AllergyNCT02968394
Omalizumab Treatment in Venom Immunotherapy With Systemic Reactions
A study testing omalizumab in people with Allergy and Bee Venom, run by The University Clinic of Pulmonary and Allergic Diseases Golnik at 1 site in Slovenia.
Trial summary
The purpose of this study is to evaluate if omalizumab co-treatment may allow reintroduction of honey bee venom immunotherapy in patients with immunotherapy treatment failure due to systemic reactions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergy, Bee Venom, Immunotherapy
- What is being tested?
- omalizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSlovenia
- Study dates
- Mar 2014to Mar 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- severe anaphylactic reaction after honey-bee sting (Mueller grade III or IV) confirmed sensitization to honey-bee venom,
- honey-bee venom immunotherapy treatment failure due to systemic reactions.
Who cannot join
- systemic mastocytosis,
- pregnancy,
- use of beta-adrenergic blocking agents.
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
University Clinic of Pulmonary and Allergic Diseases Golnik
Golnik, 4204
Peter Kopac, MD, +386 4 25 69 100, peter.kopac@klinika-golnik.si
About this study
Official title: Influence of Omalizumab Co-treatment on Honey-bee Venom Immunotherapy Failure Due to Systemic Reactions
The purpose of this study is to evaluate if omalizumab co-treatment may allow reintroduction of honey bee venom immunotherapy in patients with immunotherapy treatment failure due to systemic reactions.
Read the detailed description
Some honey bee venom allergic patients cannot be treated with venom immunotherapy due to systemic reactions during immunotherapy - immunotherapy failure due to systemic reactions. High basophil allergen sensitivity is a risk factor for venom immunotherapy failure due to systemic reactions. Omalizumab decreases basophil sensitivity. Venom immunotherapy failure patients will be co-treated with omalizumab during another attempt of immunotherapy introduction. Patients will be clinically and immunologically followed up after the introduction.
- Conditions
- Allergy, Bee Venom, Immunotherapy, Omalizumab
- Being tested
- omalizumab
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omalizumabDrug
| Study group | Role | What they receive |
|---|---|---|
| NEVIT | Experimental | Co treatment with omalizumab during another attempt of immunotherapy introduction Receives: Drug: omalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of systemic reactions during ultra rush immunotherapy build up phase and maintenance phase followed by omalizumab co-treatment.
Measured: 2 months
Secondary outcomes (1)
Changes in basophil sensitivity during omalizumab co-treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study startMar 2014
- Primary completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University Clinic of Pulmonary and Allergic Diseases Golnik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mitja Košnik, MD, PhD, Study director, University Clinic of Pulmonary and Allergic Diseases Golnik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968394
- Sponsor's protocol ID
- NEVIT
- Status last verified
- Nov 2016
- First submitted
- 11 Nov 2016
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Omalizumab Co-treatment on Honey-bee Venom Immunotherapy Failure Due to Systemic Reactions
- ClinicalTrials.gov ID
- NCT02968394
- Acronym / sponsor ID
- NEVIT
- Conditions
- Allergy, Bee Venom, Immunotherapy, Omalizumab
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- The University Clinic of Pulmonary and Allergic Diseases GolnikUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2017 (estimated)
- First posted
- 18 Nov 2016 (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.
The purpose of this study is to evaluate if omalizumab co-treatment may allow reintroduction of honey bee venom immunotherapy in patients with immunotherapy treatment failure due to systemic reactions.
Detailed description
Some honey bee venom allergic patients cannot be treated with venom immunotherapy due to systemic reactions during immunotherapy - immunotherapy failure due to systemic reactions. High basophil allergen sensitivity is a risk factor for venom immunotherapy failure due to systemic reactions. Omalizumab decreases basophil sensitivity. Venom immunotherapy failure patients will be co-treated with omalizumab during another attempt of immunotherapy introduction. Patients will be clinically and immunologically followed up after the introduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NEVIT | Experimental | Drug: omalizumabCo treatment with omalizumab during another attempt of immunotherapy introduction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- severe anaphylactic reaction after honey-bee sting (Mueller grade III or IV) confirmed sensitization to honey-bee venom,
- honey-bee venom immunotherapy treatment failure due to systemic reactions.
Key exclusion criteria (3 listed)
- systemic mastocytosis,
- pregnancy,
- use of beta-adrenergic blocking agents.
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 |
|---|---|---|
| omalizumab | Drug | NEVIT |
Primary outcome
Number of systemic reactions during ultra rush immunotherapy build up phase and maintenance phase followed by omalizumab co-treatment.
Time frame: 2 months
1 secondary outcome
Changes in basophil sensitivity during omalizumab co-treatment
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 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.
Mitja Košnik, MD, PhD study director
University Clinic of Pulmonary and Allergic Diseases Golnik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omalizumab in people with Allergy and Bee Venom, run by The University Clinic of Pulmonary and Allergic Diseases Golnik at 1 site in Slovenia.
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 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: status not confirmed, as of the sponsor's last update on 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Kopac, MD (+386 4 25 69 100, peter.kopac@klinika-golnik.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of systemic reactions during ultra rush immunotherapy build up phase and maintenance phase followed by omalizumab co-treatment. (time frame: 2 months). 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 21 Nov 2016.