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

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 - CQAW039A2315

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48545

Enrollment

Registered

2019-10-30

Start date

2017-11-07

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

asthma N/A

Interventions

Treatment with 150 mg or 450 mg QAW039 or placebo once daily.

asthma

CRHT2

QAW039

safety

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 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 =1.5 prior to entering the study.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Treatment Period 1 (double-blind, 52-week treatment period): In patients with moderate-to-severe asthma receiving SoC asthma therapy, to evaluate the long-term safety of QAW039 (150 mg once daily and 450 mg once daily), compared with placebo, as assessed by: - treatment emergent adverse events (AEs); - treatment emergent serious adverse events (SAEs); and - study treatment discontinuations due to treatment emergent AEs. Treatment Period 1 and Treatment Period 2 combined: In patients with moderate-to-severe-asthma receiving SoC asthma therapy, to evaluate the long-term safety of QAW039 (150 mg once daily and 450 mg once daily), compared with placebo, as assessed by: - treatment emergent AEs - treatment emergent SAEs; and - study treatment discontinuations due to treatment emergent AEs.	—

Measure

Time frame

Treatment Period 1 (double-blind, 52-week treatment period): In patients with moderate-to-severe asthma receiving SoC asthma therapy, to evaluate the long-term safety of QAW039 (150 mg once daily and 450 mg once daily), compared with placebo, as assessed by: - treatment emergent adverse events (AEs); - treatment emergent serious adverse events (SAEs); and - study treatment discontinuations due to treatment emergent AEs. Treatment Period 1 and Treatment Period 2 combined: In patients with moderate-to-severe-asthma receiving SoC asthma therapy, to evaluate the long-term safety of QAW039 (150 mg once daily and 450 mg once daily), compared with placebo, as assessed by: - treatment emergent AEs - treatment emergent SAEs; and - study treatment discontinuations due to treatment emergent AEs.

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Secondary

Measure	Time frame
Treatment Period 1 (double-blind, 52-week treatment period): In patients with moderate-to-severe asthma receiving SoC asthma therapy, to evaluate the long-term safety of QAW039 (150 mg once daily and 450 mg once daily), compared with placebo, as assessed by: - the rate of patients with at least 1 treatment emergent AE by primary system organ class; and. - the rate of treatment emergent patient deaths and patient hospitalizations (any visit to the hospital requiring an overnight stay or an emergency room visit greater than 24 hours) due to an asthma exacerbation. Treatment Period 1 and Treatment Period 2 combined: In patients with moderate-to-severe-asthma receiving SoC asthma therapy, to evaluate the long-term safety of QAW039 (150 mg once daily and 450 mg once daily), compared with placebo, as assessed by: • the rate of patients with at least 1 treatment emergent AE by primary system organ class; and • the rate of treatment emergent patient deaths and patient hospitalizations (any visit to the hospital requiring an overnight stay or an emergency room visit greater than 24 hours) due to an asthma exacerbation.	—

Measure

Time frame

Treatment Period 1 (double-blind, 52-week treatment period): In patients with moderate-to-severe asthma receiving SoC asthma therapy, to evaluate the long-term safety of QAW039 (150 mg once daily and 450 mg once daily), compared with placebo, as assessed by: - the rate of patients with at least 1 treatment emergent AE by primary system organ class; and. - the rate of treatment emergent patient deaths and patient hospitalizations (any visit to the hospital requiring an overnight stay or an emergency room visit greater than 24 hours) due to an asthma exacerbation. Treatment Period 1 and Treatment Period 2 combined: In patients with moderate-to-severe-asthma receiving SoC asthma therapy, to evaluate the long-term safety of QAW039 (150 mg once daily and 450 mg once daily), compared with placebo, as assessed by: • the rate of patients with at least 1 treatment emergent AE by primary system organ class; and • the rate of treatment emergent patient deaths and patient hospitalizations (any visit to the hospital requiring an overnight stay or an emergency room visit greater than 24 hours) due to an asthma exacerbation.

—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czechia, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hungary, Iceland, India, Israel, Italy, Japan, Korea (the Democratic Peoples Republic of), Korea (the Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan (Province of China), Thailand, Turkey, United Kingdom, United States of America, Viet Nam

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)