AsthmaPhase 2NCT02336425
Efficacy and Safety of QGE031 Compared With Placebo in Patients Aged 18-75 Years With Asthma
A Phase 2 study testing QGE031 in people with Asthma, run by Novartis Pharmaceuticals at 37 sites in 10 countries.
Trial summary
This study planned to assess the effect on the reduction in rate of severe asthma exacerbations of different dose levels of QGE031 in asthma patients that are inadequately controlled with inhaled steroid plus beta-2 agonist medication with or without oral steroid. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 37 sitesin 10 countries
- Study dates
- Sep 2015to 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 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 2 asthma exacerbations 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.
Who cannot join
- 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
37 sites in 10 countries.
37 sites in 10 countries
Japan14 sites
Novartis Investigative Site
Chuo-ku, Tokyo, 103-0027
Novartis Investigative Site
Edogawa-ku, Tokyo, 134-0083
Novartis Investigative Site
Habikino, Osaka, 583-8588
Novartis Investigative Site
Kishiwada, Osaka, 596-8501
Novartis Investigative Site
Ōta-ku, Tokyo, 140-0063
Novartis Investigative Site
Ōta-ku, Tokyo, 143-0023
Novartis Investigative Site
Sagamihara, Kanagawa, 228-8522
Novartis Investigative Site
Sakaidechō, Kagawa-ken, 762-8550
Novartis Investigative Site
Sapporo, Hokkaido, 064-0804
Novartis Investigative Site
Shinagawa-ku, Tokyo, 142-8666
Novartis Investigative Site
tabashi City, Tokyo, 173-8610
Novartis Investigative Site
Toshima-ku, Tokyo, 171-0014
Novartis Investigative Site
Yokohama, Kanagawa, 232-0024
Novartis Investigative Site
Yokohama, Kanagawa, 234-8503
Germany7 sites
Novartis Investigative Site
Berlin, 12099
Novartis Investigative Site
Cottbus, Saxony, 03050
Novartis Investigative Site
Frankfurt, 60596
Novartis Investigative Site
Hamburg, 20354
Novartis Investigative Site
Leipzig, 04103
Novartis Investigative Site
Marburg, 35037
Novartis Investigative Site
Münster, 48145
Slovakia4 sites
Novartis Investigative Site
Bojnice, Slovak Republic, 972 01
Novartis Investigative Site
Liptovský Hrádok, Slovak Republic, 033 01
Novartis Investigative Site
Nitra, Slovak Republic, 949 01
Novartis Investigative Site
Zvolen, 960 01
United States3 sites
Novartis Investigative Site
Birmingham, Alabama, 35209
Novartis Investigative Site
Kingwood, Texas, 77339
Novartis Investigative Site
Plano, Texas, 75093
Canada2 sites
Novartis Investigative Site
Toronto, Ontario, M5T 3A9
Novartis Investigative Site
Trois-Rivières, Quebec, G8T 7A1
Hungary2 sites
Novartis Investigative Site
Balassagyarmat, 2660
Novartis Investigative Site
Miskolc, HUN, 3529
Netherlands2 sites
Novartis Investigative Site
Harderwijk, 3840 AC
Novartis Investigative Site
Leiden, 2333 ZA
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Placebo- Controlled Study to Investigate the Efficacy and Safety of 52 Weeks Treatment With QGE031 Subcutaneous (s.c). in Asthma Patients Not Adequately Controlled by Medium- or High-dose Inhaled Corticosteroid (ICS) Plus Long Acting β2-agonist (LABA) With or Without Oral Corticosteroid (OCS)
This study planned to assess the effect on the reduction in rate of severe asthma exacerbations of different dose levels of QGE031 in asthma patients that are inadequately controlled with inhaled steroid plus beta-2 agonist medication with or without oral steroid. However, this study was terminated due to the efficacy results from an interim analysis (at the end of treatment epoch) of the Phase II study CQGE031B2201 (NCT01716754). Planned data analyses were not performed for this study due to the early termination and the very limited dataset (only 10 participants received study medication of the 440 participants planned).
- Conditions
- Asthma
- Being tested
- QGE031, Placebo
- Keywords
- Asthma
- 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 per 1 mL liquid in vial
PlaceboDrug
Placebo to QGE031 0 mg per 1 mL liquid in vial
| Study group | Role | What they receive |
|---|---|---|
| QGE031 240 mg | Experimental | QGE031 240 mg subcutaneous injection every 4 weeks Receives: Drug: QGE031 |
| QGE031 72 mg | Experimental | QGE031 72 mg subcutaneous injection every 4 weeks Receives: Drug: QGE031 |
| QGE031 24 mg | Experimental | QGE031 24 mg subcutaneous injection every 4 weeks Receives: Drug: QGE031 |
| Placebo to QGE031 | Placebo comparator | Placebo subcutaneous injection every 4 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
QGE031 Compared to Placebo in Atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations
Measured: Week 52
Secondary outcomes (10)
QGE031 Compared to Placebo in All Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations
Measured: Week 52
QGE031 Compared to Placebo in Non-atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations
Measured: Week 52
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on the Reduction in Rate of Asthma Exacerbations (by Severity)
Measured: Week 52
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Time to First Asthma Exacerbations (by Severity)
Measured: Week 52
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Change From Baseline in Asthma Control Questionnaire (ACQ)
Measured: Baseline, Treatment (Weeks 4, 8, 12, 16, 24, 36, 52), follow up (Weeks 60 and 72)
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Change From Baseline in Asthma Control Diary (ACD)
Measured: Over 52 weeks (Treatment) and 20 weeks (follow-up)
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Forced Expiratory Volume in 1 Second (FEV1)
Measured: Baseline, Treatment (Weeks 4, 8, 12, 16, 24, 36, 52), follow up (Weeks 60 and 72)
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Peak Expiratory Flow (PEF) in the Morning and Evening
Measured: Over 52 weeks (Treatment) and 20 weeks (follow-up)
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Total Daily Symptom Score
Measured: Over 52 weeks (Treatment) and 20 weeks (follow-up)
Response to QGE031 Between Atopic Asthma and Non-atopic Asthma
Measured: Over 52 weeks (treatment) and 20 weeks (follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: This study was terminated due to the efficacy results from an interim analysis (at the end of treatment epoch) of the Phase II study CQGE031B2201 (NCT01716754).
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336425
- Sponsor's protocol ID
- CQGE031B2204
- Other IDs
- 2014-003155-57, 2014
- Status last verified
- Aug 2017
- First submitted
- 8 Jan 2015
- Last updated
- 11 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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
- A Multi-Center, Randomized, Double-Blind, Placebo- Controlled Study to Investigate the Efficacy and Safety of 52 Weeks Treatment With QGE031 Subcutaneous (s.c). in Asthma Patients Not Adequately Controlled by Medium- or High-dose Inhaled Corticosteroid (ICS) Plus Long Acting β2-agonist (LABA) With or Without Oral Corticosteroid (OCS)
- ClinicalTrials.gov ID
- NCT02336425
- Acronym / sponsor ID
- CQGE031B2204
- Conditions
- Asthma
- Keywords
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated due to the efficacy results from an interim analysis (at the end of treatment epoch) of the Phase II study CQGE031B2201 (NCT01716754).
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 13 Jan 2015 (estimated)
- Results
- Posted 7 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 the effect on the reduction in rate of severe asthma exacerbations of different dose levels of QGE031 in asthma patients that are inadequately controlled with inhaled steroid plus beta-2 agonist medication with or without oral steroid. However, this study was terminated due to the efficacy results from an interim analysis (at the end of treatment epoch) of the Phase II study CQGE031B2201 (NCT01716754). Planned data analyses were not performed for this study due to the early termination and the very limited dataset (only 10 participants received study medication of the 440 participants planned).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| QGE031 240 mg | Experimental | Drug: QGE031QGE031 240 mg subcutaneous injection every 4 weeks |
| QGE031 72 mg | Experimental | Drug: QGE031QGE031 72 mg subcutaneous injection every 4 weeks |
| QGE031 24 mg | Experimental | Drug: QGE031QGE031 24 mg subcutaneous injection every 4 weeks |
| Placebo to QGE031 | Placebo comparator | Drug: PlaceboPlacebo subcutaneous injection every 4 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A diagnosis of allergic asthma, uncontrolled on current medication.
- History of at least 2 asthma exacerbations 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.
Key exclusion criteria (2 listed)
- Use of tobacco products within the previous 6 months (Social occasional smokers may be included).
- Recent asthma attack/exacerbation or asthma worsening/ respiratory infection.
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 per 1 mL liquid in vial | Drug | QGE031 24 mg, QGE031 240 mg, QGE031 72 mg |
| PlaceboPlacebo to QGE031 0 mg per 1 mL liquid in vial | Drug | Placebo to QGE031 |
Primary outcome
QGE031 Compared to Placebo in Atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations
Time frame: Week 52
10 secondary outcomes
QGE031 Compared to Placebo in All Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations
Time frame: Week 52
QGE031 Compared to Placebo in Non-atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations
Time frame: Week 52
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on the Reduction in Rate of Asthma Exacerbations (by Severity)
Time frame: Week 52
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Time to First Asthma Exacerbations (by Severity)
Time frame: Week 52
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Change From Baseline in Asthma Control Questionnaire (ACQ)
Time frame: Baseline, Treatment (Weeks 4, 8, 12, 16, 24, 36, 52), follow up (Weeks 60 and 72)
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Change From Baseline in Asthma Control Diary (ACD)
Time frame: Over 52 weeks (Treatment) and 20 weeks (follow-up)
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline, Treatment (Weeks 4, 8, 12, 16, 24, 36, 52), follow up (Weeks 60 and 72)
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Peak Expiratory Flow (PEF) in the Morning and Evening
Time frame: Over 52 weeks (Treatment) and 20 weeks (follow-up)
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Total Daily Symptom Score
Time frame: Over 52 weeks (Treatment) and 20 weeks (follow-up)
Response to QGE031 Between Atopic Asthma and Non-atopic Asthma
Time frame: Over 52 weeks (treatment) and 20 weeks (follow up)
Results and safety
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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
37 sites in 10 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 37 sites in 10 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 2 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 37 sites in Japan, Germany, Slovakia, United States, Canada and 5 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 7 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?
QGE031 Compared to Placebo in Atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations (time frame: Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.