The overall purpose of this study is to provide long-term safety data for fevipiprant (QAW039) (150 mg once daily and 450 mg once daily),compared with placebo, when added to the Global Initiative for Asthma (GINA) steps 3, 4, and 5 standard-of-care…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
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:
- the rate of patients with at least 1 treatment emergent AE by primary system
organ class; and.
- the rate of treatment emergent patient deaths and patient hospitalizations
(any visit to the hospital requiring an overnight stay or an emergency room
visit greater than 24 hours) 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:
• the rate of patients with at least 1 treatment emergent AE by primary system
organ class; and
• the rate of treatment emergent patient deaths and patient hospitalizations
(any visit to the hospital requiring an overnight stay or an emergency room
visit greater than 24 hours) due to an asthma exacerbation.
Background summary
Despite existing therapies, there is still significant unmet medical need in
asthma.
Severe asthma is defined as asthma that requires treatment with high dose
inhaled corticosteroids plus a second controller and/or systemic
corticosteroids. Severe asthma is a heterogeneous condition consisting of
phenotypes such as eosinophilic asthma.This subgroup has also been defined as
"refractory" asthma.
Recurrent exacerbations are a major problem in some patients with severe
asthma. It seems inhalation therapy, and oral cortico-steroids are not as
effective for this sub-group as in the milder forms of asthma.Therefore, there
remains a need for therapy, which is well tolerated, is easy to administrate,
and anti-inflammatory works, in which it suppresses the sputum eosinophils and
thereby reduces the asthma exacerbations.
QAW039 is a CRTh2 antagonist expected to provide benefit in asthma by binding
to CRTh2 receptors on eosinophils, basophils, and T lymphocytes in the blood
and tissues; thus, inhibiting migration and activation of these cells into the
airway tissues and blocking the PGD2-driven release of Th2 cytokines
(Chevalier, et al 2005). Since these are the major effector cells and soluble
factors driving airway inflammation in asthma, treatment with QAW039 should
result in a decrease in these parameters of airway inflammation as well as a
clinical improvement in asthma.
The overall purpose of this study is to provide long-term safety data for
fevipiprant (QAW039) (150 mg once daily and 450 mg once daily),
compared with placebo, when added to the Global Initiative for Asthma (GINA)
steps 3, 4, and 5 standard-of-care (SoC) asthma therapy (GINA
2016), in adult and adolescent (>=12 years) patients with moderate-tosevere
asthma.
Study objective
The overall purpose of this study is to provide long-term safety data for
fevipiprant (QAW039) (150 mg once daily and 450 mg once daily),
compared with placebo, when added to the Global Initiative for Asthma (GINA)
steps 3, 4, and 5 standard-of-care (SoC) asthma therapy (GINA
2016), in adult and adolescent (>=12 years) patients with moderate-tosevere
asthma.
Study design
This study is a 2-treatment period, randomized, multicenter parallel-group
safety study. Treatment Period 1 is a 52-week, double-blind
treatment period in which QAW039 or placebo is added to GINA steps 3, 4 and 5
SoC asthma therapy. Treatment Period 2 is an optional 104-week, single-blind
treatment period in which patients will receive QAW039 or placebo added to GINA
steps 3, 4 and 5 SoC asthma therapy.
The study will include the following:
- Screening Period of up to 2 weeks to assess eligibility of new patients.
- Treatment Period 1*double-blind period of 52 weeks.
- Treatment Period 2*single-blind period of 104 weeks.
- Follow-up Period of 4 weeks, investigational and drug-free, following the
last dose of study drug.
Intervention
Treatment with 150 mg or 450 mg QAW039 or placebo once daily.
Study burden and risks
The study consists of 2 periods.
Burden:
Period 1:
Physical examination: 7x
ECG: 7x
Females of childbearing potential: Pregnancy test: 1x in serum, 7x in urine
Blood collection: 7x
Reversibility test: 1x in case not participated previously in another QAW039
trial.
Spirometry: 12x
Completion Questionnaire: 1x in case not participated previously in another
QAW039 trial.
Period 2:
Physical examination:97x
ECG: 9x
Females of childbearing potential: Pregnancy test: 10x in urine
Blood collection: 9x
Urine collection: 9x
Risks:
Side effects QAW0139 and risks of study procedures.
Haaksbergweg 16
Amsterdam 1101 BX
NL
Haaksbergweg 16
Amsterdam 1101 BX
NL
Listed location countries
Age
Inclusion criteria
Patients completing a prior Phase 3 study of QAW039 (NLD: CQAW039A2314):
- Written Informed consent
- 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 (NLD: >=18 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.
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) at Visit 1 or
Visit 201 on the ECG Analysis Report provided by the ECG core laboratory.
- 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-001560-11-NL |
| ClinicalTrials.gov | NCT03052517 |
| CCMO | NL61901.018.17 |