Grass Pollen Induced Allergic RhinoconjunctivitisPhase 2AV-G-03NCT02166268
Evaluation of the Efficacy and Safety of AVANZ® Phleum Pratense in Grass Pollen-induced Allergic Rhinitis During Controlled Exposure in an Environmental Challenge Chamber
A Phase 2 study testing AVANZ Phleum pratense 15,000 SQ+ in people with Grass Pollen Induced Allergic Rhinoconjunctivitis, run by ALK-Abelló A/S at 1 site in Germany.
Trial summary
The clinical trial will investigate the efficacy of Avanz Phleum pratense in the treatment of rhinitis in an environmental challenge chamber. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Grass Pollen Induced Allergic Rhinoconjunctivitis
- What is being tested?
- AVANZ Phleum pratense 15,000 SQ+
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2014to Oct 2015
- 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
- Written informed consent
- Male or female aged 18 to 65 years
- The subject fulfills one of the following criteria:
- Male
- Female, infertile
- Female of child-bearing potential, with a negative pregnancy test
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- Moderate-to-severe grass pollen induced rhinoconjunctivitis
- Positive skin prick test response (wheal diameter ≥ 3 mm) to Phleum pratense
- Positive specific Immunoglobulin E (IgE) against Phleum pratense (≥ IgE Class 2; ≥0.70 kilo Unit/L)
- Minimum level of rhinitis symptoms in an grass pollen challenge, defined as a total nasal symptom score of at least 6 (of 12) within the 3-hour grass pollen challenge at performed at the baseline ECC visit
- The subject must be willing and able to comply with the trial protocol
Who cannot join
- Rhinoconjunctivitis caused by ragweed, mugwort or Alternaria alternate
- Rhinoconjunctivitis caused by animal hair and dander, house dust mites and moulds
- Clinical history of uncontrolled asthma within 3 months prior to screening
- Subjects with reduced lung function forced expiratory volume in 1 second <70% of the predicted value after adequate pharmacologic treatment
- Subjects with asthma requiring treatment with inhaled corticosteroids outside the grass pollen seasons
- Previous treatment with immunotherapy to a grass pollen allergen or a cross reacting allergen within the past 5 years
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- Ongoing treatment with any allergen-specific immunotherapy product
- Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process at randomisation and at the baseline challenge
- Clinically relevant nasal polyps
- History of paranasal sinus surgery
- History of surgery of nasal turbinates
- History of anaphylaxis with cardiorespiratory symptoms (immunotherapy, exercise induced, food allergy, drugs or an idiopathic reaction)
- History of recurrent (defined as 2 or more episodes) generalised urticaria during the last 2 years
- History of drug-induced (including immunotherapy) facial angioedema or a family (parents and siblings) history of hereditary angioedema
- Any clinically relevant chronic disease (≥3 months duration) (e.g. cystic fibrosis, malignancy, malabsorption or malnutrition, renal or hepatic abnormality, or any other diseases that in the opinion of the investigator would interfere with the trial evaluations or the safety of the subjects)
- Systemic disease affecting the immune system (e.g. insulin-dependent diabetes, autoimmune disease, immune complex disease, or immune deficiency disease)
- Immunosuppressive treatment (ATC code L04 or L01) within 3 months prior to the screening visit
- Currently treated with tricyclic antidepressants, catecholamine-O
- methyltransferase inhibitors and/or mono amine oxidase inhibitors
- Treatment with antidepressant medication with antihistaminic effect (e.g. doxepin, mianserin)
- Treatment with antipsychotic medications with antihistaminic effect (e.g. chlorpromazine, levomepromazine, clozapine, olanzapine, thioridazine)
- Treatment with anti-IgE drugs (e.g. omalizumab) within 130 days/5 half-lives which ever longest
- Treatment with systemic and/or topical β-blockers
- Use of an investigational drug within 30 days/5 half-lives of the drug, which ever the longest, prior to screening
- History of allergy, hypersensitivity or intolerance to an excipient the investigational drug (except Phleum pratense)
- Being immediate family of the investigator or trial staff, defined as the investigator's/staff's spouse, parent, child, grandparent, or grandchild
- History of alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
The clinical trial will investigate the efficacy of Avanz Phleum pratense in the treatment of rhinitis in an environmental challenge chamber.
- Being tested
- AVANZ Phleum pratense 15,000 SQ+, Placebo
- Keywords
- Allergic rhinoconjunctivitis, Allergic rhinitis, Allergy, Grass pollen
- Medical subject headings
- Rhinitis, Allergic, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVANZ Phleum pratense 15,000 SQ+Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Avanz Phleum pratense | Active comparator | Avanz Phleum pratense 15,000 SQ+ (standardised quality), suspension for subcutaneous injection. Receives: Drug: AVANZ Phleum pratense 15,000 SQ+ |
| Placebo | Placebo comparator | Placebo, suspension for subcutaneous injection. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average total nasal symptom score
The Total Nasal Symptom Score consist of 4 symptoms: runny nose, blocked nose, sneezing and itchy nose scored on a scale form 0-3. Measured during the final Environmental challenge chamber (ECC) visit.
Measured: After 1-year of treatment
Secondary outcomes (3)
Total nasal symptom score collected at the 2nd ECC visit
The Total Nasal Symptom Score consist of 4 symptoms: runny nose, blocked nose, sneezing and itchy nose scored on a scale form 0-3. Measured during the 2nd ECC visit.
Measured: After 16 weeks of treatment
Average Total Symptom Score
The total symptom score consist of 4 nasal symptoms and 2 eye symptoms measured on a scale from 0-3. Measured during the 2nd and the final ECC visit
Measured: Meaured after 16 weeks and 1 year of treatment.
Treatment emergent adverse events
Adverse events (AE) will be collected during the trial. AEs will be summaries by treatment group, Medical Dictionary for Regulatory Activities (MedDRA) system organ class, preferred term and broken down by severity, seriousness, action taken, dosing step and outcome. An analysis of local and systemic reactions and AEs leading to discontinuation. An analysis of early and delayed reactions after the treatment will further be performed.
Measured: During the 1-year treatment period with Avanz
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grass Pollen Induced Allergic RhinoconjunctivitisStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jens Hohlfeld, Prof., Principal investigator, Fraunhofer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166268
- Sponsor's protocol ID
- AV-G-03
- Other IDs
- 2013-005130-38
- Acronym
- AV-G-03
- Status last verified
- Jan 2016
- First submitted
- 11 Jun 2014
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of AVANZ® Phleum Pratense in Grass Pollen-induced Allergic Rhinitis During Controlled Exposure in an Environmental Challenge Chamber
- ClinicalTrials.gov ID
- NCT02166268
- Acronym / sponsor ID
- AV-G-03 / AV-G-03
- Keywords
- Allergic rhinoconjunctivitis, Allergic rhinitis, Allergy, Grass pollen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 18 Jun 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.
The clinical trial will investigate the efficacy of Avanz Phleum pratense in the treatment of rhinitis in an environmental challenge chamber.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Avanz Phleum pratense | Active comparator | Drug: AVANZ Phleum pratense 15,000 SQ+Avanz Phleum pratense 15,000 SQ+ (standardised quality), suspension for subcutaneous injection. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, suspension for subcutaneous injection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent
- Male or female aged 18 to 65 years
- The subject fulfills one of the following criteria:
- Moderate-to-severe grass pollen induced rhinoconjunctivitis
- Positive skin prick test response (wheal diameter ≥ 3 mm) to Phleum pratense
Key exclusion criteria (27 listed)
- Rhinoconjunctivitis caused by ragweed, mugwort or Alternaria alternate
- Rhinoconjunctivitis caused by animal hair and dander, house dust mites and moulds
- Clinical history of uncontrolled asthma within 3 months prior to screening
- Subjects with reduced lung function forced expiratory volume in 1 second <70% of the predicted value after adequate pharmacologic treatment
- Subjects with asthma requiring treatment with inhaled corticosteroids outside the grass pollen seasons
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 Phleum pratense 15,000 SQ+ | Drug | Avanz Phleum pratense |
| Placebo | Drug | Placebo |
Primary outcome
Average total nasal symptom score
Time frame: After 1-year of treatment
The Total Nasal Symptom Score consist of 4 symptoms: runny nose, blocked nose, sneezing and itchy nose scored on a scale form 0-3. Measured during the final Environmental challenge chamber (ECC) visit.
3 secondary outcomes
Total nasal symptom score collected at the 2nd ECC visit
Time frame: After 16 weeks of treatment
Average Total Symptom Score
Time frame: Meaured after 16 weeks and 1 year of treatment.
Treatment emergent adverse events
Time frame: During the 1-year treatment period with Avanz
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 26 Jan 2016.
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.
Jens Hohlfeld, Prof. principal investigator
Fraunhofer Institute
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 Phleum pratense 15,000 SQ+ in people with Grass Pollen Induced Allergic Rhinoconjunctivitis, run by ALK-Abelló A/S at 1 site in Germany.
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 11 inclusion and 27 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 26 Jan 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 Germany. 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?
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?
Average total nasal symptom score (time frame: After 1-year of treatment). 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 26 Jan 2016.