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

NCT ID: NCT03052517

Last Updated: 2020-10-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 2538 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-21
• Study Completion Date: 2020-03-16

Brief Summary

This study was a 2-treatment period, randomized, multicenter parallel-group study. The overall purpose of this study was to provide long- term safety data for fevipiprant (QAW039) (Dose 1 and Dose 2), 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 patients with moderate-to- severe asthma.

The purpose of this study was to provide long-term safety data for QAW039 150 mg once daily and 450 mg once daily, compared with placebo, when added to GINA steps 3, 4, and 5 standard-of-care asthma therapy (GINA 2020) in adult and adolescent (≥12 years) patients with moderate-to-severe asthma. The study included 2 cohorts of patients:

1. Rollover patients who had completed any of the four Phase 3 pivotal efficacy studies with QAW039 (QAW039A2307, QAW039A2314, QAW039A2316, or QAW039A2317, hereafter referred to as Studies A2307, A2314, A2316, and A2317), thus providing data for a longer duration of exposure, and

2. New patients who had not previously participated in a study of QAW039, permitting an increase in the number of patients with long-term exposure to QAW039.

By including these 2 categories of patients, the total number of patients treated with QAW039 as well as the duration of exposure to QAW039 treatment was substantially increased, supporting evaluation of the safety profile of QAW039.

Detailed Description

The study comprised 2-treatment period. Treatment Period 1 was a 52-week, double-blind treatment period in which QAW039 450 mg or 150 mg or placebo was added to standard-of-care asthma therapy according to GINA guidelines. Treatment Period 2 was an optional 104-week, single-blind treatment period in which patients received QAW039 450 mg or 150 mg or placebo added to standard-of-care asthma therapy according to GINA guidelines.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

QAW039 150mg

QAW039 Dose 1 once daily

Group Type: EXPERIMENTAL

QAW039 150 mg

Intervention Type: DRUG

One tablet of QAW039 150 mg once daily

QAW039 450 mg

QAW039 Dose 2 once daily

Group Type: EXPERIMENTAL

QAW039 450 mg

Intervention Type: DRUG

One tablet of QAW039 450 mg once daily

Placebo

Placebo once daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

One tablet of Placebo once daily

Interventions

QAW039 150 mg

One tablet of QAW039 150 mg once daily

Intervention Type: DRUG

QAW039 450 mg

One tablet of QAW039 450 mg once daily

Intervention Type: DRUG

Placebo

One tablet of Placebo once daily

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Encinitas, California, United States

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Marbella, Andalusia, Spain

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Málaga, Andalusia, Spain

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Málaga, Andalusia, Spain

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Palma de Mallorca, Balearic Islands, Spain

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Jerez de la Frontera, Cadiz, Spain

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Laredo, Cantabria, Spain

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Lugo, Galicia, Spain

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Barcelona, Vic, Spain

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Barcelona, , Spain

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Girona, , Spain

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Guadalajara, , Spain

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Madrid, , Spain

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Santiago de Compostela, , Spain

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Zaragoza, , Spain

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Liestal, , Switzerland

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Lugano, , Switzerland

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Taichung, , Taiwan

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Istanbul, TUR, Turkey (Türkiye)

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Adana, , Turkey (Türkiye)

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Ankara, , Turkey (Türkiye)

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Bursa, , Turkey (Türkiye)

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Mersin, , Turkey (Türkiye)

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Yenisehir/Izmir, , Turkey (Türkiye)

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Cambridge, Cambrigdeshire, United Kingdom

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Plymouth, Devon, United Kingdom

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Chertsey, Surrey, United Kingdom

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Bradford, West Yorkshire, United Kingdom

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East Yorkshire, , United Kingdom

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Leicester, , United Kingdom

Countries

United States; 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; Russia; Saudi Arabia; Serbia; Singapore; Slovakia; Spain; Switzerland; Taiwan; Turkey (Türkiye); United Kingdom

References

Maspero J, Agache IO, Kamei T, Yoshida M, Boone B, Felser JM, Kawakami F, Knorr B, Lawrence D, Lehmann T, Wang W, Pedinoff AJ. Long-term safety and exploratory efficacy of fevipiprant in patients with inadequately controlled asthma: the SPIRIT randomised clinical trial. Respir Res. 2021 Dec 11;22(1):311. doi: 10.1186/s12931-021-01904-8.

Reference Type: DERIVED

PMID: 34895218 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

2016-001560-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CQAW039A2315

Identifier Type: -

Identifier Source: org_study_id