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

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.

Conditions

• Asthma

Interventions

DRUG

QAW039 150 mg

One tablet of QAW039 150 mg once daily

DRUG

QAW039 450 mg

One tablet of QAW039 450 mg once daily

DRUG

Placebo

One tablet of Placebo once daily

Sponsors & Collaborators

• Novartis Pharmaceuticals

  lead INDUSTRY

Principal Investigators

• Novartis Pharmaceuticals Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-03-21

Primary Completion

2020-02-19

Completion

2020-03-16

FDA Drug

Yes

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

Study Locations