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

Phase 1

• Conditions: Asthma; MedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-001560-11-BG
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-09
• Last Update Posted: 15 September 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2406

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified