Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.

A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Existing Asthma Therapy in Patients With Uncontrolled Severe Asthma.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223052

Enrollment

864

Registered

2015-12-22

Start date

2016-03-15

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Asthma

Interventions

investigational material(s) Generic name etc : QAW039 INN of investigational material : Fevipiprant Therapeutic category code : 449 Other antiallergic agents Dosage and Administration for Investigatio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Written informed consent. -Male and female patients aged >=12 years. -A diagnosis of severe asthma, uncontrolled on GINA 4/5 asthma medication. -Evidence of airway reversibility or airway hyper- reactivity. -FEV1 of >=40% and =1.5. -A history of 2 or more asthma exacerbations within the 12 months prior to entering the study.

Exclusion criteria

Exclusion criteria: 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 >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin.

Design outcomes

Primary

Measure	Time frame
efficacy Moderate-to-severe asthma exacerbations [ Time Frame: 52 weeks ] [ Designated as safety issue: No ] Reduction in the rate of moderate-to-severe asthma exacerbations.	—

Secondary

Measure	Time frame
efficacy Asthma Quality of Life Questionnaire+12 (AQLQ+12) score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ] Change from baseline in AQLQ+12 score. AQLQ+12 consists of 32 questions each scaled from 1 to 7, where 1 indicates maximal impairment and 7 indicates no impairment. efficacy Asthma Control Questionnaire-5 (ACQ-5) score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ] Change from baseline in ACQ-5 score. The ACQ-5 consists of 5 questions on a 7-point scale (0=no impairment, 6=maximum impairment). efficacy Pre-dose Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ] Change from baseline in pre-dose FEV1 (liters). safety Safety (Incidence of Treatment-Emergent Adverse Events) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]	—

Measure

Time frame

efficacy Asthma Quality of Life Questionnaire+12 (AQLQ+12) score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ] Change from baseline in AQLQ+12 score. AQLQ+12 consists of 32 questions each scaled from 1 to 7, where 1 indicates maximal impairment and 7 indicates no impairment. efficacy Asthma Control Questionnaire-5 (ACQ-5) score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ] Change from baseline in ACQ-5 score. The ACQ-5 consists of 5 questions on a 7-point scale (0=no impairment, 6=maximum impairment). efficacy Pre-dose Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ] Change from baseline in pre-dose FEV1 (liters). safety Safety (Incidence of Treatment-Emergent Adverse Events) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

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Countries

Asia except Japan, Europe, Japan, North America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026