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

September 14, 2020 updated by: Novartis Pharmaceuticals

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2538

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1125ABE
        • Novartis Investigative Site
      • Buenos Aires, Argentina, C1012AAR
        • Novartis Investigative Site
      • Buenos Aires, Argentina, C1425FVH
        • Novartis Investigative Site
      • Cordoba, Argentina, X5003DCE
        • Novartis Investigative Site
      • Mendoza, Argentina, 5500
        • Novartis Investigative Site
      • Mendoza, Argentina, M5500CBA
        • Novartis Investigative Site
      • Salta, Argentina, 4000
        • Novartis Investigative Site
      • Santa Fe, Argentina, S3000FIL
        • Novartis Investigative Site
    • Buenos Aires
      • Berazategui, Buenos Aires, Argentina, 1888
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, C1056ABJ
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, C1122AAK
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, C1426ABP
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, C1425BEN
        • Novartis Investigative Site
      • Lanus, Buenos Aires, Argentina, B8000XAV
        • Novartis Investigative Site
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Novartis Investigative Site
      • Ranelagh, Partido De Berazate, Buenos Aires, Argentina, 1884
        • Novartis Investigative Site
    • La Pampa
      • Santa Rosa, La Pampa, Argentina, 6300
        • Novartis Investigative Site
    • Rosario
      • Santa Fe, Rosario, Argentina, S2000DBS
        • Novartis Investigative Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000AII
        • Novartis Investigative Site
      • Rosario, Santa Fe, Argentina, S2000BRH
        • Novartis Investigative Site
      • Rosario, Santa Fe, Argentina, S2000JKR
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    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina, 4000
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      • San Miguel de Tucuman, Tucuman, Argentina, T4000IFL
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  • Australia
    • Victoria
      • Clayton, Victoria, Australia, 3168
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      • Footscray, Victoria, Australia, 3011
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      • Melbourne, Victoria, Australia, 3004
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  • Austria
      • Feldkirch, Austria, 6800
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      • Vienna, Austria, A-1130
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      • Wien, Austria, A 1090
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  • Belgium
      • Aalst, Belgium, 9300
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      • Brussel, Belgium, 1020
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      • Bruxelles, Belgium, 1000
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      • Eghezee, Belgium, 5310
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      • Erpent, Belgium, 5100
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      • Herentals, Belgium, 2200
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      • Kortrijk, Belgium, 8500
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      • Liege, Belgium, 4000
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  • Brazil
    • GO
      • Goiania, GO, Brazil, 74110-030
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    • Porto Alegre RS
      • Porto Alegre, Porto Alegre RS, Brazil, 90610 000
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    • RJ
      • Rio de Janeiro, RJ, Brazil, 21941-590
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    • RS
      • Porto Alegre, RS, Brazil, 90020-090
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    • SP
      • Sao Bernardo do Campo, SP, Brazil, 09715 090
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      • Sao Paulo, SP, Brazil, 05403 000
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      • Sao Paulo, SP, Brazil, 05437 010
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      • Sorocaba, SP, Brazil
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    • Santa Catarina
      • Blumenau, Santa Catarina, Brazil, 89030101
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  • Bulgaria
      • Pleven, Bulgaria, 5800
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      • Ruse, Bulgaria, 7002
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      • Sofia, Bulgaria, 1000
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      • Stara Zagora, Bulgaria, 6000
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  • Canada
      • Quebec, Canada, G1V 4W2
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      • Vancouver, Canada
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    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
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    • Ontario
      • Toronto, Ontario, Canada, M6H 3M2
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      • Toronto, Ontario, Canada, M9V 4B4
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      • Windsor, Ontario, Canada, N8X 5A6
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    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
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      • Montreal, Quebec, Canada, H3G 1L5
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      • Montreal, Quebec, Canada, H4J 1C5
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  • China
      • Beijing, China, 100050
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      • Chongqing, China, 400037
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      • Shanghai, China, 200433
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    • Guang Dong Province
      • Guang Zhou, Guang Dong Province, China, 510120
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    • Hebei
      • Shijiazhuang, Hebei, China, 050000
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    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
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      • Nanjing, Jiangsu, China, 210009
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    • Jilin
      • Chang Chun, Jilin, China, 130021
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    • Liaoning
      • Shenyang, Liaoning, China, 110000
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      • Shenyang, Liaoning, China, 110003
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    • Shanxi
      • Xian, Shanxi, China, 710061
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    • Sichuan
      • Chengdu, Sichuan, China, 610041
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  • Colombia
      • Bogota, Colombia, 110221
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      • Bucaramanga, Colombia
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    • Tolima
      • Ibague, Tolima, Colombia, 730006
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  • Czechia
      • Brno, Czechia, 615 00
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      • Karlovy Vary, Czechia, 360 17
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      • Mlada Boleslav, Czechia, 293 50
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    • CZE
      • Teplice, CZE, Czechia, 415 01
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    • Czech Republic
      • Jindrichuv Hradec, Czech Republic, Czechia, 377 01
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      • Teplice, Czech Republic, Czechia, 415 01
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  • Estonia
      • Tallinn, Estonia, 13419
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      • Tartu, Estonia, 51014
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  • Finland
      • Helsinki, Finland, 00029
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  • France
      • Dijon, France, 21000
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      • Le Kremlin Bicetre, France, 94275
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      • Lyon Cedex 04, France, 69317
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      • Marseille, France, 13015
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      • Nantes, France, 44093
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      • Paris cedex 18, France, 75877
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      • Strasbourg Cedex, France, 67091
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    • Herault
      • Montpellier cedex 5, Herault, France, 34059
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  • Germany
      • Aschaffenburg, Germany, 63739
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      • Berlin, Germany, 12203
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      • Berlin, Germany, 10717
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      • Berlin, Germany, 10969
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      • Berlin, Germany, 12159
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      • Frankfurt, Germany, 60596
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      • Frankfurt, Germany, 60389
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      • Landsberg, Germany, 86899
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      • Leipzig, Germany, 04357
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      • Witten, Germany, 58452
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    • Sachsen
      • Cottbus, Sachsen, Germany, 03050
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  • Greece
      • Athens, Greece, 115 27
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      • Athens, Greece, 115 21
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      • Athens, Greece, 175 62
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    • GR
      • Athens, GR, Greece, 115 27
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      • Athens, GR, Greece, 115 25
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      • Thessaloniki, GR, Greece, 570 10
        • Novartis Investigative Site
  • Guatemala
      • Guatemala City, Guatemala, 01010
        • Novartis Investigative Site
      • Guatemala City, Guatemala, 01011
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    • GTM
      • Guatemala City, GTM, Guatemala, 01010
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      • Guatemala City, GTM, Guatemala, 01011
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    • Gautemala
      • Gautemala City, Gautemala, Guatemala, 01010
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, 1106
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      • Godollo, Hungary, 2100
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      • Komarom, Hungary, 2900
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      • Mako, Hungary, 6900
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      • Pecs, Hungary, 7635
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      • Siofok, Hungary, 8600
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      • Szeged, Hungary, 6722
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      • Torokbalint, Hungary, 2045
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    • HUN
      • Budaors, HUN, Hungary, 2040
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      • Gyor, HUN, Hungary, 9024
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      • Hajdunanas, HUN, Hungary, 4080
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      • Puspokladany, HUN, Hungary, 4150
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      • Szazhalombatta, HUN, Hungary, 2440
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  • India
    • Gujarat
      • Ahmedabad, Gujarat, India, 380 060
        • Novartis Investigative Site
      • Vadodara, Gujarat, India, 390022
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    • Maharashtra
      • Nagpur, Maharashtra, India, 440015
        • Novartis Investigative Site
      • Pune, Maharashtra, India, 411014
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    • Rajasthan
      • Bikaner, Rajasthan, India, 334 001
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      • Jaipur, Rajasthan, India, 302039
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    • Tamil Nadu
      • Coimbatore, Tamil Nadu, India, 641 045
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    • Uttarakhand
      • DehraDun, Uttarakhand, India, 248001
        • Novartis Investigative Site
  • Israel
      • Ashkelon, Israel, 78278
        • Novartis Investigative Site
      • Haifa, Israel, 310 9601
        • Novartis Investigative Site
      • Haifa, Israel, 3436212
        • Novartis Investigative Site
      • Jerusalem, Israel, 91120
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      • Jerusalem, Israel, 91031
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      • Petach Tikva, Israel, 49100
        • Novartis Investigative Site
      • Rehovot, Israel, 76100
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  • Japan
    • Aichi
      • Nagoya, Aichi, Japan, 466 8560
        • Novartis Investigative Site
    • Ehime
      • Matsuyama-city, Ehime, Japan, 790-8524
        • Novartis Investigative Site
      • Matsuyama-city, Ehime, Japan, 790-0024
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    • Fukuoka
      • Chikushino-city, Fukuoka, Japan, 818-8502
        • Novartis Investigative Site
      • Fukuoka city, Fukuoka, Japan, 811-1394
        • Novartis Investigative Site
      • Iizuka-city, Fukuoka, Japan, 820-8505
        • Novartis Investigative Site
      • Kasuga-city, Fukuoka, Japan, 816-0813
        • Novartis Investigative Site
      • Koga city, Fukuoka, Japan, 811 3195
        • Novartis Investigative Site
      • Yanagawa-city, Fukuoka, Japan, 832-0059
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    • Gifu
      • Mizunami-city, Gifu, Japan, 509 6134
        • Novartis Investigative Site
    • Hiroshima
      • Hiroshima-city, Hiroshima, Japan, 734-8530
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    • Hokkaido
      • Sapporo, Hokkaido, Japan, 062-0931
        • Novartis Investigative Site
      • Sapporo, Hokkaido, Japan, 064-0804
        • Novartis Investigative Site
    • Hyogo
      • Himeji-city, Hyogo, Japan, 672-8064
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    • Ibaraki
      • Naka-gun, Ibaraki, Japan, 319-1113
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    • Kagawa
      • Sakaide, Kagawa, Japan, 762-8550
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      • Takamatsu-city, Kagawa, Japan, 761-8073
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    • Kagoshima
      • Kagoshima city, Kagoshima, Japan, 890 8520
        • Novartis Investigative Site
    • Kanagawa
      • Sagamihara-city, Kanagawa, Japan, 228-8522
        • Novartis Investigative Site
      • Sagamihara-city, Kanagawa, Japan, 229-1103
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japan, 234-0054
        • Novartis Investigative Site
      • Yokohama city, Kanagawa, Japan, 232 0024
        • Novartis Investigative Site
      • Yokohama-city, Kanagawa, Japan, 223-0059
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    • Kumamoto
      • Koshi-city, Kumamoto, Japan, 861-1196
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    • Mie
      • Matsusaka-city, Mie, Japan, 515-8544
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      • Tsu-city, Mie, Japan, 514-0125
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    • Miyagi
      • Sendai-city, Miyagi, Japan, 980-0871
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      • Sendai-city, Miyagi, Japan, 984-8560
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    • Nara
      • Kashihara city, Nara, Japan, 634 8522
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    • Osaka
      • Habikino city, Osaka, Japan, 583 8588
        • Novartis Investigative Site
      • Kishiwada-city, Osaka, Japan, 596-8501
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    • Shibuya Ku
      • Tokyo, Shibuya Ku, Japan, 150 0013
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    • Shizuoka
      • Hamamatsu-city, Shizuoka, Japan, 431-3192
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    • Tokyo
      • Chuo ku, Tokyo, Japan, 104-8560
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      • Chuo ku, Tokyo, Japan, 104-0031
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      • Chuo-ku, Tokyo, Japan, 103-0003
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      • Chuo-ku, Tokyo, Japan, 103-0028
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      • Itabashi-ku, Tokyo, Japan, 173-8610
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      • Kiyose-city, Tokyo, Japan, 204-8585
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      • Ota-ku, Tokyo, Japan, 145 0063
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      • Setagaya-Ku, Tokyo, Japan, 157-0072
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      • Setagaya-ku, Tokyo, Japan, 157006
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      • Shinagawa-ku, Tokyo, Japan, 142-8666
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      • Shinjuku ku, Tokyo, Japan, 162 8655
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      • Shinjuku-ku, Tokyo, Japan, 169-0073
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      • Toshima ku, Tokyo, Japan, 170 0003
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  • Latvia
      • Daugavpils, Latvia, LV-5401
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      • Riga, Latvia, LV 1002
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  • Lebanon
      • Ashrafieh, Lebanon, 166830
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      • Beirut, Lebanon, 166378
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    • LBN
      • El Chouf, LBN, Lebanon, 1503201002
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  • Lithuania
      • Klaipeda, Lithuania, LT-92231
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      • Vilnius, Lithuania, LT-04129
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    • LT
      • Kaunas, LT, Lithuania, LT-45130
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      • Kaunas, LT, Lithuania, LT-50128
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    • LTU
      • Kaunas, LTU, Lithuania, LT 50161
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      • Vilnius, LTU, Lithuania, LT-10207
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  • Malaysia
    • Kelantan
      • Kota Bharu, Kelantan, Malaysia, 15586
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    • Pahang
      • Kuantan, Pahang, Malaysia, 25100
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    • Perak
      • Taiping, Perak, Malaysia, 34000
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  • Mexico
      • Rio De Janeiro, Mexico, 06700
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    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44130
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      • Guadalajara Jalisco, Jalisco, Mexico, 44220
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  • Netherlands
      • Arnhem, Netherlands, 6815 AD
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      • Leeuwarden, Netherlands, 8934 AD
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  • Peru
      • Cusco, Peru, 84
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      • Lima, Peru, 1
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      • Piura, Peru, 2000
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    • Lima
      • Cercado De Lima, Lima, Peru, 01
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      • San Isidro, Lima, Peru, 27
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      • San Martin de Porres, Lima, Peru, 31
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  • Philippines
      • Bulacan, Philippines, 3020
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      • Iloilo City, Philippines, 5000
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      • Manila, Philippines, 1000
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      • Quezon City, Philippines, 1100
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    • Batangas
      • Lipa City, Batangas, Philippines, 4217
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    • Manila
      • Quezon City, Manila, Philippines, 1100
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  • Poland
      • Bialystok, Poland, 15-010
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      • Kielce, Poland, 25-371
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      • Poznan, Poland, 60-693
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      • Poznan, Poland, 60-214
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      • Poznan, Poland, 60-823
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      • Strzelce Opolskie, Poland, 47 100
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  • Puerto Rico
      • San Juan, Puerto Rico, 00909
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  • Romania
      • Bragadiru, Romania, 077025
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      • Brasov, Romania, 500051
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      • Brasov, Romania, 500086
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      • Brasov, Romania, 500283
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      • Brasov, Romania, 500366
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      • Cluj Napoca, Romania, 400139
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      • Cluj-Napoca, Romania, 400371
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      • Deva, Romania, 330162
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    • District 3
      • Bucharest, District 3, Romania, 030303
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    • ROM
      • Constanta, ROM, Romania, 900412
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    • Timis
      • Timisoara, Timis, Romania, 300310
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  • Russian Federation
      • Barnaul, Russian Federation, 656024
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      • Chelyabinsk, Russian Federation, 454021
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      • Izhevsk, Russian Federation, 426061
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      • Moscow, Russian Federation, 115478
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      • Moscow, Russian Federation, 125315
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      • Nizhnii Novgorod, Russian Federation, 603126
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      • Penza, Russian Federation, 440067
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      • Perm, Russian Federation, 614068
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      • Ryazan, Russian Federation, 390039
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      • Saint Petersburg, Russian Federation, 194354
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      • Saint-Petersburg, Russian Federation, 191186
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      • Sestroretsk, Russian Federation, 197706
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      • Smolensk, Russian Federation
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      • St Petersburg, Russian Federation, 194354
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      • Stavropol, Russian Federation, 355000
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      • Yaroslavl, Russian Federation, 150054
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      • Yekaterinburg, Russian Federation, 620109
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  • Saudi Arabia
      • Jeddah, Saudi Arabia, 21423
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  • Serbia
      • Belgrade, Serbia, 11000
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      • Belgrade, Serbia, 11070
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      • Kragujevac, Serbia, 34000
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      • Nis, Serbia, 18000
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      • Sremska Kamenica, Serbia, 21204
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  • Singapore
      • Singapore, Singapore, 119228
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      • Singapore, Singapore, 529889
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  • Slovakia
      • Kezmarok, Slovakia, 060 01
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      • Komarno, Slovakia, 945 01
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      • Kosice, Slovakia, 040 01
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      • Levice, Slovakia, 934 01
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      • Levice, Slovakia, 93401
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      • Poprad, Slovakia, 058 01
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      • Presov, Slovakia, 080 01
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      • Spisska Nova Ves, Slovakia, 052 01
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      • Zilina, Slovakia, 01207
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    • Slovak Republic
      • Bardejov, Slovak Republic, Slovakia, 085 01
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      • Bojnice, Slovak Republic, Slovakia, 972 01
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  • Spain
      • Barcelona, Spain, 08006
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      • Girona, Spain, 17005
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      • Guadalajara, Spain, 19002
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      • Madrid, Spain, 28046
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      • Santiago de Compostela, Spain, 15706
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      • Zaragoza, Spain, 50009
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    • Andalucia
      • Malaga, Andalucia, Spain, 29010
        • Novartis Investigative Site
      • Malaga, Andalucia, Spain, 29009
        • Novartis Investigative Site
      • Marbella, Andalucia, Spain, 29603
        • Novartis Investigative Site
    • Cadiz
      • Jerez, Cadiz, Spain, 11407
        • Novartis Investigative Site
    • Cantabria
      • Laredo, Cantabria, Spain, 39770
        • Novartis Investigative Site
    • Catalunya
      • Barcelona, Catalunya, Spain, 08036
        • Novartis Investigative Site
    • Galicia
      • Lugo, Galicia, Spain, 27003
        • Novartis Investigative Site
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spain, 07010
        • Novartis Investigative Site
    • Vic
      • Barcelona, Vic, Spain, 08500
        • Novartis Investigative Site
  • Switzerland
      • Liestal, Switzerland, 4410
        • Novartis Investigative Site
      • Lugano, Switzerland, 6900
        • Novartis Investigative Site
  • Taiwan
      • Taichung, Taiwan, 40705
        • Novartis Investigative Site
  • Turkey
      • Adana, Turkey, 01330
        • Novartis Investigative Site
      • Ankara, Turkey, 06100
        • Novartis Investigative Site
      • Bursa, Turkey, 16059
        • Novartis Investigative Site
      • Mersin, Turkey, 33343
        • Novartis Investigative Site
      • Yenisehir/Izmir, Turkey, 35110
        • Novartis Investigative Site
    • TUR
      • Istanbul, TUR, Turkey, 34098
        • Novartis Investigative Site
  • United Kingdom
      • East Yorkshire, United Kingdom, HU16 5JQ
        • Novartis Investigative Site
      • Leicester, United Kingdom, LE3 9QP
        • Novartis Investigative Site
    • Cambrigdeshire
      • Cambridge, Cambrigdeshire, United Kingdom, CB2 0QQ
        • Novartis Investigative Site
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8DH
        • Novartis Investigative Site
    • Surrey
      • Chertsey, Surrey, United Kingdom, KT16 0PZ
        • Novartis Investigative Site
    • West Yorkshire
      • Bradford, West Yorkshire, United Kingdom, BD9 6RJ
        • Novartis Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Novartis Investigative Site
    • California
      • Encinitas, California, United States, 92024
        • Novartis Investigative Site
      • Newport Beach, California, United States, 92663
        • Novartis Investigative Site
      • Orange, California, United States, 92868
        • Novartis Investigative Site
      • San Diego, California, United States, 92117
        • Novartis Investigative Site
      • Stockton, California, United States, 95207
        • Novartis Investigative Site
      • Walnut Creek, California, United States, 94598
        • Novartis Investigative Site
      • Westminster, California, United States, 92683
        • Novartis Investigative Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Novartis Investigative Site
      • Denver, Colorado, United States, 80230
        • Novartis Investigative Site
      • Lafayette, Colorado, United States, 80026
        • Novartis Investigative Site
    • Florida
      • Miami, Florida, United States, 33176
        • Novartis Investigative Site
      • Tamarac, Florida, United States, 33321
        • Novartis Investigative Site
      • Winter Park, Florida, United States, 32789
        • Novartis Investigative Site
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Novartis Investigative Site
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Novartis Investigative Site
    • Kentucky
      • Louisville, Kentucky, United States, 40215
        • Novartis Investigative Site
    • Louisiana
      • Zachary, Louisiana, United States, 70791
        • Novartis Investigative Site
    • Maine
      • Bangor, Maine, United States, 04401
        • Novartis Investigative Site
    • Maryland
      • Columbia, Maryland, United States, 21044
        • Novartis Investigative Site
      • Waldorf, Maryland, United States, 20602
        • Novartis Investigative Site
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Novartis Investigative Site
    • Montana
      • Missoula, Montana, United States, 59804
        • Novartis Investigative Site
    • Nebraska
      • Bellevue, Nebraska, United States, 68123
        • Novartis Investigative Site
      • La Vista, Nebraska, United States, 68128
        • Novartis Investigative Site
      • Omaha, Nebraska, United States, 68131
        • Novartis Investigative Site
      • Omaha, Nebraska, United States, 68134
        • Novartis Investigative Site
    • New York
      • Bronx, New York, United States, 10459
        • Novartis Investigative Site
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Novartis Investigative Site
      • Gastonia, North Carolina, United States, 28054
        • Novartis Investigative Site
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Novartis Investigative Site
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • Novartis Investigative Site
      • Oklahoma City, Oklahoma, United States, 73120
        • Novartis Investigative Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Novartis Investigative Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Novartis Investigative Site
      • Pittsburgh, Pennsylvania, United States, 15221
        • Novartis Investigative Site
      • Pittsburgh, Pennsylvania, United States, 15241
        • Novartis Investigative Site
    • Rhode Island
      • East Providence, Rhode Island, United States, 02941
        • Novartis Investigative Site
    • Texas
      • Boerne, Texas, United States, 78006
        • Novartis Investigative Site
      • Fort Worth, Texas, United States, 76244
        • Novartis Investigative Site
      • McKinney, Texas, United States, 75069
        • Novartis Investigative Site
      • Plano, Texas, United States, 75093
        • Novartis Investigative Site
      • San Antonio, Texas, United States, 78205
        • Novartis Investigative Site
    • Virginia
      • Richmond, Virginia, United States, 23225
        • Novartis Investigative Site
    • Washington
      • Bellingham, Washington, United States, 98225
        • Novartis Investigative Site
      • Spokane, Washington, United States, 99204
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo once daily
Drug: Placebo
One tablet of Placebo once daily
Experimental: QAW039 150mg
QAW039 Dose 1 once daily
Drug: QAW039 150 mg
One tablet of QAW039 150 mg once daily
Experimental: QAW039 450 mg
QAW039 Dose 2 once daily
Drug: QAW039 450 mg
One tablet of QAW039 450 mg once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 52 - Cox Regression Model
Time Frame: 52 weeks
Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs. For this Outcome Measure, AE up to week 52 are reported.
52 weeks
Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 156 - Cox Regression Model
Time Frame: 156 weeks
Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs
156 weeks
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 52 - Cox Regression Model
Time Frame: 52 weeks
Serious Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +30 days were classified as treatment emergent SAEs. For this Outcome Measure, AE up to week 52 are reported.
52 weeks
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 156 - Cox Regression Model
Time Frame: 156 weeks
Serious Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +30 days were classified as treatment emergent SAEs.
156 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
Adverse events leading to study treatment discontinuation starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs leading to study treatment discontinuation. For this Outcome Measure, AE up to week 52 are reported.
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
Adverse events leading to study treatment discontinuation starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs leading to study treatment discontinuation
156 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The number of patients per patient year of follow-up having a treatment emergent adverse event, categorized by system organ class. Treatment emergent adverse events are defined as an AEs starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE)
52 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
The number of patients per patient year of follow-up having a treatment emergent adverse event, categorized by system organ class. Treatment emergent adverse events are defined as an AEs starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE)
156 weeks
Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 52
Time Frame: 52 weeks
The number of treatment emergent patient deaths due to an asthma exacerbation. Treatment emergent deaths are defined as deaths resulting from treatment emergent AEs.
52 weeks
Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 156
Time Frame: 156 weeks
The number of treatment emergent patient deaths due to an asthma exacerbation. Treatment emergent deaths are defined as deaths resulting from treatment emergent AEs.
156 weeks
Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 52
Time Frame: 52 weeks

Number of treatment emergent severe asthma exacerbation episodes requiring hospitalizations (any visit to the hospital requiring an overnight stay or an emergency room visit greater than 24 hours) per person year of follow-up. Treatment emergent severe asthma exacerbation episodes are defined as episodes occurring on or after the day of the first intake of study drug and until the day of last intake of study drug +7 days (30 days in the case of a serious AE).

Rate of exacerbations per person year = total number of exacerbations / total number of treatment years
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 treatment emergent severe asthma exacerbation episodes requiring hospitalizations (any visit to the hospital requiring an overnight stay or an emergency room visit greater than 24 hours) per person year of follow-up. Treatment emergent severe asthma exacerbation episodes are defined as episodes occurring on or after the day of the first intake of study drug and until the day of last intake of study drug +7 days (30 days in the case of a serious AE).

Rate of exacerbations per person year = total number of exacerbations / total number of treatment years
156 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2017

Primary Completion (Actual)

February 19, 2020

Study Completion (Actual)

March 16, 2020

Study Registration Dates

First Submitted

January 23, 2017

First Submitted That Met QC Criteria

February 9, 2017

First Posted (Actual)

February 14, 2017

Study Record Updates

Last Update Posted (Actual)

October 12, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQAW039A2315
  • 2016-001560-11 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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