A Study to review the Effectiveness and Safety of QAW039 in Patients With Severe Asthma who are Inadequately Controlled With Standard of Care Treatment.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2018/01/011183
• Date of registration: 08-01-2018
• Prospective Registration: Yes
• Primary sponsor: Novartis Healthcare Pvt Ltd
• Public title: A Study to review the Effectiveness and Safety of QAW039 in Patients With Severe Asthma who are Inadequately Controlled With Standard of Care Treatment.
• Scientific title: 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
• Date of first enrolment: 08-01-2018
• Target sample size: 2314
• Recruitment status: Closed to Recruitment of Participants
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=22084
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant and Investigator Blinded
• Phase: Phase 3

Countries of recruitment

Argentina, Canada, Czech Republic, Greece, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Panama, Russian Federation, Serbia , Slovakia, South Africa, Spain, Taiwan, United States of America

Contacts

• Name: Murugananthan K
• Affiliation: Novartis Healthcare Private Limited

• Name: Murugananthan K
• Affiliation: Novartis Healthcare Private Limited

Key inclusion & exclusion criteria

Inclusion criteria: Patients completing A PRIOR PHASE 3 STUDY OF QAW039:

1a. Informed consent and assent (if applicable) may be obtained at Visit 1 or within 14 days

of Visit 1. Informed consent and assent (if applicable) must be obtained before any study

assessment is performed.



2a. Completion of the treatment period (on blinded study drug) of a prior Phase 3 study of

QAW039 (i.e., did not discontinue blinded study treatment prematurely).



3a. 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:

1a. Informed consent and assent (if applicable) may be obtained at Visit 1 or within 14 days

of Visit 1. Informed consent and assent (if applicable) must be obtained before any study

assessment is performed.



2b. Male and female patients at a minimum age of 12 years (or higher minimum age limit as

allowed by health authority and/or ethics committee/institutional review board (IRB)

approvals).



3b. Patients must have a diagnosis of asthma (according to GINA 2016) for a period of at least

24 months prior to screening visit (Visit 1).



4b. Patients have been treated with GINA steps 4 or 5 standard-of-care (SoC) asthma therapy

for at least 3 months prior to Visit 1. The doses must have been stable for at least 4 weeks

prior to Visit 1.



5b. Demonstration of inadequate control of asthma based on an ACQ score greater than or equal to 1.5 at Visit 1.



6b. For patients aged greater than or equal to 18 years, FEV1 of greater than or equal to 40% and less than or equal to 85% of the predicted normal value for the patient, after withholding bronchodilators at Visit 1. For patients aged 12 to less than 18 years, FEV1 of greater than or equal to 40% and less than or equal to 90% of the predicted normal value for the patient, after withholding bronchodilators at Visit 1.



7b. An increase of greater than or equal to 12% and greater than or equal to 200 ml in FEV1 approximately 10 to 15 minutes after

administration of 400 mcg of salbutamol/albuterol (or equivalent dose) prior to randomization. Spacer devices are not permitted during reversibility testing. All patients must perform a reversibility test at the Visit 1.


Exclusion criteria: Patients completing a prior phase 3 study of QAW039:

1. Pregnant or nursing (lactating) women.



2. Women of child-bearing potential unless they are using basic methods of contraception during dosing of study drug



3. Patients who did not complete the Treatment Period on blinded study drug of the prior QAW039 study they participated in.



4. Inability to comply with all study requirements.



5. 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:

6. Use of other investigational drugs within 5 half-lives of study entry, or within 30 days, whichever is longer.



7. Subjects who have participated in another trial of QAW039 (i.e. the patient was randomized in another study).



8. A QTcF (Fridericia) greater than or equal to 450 msec (male) or greater than or equal to 460 msec (female).



9. History of malignancy with the exception of local basal cell carcinoma of the skin



10. Pregnant or nursing (lactating) women.



11. Serious co-morbidities



12. Patients on greater than 20 mg of simvastatin, greater than 40 mg of atorvastatin, greater than 40 mg of pravastatin, or greater than 2 mg of pitavastatin. Statin doses less than or equal to these doses as well as other statins will be permitted during the study.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Asthma Health Condition 2: J455- Severe persistent asthma

Intervention(s)

Intervention1: QAW039 150 mg Tablet: 1 tablet of blinded QAW039 at
150 mg + 1 tablet blinded
placebo to QAW039 450 mg.
Frequency - Once daily. Route
of Administration - Oral.
Duration: 52 weeks
Intervention2: QAW039 450 mg Tablet: 1 tablet of blinded QAW039 at
450 mg + 1 tablet blinded
placebo to QAW039 150 mg.
Frequency - Once daily. Route
of Administration - Oral.
Duration: 52 weeks
Control Intervention1: QAW039 Placebo Tablet: 1 tablet blinded placebo to
QAW039 150 mg + 1 tablet
blinded placebo to QAW039
450 mg. Frequency - Once
daily. Route of Administration
-Oral. Duration: 52 weeks

Primary Outcome(s)

Moderate-to-severe asthma exacerbationsTimepoint: 52 weeks

Secondary Outcome(s)

Asthma quality of life quesstionairesTimepoint: 52 weeks

Secondary ID(s)

NCT03052517

CQAW039A2315, Version 00 dated 2 November 2016

Source(s) of Monetary Support

Novartis Pharma AG, Basel, Switzerland

Ethics review

Status: Approved
Approval date: 18/12/2017
Contact:

Orange City Hospital Institutional Ethics Committee Dr Vinit Niranjane

Status: Approved
Approval date: 25/12/2017
Contact:

Institutional Ethics Committee, CARE INSTITUTE OF MEDICAL SCIENCES Dr Amit Patel

Status: Approved
Approval date: 12/02/2018
Contact:

Institutional EthicsCommittee Asthma Bhawan Dr Sharad Tikkiwal

Status: Approved
Approval date: 12/02/2018
Contact:

Institutional Human Ethics Committee (IHEC), Sri Bala Medical Centre & Hospital , Dr Srikanth Krishnamurthy

Status: Approved
Approval date: 17/07/2018
Contact:

Institutional Ethics Committee, Chest Research Foundation, Dr Sundeep Salvi

Status: Approved
Approval date: 05/11/2018
Contact:

Rhythm Heart Institute Ethics Committee, Rhythm Heart Institute, Dr Manoj DayaramYadav

Status: Approved
Approval date: 05/12/2018
Contact:

Institutional Ethics Committee, Midland Health Care and Research Centre, Dr Bhanu Pratap Singh

Status: Approved
Approval date: 15/01/2019
Contact:

Institutional Ethics Committee, Shri Mahant Indiresh Hospital, Dr Jagdish Rawat

Status: Approved
Approval date: 14/03/2019
Contact:

Ethics Committee, S. P.Medical & A.G.Hospital, Dr Surendra Kumar