Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.

NCT02563067 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CQAW039A23142015-003172-67
• Study Type: interventional
• Target: 877
• Locations: 19 countries
• Sites: 163

Brief Summary

This study aimed to determine the efficacy and safety of QAW039 and QAW039 450 mg compared to placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2016) in the following two populations:

• patient with inadequately controlled severe asthma and high eosinophil counts (eosinophil count at Visit 1 ≥250 cells/ µl) (sub-population)
• patients with inadequately controlled severe asthma (overall study population) Inadequate control is defined as partly controlled or uncontrolled asthma (GINA 2016)

Conditions

Asthma

Keywords

Asthma; QAW039

Outcome Measures

Primary Outcomes (2)

• Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in High Eosinophils Subpopulation

  A severe asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and hospitalization; or treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and emergency department visit (greater than 24 hours\*); or death due to asthma. A moderate asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days either as an outpatient or in emergency department visits (Emergency department visit less than or equal to 24 hours). The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline.

  52 weeks

• Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in Overall Population

  A severe asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and hospitalization; or treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and emergency department visit (greater than 24 hours\*); or death due to asthma. A moderate asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days either as an outpatient or in emergency department visits (Emergency department visit less than or equal to 24 hours).

  52 weeks

Secondary Outcomes (6)

• Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in High Eosinophils Subpopulation

  Baseline, Week 52

• Change From Baseline to Week 52 in Asthma Control Questionnaire-5 (ACQ-5) Score in High Eosinophils Subpopulation

  Baseline, Week 52

• Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in High Eosinophils Subpopulation

  Baseline, Week 52

• Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in Overall Population

  Baseline, Week 52

• Change From Baseline to Week 52 in Asthma Control Questionnaire-5 (ACQ-5) Score in Overall Population

  Baseline, Week 52

Study Arms (3)

QAW039 150 mg

EXPERIMENTAL

QAW039 150 mg once daily

Drug: QAW039

QAW039 450 mg

EXPERIMENTAL

QAW039 450 mg once daily

Drug: QAW039

Placebo

PLACEBO COMPARATOR

Placebo once daily

Drug: Placebo

Interventions

QAW039 DRUG

QAW039 150 mg once daily

QAW039 150 mg

Placebo DRUG

Placebo once daily

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• Male and female patients aged ≥12 years.
• A diagnosis of severe asthma, uncontrolled on GINA 4/5 asthma medication.
• Evidence of airway reversibility or airway hyper- reactivity.
• FEV1 ≤80% of the predicted normal value for patients aged ≥18 years; FEV1 of ≤90% for patients aged 12 to \<18 years
• An ACQ score ≥1.5
• A history of 2 or more asthma exacerbations within the 12 months prior to entering the study.

You may not qualify if:

• 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 \>20 mg of simvastatin, \> 40 mg of atorvastatin, \>40 mg of pravastatin, or \>2 mg of pitavastatin.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (163)

Novartis Investigative Site

Little Rock, Arkansas, 72209, United States

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San Jose, California, 95117, United States

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Stockton, California, 95207, United States

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Colorado Springs, Colorado, 80907, United States

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Denver, Colorado, 80206, United States

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Winter Park, Florida, 32789, United States

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Overland Park, Kansas, 66210, United States

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Louisville, Kentucky, 40215, United States

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New York, New York, 10016, United States

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The Bronx, New York, 10459, United States

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Edmond, Oklahoma, 73034, United States

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Philadelphia, Pennsylvania, 19115, United States

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Greenville, South Carolina, 29615, United States

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Dallas, Texas, 75230, United States

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Houston, Texas, 77005, United States

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Plano, Texas, 75093, United States

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Richmond, Virginia, 23220, United States

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Richmond, Virginia, 23225, United States

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Berazategui, Buenos Aires, 1888, Argentina

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CABA, Buenos Aires, C1122AAK, Argentina

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CABA, Buenos Aires, C1425BEN, Argentina

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CABA, Buenos Aires, C1426ABP, Argentina

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Lanús, Buenos Aires, B8000XAV, Argentina

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Mar del Plata, Buenos Aires, 7600, Argentina

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Ranelagh, Partido de Berazate, Buenos Aires, 1884, Argentina

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Buenos Aires, Ciudad Autonoma de Bs As, C1425FVH, Argentina

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Santa Rosa, La Pampa Province, 6300, Argentina

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Santa Fe, Rosario, S2000DBS, Argentina

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Rosario, Santa Fe Province, S2000AII, Argentina

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Rosario, Santa Fe Province, S2000BRH, Argentina

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San Miguel de Tucumán, Tucumán Province, 4000, Argentina

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Buenos Aires, C1012AAR, Argentina

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Buenos Aires, C1125ABE, Argentina

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Mendoza, 5500, Argentina

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Mendoza, M5500CBA, Argentina

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Santa Fe, S3000FIL, Argentina

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Vancouver, British Columbia, V5Z 1M9, Canada

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Vancouver BC, British Columbia, V6Z 1Y6, Canada

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Montreal, Quebec, H3G 1L5, Canada

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Montreal, Quebec, H4J 1C5, Canada

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Québec, G1V 4W2, Canada

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Jindřichův Hradec, Czech Republic, 377 01, Czechia

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Teplice, Czech Republic, 415 01, Czechia

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Teplice, CZE, 415 01, Czechia

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Brno, 615 00, Czechia

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Karlovy Vary, 360 17, Czechia

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Mladá Boleslav, 293 50, Czechia

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Plzen-Bory, 305 99, Czechia

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Athens, GR, 115 27, Greece

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Thessaloniki, GR, 570 10, Greece

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Athens, 12462, Greece

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Athens, 175 62, Greece

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Ahmedabad, Gujarat, 380 008, India

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Ahmedabad, Gujarat, 380 060, India

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Bangalore, Karnataka, 560004, India

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Bangalore, Karnataka, 560099, India

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Nagpur, Maharashtra, 440015, India

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Pune, Maharashtra, 411014, India

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Jaipur, Rajasthan, 302001, India

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Jaipur, Rajasthan, 302039, India

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Coimbatore, Tamil Nadu, 641 045, India

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Madurai, Tamil Nadu, 625 020, India

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Hyderabad, Telangana, 500082, India

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Lucknow, Uttar Pradesh, 226006, India

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Haifa, 3525408, Israel

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Jerusalem, 91031, Israel

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Jerusalem, 91120, Israel

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Petah Tikva, 49100, Israel

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Rehovot, 76100, Israel

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Ancona, AN, 60126, Italy

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Acquaviva delle Fonti, BA, 70021, Italy

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Bari, BA, 70124, Italy

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Brescia, BS, 25123, Italy

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Catania, CT, 95125, Italy

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Catanzaro, CZ, 88100, Italy

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Cona, FE, 44100, Italy

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Foggia, FG, 71100, Italy

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Messina, ME, 98125, Italy

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Padua, PD, 35128, Italy

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Pisa, PI, 56124, Italy

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Roma, RM, 00168, Italy

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Cagliari, Sicily, 09042, Italy

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Siena, SI, 53100, Italy

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Torino, TO, 10128, Italy

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Legnago, VR, 37045, Italy

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Verona, VR, 37126, Italy

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Milan, 20100, Italy

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Milan, 20142, Italy

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Reggio Emilia, 42123, Italy

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Salerno, 84100, Italy

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Chikushino-shi, Fukuoka, 818-8502, Japan

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Fukuoka, Fukuoka, 811-1394, Japan

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Kasuga, Fukuoka, 816-0813, Japan

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Hiroshima, Hiroshima, 734-8530, Japan

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Naka-gun, Ibaraki, 319-1113, Japan

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Sakaidechō, Kagawa-ken, 762-8550, Japan

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Takamatsu, Kagawa-ken, 761-8073, Japan

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Kagoshima, Kagoshima-ken, 890 8520, Japan

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Yokohama, Kanagawa, 232 0024, Japan

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Kishiwada, Osaka, 596-8501, Japan

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Hamamatsu, Shizuoka, 431-3192, Japan

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Bunkyo Ku, Tokyo, 113-8431, Japan

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Chuo Ku, Tokyo, 104-0031, Japan

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Setagaya-Ku, Tokyo, 157-0072, Japan

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Shinagawa-ku, Tokyo, 142-8666, Japan

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Toshima Ku, Tokyo, 170 0003, Japan

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El Chouf, LBN, 1503201002, Lebanon

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Beirut, 166378, Lebanon

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El Achrafiyé, 166830, Lebanon

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Kota Bharu, Kelantan, 15586, Malaysia

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Kuantan, Pahang, 25100, Malaysia

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Taiping, Perak, 34000, Malaysia

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Batu Caves, 68100, Malaysia

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Guadalajara, Jalisco, 44130, Mexico

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Guadalajara Jalisco, Jalisco, 44220, Mexico

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Zapopan, Jalisco, 45200, Mexico

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Amsterdam, 1105 AZ, Netherlands

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Arnhem, 6815 AD, Netherlands

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Leeuwarden, 8934 AD, Netherlands

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Leiden, 2333 ZA, Netherlands

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Izhevsk, 426061, Russia

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Moscow, 105077, Russia

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Moscow, 109544, Russia

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Moscow, 115478, Russia

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N.Novgorod, 603126, Russia

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Novosibirsk, 630091, Russia

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Saint Petersburg, 194354, Russia

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Saint Petersburg, 197022, Russia

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Sestroretsk, 197706, Russia

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Stavropol, 355000, Russia

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Yekaterinburg, 620035, Russia

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Belgrade, 11000, Serbia

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Belgrade, 11070, Serbia

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Kragujevac, 34000, Serbia

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Dúbravka, Bratislava Region, 84102, Slovakia

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Bardejov, Slovak Republic, 085 01, Slovakia

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Bojnice, Slovak Republic, 972 01, Slovakia

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Liptovský Hrádok, Slovak Republic, 033 01, Slovakia

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Bratislava, 826 06, Slovakia

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Komárno, 945 01, Slovakia

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Košice, 040 01, Slovakia

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Levice, 934 01, Slovakia

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Spišská Nová Ves, 052 01, Slovakia

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Vyšné Hágy, 5984, Slovakia

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Tygerberg, Cape Town, 7505, South Africa

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Mowbray, 7700, South Africa

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Panorama, 7500, South Africa

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Málaga, Andalusia, 29009, Spain

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Palma de Mallorca, Balearic Islands, 07120, Spain

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Jerez de la Frontera, Cadiz, 11407, Spain

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Barcelona, Catalonia, 08036, Spain

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Sabadell, Catalonia, 08208, Spain

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Lugo, Galicia, 27003, Spain

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Girona, 17005, Spain

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Guadalajara, 19002, Spain

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Las Palmas de Gran Canaria, 35010, Spain

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Madrid, 28041, Spain

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Madrid, 28046, Spain

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Santiago de Compostela, 15706, Spain

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Zaragoza, 50009, Spain

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Taichung, Taiwan ROC, 40201, Taiwan

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Taichung, 40447, Taiwan

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Novartis Investigative Site

Taichung, 40705, Taiwan

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Related Publications (1)

• Brightling CE, Gaga M, Inoue H, Li J, Maspero J, Wenzel S, Maitra S, Lawrence D, Brockhaus F, Lehmann T, Brindicci C, Knorr B, Bleecker ER. Effectiveness of fevipiprant in reducing exacerbations in patients with severe asthma (LUSTER-1 and LUSTER-2): two phase 3 randomised controlled trials. Lancet Respir Med. 2021 Jan;9(1):43-56. doi: 10.1016/S2213-2600(20)30412-4. Epub 2020 Sep 24.

  PMID: 32979986 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

fevipiprant

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: September 29, 2015
• Study Start: December 3, 2015
• Primary Completion: July 4, 2019
• Study Completion: August 2, 2019
• Last Updated: May 3, 2021
• Results First Posted: May 3, 2021

Record last verified: 2021-04

Locations

IT (21); NL (4); TW (3); GR (4); LE (3); ZA (3); JP (16); ME (3); SL (10); CA (5); US (18); AR (18); SE (3); RU (11); IL (5); IN (12); MY (4); ES (13); CZ (7)