A 2-treatment period, randomized, placebo-controlled, multicenter parallel-group study to assess the safety of QAW039 when added to existing asthma therapy in GINA steps 3, 4 and 5 patients with uncontrolled asthma
- Conditions
- asthmaN/A10006436
- Registration Number
- NL-OMON48545
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
Patients completing a prior Phase 3 study of QAW039 (NLD: CQAW039A2314):
- Written Informed consent
- Completion of the Treatment Period (on blinded study drug) of a prior Phase 3
study of QAW039.
- Patient is able to safely continue into the study as judged by the
investigator., Patients who have not previously participated in a study of
QAW039:
- Written informed consent.
- Male and female patients aged >=12 years (NLD: >=18 years).
- A diagnosis of asthma, uncontrolled on GINA 3/4/5 asthma medication.
- Evidence of airway reversibility or airway hyper- reactivity.
- FEV1 of <=85% of the predicted normal value.
- An ACQ score >=1.5 prior to entering the study.
Patients completing a prior phase 3 study of QAW039:
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential unless they are using basic methods of
contraception during dosing of study drug.
- Patients who did not complete the Treatment Period on blinded study drug of
the prior QAW039 study they participated in.
- Inability to comply with all study requirements.
- Patient who experienced a serious and drug-related AE in the prior QAW039
study they participated in., Patients who have not previously participated in a
study of QAW039:
- Use of other investigational drugs within 5 half-lives of study entry, or
within 30 days, whichever is longer.
- Subjects who have participated in another trial of QAW039.
- A QTcF (Fridericia) >=450 msec (male) or >=460 msec (female) at Visit 1 or
Visit 201 on the ECG Analysis Report provided by the ECG core laboratory.
- History of malignancy with the exception of local basal cell carcinoma of the
skin.
- Pregnant or nursing (lactating) women.
- Serious co-morbidities.
- Patients on greater than 20 mg of simvastatin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Treatment Period 1 (double-blind, 52-week treatment period):<br /><br>In patients with moderate-to-severe asthma receiving SoC asthma therapy, to<br /><br>evaluate the long-term safety of QAW039 (150 mg once daily and 450 mg once<br /><br>daily), compared with placebo, as assessed by:<br /><br>- treatment emergent adverse events (AEs);<br /><br>- treatment emergent serious adverse events (SAEs); and<br /><br>- study treatment discontinuations due to treatment emergent AEs.<br /><br>Treatment Period 1 and Treatment Period 2 combined:<br /><br>In patients with moderate-to-severe-asthma receiving SoC asthma therapy, to<br /><br>evaluate the long-term safety of QAW039 (150 mg once daily and 450 mg once<br /><br>daily), compared with placebo, as assessed by:<br /><br>- treatment emergent AEs<br /><br>- treatment emergent SAEs; and<br /><br>- study treatment discontinuations due to treatment emergent AEs.</p><br>
- Secondary Outcome Measures
Name Time Method