Peanut AllergyPhase 2NCT01451450
Efficacy and Safety of 4 Doses of QGE031 in Patients 18-50 Years of Age With Peanut Allergy
A Phase 2 study testing QGE031 in people with Peanut Allergy, run by Novartis Pharmaceuticals.
Trial summary
This study will assess the clinical potency of several exposure levels of QGE031 in decreasing the sensitivity against peanut allergen. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Peanut Allergy
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 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 50 years
- All sexes
- No healthy volunteers
- Adult
Main Inclusion Criteria:
- Diagnosis of acute peanut allergy as manifested by urticaria, angioedema, gastro-intestinal or respiratory tract symptoms, with acute onset of symptoms after ingestion (up to 2 hours).
- Positive peanut food challenge at baseline, i.e., have objective allergic events at a level of 300mg (not cumulative) or below of peanut protein but not to the placebo test.
Main Exclusion Criteria:
- Prior exposure to any monoclonal antibody treatment
- Asthma patients on maintenance long acting beta-agonists
- Use of systemic corticosteroids
- Concomitant use of beta blockers, ACE inhibitors, tiotropium or ipratropium, antidepressants, oral beta-agonists
- Use of immunosuppressants within 6 months of visit 1 Other protocol-defined inclusion/exclusion criteria may appy
About this study
Official title: A Phase II, Randomized, Double Blind, Placebo-controlled, Parallel Design, Dose Ranging, Multi-center Trial of Four Levels of Exposure of QGE031 s.c. for 16 Weeks in Subjects Aged 18-50 Years of Age With Peanut Allergy
This study will assess the clinical potency of several exposure levels of QGE031 in decreasing the sensitivity against peanut allergen.
- Conditions
- Peanut Allergy
- Being tested
- QGE031, Placebo
- Keywords
- Peanut Allergy
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QGE031Drug
QGE031 liquid for subcutaneous injection.
PlaceboDrug
Placebo liquid for subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| QGE031 A | Experimental | Not described Receives: Drug: QGE031 |
| QGE031 B | Experimental | Not described Receives: Drug: QGE031 |
| QGE031 C | Experimental | Not described Receives: Drug: QGE031 |
| QGE031 D | Experimental | Not described Receives: Drug: QGE031 |
| Placebo A | Placebo comparator | Not described Receives: Drug: Placebo |
| Placebo B | Placebo comparator | Not described Receives: Drug: Placebo |
| Placebo C | Placebo comparator | Not described Receives: Drug: Placebo |
| Placebo D | Placebo comparator | Not described Receives: Drug: Placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peanut AllergyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 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
- NCT01451450
- Sponsor's protocol ID
- CQGE031A2208
- Other IDs
- 2011-000631-92
- Status last verified
- Jul 2012
- First submitted
- 10 Oct 2011
- Last updated
- 23 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double Blind, Placebo-controlled, Parallel Design, Dose Ranging, Multi-center Trial of Four Levels of Exposure of QGE031 s.c. for 16 Weeks in Subjects Aged 18-50 Years of Age With Peanut Allergy
- ClinicalTrials.gov ID
- NCT01451450
- Acronym / sponsor ID
- CQGE031A2208
- Conditions
- Peanut Allergy
- Keywords
- Peanut Allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 13 Oct 2011 (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 assess the clinical potency of several exposure levels of QGE031 in decreasing the sensitivity against peanut allergen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| QGE031 A | Experimental | Drug: QGE031 |
| QGE031 B | Experimental | Drug: QGE031 |
| QGE031 C | Experimental | Drug: QGE031 |
| QGE031 D | Experimental | Drug: QGE031 |
| Placebo A | Placebo comparator | Drug: Placebo |
| Placebo B | Placebo comparator | Drug: Placebo |
| Placebo C | Placebo comparator | Drug: Placebo |
| Placebo D | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 liquid for subcutaneous injection. | Drug | QGE031 A, QGE031 B, QGE031 C, QGE031 D |
| PlaceboPlacebo liquid for subcutaneous injection. | Drug | Placebo A, Placebo B, Placebo C, Placebo D |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2012.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QGE031 in people with Peanut Allergy, run by Novartis Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 23 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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.
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 23 Jul 2012.