Asthma
Conditions
Keywords
asthma, allergic asthma, QGE031, open-label, IgE, long-term safety
Brief summary
This study planned to assess long-term safety of QGE031 during 12 months treatment in asthma patients who completed study CQGE031B2201.
Detailed description
This study planned to assess long-term safety and tolerability of QGE031 administered every 4 weeks for an additional 12 months in patients with allergic asthma who previously completed study CQGE031B2201. The study was terminated early due to the efficacy results from an interim analysis of the Phase II study CQGE031B2201.
Interventions
DRUGQGE031
QGE031 120 mg/mL solution for subcutaneous injection
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 76 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * forced Expiratory Volume in one second ( FEV1) \>= 40% predicted * patients who completed CQGE031B2201 study Key
Exclusion criteria
* life-threatening asthma attack, intubation, respiratory arrest during or after completion of CQGE031B2201 study * new malignancy * ongoing SAE from CQGE031B2201 that was assessed as related to study drug * patient experienced platelets drop to \< 75,000/uL * patient experienced one unexpected grade 4 or two unexpected grade 3 hypersensitivity reactions * patient is pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numbers of Participants With Non-serious Adverse Events (AEs), Serious AEs and Deaths as a Measure of Safety and Tolerability | 52 weeks | Safety was monitored throughout the study. |
Countries
Argentina, Canada, Czechia, Finland, France, Germany, Hungary, Israel, Italy, Mexico, Poland, Portugal, Romania, Russia, Slovakia, South Africa, South Korea, Turkey (Türkiye), United Kingdom, United States
Participant flow
Pre-assignment details
This was an open-label, single arm study for participants who completed the core study CQGE031B2201 (NCT01716754).
Participants by arm
| Arm | Count |
|---|---|
| QGE031 Every 4 Weeks (q4w) QGE031 240 mg subcutaneously q4w | 270 |
| Total | 270 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
| Overall Study | Death | 1 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Study terminated by Sponsor | 159 |
| Overall Study | Technical problems | 1 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | QGE031 Every 4 Weeks (q4w) |
|---|---|
| Age, Continuous | 48.2 Years STANDARD_DEVIATION 13.17 |
| Sex: Female, Male Female | 168 Participants |
| Sex: Female, Male Male | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 130 / 270 |
| serious Total, serious adverse events | 19 / 270 |
Outcome results
Primary
Numbers of Participants With Non-serious Adverse Events (AEs), Serious AEs and Deaths as a Measure of Safety and Tolerability
Safety was monitored throughout the study.
Time frame: 52 weeks
Population: The safety set, which included all participants, was analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| QGE031 Every 4 Weeks (q4w) | Numbers of Participants With Non-serious Adverse Events (AEs), Serious AEs and Deaths as a Measure of Safety and Tolerability | Non-serious AEs | 176 Participants |
| QGE031 Every 4 Weeks (q4w) | Numbers of Participants With Non-serious Adverse Events (AEs), Serious AEs and Deaths as a Measure of Safety and Tolerability | Serious AEs | 19 Participants |
| QGE031 Every 4 Weeks (q4w) | Numbers of Participants With Non-serious Adverse Events (AEs), Serious AEs and Deaths as a Measure of Safety and Tolerability | Deaths | 1 Participants |