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AsthmaPhase 2NCT01716754

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

A Phase 2 study testing QGE031 and Omalizumab in people with Asthma, run by Novartis Pharmaceuticals at 150 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Asthma
What is being tested?
QGE031 and Omalizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
471 participants
Where
150 sitesin 24 countries
Study dates
Dec 2012to Jan 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

150 sites in 24 countries.

150 sites in 24 countries

United States22 sites

  • Novartis Investigative Site

    Brooklyn, New York, 11229

  • Novartis Investigative Site

    Cincinnati, Ohio, 45231

  • Novartis Investigative Site

    Columbia, Maryland, 21044

  • Novartis Investigative Site

    Evansville, Indiana, 47713

  • Novartis Investigative Site

    Everett, Washington, 98208

  • Novartis Investigative Site

    Fairfax, Virginia, 22030

  • Novartis Investigative Site

    Fresno, California, 93720

  • Novartis Investigative Site

    Hawaiian Gardens, California, 90716

  • Novartis Investigative Site

    Lincoln, Rhode Island, 02865

  • Novartis Investigative Site

    Mineola, New York, 11501

  • Novartis Investigative Site

    Minneapolis, Minnesota, 55402

  • Novartis Investigative Site

    Mt. Pleasant, South Carolina, 29464

  • Novartis Investigative Site

    Novi, Michigan, 48375

  • Novartis Investigative Site

    Omaha, Nebraska, 68130

  • Novartis Investigative Site

    Owensboro, Kentucky, 42301

  • Novartis Investigative Site

    Papillion, Nebraska, 68046

  • Novartis Investigative Site

    Riverside, California, 92506

  • Novartis Investigative Site

    Salt Lake City, Utah, 84108

  • Novartis Investigative Site

    San Jose, California, 95117

  • Novartis Investigative Site

    Summerville, South Carolina, 29485

  • Novartis Investigative Site

    Vista, California, 92083

  • Novartis Investigative Site

    Waldorf, Maryland, 20602

Other trials in United States

Russia15 sites

  • Novartis Investigative Site

    Barnaul, 656045

  • Novartis Investigative Site

    Chelyabinsk, 454000

  • Novartis Investigative Site

    Chelyabinsk, 454021

  • Novartis Investigative Site

    Moscow, 119992

  • Novartis Investigative Site

    Moscow, 125315

  • Novartis Investigative Site

    Moscow, 127018

  • Novartis Investigative Site

    N.Novgorod, 603126

  • Novartis Investigative Site

    Nizhny Novgorod, 603018

  • Novartis Investigative Site

    Penza, 440026

  • Novartis Investigative Site

    Ryazan, 390026

  • Novartis Investigative Site

    Saint Petersburg, 193312

  • Novartis Investigative Site

    Saint Petersburg, 194354

  • Novartis Investigative Site

    Saint Petersburg, 197022

  • Novartis Investigative Site

    Saratov, 410012

  • Novartis Investigative Site

    Yaroslavl, 150003

Other trials in Russia

Argentina13 sites

  • Novartis Investigative Site

    Buenos Aires, B1842DID

  • Novartis Investigative Site

    Buenos Aires, C1125ABE

  • Novartis Investigative Site

    CABA, Buenos Aires, C1122AAK

  • Novartis Investigative Site

    CABA, Buenos Aires, C1426ABP

  • Novartis Investigative Site

    CABA, Buenos Aires F.D., C1430CKE

  • Novartis Investigative Site

    Mar del Plata, Buenos Aires, 7600

  • Novartis Investigative Site

    Mendoza, M5500CBA

  • Novartis Investigative Site

    Mendoza, M5500FIK

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000AII

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000CXH

  • Novartis Investigative Site

    San Miguel de Tucumán, Tucumán Province, 4000

  • Novartis Investigative Site

    Santa Fe, Rosario, S2000DBS

  • Novartis Investigative Site

    Santa Fe, S3000FIL

Other trials in Argentina

Romania13 sites

  • Novartis Investigative Site

    Brasov, 500086

  • Novartis Investigative Site

    Brasov, 500112

  • Novartis Investigative Site

    Brasov, 500281

  • Novartis Investigative Site

    Bucharest, District 1, 10457

  • Novartis Investigative Site

    Bucharest, District 3, 030303

  • Novartis Investigative Site

    Bucharest, District 3, 030317

  • Novartis Investigative Site

    Bucharest, ROM, 12071

  • Novartis Investigative Site

    Bucharest, 011461

  • Novartis Investigative Site

    Bucharest, 050159

  • Novartis Investigative Site

    Cluj-Napoca, 400139

  • Novartis Investigative Site

    Cluj-Napoca, 400371

  • Novartis Investigative Site

    Constanța, Jud. Constanta, 900002

  • Novartis Investigative Site

    Piteşti, 110114

Other trials in Romania

Germany8 sites

  • Novartis Investigative Site

    Frankfurt, 60596

  • Novartis Investigative Site

    Hamburg, 20354

  • Novartis Investigative Site

    Homburg, 66421

  • Novartis Investigative Site

    Leipzig, 04103

  • Novartis Investigative Site

    Leipzig, 04275

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    Roth, 91154

  • Novartis Investigative Site

    Rüdersdorf, 15562

Other trials in Germany

Slovakia8 sites

  • Novartis Investigative Site

    Bardejov, 085 01

  • Novartis Investigative Site

    Bratislava, Slovak Republic, 831 03

  • Novartis Investigative Site

    Bratislava, 826 06

  • Novartis Investigative Site

    Košice, 04001

  • Novartis Investigative Site

    Nitra, Slovak Republic, 949 01

  • Novartis Investigative Site

    Prievidza, 97101

  • Novartis Investigative Site

    Ružomberok, 034 26

  • Novartis Investigative Site

    Trenčín, 91101

Other trials in Slovakia

South Korea7 sites

  • Novartis Investigative Site

    Bucheon-si, Gyeonggi-do, 14584

  • Novartis Investigative Site

    Cheongju-si, North Chungcheong, 28644

  • Novartis Investigative Site

    Gwangju, 501-757

  • Novartis Investigative Site

    Seoul, Korea, 08308

  • Novartis Investigative Site

    Seoul, 120-752

  • Novartis Investigative Site

    Seoul, 156-755

  • Novartis Investigative Site

    Suwon, Gyeonggi-do, 16499

Other trials in South Korea

Czechia6 sites

  • Novartis Investigative Site

    Břeclav, 690 02

  • Novartis Investigative Site

    Brno, Czech Republic, 639 00

  • Novartis Investigative Site

    Brno, 615 00

  • Novartis Investigative Site

    Tábor, 390 01

  • Novartis Investigative Site

    Teplice, CZE, 415 01

  • Novartis Investigative Site

    Trutnov, Czech Republic, 541 01

Other trials in Czechia

Israel6 sites

  • Novartis Investigative Site

    Haifa, 3436212

  • Novartis Investigative Site

    Jerusalem, 91031

  • Novartis Investigative Site

    Jerusalem, 9112001

  • Novartis Investigative Site

    Kfar Saba, 4428164

  • Novartis Investigative Site

    Petah Tikva, 49100

  • Novartis Investigative Site

    Rehovot, 7610001

Other trials in Israel

Italy6 sites

  • Novartis Investigative Site

    Messina, ME, 98125

  • Novartis Investigative Site

    Milan, MI, 20123

  • Novartis Investigative Site

    Padova, PD, 35128

  • Novartis Investigative Site

    Pisa, PI, 56124

  • Novartis Investigative Site

    Reggio Emilia, RE, 42123

  • Novartis Investigative Site

    Verona, VR, 37126

Other trials in Italy

Turkey (Türkiye)6 sites

  • Novartis Investigative Site

    Aydin, 09100

  • Novartis Investigative Site

    Fatih / Istanbul, 34098

  • Novartis Investigative Site

    Istanbul, 34093

  • Novartis Investigative Site

    Istanbul, 34854

  • Novartis Investigative Site

    Izmir, 35040

  • Novartis Investigative Site

    Mersin, 33079

Other trials in Turkey (Türkiye)

Portugal5 sites

  • Novartis Investigative Site

    Coimbra, 3041-853

  • Novartis Investigative Site

    Lisbon, 1169-024

  • Novartis Investigative Site

    Lisbon, 1749-035

  • Novartis Investigative Site

    Porto, 4100-180

  • Novartis Investigative Site

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Canada4 sites

  • Novartis Investigative Site

    Montreal, Quebec, H3G 1L5

  • Novartis Investigative Site

    Ottawa, Ontario, K1Y 4G2

  • Novartis Investigative Site

    Québec, G1V 4W2

  • Novartis Investigative Site

    Saint-Charles-Borromée, Quebec, J6E 2B4

Other trials in Canada

France4 sites

  • Novartis Investigative Site

    Le Kremlin-Bicêtre, 94275

  • Novartis Investigative Site

    Marseille, 13915

  • Novartis Investigative Site

    Montpellier, 34059

  • Novartis Investigative Site

    Strasbourg, 67091

Other trials in France

Hungary4 sites

  • Novartis Investigative Site

    Budapest, 1121

  • Novartis Investigative Site

    Debrecen, 4032

  • Novartis Investigative Site

    Pécs, 7635

  • Novartis Investigative Site

    Törökbálint, 2045

Other trials in Hungary

United Kingdom4 sites

  • Novartis Investigative Site

    Birmingham, B9 5SS

  • Novartis Investigative Site

    Bradford, West Yorkshire, BD9 6RJ

  • Novartis Investigative Site

    East Yorkshire, HU16 5JQ

  • Novartis Investigative Site

    Southampton, SO16 6YD

Other trials in United Kingdom

Finland3 sites

  • Novartis Investigative Site

    Helsinki, 00290

  • Novartis Investigative Site

    Tampere, 33520

  • Novartis Investigative Site

    Turku, 20521

Other trials in Finland

Guatemala3 sites

  • Novartis Investigative Site

    Guatemala City, GTM, 01010

  • Novartis Investigative Site

    Guatemala City, GTM, 01011

  • Novartis Investigative Site

    Guatemala City, 01011

Other trials in Guatemala

India3 sites

  • Novartis Investigative Site

    Dhantoli, Nagpur, 12

  • Novartis Investigative Site

    Karamsad, Gujarat, 388325

  • Novartis Investigative Site

    Panjim, Goa, 403 002

Other trials in India

South Africa3 sites

  • Novartis Investigative Site

    Cape Town, 7505

  • Novartis Investigative Site

    Cape Town, 7531

  • Novartis Investigative Site

    Durban, 4001

Other trials in South Africa

Mexico2 sites

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44130

  • Novartis Investigative Site

    México, D.F., Mexico City, 06700

Other trials in Mexico

Poland2 sites

  • Novartis Investigative Site

    Bialystok, 15-276

  • Novartis Investigative Site

    Lodz, 90-153

Other trials in Poland

Singapore2 sites

  • Novartis Investigative Site

    Singapore, 169608

  • Novartis Investigative Site

    Singapore, 308433

Other trials in Singapore

Panama1 site

  • Novartis Investigative Site

    Panama City

Other trials in Panama

About this study

Official title: A Multi-center, Randomized, Double-blind, Placebo and Active-controlled Study With Exploratory Dose-ranging to Investigate the Efficacy and Safety of 16 Weeks Treatment With Subcutaneous (s.c.) QGE031 in Asthma Patients Not Adequately Controlled With High-dose Inhaled Corticosteroids and Long Acting β2-agonists

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
Being tested
QGE031, Omalizumab, Placebo
Keywords
asthma, asthma control, allergy, atopic, IgE, double-blind, placebo, omalizumab
Medical subject headings
Asthma, Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QGE031Drug

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

  • OmalizumabDrug

    Also called Xolair

    Omalizumab was supplied as 150 mg lyophilisate in vial

  • PlaceboDrug

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

Study groups in NCT01716754
Study groupRoleWhat they receive
QGE031 240 mg every 2 weeks (q2w)ExperimentalParticipants received QGE031 240 mg subcutaneously (s.c.) q2w for 16 weeks.
Receives: Drug: QGE031
QGE031 240 mg q4wExperimentalParticipants received QGE031 240 mg s.c. q4w for 16 weeks.
Receives: Drug: QGE031
QGE031 180 mg q2wExperimentalParticipants received QGE031 180 mg s.c. q2w for 16 weeks.
Receives: Drug: QGE031
QGE031 120 mg q2wExperimentalParticipants received QGE031 120 mg s.c. q2w for 16 weeks.
Receives: Drug: QGE031
QGE031 36 mg q2wExperimentalParticipants received QGE031 36 mg s.c. q2w for 16 weeks.
Receives: Drug: QGE031
QGE031 12 mg q2wExperimentalParticipants received QGE031 12 mg s.c. q2w for 16 weeks.
Receives: Drug: QGE031
Omalizumab (as per locally approved dosing table)Active comparatorParticipants received omalizumab as per locally approved dosing table s.c. q2w or q4w for 16 weeks.
Receives: Drug: Omalizumab
Placebo to QGE031 240 mg q2wPlacebo comparatorParticipants received matching placebo to QGE031 240 mg s.c. q2w for 16 weeks.
Receives: Drug: Placebo
Placebo to QGE031 240 mg q4wPlacebo comparatorParticipants received placebo to QGE031 240 mg s.c. q2w for 16 weeks.
Receives: Drug: Placebo
Placebo to QGE031 180 mg q2wPlacebo comparatorParticipants received QGE031 180 mg s.c. q2w for 16 weeks.
Receives: Drug: Placebo
Placebo to QGE031 120 mg q2wPlacebo comparatorParticipants received QGE031 120 mg s.c. q2w for 16 weeks.
Receives: Drug: Placebo
Placebo to QGE031 36 mg q2wPlacebo comparatorParticipants received QGE031 36 mg s.c. q2w for 16 weeks.
Receives: Drug: Placebo
Placebo to QGE031 12 mg q2wPlacebo comparatorParticipants received QGE031 12 mg s.c. q2w for 16 weeks.
Receives: Drug: Placebo
Placebo to omalizumabPlacebo comparatorParticipants received placebo to omalizumab s.c. q2w or q4w for 16 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 16

Secondary outcomes (4)

  1. Change From Baseline in ACQ-7 Score

    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. A negative change from baseline indicates improvement.

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

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

    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.

    Measured: Week 16

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

    The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to participants with asthma. The 32 items in the AQLQ were divided into four domain-specific scores and a total score as follows: Activity limitations = Mean of Items 1, 2, 3, 4, 5, 11, 19, 25, 28, 31, 32 (11 items); Symptoms = Mean of Items 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 29, 30 (12 items); Emotional function = Mean of Items 7, 13, 15, 21, 27 (5 items); Environmental stimuli = Mean of Items 9, 17, 23, 26 (4 items); and Overall Score = Mean of Items 1 to 32 (32 items). Each item of the AQLQ was equally weighted and scored along a 7-point scale, where 1 indicates maximal impairment and 7 indicates no impairment. Thus, higher scores indicate better asthma-related quality of life. The mean overall score ranged from 1 to 7. A positive change from baseline indicates improvement.

    Measured: Baseline, Week 16, Week 28

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

    Participants recorded their use of rescue medication into an electronic diary (eDiary). A negative change from baseline indicates improvement.

    Measured: Baseline, Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
471 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01716754
Sponsor's protocol ID
CQGE031B2201
Other IDs
2012-002298-69
Status last verified
Aug 2017
First submitted
19 Oct 2012
Last updated
11 Aug 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing QGE031 and Omalizumab in people with Asthma, run by Novartis Pharmaceuticals at 150 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 150 sites in United States, Russia, Argentina, Romania, Germany and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of QGE031 Participants With Clinically Important Improvement of <= -0.5 in the Asthma Control Questionnaire 7 (ACQ-7) Score Compared to Placebo (time frame: Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01716754.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2017.

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