Allergic RhinoconjunctivitisPhase 2NCT02297490
Evaluation of the Utility of an EEC for Assessing Efficacy of SIT in Pivotal Clinical Trials
A Phase 2 study testing Allergovit 6-grasses in people with Allergic Rhinoconjunctivitis and Healthy Volunteers, run by Allergopharma GmbH & Co. KG at 1 site in Canada.
Trial summary
The study will explore how allergy symptoms experienced during the grass pollen season compare to symptoms experienced in the Environmental Exposure Chamber (EEC). There are 2 treatments in this study. Both treatments are injected under the skin. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinoconjunctivitis, Healthy Volunteers
- What is being tested?
- Allergovit 6-grasses
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- IgE-mediated seasonal allergic rhinitis/rhinoconjunctivitis with or without allergic asthma
- positive skin prick test
- specific IgE ≥ 0.70 kU/L to mixture of grass pollen allergens
- symptom score of at least 4 per day during the week following the peak-pollen count in the baseline season
Who cannot join
- undergone previous specific immunotherapy with grass pollen allergens in any formulation less than 5 years prior to the screening date
- currently undergoing any sort of immunotherapy, or has ever undergone specific immunotherapy with unknown allergen
- allergens which are expected to interfere with the grass pollen season
- uncontrolled or partly controlled asthma
- patients with contraindications for SIT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Utility of an Environmental Exposure Chamber (EEC) for Assessing Efficacy of Specific Immunotherapy (SIT) in Pivotal Clinical Trials
The study will explore how allergy symptoms experienced during the grass pollen season compare to symptoms experienced in the Environmental Exposure Chamber (EEC).
There are 2 treatments in this study. Both treatments are injected under the skin. Allergovit® Grasses works by helping the body's immune system get used to grass-pollen before the grass pollen season begins which may lead to decreased sensitivity and reduced allergy symptoms during the grass season. Placebo treatment does not contain grass pollen mixture, and is not expected to reduce allergic symptoms overtime.
Read the detailed description
This is a Phase II trial, with a one year observational/baseline phase followed by a one year double-blind placebo-controlled, randomized, treatment phase. Approx. 137 grass pollen-allergic subjects and 20 non-allergic subjects will be enrolled in the baseline phase of the study. The primary objective of the trial is to investigate the relationship between allergy symptoms experienced by subjects (allergic and non-allergic) upon exposure to grass pollen-allergen in the EEC and the allergy symptoms experienced by subjects during the grass pollen season.
- Conditions
- Allergic Rhinoconjunctivitis, Healthy Volunteers
- Being tested
- Placebo, Allergovit 6-grasses
- Keywords
- Environmental Exposure Chamber, Specific Immunotherapy, SIT, SCIT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Comparator
Placebo treatment is identical to the active treatment schedule. The placebo-preparation used is identical to the active solution but without any allergen substance in it.
Allergovit 6-grassesBiological
Also called Specific immunotherapy with an allergoid preparation.
Immunotherapy will be performed for approx. 5 months. 7 injections will be administered at weekly intervals to reach the maintenance dose. However, dosing must be individualised.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo treatment is identical to the active treatment schedule. The placebo-preparation used is identical to the active solution but without any allergen substance in it. Receives: Drug: Placebo |
| Allergovit 6-grasses immunotherapy | Experimental | Immunotherapy will be performed for approx. 5 months. 7 injections will be administered at weekly intervals to reach the maintenance dose. However, dosing must be individualised. Receives: Biological: Allergovit 6-grasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Symptom Score (TSS)
Analysis of the relationship between different methods of measurement of efficacy of SIT.
The AUC of the Total Symptom Score (TSS) as primary endpoint assessed in an EEC after preseasonal treatment
Measured: 1 year
Rhinoconjunctivitis Symptom and Medication Score (RC-SMS)
The AUC of the Rhinoconjunctivitis Symptom and Medication Score (RC-SMS) assessed as primary endpoint during the natural grass pollen season (field-based)
Measured: Grass pollen season from March until July (approx. 11 weeks avarage)
Medication-adjusted Rhinoconjunctivitis Symptom Score (ma-RC-SS)
The AUC of the Medication-adjusted Rhinoconjunctivitis Symptom Score (ma-RC-SS) assessed as primary endpoint during the natural grass pollen season (field-based)
Measured: Grass pollen season from March until July (approx. 11 weeks avarage)
Secondary outcomes (1)
Symptoms (by TSS, RC-SMS, ma-RC-SS) in non-allergic subjects
Evaluation of the relationship of symptoms experienced in EEC and natural grass pollen season. Assessment of symptom specificity provoked by EEC in non-allergic subjects.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startJan 2014
- Primary completionNov 2014
- Study completionDec 2014
Why it stopped: The study was terminated due to the interim Analysis results indicating a weaker correlation than anticipated and reported by other study groups.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergopharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Inflamax Research Incorporated
- Responsible party
- Sponsor
- Investigators
- Piyush Patel, Dr., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297490
- Sponsor's protocol ID
- AL1304AV
- Other IDs
- AL13BP01
- Status last verified
- Jan 2018
- First submitted
- 12 Nov 2014
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Utility of an Environmental Exposure Chamber (EEC) for Assessing Efficacy of Specific Immunotherapy (SIT) in Pivotal Clinical Trials
- ClinicalTrials.gov ID
- NCT02297490
- Acronym / sponsor ID
- AL1304AV
- Conditions
- Allergic Rhinoconjunctivitis, Healthy Volunteers
- Keywords
- Environmental Exposure Chamber, Specific Immunotherapy, SIT, SCIT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to the interim Analysis results indicating a weaker correlation than anticipated and reported by other study groups.
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Allergopharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Collaborators
- Inflamax Research Incorporated
- Study start
- Jan 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Nov 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 study will explore how allergy symptoms experienced during the grass pollen season compare to symptoms experienced in the Environmental Exposure Chamber (EEC).
There are 2 treatments in this study. Both treatments are injected under the skin. Allergovit® Grasses works by helping the body's immune system get used to grass-pollen before the grass pollen season begins which may lead to decreased sensitivity and reduced allergy symptoms during the grass season. Placebo treatment does not contain grass pollen mixture, and is not expected to reduce allergic symptoms overtime.
Detailed description
This is a Phase II trial, with a one year observational/baseline phase followed by a one year double-blind placebo-controlled, randomized, treatment phase. Approx. 137 grass pollen-allergic subjects and 20 non-allergic subjects will be enrolled in the baseline phase of the study. The primary objective of the trial is to investigate the relationship between allergy symptoms experienced by subjects (allergic and non-allergic) upon exposure to grass pollen-allergen in the EEC and the allergy symptoms experienced by subjects during the grass pollen season.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo treatment is identical to the active treatment schedule. The placebo-preparation used is identical to the active solution but without any allergen substance in it. |
| Allergovit 6-grasses immunotherapy | Experimental | Biological: Allergovit 6-grassesImmunotherapy will be performed for approx. 5 months. 7 injections will be administered at weekly intervals to reach the maintenance dose. However, dosing must be individualised. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- IgE-mediated seasonal allergic rhinitis/rhinoconjunctivitis with or without allergic asthma
- positive skin prick test
- specific IgE ≥ 0.70 kU/L to mixture of grass pollen allergens
- symptom score of at least 4 per day during the week following the peak-pollen count in the baseline season
Key exclusion criteria (5 listed)
- undergone previous specific immunotherapy with grass pollen allergens in any formulation less than 5 years prior to the screening date
- currently undergoing any sort of immunotherapy, or has ever undergone specific immunotherapy with unknown allergen
- allergens which are expected to interfere with the grass pollen season
- uncontrolled or partly controlled asthma
- patients with contraindications for SIT
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 |
|---|---|---|
| PlaceboAlso: ComparatorPlacebo treatment is identical to the active treatment schedule. The placebo-preparation used is identical to the active solution but without any allergen substance in it. | Drug | Placebo |
| Allergovit 6-grassesAlso: Specific immunotherapy with an allergoid preparation.Immunotherapy will be performed for approx. 5 months. 7 injections will be administered at weekly intervals to reach the maintenance dose. However, dosing must be individualised. | Biological | Allergovit 6-grasses immunotherapy |
Primary outcome
Total Symptom Score (TSS)
Time frame: 1 year
Analysis of the relationship between different methods of measurement of efficacy of SIT. The AUC of the Total Symptom Score (TSS) as primary endpoint assessed in an EEC after preseasonal treatment
Rhinoconjunctivitis Symptom and Medication Score (RC-SMS)
Time frame: Grass pollen season from March until July (approx. 11 weeks avarage)
The AUC of the Rhinoconjunctivitis Symptom and Medication Score (RC-SMS) assessed as primary endpoint during the natural grass pollen season (field-based)
Medication-adjusted Rhinoconjunctivitis Symptom Score (ma-RC-SS)
Time frame: Grass pollen season from March until July (approx. 11 weeks avarage)
The AUC of the Medication-adjusted Rhinoconjunctivitis Symptom Score (ma-RC-SS) assessed as primary endpoint during the natural grass pollen season (field-based)
1 secondary outcome
Symptoms (by TSS, RC-SMS, ma-RC-SS) in non-allergic subjects
Time frame: 1 year
Results and safety
The study was stopped early (reason given: The study was terminated due to the interim Analysis results indicating a weaker correlation than anticipated and reported by other study groups.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
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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.
Piyush Patel, Dr. principal investigator
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 Allergovit 6-grasses in people with Allergic Rhinoconjunctivitis and Healthy Volunteers, run by Allergopharma GmbH & Co. KG at 1 site in Canada.
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 4 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: stopped early, as of the sponsor's last update on 17 Jan 2018. 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 Canada. 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 was stopped early (reason given: The study was terminated due to the interim Analysis results indicating a weaker correlation than anticipated and reported by other study groups.). Results are not available in the source record.
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?
Total Symptom Score (TSS) (time frame: 1 year). The study lists 3 primary outcomes in all. 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 17 Jan 2018.