Efficacy and Safety Study of GSK679586 in Patients with Severe Asthma
Trial overview
Change from baseline in Asthma Control Questionnaire (ACQ-7) over 12 weeks
Timeframe: Baseline to Week 12
Change from baseline in ACQ-7 over 16 weeks and 24 weeks
Timeframe: Week 16 and Week 24
Number of participants who demonstrated a clinically meaningful change in ACQ-7 over the 12 weeks assessment period.
Timeframe: Upto 12 weeks
Change from baseline in Forced Expiratory Volume (FEV1) over 12 weeks.
Timeframe: Baseline to Week 12
Change from baseline in FEV1 over 16 weeks and 24 weeks
Timeframe: Week 16 and 24
Percentage of participants who demonstrated a clinically meaningful increase in FEV1 over the 12 week assessment period
Timeframe: Upto 12 weeks
Number of participants with any Adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Up to Week 25
Number of participants with abnormal vital signs of potential clinical importance: Systolic and distolic blood pressure and Heart rate.
Timeframe: Screening, Day -28, 1, 15, 29, 50, 57 and 169 (follow-up 3)
Number of participants with clinically significant abnormality in 12-lead electrocardiogram (ECG)
Timeframe: Upto Week 25
Number of participants with abnormal hematological parameters of potential clinical importance
Timeframe: Upto Week 25
Number of participants with abnormal clinical chemistry parameters of potential clinical importance
Timeframe: Upto Week 25
Number of participants with abnormal urinanalysis parameters of potential clinical importance
Timeframe: Upto Week 25
Pharmacokinetic (PK) Parameter: Area under the concentration-time curve over the dosing interval (AUC (0-τ)).
Timeframe: Day 1 (Pre-dose, 0.25h, 1.00h), Day 4 (72h), Day 29 (672h), Day 57 (1344h), Day 61 (1440h), Day 85 (2016h), Day 141 (3360h), Day 169 (4032h) and Follow up visits.
PK Parameter:Maximum observed concentration (Cmax)
Timeframe: Day 1 (Pre-dose, 0.25h, 1.00h), Day 4 (72h), Day 29 (672 h), Day 57 (1344h), Day 61 (1440h), Day 85 (2016h), Day 141 (3360h), Day 169 (4032h) and Follow up visits.
PK Parameter: Systemic clearance of parent drug
Timeframe: Day 1 (Pre-dose, 0.25h, 1.00h), Day 4 (72h), Day 29 (672 h), Day 57 (1344h), Day 61 (1440h), Day 85 (2016h), Day 141 (3360h), Day 169 (4032h) and Follow up visits.
PK Parameter: volume of distribution
Timeframe: Day 1 (Pre-dose, 0.25h, 1.00h), Day 4 (72h), Day 29 (672 h), Day 57 (1344h), Day 61 (1440h), Day 85 (2016h), Day 141 (3360h), Day 169 (4032h) and Follow up visits.
Number of participants with confirmed positive Anti-GSK679586 antibody results after initiation of study treatment
Timeframe: Up to Week 25
Participation criteria
- history of asthma for ≥ 6 months
- taking inhaled corticosteroids
- Unstable severe asthma
- Recent respiratory illness
- history of asthma for ≥ 6 months
- taking inhaled corticosteroids
- non-smoking
- Baseline (pre-bronchodilator) FEV1 35-80% predicted at screening.
- Reversible airways disease as indicated by an increase of FEV1 ≥12% from baseline after nebulised salbutamol or albuterol.
- symptomatic according to the ACQ-7
- Unstable severe asthma
- Recent respiratory illness
- Presence of other respiratory disease or chronic pulmonary condition other than asthma
- Treatment with omalizumab within 4 months of study
- Recent gastrointestinal or respiratory parasitic infestation
- History of severe allergy to food or drugs Other protocol-defined inclusion/exclusion criteria may apply
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.