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

Phase 3

Completed

• Conditions: Respiratory - Asthma; Respiratory , Asthma; J45.9

• Registration Number: LBCTR2019121309
• Lead Sponsor: ovartis Pharma Services Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-11-28
• Study Start: 2021-01-27
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

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 =85% of the predicted normal value.
•An ACQ score =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 (i.e.-the patient was randomized in another study).
•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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified