Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma Treatment

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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223509

Enrollment

200

Registered

2017-04-17

Start date

2017-04-10

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: 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. *A diagnosis of asthma,uncontrolled on GINA 3/4/5 asthma medication. *Evidence of airway reversibility or airway hyper- reactivity. *FEV1 of >=40% and ==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. *Patient who developed a condition during the prior study that would have excluded them from participation in that study. 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> 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin. Statin doses less than or equal to these doses as well as other statins will be permitted during the study. Other protocol defined inclusion/exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
safety treatment-emergent adverse events (AEs) [ Time Frame: 52 weeks/160 weeks ] Adverse events (AEs) starting on or after the time of the first intake of study drug and until the day after the last intake of study drug will be classified as treatment emergent AEs. safety treatment emergent serious adverse events [ Time Frame: 52 weeks/160 weeks ] Serious Adverse events starting on or after the time of the first intake of study drug and until the day after the last intake of study drug will be classified as treatment emergent SAEs. safety treatment emergent AEs leading to discontinuation from the study [ Time Frame: 52 weeks/160 weeks ] Adverse events leading to discontinuation from the study starting on or after the time of the first intake of study drug and until the day after the last intake of study drug will be classified as treatment emergent AEs leading to discontinuation.	—

Measure

Time frame

safety treatment-emergent adverse events (AEs) [ Time Frame: 52 weeks/160 weeks ] Adverse events (AEs) starting on or after the time of the first intake of study drug and until the day after the last intake of study drug will be classified as treatment emergent AEs. safety treatment emergent serious adverse events [ Time Frame: 52 weeks/160 weeks ] Serious Adverse events starting on or after the time of the first intake of study drug and until the day after the last intake of study drug will be classified as treatment emergent SAEs. safety treatment emergent AEs leading to discontinuation from the study [ Time Frame: 52 weeks/160 weeks ] Adverse events leading to discontinuation from the study starting on or after the time of the first intake of study drug and until the day after the last intake of study drug will be classified as treatment emergent AEs leading to discontinuation.

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Secondary

Measure	Time frame
safety Rate of patients with at least 1 treatment emergent AE by primary system organ class [ Time Frame: 52 weeks/160 weeks ] The number of patients per patient year of follow-up having a treatment emergent adverse event, categorized by system organ class. Treatment emergent adverse events are defined as an AEs starting on or after the time of the first intake of study drug and until the day after the last intake of study drug. safety Rate of treatment emergent patient deaths and patient hospitalizations due to an asthma exacerbation [ Time Frame: 52 weeks/160 weeks ] The number 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) per patient year of follow-up due to an asthma exacerbation. Treatment emergent deaths are defined as an deaths occurring on or after the time of the first intake of study drug and until the day after the last intake of study drug. Treatment emergent hospitalizations are defined as hospitalizations occurring on or after the time of the first intake of study drug and until the day after the last intake of study drug.	—

Measure

Time frame

safety Rate of patients with at least 1 treatment emergent AE by primary system organ class [ Time Frame: 52 weeks/160 weeks ] The number of patients per patient year of follow-up having a treatment emergent adverse event, categorized by system organ class. Treatment emergent adverse events are defined as an AEs starting on or after the time of the first intake of study drug and until the day after the last intake of study drug. safety Rate of treatment emergent patient deaths and patient hospitalizations due to an asthma exacerbation [ Time Frame: 52 weeks/160 weeks ] The number 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) per patient year of follow-up due to an asthma exacerbation. Treatment emergent deaths are defined as an deaths occurring on or after the time of the first intake of study drug and until the day after the last intake of study drug. Treatment emergent hospitalizations are defined as hospitalizations occurring on or after the time of the first intake of study drug and until the day after the last intake of study drug.

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Countries

Japan

Outcome results

None listed

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