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

• Register: EUCTR
• Last refreshed on: 4 May 2020
• Main ID: EUCTR2016-001560-11-SK
• Date of registration: 12/01/2017
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma AG
• Public title: Study of safety of QAW039 in patients (= 12 yrs) with asthma inadequately controlled on standard-of-care asthma therapy
• 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. - SPIRIT
• Date of first enrolment: 21/03/2017
• Target sample size: 2406
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-001560-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: While Part 1 is double-blind, Part 2 is single-blind If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: DRA information desk
• Affiliation: Novartis Slovakia s.r.o.

• Name: DRA information desk
• Affiliation: Novartis Slovakia s.r.o.

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.
-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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Asthma
MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Intervention(s)

Product Name: Fevipiprant
Product Code: QAW039
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Fevipiprant
CAS Number: 872365-14-5
Current Sponsor code: QAW039
Other descriptive name: QAW039-NXA.001
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: Fevipiprant
Product Code: QAW039
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Fevipiprant
CAS Number: 872365-14-5
Current Sponsor code: QAW039
Other descriptive name: QAW039-NXA.001
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 450-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: Treatment Period 1 (double-blind, 52-week treatment period):
In patients with moderate-to-severe asthma receiving SoC asthma therapy, to evaluate the long-term safety of QAW039 (150 mg once daily and 450 mg once daily), compared with placebo, as assessed by:
-rate of patients with at least 1 treatment emergent AE by primary system organ class;
-rate of treatment emergent patient deaths and patient hospitalizations due to an asthma exacerbation.

Treatment Period 1 and Treatment Period 2 combined:
In patients with moderate-to-severe-asthma receiving SoC asthma therapy, to evaluate the long-term safety of QAW039 (150 mg once daily and 450 mg once daily), compared with placebo, as assessed by:
-rate of patients with at least 1 treatment emergent AE by primary system organ class; and
-rate of treatment emergent patient deaths and patient hospitalizations due to an asthma exacerbation.

Primary end point(s): -treatment emergent adverse events (AEs)
-treatment emergent serious adverse events
-treatment emergent AEs leading to treatment discontinuation

Main Objective: Treatment Period 1 (double-blind, 52-week treatment period):
In patients with moderate-to-severe asthma receiving SoC asthma therapy, to evaluate the long-term safety of QAW039 (150 mg once daily and 450 mg once daily), compared with placebo, as assessed by:
-treatment emergent adverse events (AEs);
-treatment emergent serious adverse events (SAEs); and
-study treatment discontinuations due to treatment emergent AEs.

Treatment Period 1 and Treatment Period 2 combined:
In patients with moderate-to-severe-asthma receiving SoC asthma therapy, to evaluate the long-term safety of QAW039 (150 mg once daily and 450 mg once daily), compared with placebo, as assessed by:
-treatment emergent AEs
-treatment emergent SAEs; and
-study treatment discontinuations due to treatment emergent AEs.

Timepoint(s) of evaluation of this end point: 52 weeks (end Treatment Period 1)
160 weeks (end Treatment Period 2)

Secondary Outcome(s)

Secondary end point(s): -Rate of patients with at least 1 treatment emergent AE by primary system organ class
-Rate of treatment emergent patient deaths for asthma exacerbations
-Rate of treatment emergent patient hospitalizations for an asthma exacerbation

Timepoint(s) of evaluation of this end point: 52 weeks (end Treatment Period 1)
160 weeks (end Treatment Period 2)

Secondary ID(s)

CQAW039A2315

Source(s) of Monetary Support

Novartis Pharma AG

Ethics review

Status: Approved
Approval date: 24/01/2017
Contact: