AsthmaPhase 2NCT02075008

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

A Phase 2 study testing QGE031 in people with Asthma, run by Novartis Pharmaceuticals at 84 sites in 20 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

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

Who is it for?: Ages 18 to 76 years
Conditions the study is for: Asthma
What is being tested?: QGE031
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 270 participants
Where: 84 sitesin 20 countries
Study dates: 27 Mar 2014to 22 Mar 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 76 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

84 sites in 20 countries.

Country

City, postcode or hospital

84 sites in 20 countries

Argentina11 sites

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
San Miguel de Tucumán, Tucumán Province, 4000
Novartis Investigative Site
Santa Fe, Rosario, S2000DBS
Novartis Investigative Site
Santa Fe, S3000FIL

Other trials in Argentina

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

Germany6 sites

Novartis Investigative Site
Frankfurt, 60596
Novartis Investigative Site
Hamburg, 20354
Novartis Investigative Site
Leipzig, 04103
Novartis Investigative Site
Leipzig, 04275
Novartis Investigative Site
Mainz, 55131
Novartis Investigative Site
Rüdersdorf, 15562

Other trials in Germany

Russia6 sites

Novartis Investigative Site
Barnaul, 656045
Novartis Investigative Site
Nizhny Novgorod, 603018
Novartis Investigative Site
Ryazan, 390026
Novartis Investigative Site
Saint Petersburg, 194354
Novartis Investigative Site
Saint Petersburg, 197022
Novartis Investigative Site
Yaroslavl, 150003

Other trials in Russia

Slovakia6 sites

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

Other trials in Slovakia

United States5 sites

Novartis Investigative Site
Evansville, Indiana, 47713
Novartis Investigative Site
Fairfax, Virginia, 22030
Novartis Investigative Site
Minneapolis, Minnesota, 55402
Novartis Investigative Site
Owensboro, Kentucky, 42301
Novartis Investigative Site
Waldorf, Maryland, 20602

Other trials in United States

Czechia5 sites

Novartis Investigative Site
Břeclav, 690 02
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

Israel5 sites

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

Italy5 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
Verona, VR, 37126

Other trials in Italy

Romania5 sites

Novartis Investigative Site
Brasov, 500112
Novartis Investigative Site
Brasov, 500281
Novartis Investigative Site
Bucharest, ROM, 12071
Novartis Investigative Site
Bucharest, 030317
Novartis Investigative Site
Cluj-Napoca, 400371

Other trials in Romania

Turkey (Türkiye)4 sites

Novartis Investigative Site
Istanbul, 34098
Novartis Investigative Site
Istanbul, 34854
Novartis Investigative Site
Izmir, 35040
Novartis Investigative Site
Mersin, 33079

Other trials in Turkey (Türkiye)

Canada3 sites

Novartis Investigative Site
Montreal, Quebec, H3G 1L5
Novartis Investigative Site
Ottawa, Ontario, K1Y 4G2
Novartis Investigative Site
Québec, G1V 4W2

Other trials in Canada

Hungary3 sites

Novartis Investigative Site
Budapest, 1121
Novartis Investigative Site
Pécs, 7635
Novartis Investigative Site
Törökbálint, 2045

Other trials in Hungary

Portugal3 sites

Novartis Investigative Site
Coimbra, 3041-853
Novartis Investigative Site
Lisbon, 1749-035
Novartis Investigative Site
Porto, 4100-180

Other trials in Portugal

Finland2 sites

Novartis Investigative Site
Tampere, 33520
Novartis Investigative Site
Turku, 20521

Other trials in Finland

France2 sites

Novartis Investigative Site
Le Kremlin, 94275
Novartis Investigative Site
Montpellier, 34059

Other trials in France

Poland2 sites

Novartis Investigative Site
Bialystok, 15-276
Novartis Investigative Site
Lodz, 90-153

Other trials in Poland

United Kingdom2 sites

Novartis Investigative Site
Bradford, West Yorkshire, BD9 6RJ
Novartis Investigative Site
Southampton, SO16 6YD

Other trials in United Kingdom

Mexico1 site

Novartis Investigative Site
Guadalajara, Jalisco, 44130

Other trials in Mexico

South Africa1 site

Novartis Investigative Site
Berea, Durban, 4001

Other trials in South Africa

About this study

Official title: An Open-label, Multi-center, Extension Study to Evaluate the Long-term Safety of Subcutaneous 240mg QGE031 Given Every 4 Weeks for 52 Weeks in Allergic Asthma Patients Who Completed Study CQGE031B2201

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

Read the detailed description

This study planned to assess long-term safety and tolerability of QGE031 administered every 4 weeks for an additional 12 months in patients with allergic asthma who previously completed study CQGE031B2201. The study was terminated early due to the efficacy results from an interim analysis of the Phase II study CQGE031B2201.

Conditions: Asthma
Being tested: QGE031
Keywords: asthma, allergic asthma, QGE031, open-label, IgE, long-term safety
Medical subject headings: Asthma

What participants receive

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

QGE031Drug
QGE031 120 mg/mL solution for subcutaneous injection

Study groups in NCT02075008
Study group	Role	What they receive
QGE031 every 4 weeks (q4w)	Experimental	QGE031 240 mg subcutaneously q4w Receives: Drug: QGE031

What is being measured

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

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.
Measured: 52 weeks

Timeline

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

27 Mar 201422 Mar 2016

First posted3 Mar 2014 (estimated)
Study start27 Mar 2014
Primary completion22 Mar 2016
Study completion22 Mar 2016

Why it stopped: The study was prematurely terminated after core study CQGE031B2201 failed to meet the primary objective of demonstrating superiority for QGE031 versus placebo.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 270 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02075008
Sponsor's protocol ID: CQGE031B2201E1
Other IDs: 2013-003683-31
Status last verified: Aug 2017
First submitted: 27 Feb 2014
Last updated: 11 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Multi-center, Extension Study to Evaluate the Long-term Safety of Subcutaneous 240mg QGE031 Given Every 4 Weeks for 52 Weeks in Allergic Asthma Patients Who Completed Study CQGE031B2201
ClinicalTrials.gov ID: NCT02075008
Acronym / sponsor ID: CQGE031B2201E1
Conditions: Asthma
Keywords: asthma, allergic asthma, QGE031, open-label, IgE, long-term safety
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was prematurely terminated after core study CQGE031B2201 failed to meet the primary objective of demonstrating superiority for QGE031 versus placebo.
Enrolment: 270 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 27 Mar 2014 (actual)
Primary completion: 22 Mar 2016 (actual)
Study completion: 22 Mar 2016 (actual)
First posted: 3 Mar 2014 (estimated)
Results: Posted 25 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
QGE031 every 4 weeks (q4w)	Experimental	Drug: QGE031QGE031 240 mg subcutaneously q4w

Who may qualify

Ages: 18 to 76 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
QGE031QGE031 120 mg/mL solution for subcutaneous injection	Drug	QGE031 every 4 weeks (q4w)

Primary outcome

Numbers of Participants With Non-serious Adverse Events (AEs), Serious AEs and Deaths as a Measure of Safety and Tolerability
Time frame: 52 weeks
Safety was monitored throughout the study.

Results and safety

Results posted to the registry on 25 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
QGE031 Every 4 Weeks (q4w)	270	94

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

Time frame: 52 weeks. Count of participants. Unit: Participants

Measure	QGE031 Every 4 Weeks (q4w) n = 270
Non-serious AEs	176
Serious AEs	19
Deaths	1

Population analysed: The safety set, which included all participants, was analyzed.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
QGE031 Every 4 Weeks (q4w)	19 of 270 (7%)	130 of 270 (48.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

84 sites in 20 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing QGE031 in people with Asthma, run by Novartis Pharmaceuticals at 84 sites in 20 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 2 inclusion and 6 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: stopped early, 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 84 sites in Argentina, South Korea, Germany, Russia, Slovakia and 15 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. 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 25 Apr 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?

Numbers of Participants With Non-serious Adverse Events (AEs), Serious AEs and Deaths as a Measure of Safety and Tolerability (time frame: 52 weeks). 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 NCT02075008.

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.