Allergic AsthmaPhase 1/2NCT01703312
A Study Evaluating the Efficacy of QGE031 Compared to Omalizumab in Patients With Allergic Asthma
A Phase 1/2 study testing QGE031 and omalizumab in people with Allergic Asthma, run by Novartis Pharmaceuticals at 7 sites in 2 countries.
Trial summary
This study will evaluate the efficacy of QGE031 compared to omalizumab in patients with allergic asthma. Each treatment's effect in changing the concentration of inhaled allergen that is required to elicit a 15% fall in the forced expiratory volume in one second (FEV1) at 12 weeks compared to baseline will be… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic 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
- 37 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Nov 2012to Oct 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients 18 to 65 years
- Positive skin prick test to one or more common airborne allergens
- Presence of airway hyperresponsiveness documented by a provocative concentration of methacholine causing a 20% fall in FEV1 (PC20 FEV1) of less than or equal to 16 mg/mL
- Presence of an early asthmatic response demonstrated by an allergen challenge at screening and including a 15% fall in the FEV1
- Patients with a body weight and total IgE in a range specified by local country prescribing information for omalizumab
Who cannot join
- Pregnant or nursing (lactating) women
- Women of child-bearing potential unless they are using a highly effective method of birth control (as further defined in the study protocol)
- Smokers
- Patients with poorly controlled asthma or patients who have had an asthma exacerbation within the past year
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Canada6 sites
Novartis Investigative Site
Calgary, Alberta, T2N 4N1
Novartis Investigative Site
Edmonton, Alberta, T6G 2B7
Novartis Investigative Site
Hamilton, Ontario, L8N 3Z5
Novartis Investigative Site
Saskatoon, Saskatchewan, S7N 0W8
Novartis Investigative Site
Ste-Foy, Quebec, G1V 4G5
Novartis Investigative Site
Vancouver
About this study
Official title: A Randomized, Double-blind, Placebo- and Comparator-controlled Study Evaluating the Effect of Multiple Doses of QGE031 Compared to Omalizumab in Asthma Induced by Allergen Bronchial Provocation
This study will evaluate the efficacy of QGE031 compared to omalizumab in patients with allergic asthma. Each treatment's effect in changing the concentration of inhaled allergen that is required to elicit a 15% fall in the forced expiratory volume in one second (FEV1) at 12 weeks compared to baseline will be evaluated.
- Conditions
- Allergic Asthma
- Being tested
- QGE031, omalizumab, placebo
- Keywords
- Allergies, asthma, IgE
- Medical subject headings
- Hypersensitivity, Asthma, Epilepsy, Idiopathic Generalized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QGE031Drug
Drug administered by subcutaneous injection
omalizumabDrug
Drug administered by subcutaneous injection
placeboDrug
Drug administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| QGE031 | Experimental | During the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses). Three dose levels of QGE031 will be offered during the study: low, medium, and high. Participants will be randomized to receive one of these dose levels for all dosing visits. Receives: Drug: QGE031 |
| omalizumab | Active comparator | During the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses) or once every four weeks (total of three doses). The dose that a participant receives will depend upon the participant's body weight and IgE level; dosage will be determined based upon local omalizumab dosing charts. Receives: Drug: omalizumab |
| placebo | Placebo comparator | During the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses). Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the concentration of inhaled allergen that elicits a 15% fall in the forced expiratory volume in one second (FEV1)
Measured: Baseline, 12 weeks
Secondary outcomes (3)
Change in the concentration of inhaled allergen that elicits a 15% fall in the forced expiratory volume in one second (FEV1) following treatment with placebo and various doses of QGE031
Measured: Baseline, 12 weeks
QGE031 blood concentrations
Measured: 24 weeks
Number of participants with adverse events or other safety concerns
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01703312
- Sponsor's protocol ID
- CQGE031B2203
- Status last verified
- Apr 2016
- First submitted
- 5 Oct 2012
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo- and Comparator-controlled Study Evaluating the Effect of Multiple Doses of QGE031 Compared to Omalizumab in Asthma Induced by Allergen Bronchial Provocation
- ClinicalTrials.gov ID
- NCT01703312
- Acronym / sponsor ID
- CQGE031B2203
- Conditions
- Allergic Asthma
- Keywords
- Allergies, asthma, IgE
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 10 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy of QGE031 compared to omalizumab in patients with allergic asthma. Each treatment's effect in changing the concentration of inhaled allergen that is required to elicit a 15% fall in the forced expiratory volume in one second (FEV1) at 12 weeks compared to baseline will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| QGE031 | Experimental | Drug: QGE031During the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses). Three dose levels of QGE031 will be offered during the study: low, medium, and high. Participants will be randomized to receive one of these dose levels for all dosing visits. |
| omalizumab | Active comparator | Drug: omalizumabDuring the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses) or once every four weeks (total of three doses). The dose that a participant receives will depend upon the participant's body weight and IgE level; dosage will be determined based upon local omalizumab dosing charts. |
| placebo | Placebo comparator | Drug: placeboDuring the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients 18 to 65 years
- Positive skin prick test to one or more common airborne allergens
- Presence of airway hyperresponsiveness documented by a provocative concentration of methacholine causing a 20% fall in FEV1 (PC20 FEV1) of less than or equal to 16 mg/mL
- Presence of an early asthmatic response demonstrated by an allergen challenge at screening and including a 15% fall in the FEV1
- Patients with a body weight and total IgE in a range specified by local country prescribing information for omalizumab
Key exclusion criteria (5 listed)
- Pregnant or nursing (lactating) women
- Women of child-bearing potential unless they are using a highly effective method of birth control (as further defined in the study protocol)
- Smokers
- Patients with poorly controlled asthma or patients who have had an asthma exacerbation within the past year
- Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| QGE031Drug administered by subcutaneous injection | Drug | QGE031 |
| omalizumabDrug administered by subcutaneous injection | Drug | omalizumab |
| placeboDrug administered by subcutaneous injection | Drug | placebo |
Primary outcome
Change in the concentration of inhaled allergen that elicits a 15% fall in the forced expiratory volume in one second (FEV1)
Time frame: Baseline, 12 weeks
3 secondary outcomes
Change in the concentration of inhaled allergen that elicits a 15% fall in the forced expiratory volume in one second (FEV1) following treatment with placebo and various doses of QGE031
Time frame: Baseline, 12 weeks
QGE031 blood concentrations
Time frame: 24 weeks
Number of participants with adverse events or other safety concerns
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing QGE031 and omalizumab in people with Allergic Asthma, run by Novartis Pharmaceuticals at 7 sites in 2 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 5 inclusion and 5 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 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada, Sweden. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in the concentration of inhaled allergen that elicits a 15% fall in the forced expiratory volume in one second (FEV1) (time frame: Baseline, 12 weeks). 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 20 Apr 2016.