Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma

NCT01716754 | Completed Phase 2 Results

• 2 other identifiers: CQGE031B22012012-002298-69
• Study Type: interventional
• Target: 471
• Locations: 24 countries
• Sites: 150

Brief Summary

This study assessed the effect on asthma control of different dose levels and regimens of QGE031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2 agonist medication. Safety was assessed also. Comparison was to placebo and omalizumab. Information from this study was planned to support the design of future studies.

Conditions

Asthma

Keywords

asthma; asthma control; allergy; atopic; IgE; double-blind; placebo; omalizumab

Outcome Measures

Primary Outcomes (1)

• Percentage of QGE031 Participants With Clinically Important Improvement of <= -0.5 in the Asthma Control Questionnaire 7 (ACQ-7) Score Compared to Placebo

  The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - \> 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - \< 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7.

  Week 16

Secondary Outcomes (4)

• Change From Baseline in ACQ-7 Score

  Baseline, Weeks 4, 8, 12, 16 and 28

• Percentage of Participants With a Change From Baseline in ACQ-7 Score Less Than -1.1

  Week 16

• Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score

  Baseline, Week 16, Week 28

• Change From Baseline in Mean Number of Puffs of Morning, Evening and Total Daily Asthma Rescue Medication

  Baseline, Week 16

Study Arms (14)

QGE031 240 mg every 2 weeks (q2w)

EXPERIMENTAL

Participants received QGE031 240 mg subcutaneously (s.c.) q2w for 16 weeks.

Drug: QGE031

QGE031 240 mg q4w

EXPERIMENTAL

Participants received QGE031 240 mg s.c. q4w for 16 weeks.

Drug: QGE031

QGE031 180 mg q2w

EXPERIMENTAL

Participants received QGE031 180 mg s.c. q2w for 16 weeks.

Drug: QGE031

QGE031 120 mg q2w

EXPERIMENTAL

Participants received QGE031 120 mg s.c. q2w for 16 weeks.

Drug: QGE031

QGE031 36 mg q2w

EXPERIMENTAL

Participants received QGE031 36 mg s.c. q2w for 16 weeks.

Drug: QGE031

QGE031 12 mg q2w

EXPERIMENTAL

Participants received QGE031 12 mg s.c. q2w for 16 weeks.

Drug: QGE031

Omalizumab (as per locally approved dosing table)

ACTIVE COMPARATOR

Participants received omalizumab as per locally approved dosing table s.c. q2w or q4w for 16 weeks.

Drug: Omalizumab

Placebo to QGE031 240 mg q2w

PLACEBO COMPARATOR

Participants received matching placebo to QGE031 240 mg s.c. q2w for 16 weeks.

Drug: Placebo

Placebo to QGE031 240 mg q4w

PLACEBO COMPARATOR

Participants received placebo to QGE031 240 mg s.c. q2w for 16 weeks.

Drug: Placebo

Placebo to QGE031 180 mg q2w

PLACEBO COMPARATOR

Participants received QGE031 180 mg s.c. q2w for 16 weeks.

Drug: Placebo

Placebo to QGE031 120 mg q2w

PLACEBO COMPARATOR

Participants received QGE031 120 mg s.c. q2w for 16 weeks.

Drug: Placebo

Placebo to QGE031 36 mg q2w

PLACEBO COMPARATOR

Participants received QGE031 36 mg s.c. q2w for 16 weeks.

Drug: Placebo

Placebo to QGE031 12 mg q2w

PLACEBO COMPARATOR

Participants received QGE031 12 mg s.c. q2w for 16 weeks.

Drug: Placebo

Placebo to omalizumab

PLACEBO COMPARATOR

Participants received placebo to omalizumab s.c. q2w or q4w for 16 weeks.

Drug: Placebo

Interventions

QGE031 DRUG

QGE031 was supplied as 120 mg liquid in vial per 1 mL

QGE031 12 mg q2w; QGE031 120 mg q2w; QGE031 180 mg q2w; QGE031 240 mg every 2 weeks (q2w); QGE031 240 mg q4w; QGE031 36 mg q2w

Omalizumab DRUG

Omalizumab was supplied as 150 mg lyophilisate in vial

Also known as: Xolair

Omalizumab (as per locally approved dosing table)

Placebo DRUG

Placebo to QGE031 and Omalizumab was supplied as QGE031 0 mg in vial per 1 mL

Placebo to QGE031 12 mg q2w; Placebo to QGE031 120 mg q2w; Placebo to QGE031 180 mg q2w; Placebo to QGE031 240 mg q2w; Placebo to QGE031 240 mg q4w; Placebo to QGE031 36 mg q2w; Placebo to omalizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of allergic asthma , uncontrolled on current medication.
• History of at least 1 asthma exacerbation during the last 1 year
• Forced Expiratory Volume in one second (FEV1) of ≥ 40% and ≤ 80% of the predicted normal value; reversibility following administration of bronchodilator must also be demonstrated (historical positive reversibility or bronchoprovocation result can be used).

You may not qualify if:

• Baseline IgE levels or body weight outside the omalizumab dosing table.
• Use of tobacco products within the previous 6 months (Social occasional smokers may be included).
• Recent asthma attack/exacerbation or asthma worsening/ respiratory infection.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (150)

Novartis Investigative Site

Fresno, California, 93720, United States

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Hawaiian Gardens, California, 90716, United States

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Riverside, California, 92506, United States

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San Jose, California, 95117, United States

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Vista, California, 92083, United States

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Evansville, Indiana, 47713, United States

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Owensboro, Kentucky, 42301, United States

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Columbia, Maryland, 21044, United States

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Waldorf, Maryland, 20602, United States

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Novi, Michigan, 48375, United States

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Minneapolis, Minnesota, 55402, United States

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Omaha, Nebraska, 68130, United States

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Papillion, Nebraska, 68046, United States

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Brooklyn, New York, 11229, United States

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Mineola, New York, 11501, United States

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Cincinnati, Ohio, 45231, United States

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Lincoln, Rhode Island, 02865, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Summerville, South Carolina, 29485, United States

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Salt Lake City, Utah, 84108, United States

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Fairfax, Virginia, 22030, United States

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Everett, Washington, 98208, United States

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CABA, Buenos Aires, C1122AAK, Argentina

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CABA, Buenos Aires, C1426ABP, Argentina

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Mar del Plata, Buenos Aires, 7600, Argentina

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CABA, Buenos Aires F.D., C1430CKE, 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, S2000CXH, Argentina

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San Miguel de Tucumán, Tucumán Province, 4000, Argentina

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Buenos Aires, B1842DID, Argentina

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Buenos Aires, C1125ABE, Argentina

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Mendoza, M5500CBA, Argentina

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Mendoza, M5500FIK, Argentina

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Santa Fe, S3000FIL, Argentina

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Ottawa, Ontario, K1Y 4G2, Canada

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Montreal, Quebec, H3G 1L5, Canada

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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada

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Québec, G1V 4W2, Canada

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Brno, Czech Republic, 639 00, Czechia

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Trutnov, Czech Republic, 541 01, Czechia

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Teplice, CZE, 415 01, Czechia

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Brno, 615 00, Czechia

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Břeclav, 690 02, Czechia

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Tábor, 390 01, Czechia

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Helsinki, 00290, Finland

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Tampere, 33520, Finland

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Turku, 20521, Finland

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Le Kremlin-Bicêtre, 94275, France

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Marseille, 13915, France

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Montpellier, 34059, France

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Strasbourg, 67091, France

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Frankfurt, 60596, Germany

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Hamburg, 20354, Germany

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Homburg, 66421, Germany

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Leipzig, 04103, Germany

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Leipzig, 04275, Germany

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Mainz, 55131, Germany

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Roth, 91154, Germany

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Rüdersdorf, 15562, Germany

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Guatemala City, GTM, 01010, Guatemala

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Guatemala City, GTM, 01011, Guatemala

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Guatemala City, 01011, Guatemala

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Budapest, 1121, Hungary

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Debrecen, 4032, Hungary

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Pécs, 7635, Hungary

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Törökbálint, 2045, Hungary

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Panjim, Goa, 403 002, India

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Karamsad, Gujarat, 388325, India

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Dhantoli, Nagpur, 12, India

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Haifa, 3436212, Israel

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Jerusalem, 91031, Israel

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Jerusalem, 9112001, Israel

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Kfar Saba, 4428164, Israel

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Petah Tikva, 49100, Israel

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Rehovot, 7610001, Israel

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Messina, ME, 98125, Italy

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Milan, MI, 20123, Italy

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Padua, PD, 35128, Italy

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Pisa, PI, 56124, Italy

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Reggio Emilia, RE, 42123, Italy

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Verona, VR, 37126, Italy

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Guadalajara, Jalisco, 44130, Mexico

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México, D.F., Mexico City, 06700, Mexico

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Panama City, Panama

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Bialystok, 15-276, Poland

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Lodz, 90-153, Poland

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Coimbra, 3041-853, Portugal

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Lisbon, 1169-024, Portugal

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Lisbon, 1749-035, Portugal

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Porto, 4100-180, Portugal

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Vila Nova de Gaia, 4434-502, Portugal

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Bucharest, District 1, 10457, Romania

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Bucharest, District 3, 030303, Romania

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Bucharest, District 3, 030317, Romania

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Constanța, Jud. Constanta, 900002, Romania

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Bucharest, ROM, 12071, Romania

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Brasov, 500086, Romania

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Brasov, 500112, Romania

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Brasov, 500281, Romania

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Bucharest, 011461, Romania

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Bucharest, 050159, Romania

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Cluj-Napoca, 400139, Romania

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Cluj-Napoca, 400371, Romania

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Piteşti, 110114, Romania

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Barnaul, 656045, Russia

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Chelyabinsk, 454000, Russia

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Chelyabinsk, 454021, Russia

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Moscow, 119992, Russia

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Moscow, 125315, Russia

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Moscow, 127018, Russia

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N.Novgorod, 603126, Russia

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Nizhny Novgorod, 603018, Russia

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Penza, 440026, Russia

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Ryazan, 390026, Russia

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Saint Petersburg, 193312, Russia

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Saint Petersburg, 194354, Russia

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Saint Petersburg, 197022, Russia

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Saratov, 410012, Russia

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Yaroslavl, 150003, Russia

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Singapore, 169608, Singapore

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Singapore, 308433, Singapore

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Bratislava, Slovak Republic, 831 03, Slovakia

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Nitra, Slovak Republic, 949 01, Slovakia

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Bardejov, 085 01, Slovakia

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Bratislava, 826 06, Slovakia

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Košice, 04001, Slovakia

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Prievidza, 97101, Slovakia

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Ružomberok, 034 26, Slovakia

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Trenčín, 91101, Slovakia

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Cape Town, 7505, South Africa

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Cape Town, 7531, South Africa

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Durban, 4001, South Africa

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Bucheon-si, Gyeonggi-do, 14584, South Korea

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Suwon, Gyeonggi-do, 16499, South Korea

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Seoul, Korea, 08308, South Korea

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Cheongju-si, North Chungcheong, 28644, South Korea

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Gwangju, 501-757, South Korea

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Seoul, 120-752, South Korea

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Seoul, 156-755, South Korea

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Novartis Investigative Site

Aydin, 09100, Turkey (Türkiye)

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Fatih / Istanbul, 34098, Turkey (Türkiye)

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Istanbul, 34093, Turkey (Türkiye)

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Istanbul, 34854, Turkey (Türkiye)

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Izmir, 35040, Turkey (Türkiye)

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Mersin, 33079, Turkey (Türkiye)

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Bradford, West Yorkshire, BD9 6RJ, United Kingdom

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Birmingham, B9 5SS, United Kingdom

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East Yorkshire, HU16 5JQ, United Kingdom

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Southampton, SO16 6YD, United Kingdom

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MeSH Terms

Conditions

Asthma; Hypersensitivity

Interventions

ligelizumab; Omalizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2012
• First Posted: October 30, 2012
• Study Start: December 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: August 11, 2017
• Results First Posted: March 8, 2017

Record last verified: 2017-08

Locations

RO (13); SG (2); IT (6); HU (4); KR (7); GB (4); FR (4); IN (3); SL (8); IL (6); ME (2); TU (6); ZA (3); US (22); CA (4); AR (13); CZ (6); PA (1); FI (3); DE (8); GU (3); RU (15); PL (2); PT (5)