Study of safety of QAW039 in patients (= 12 yrs) with asthma inadequately controlled on standard-of-care asthma therapy

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. - SPIRIT

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001560-11-DE

Enrollment

2406

Registered

2017-01-12

Start date

2017-02-23

Completion date

Unknown

Last updated

2020-09-28

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

Conditions

Asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: Fevipiprant Product Code: QAW039 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Fevipiprant CAS Number: 872365-14-5 Current Sponsor code: QAW039 Other descriptive name: QAW

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients completing a prior Phase 3 study of QAW039: - Informed consent and assent (if applicable). -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. -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. Are the trial subjects under 18? yes Number of subjects for this age range: 80 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2085 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 241

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). -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
Main Objective: 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 treatmentdiscontinuations due to treatment emergent AEs.;Secondary Objective: 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: -rate of patients with at least 1 treatment emergent AE by primary system organ class; -rate of treatment emergent patient deaths and patient hospitalizations 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: -rate of patients with at least 1 treatment emergent AE by primary system organ class; and -rate of treatment emergent patient deaths and patient hospitalizations due to an asthma exacerbation.;Primary end point(s): -treatment emergent adverse events (AEs) -treatment emergent serious adverse events -treatment emergent AEs leading to discontinuation ;Timepoint(s) of evaluation of this end point: 52 weeks (end Treatment Period 1) 160 weeks (end Treatment Period 2)	—

Measure

Time frame

Main Objective: 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 treatmentdiscontinuations due to treatment emergent AEs.;Secondary Objective: 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: -rate of patients with at least 1 treatment emergent AE by primary system organ class; -rate of treatment emergent patient deaths and patient hospitalizations 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: -rate of patients with at least 1 treatment emergent AE by primary system organ class; and -rate of treatment emergent patient deaths and patient hospitalizations due to an asthma exacerbation.;Primary end point(s): -treatment emergent adverse events (AEs) -treatment emergent serious adverse events -treatment emergent AEs leading to discontinuation ;Timepoint(s) of evaluation of this end point: 52 weeks (end Treatment Period 1) 160 weeks (end Treatment Period 2)

—

Secondary

Measure	Time frame
Secondary end point(s): -Rate of patients with at least 1 treatment emergent AE by primary system organ class -Rate of treatment emergent patient deaths for asthma exacerbations -Rate of treatment emergent patient hospitalizations for an asthma exacerbation;Timepoint(s) of evaluation of this end point: 52 weeks (end Treatment Period 1) 160 weeks (end Treatment Period 2)	—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, Estonia, Finland, France, Germany, Greece, Guatemala, Hungary, India, Israel, Japan, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, Peru, Philippines, Poland, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Switzerland, Taiwan, Turkey, United Kingdom, United States

Contacts

Public ContactMedizinischer Infoservice (MCC)

Novartis Pharma GmbH

infoservice.novartis@novartis.com+49 1802 232300

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026