Long-term Safety Study of QGE031 in Patients With Allergic Asthma Who Completed Study CQGE031B2201

NCT02075008 | Terminated Phase 2 Results

• 2 other identifiers: CQGE031B2201E12013-003683-31
• Study Type: interventional
• Target: 270
• Locations: 20 countries
• Sites: 84

Brief Summary

This study planned to assess long-term safety of QGE031 during 12 months treatment in asthma patients who completed study CQGE031B2201.

Conditions

Asthma

Keywords

asthma; allergic asthma; QGE031; open-label; IgE; long-term safety

Outcome Measures

Primary Outcomes (1)

• Numbers of Participants With Non-serious Adverse Events (AEs), Serious AEs and Deaths as a Measure of Safety and Tolerability

  Safety was monitored throughout the study.

  52 weeks

Study Arms (1)

QGE031 every 4 weeks (q4w)

EXPERIMENTAL

QGE031 240 mg subcutaneously q4w

Drug: QGE031

Interventions

QGE031 DRUG

QGE031 120 mg/mL solution for subcutaneous injection

QGE031 every 4 weeks (q4w)

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• forced Expiratory Volume in one second ( FEV1) \>= 40% predicted
• patients who completed CQGE031B2201 study

You may not qualify if:

• life-threatening asthma attack, intubation, respiratory arrest during or after completion of CQGE031B2201 study
• new malignancy
• ongoing SAE from CQGE031B2201 that was assessed as related to study drug
• patient experienced platelets drop to \< 75,000/uL
• patient experienced one unexpected grade 4 or two unexpected grade 3 hypersensitivity reactions
• patient is pregnant

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (84)

Novartis Investigative Site

Evansville, Indiana, 47713, United States

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Novartis Investigative Site

Owensboro, Kentucky, 42301, United States

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Novartis Investigative Site

Waldorf, Maryland, 20602, United States

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Novartis Investigative Site

Minneapolis, Minnesota, 55402, United States

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Novartis Investigative Site

Fairfax, Virginia, 22030, United States

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Novartis Investigative Site

CABA, Buenos Aires, C1122AAK, Argentina

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Novartis Investigative Site

CABA, Buenos Aires, C1426ABP, Argentina

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Novartis Investigative Site

Mar del Plata, Buenos Aires, 7600, Argentina

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Novartis Investigative Site

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

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Novartis Investigative Site

Santa Fe, Rosario, S2000DBS, Argentina

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Novartis Investigative Site

Rosario, Santa Fe Province, S2000AII, Argentina

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Novartis Investigative Site

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

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Novartis Investigative Site

Buenos Aires, C1125ABE, Argentina

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Novartis Investigative Site

Mendoza, M5500CBA, Argentina

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Novartis Investigative Site

Mendoza, M5500FIK, Argentina

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Novartis Investigative Site

Santa Fe, S3000FIL, Argentina

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Novartis Investigative Site

Ottawa, Ontario, K1Y 4G2, Canada

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Novartis Investigative Site

Montreal, Quebec, H3G 1L5, Canada

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Novartis Investigative Site

Québec, G1V 4W2, Canada

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Novartis Investigative Site

Trutnov, Czech Republic, 541 01, Czechia

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Novartis Investigative Site

Teplice, CZE, 415 01, Czechia

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Novartis Investigative Site

Brno, 615 00, Czechia

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Novartis Investigative Site

Břeclav, 690 02, Czechia

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Novartis Investigative Site

Tábor, 390 01, Czechia

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Novartis Investigative Site

Tampere, 33520, Finland

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Novartis Investigative Site

Turku, 20521, Finland

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Novartis Investigative Site

Le Kremlin, 94275, France

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Novartis Investigative Site

Montpellier, 34059, France

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Novartis Investigative Site

Frankfurt, 60596, Germany

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Novartis Investigative Site

Hamburg, 20354, Germany

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Novartis Investigative Site

Leipzig, 04103, Germany

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Novartis Investigative Site

Leipzig, 04275, Germany

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Novartis Investigative Site

Mainz, 55131, Germany

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Novartis Investigative Site

Rüdersdorf, 15562, Germany

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Novartis Investigative Site

Budapest, 1121, Hungary

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Novartis Investigative Site

Pécs, 7635, Hungary

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Novartis Investigative Site

Törökbálint, 2045, Hungary

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Novartis Investigative Site

Jerusalem, 91031, Israel

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Novartis Investigative Site

Jerusalem, 9112001, Israel

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Novartis Investigative Site

Kfar Saba, 4428164, Israel

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Novartis Investigative Site

Petah Tikva, 49100, Israel

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Novartis Investigative Site

Rehovot, 7610001, Israel

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Novartis Investigative Site

Messina, ME, 98125, Italy

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Novartis Investigative Site

Milan, MI, 20123, Italy

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Novartis Investigative Site

Padua, PD, 35128, Italy

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Novartis Investigative Site

Pisa, PI, 56124, Italy

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Novartis Investigative Site

Verona, VR, 37126, Italy

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Novartis Investigative Site

Guadalajara, Jalisco, 44130, Mexico

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Novartis Investigative Site

Bialystok, 15-276, Poland

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Novartis Investigative Site

Lodz, 90-153, Poland

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Novartis Investigative Site

Coimbra, 3041-853, Portugal

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Novartis Investigative Site

Lisbon, 1749-035, Portugal

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Novartis Investigative Site

Porto, 4100-180, Portugal

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Novartis Investigative Site

Bucharest, ROM, 12071, Romania

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Novartis Investigative Site

Brasov, 500112, Romania

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Novartis Investigative Site

Brasov, 500281, Romania

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Novartis Investigative Site

Bucharest, 030317, Romania

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Novartis Investigative Site

Cluj-Napoca, 400371, Romania

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Novartis Investigative Site

Barnaul, 656045, Russia

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Novartis Investigative Site

Nizhny Novgorod, 603018, Russia

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Novartis Investigative Site

Ryazan, 390026, Russia

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Novartis Investigative Site

Saint Petersburg, 194354, Russia

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Novartis Investigative Site

Saint Petersburg, 197022, Russia

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Novartis Investigative Site

Yaroslavl, 150003, Russia

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Novartis Investigative Site

Bratislava, Slovak Republic, 831 03, Slovakia

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Novartis Investigative Site

Nitra, Slovak Republic, 949 01, Slovakia

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Novartis Investigative Site

Bratislava, 826 06, Slovakia

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Novartis Investigative Site

Košice, 04001, Slovakia

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Novartis Investigative Site

Prievidza, 97101, Slovakia

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Novartis Investigative Site

Ružomberok, 034 26, Slovakia

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Novartis Investigative Site

Berea, Durban, 4001, South Africa

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Novartis Investigative Site

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

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Novartis Investigative Site

Suwon, Gyeonggi-do, 16499, South Korea

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Novartis Investigative Site

Seoul, Korea, 08308, South Korea

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Novartis Investigative Site

Cheongju-si, North Chungcheong, 28644, South Korea

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Novartis Investigative Site

Gwangju, 501-757, South Korea

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Novartis Investigative Site

Seoul, 120-752, South Korea

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Novartis Investigative Site

Seoul, 156-755, South Korea

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Novartis Investigative Site

Istanbul, 34098, Turkey (Türkiye)

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Novartis Investigative Site

Istanbul, 34854, Turkey (Türkiye)

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Novartis Investigative Site

Izmir, 35040, Turkey (Türkiye)

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Novartis Investigative Site

Mersin, 33079, Turkey (Türkiye)

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Novartis Investigative Site

Bradford, West Yorkshire, BD9 6RJ, United Kingdom

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Novartis Investigative Site

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Interventions

ligelizumab

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

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: March 3, 2014
• Study Start: March 27, 2014
• Primary Completion: March 22, 2016
• Study Completion: March 22, 2016
• Last Updated: August 11, 2017
• Results First Posted: April 25, 2017

Record last verified: 2017-08

Locations

ZA (1); HU (3); DE (6); ME (1); SL (6); RU (6); IL (5); RO (5); CA (3); PL (2); PT (3); CZ (5); TU (4); AR (11); FR (2); IT (5); KR (7); GB (2); US (5); FI (2)