Allergic Rhinoconjunctivitis Due to Salsola Kali PollenPhase 2AV-X-02NCT02065856
An Open Trial to Assess the Tolerability of AVANZ® Salsola Immunotherapy
A Phase 2 study testing AVANZ Salsola in people with Allergic Rhinoconjunctivitis Due to Salsola Kali Pollen, run by ALK-Abelló A/S at 1 site in Spain.
Trial summary
This trial is an open, national, multi-centre trial. The trial will be initiated in December 2013 and subjects will receive treatment for 6 weeks. Safety monitoring will be performed in an ongoing basis through a Clinical Safety Group with immediate access to Adverse Events registered in the clinical database. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinoconjunctivitis Due to Salsola Kali Pollen
- What is being tested?
- AVANZ Salsola
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2013to Dec 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A clinical history of Salsola kali pollen induced allergic rhinoconjunctivitis with or without asthma at least one year prior to trial entry.
- Positive Skin Prick Test to Salsola kali pollen (wheal diameter ≥ 3 mm).
- Documenting in the last 5 years a positive specific Immunoglobulin E against Salsola kali pollen (≥ Class 2; ≥0.70 KU/L).
Who cannot join
- Forced expiratory volume at one second 1 < 70% of predicted value at screening after adequate pharmacologic treatment.
- Uncontrolled or severe asthma.
- History of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months.
- At screening, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infection (serous otitis media is not an exclusion criterion).
- Treatment with parenteral corticosteroids, oral corticosteroids or anti-IgE in the previous 3 months or during the study (except for steroids if needed as rescue medication).
- Currently treated with angiotensin converting enzyme (ACE) inhibitors, tricyclic antidepressants, β-blockers, mono amine oxidase inhibitors (MAOIs) and any other drug containing alum (e.g. antacids) taken on a daily basis.
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- Immunotherapy with Cupressus arizonica or Salsola kali pollen extracts within the previous 5 years (initiation of subcutaneous immunotherapy is acceptable if treatment has been discontinued before reaching maintenance dose; for SLIT 3 months in the last 5 years is accepted) or concomitant immunotherapy with any other allergen.
- History of anaphylactic shock due to e.g. food, insect venom, exercise or drug.
- History of severe and recurrent angioedema.
Trial locations and contacts
1 site in 1 country.
About this study
This trial is an open, national, multi-centre trial. The trial will be initiated in December 2013 and subjects will receive treatment for 6 weeks.
Safety monitoring will be performed in an ongoing basis through a Clinical Safety Group with immediate access to Adverse Events registered in the clinical database. The composition, procedures and deliverables of the Clinical Safety Group will be detailed in a Safety Agreement prior to trial start.
- Being tested
- AVANZ Salsola
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVANZ SalsolaBiological
AVANZ Salsola
| Study group | Role | What they receive |
|---|---|---|
| AVANZ Salsola kali | Experimental | Subcutaneous immunotherapy Receives: Biological: AVANZ Salsola |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of patients with adverse reactions
Measured: Participants will be followed for an expected average of 6 weeks
Secondary outcomes (1)
Frequency of patients with systemic reactions according to EAACI classification
Measured: Participants will be followed for an expected average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startDec 2013
- Primary completionAug 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Rhinoconjunctivitis Due to Salsola Kali PollenStudies 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 2
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- PURIFICACION GONZÁLEZ, PhD, Principal investigator, Hospital General Universitario de Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065856
- Sponsor's protocol ID
- 2013-001728-20
- Other IDs
- 2013-001728-20
- Acronym
- AV-X-02
- Status last verified
- Jan 2015
- First submitted
- 20 Jan 2014
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Trial to Assess the Tolerability of AVANZ® Salsola Immunotherapy
- ClinicalTrials.gov ID
- NCT02065856
- Acronym / sponsor ID
- AV-X-02 / 2013-001728-20
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 19 Feb 2014 (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 trial is an open, national, multi-centre trial. The trial will be initiated in December 2013 and subjects will receive treatment for 6 weeks.
Safety monitoring will be performed in an ongoing basis through a Clinical Safety Group with immediate access to Adverse Events registered in the clinical database. The composition, procedures and deliverables of the Clinical Safety Group will be detailed in a Safety Agreement prior to trial start.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AVANZ Salsola kali | Experimental | Biological: AVANZ SalsolaSubcutaneous immunotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A clinical history of Salsola kali pollen induced allergic rhinoconjunctivitis with or without asthma at least one year prior to trial entry.
- Positive Skin Prick Test to Salsola kali pollen (wheal diameter ≥ 3 mm).
- Documenting in the last 5 years a positive specific Immunoglobulin E against Salsola kali pollen (≥ Class 2; ≥0.70 KU/L).
Key exclusion criteria (9 listed)
- Forced expiratory volume at one second 1 < 70% of predicted value at screening after adequate pharmacologic treatment.
- Uncontrolled or severe asthma.
- History of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months.
- At screening, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infection (serous otitis media is not an exclusion criterion).
- Treatment with parenteral corticosteroids, oral corticosteroids or anti-IgE in the previous 3 months or during the study (except for steroids if needed as rescue medication).
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 |
|---|---|---|
| AVANZ SalsolaAVANZ Salsola | Biological | AVANZ Salsola kali |
Primary outcome
Frequency of patients with adverse reactions
Time frame: Participants will be followed for an expected average of 6 weeks
1 secondary outcome
Frequency of patients with systemic reactions according to EAACI classification
Time frame: Participants will be followed for an expected average of 6 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 14 Jan 2015.
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.
PURIFICACION GONZÁLEZ, PhD principal investigator
Hospital General Universitario de Alicante
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AVANZ Salsola in people with Allergic Rhinoconjunctivitis Due to Salsola Kali Pollen, run by ALK-Abelló A/S at 1 site in Spain.
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 9 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 14 Jan 2015. 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 Spain. 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?
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?
Frequency of patients with adverse reactions (time frame: Participants will be followed for an expected average of 6 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 14 Jan 2015.