventions
Secukinumab intravenous injection
DRUGPlacebo
Placebo intravenous injection
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients with asthma \>1 year duration diagnosed according to the GINA guidelines (GINA 2010). * Daily treatment with \> 1000μg beclomethasone dipropionate or equivalent, plus a long acting beta agonist for ≥ 3 months prior to Day 1, that has been stable for at least 4 weeks prior to screening. * Asthma which is not adequately controlled on current treatment * Peripheral blood eosinophil count \< 400/μl at screening
Exclusion criteria
* Women of child-bearing potential unwilling to use effective contraception during the study and for 16 weeks after stopping treatment. * Use of other investigational drugs at the time of screening, or within 30 days of screening. * Smokers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in the Severity of Asthma as Measured by Change in the Asthma Control Questionnaire (ACQ) Score | Baseline and 85 Days | The ACQ scores range from 0 to 6 with lower scores reflecting better asthma control. Without loss of generality, as Day 85 minus baseline (Visit 3) so that improvements in asthma control translate to negative change scores. |
Countries
Germany, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AIN457 AIN457 10 mg/kg | 31 |
| Placebo Placebo intravenous injection | 15 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative problems | 1 | 2 |
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | AIN457 | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 49.8 Years STANDARD_DEVIATION 11.62 | 46.2 Years STANDARD_DEVIATION 10.4 | 48.6 Years STANDARD_DEVIATION 11.25 |
| Sex: Female, Male Female | 16 Participants | 7 Participants | 23 Participants |
| Sex: Female, Male Male | 15 Participants | 8 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 21 / 31 | 13 / 15 |
| serious Total, serious adverse events | 1 / 31 | 2 / 15 |
Outcome results
Primary
Improvement in the Severity of Asthma as Measured by Change in the Asthma Control Questionnaire (ACQ) Score
The ACQ scores range from 0 to 6 with lower scores reflecting better asthma control. Without loss of generality, as Day 85 minus baseline (Visit 3) so that improvements in asthma control translate to negative change scores.
Time frame: Baseline and 85 Days
Population: The Pharmacodynamics (PD) analysis set was used, and subjects were analyzed according to the treatment actually. The number of patients who had evaluable PD data at the particular PD assessment time point received.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AIN457 | Improvement in the Severity of Asthma as Measured by Change in the Asthma Control Questionnaire (ACQ) Score | -0.173 Score |
| Placebo | Improvement in the Severity of Asthma as Measured by Change in the Asthma Control Questionnaire (ACQ) Score | -0.007 Score |
p-value: 0.539290% CI: [-0.617, 0.285]Mixed Models Analysis