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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03052517
• Date of registration: 23/01/2017
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma 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: March 21, 2017
• Target sample size: 2538
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03052517
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czechia, Estonia, Finland, France, Germany, Greece, Guatemala, Hungary, India, Israel, Japan, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, Peru, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Switzerland, Taiwan, Turkey, United Kingdom, United States

Contacts

• Name: Novartis Pharmaceuticals Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion 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:

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.



Age minimum: 12 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Drug: QAW039 150 mg

Drug: Placebo

Drug: QAW039 450 mg

Primary Outcome(s)

Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 156 - Cox Regression Model [Time Frame: 156 weeks]

Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 156 - Cox Regression Model [Time Frame: 156 weeks]

Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 52 - Cox Regression Model [Time Frame: 52 weeks]

Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 52 - Cox Regression Model [Time Frame: 52 weeks]

Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 156 - Cox Regression Model [Time Frame: 156 weeks]

Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 52 - Cox Regression Model [Time Frame: 52 weeks]

Secondary Outcome(s)

Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 52 [Time Frame: 52 weeks]

Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 156 [Time Frame: 156 weeks]

Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model [Time Frame: 156 weeks]

Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 156 [Time Frame: 156 weeks]

Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model [Time Frame: 52 weeks]

Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 52 [Time Frame: 52 weeks]

Secondary ID(s)

2016-001560-11

CQAW039A2315

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/10/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03052517