Allergic Rhinitis Due to Grass PollensPhase 4NCT01854736
Molecular and Cellular Mechanism in the Course of Immunotherapy With a Phleum Pratense Oral Lyophilisate
A Phase 4 study testing Grazax in people with Allergic Rhinitis Due to Grass Pollens, run by ALK-Abelló A/S at 2 sites in Spain.
Trial summary
This trial is an exploratory randomised, parallel-group, double-blind, placebo- controlled, national, single-centre trial. The trial will be initiated before 2013 grass pollen season and subjects will be randomised in September 2013 to receive active treatment (Grazax®) or placebo during 2 years. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis Due to Grass Pollens
- What is being tested?
- Grazax
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 2 sitesSpain
- Study dates
- Apr 2013to Dec 2015
- Phase
- Phase 4
- 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 history of grass pollen allergy
- Positive skin prick test to grass
- Positive specific IgE against Phl p 5
- Written informed consent before entering the trial.
- Female subjects who are fertile must have a negative pregnancy test and be willing to practise appropriate contraceptive methods.
- Subject willing and able to comply with the trial protocol.
Who cannot join
- Previous treatment by immunotherapy with grass allergen extracts.
- Ongoing treatment with any allergen specific immunotherapy product.
- Previous or ongoing treatment with Omalizumab, mono amine oxidase (MAO) inhibitors or tricyclic antidepressant medication.
- Use of medication at the screening visit which can interfere with SPT results
- A clinical history of symptomatic perennial allergic rhinitis or asthma.
- History of allergy, hypersensitivity or intolerance to the excipients of IMP (except for Phleum pratense).
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- Systemic disease affecting the immune system (e.g. autoimmune disease, immune complex disease, or immune deficiency disease).
- Any clinically relevant chronic disease (≥ 3 months duration) (e.g. cystic fibrosis, malignancy, type I diabetes mellitus, malabsorption or malnutrition, renal or hepatic insufficiency).
- Inflammatory conditions in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis at randomisation.
- FEV1 ≤ 70% of predicted value.
- Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process at randomisation.
- Being immediate family of the investigator or trial staff.
- A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the trial, and/or evidence of an uncooperative attitude.
- Unlikely to be able to complete the trial, for any reason, or likely to move, or travel for extended periods of time during the trial period.
- Use of an investigational drug within 30 days or 5 half-lives, whichever is longest, prior to screening.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario de La Princesa
Madrid, 28006
Hospital Clínico Universitario San Carlos
Madrid, 28040
About this study
This trial is an exploratory randomised, parallel-group, double-blind, placebo- controlled, national, single-centre trial.
The trial will be initiated before 2013 grass pollen season and subjects will be randomised in September 2013 to receive active treatment (Grazax®) or placebo during 2 years. Placebo group will be treated 2 years with placebo and a third year with active therapy (Grazax®) and active group will continue the active treatment in the third year. In the last year, all placebo patients will be changed to active group and active and placebo patients will be informed about, but the trial will not be unblinded until the end of the third year and patients won´t know what treatment they were assigned to during the first 2 years.
Read the detailed description
There is a first stage of clinical trial (GT-20) in which ALK- Abelló is directly working into the MEICA project to explore human immunological mechanisms of SIT (observed after Grazax® treatment). In this trial, different potential biomarkers of early and sustained effect of specific immunotherapy have been identified. Therefore, for a further research, it was necessary to carry on a new clinical double blind placebo control trial to evaluate a selected panel of biomarkers that can be applied in the selection and monitoring of patients during immunotherapy. They can be of value in the evaluation of future product candidates for specific immunotherapy. For this purpose, it is necessary that the Biomarkers selected, clearly differentiate between active and placebo treated groups. Moreover, specific immunological changes differences between active and placebo patients during pollen seasons are unknown. This first study allowed us identifying a potential set of biomarkers and time points for each of them that might correlate with treatment effect. This second study is needed to evaluate the potential of these biomarkers to discriminate placebo treated patients and it is a necessary step before incorporating them in big prospective efficacy studies.
A third year in an active IMP design after the two years in a double blind placebo setup is included as a way to validate the differences observed intergroup during the first year of therapy. This is needed as pollen seasons significantly differ in strength and duration. Moreover, there is a unique opportunity of analysing immunological changes of the intervention before a careful baseline monitoring of patients undergoing placebo treatment, with the opportunity of understanding immunological clues in the natural evolution of allergy disease.
- Conditions
- Allergic Rhinitis Due to Grass Pollens
- Being tested
- Grazax, Placebo
- Keywords
- Allergy, Phleum pratense, Rhinoconjunctivitis, asthma, positive SPT to Phleum pratense
- Medical subject headings
- Hypersensitivity, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GrazaxDrug
GRAZAX
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| GRAZAX | Active comparator | Tablet 75.000SQ-T once daily Receives: Drug: Grazax |
| Placebo | Placebo comparator | Tablet with no active grass component Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cellular populations (neutrophils, eosinophils, basophils, monocytes, DCs and lymphocytes populations)
Measured: 2 years
Secondary outcomes (2)
Global improvement on the Visual Analogue Scale
Measured: 2 years
Number of participants with IMP related adverse events
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 posted15 May 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Rhinitis Due to Grass PollensStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- CARLOS BLANCO, MD, Principal investigator, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854736
- Sponsor's protocol ID
- GT-24
- Other IDs
- 2012-005092-14
- Status last verified
- Jun 2017
- First submitted
- 29 Apr 2013
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular and Cellular Mechanism in the Course of Immunotherapy With a Phleum Pratense Oral Lyophilisate
- ClinicalTrials.gov ID
- NCT01854736
- Acronym / sponsor ID
- GT-24
- Conditions
- Allergic Rhinitis Due to Grass Pollens
- Keywords
- Allergy, Phleum pratense, Rhinoconjunctivitis, asthma, positive SPT to Phleum pratense
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Study start
- Apr 2013 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 May 2013 (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 exploratory randomised, parallel-group, double-blind, placebo- controlled, national, single-centre trial.
The trial will be initiated before 2013 grass pollen season and subjects will be randomised in September 2013 to receive active treatment (Grazax®) or placebo during 2 years. Placebo group will be treated 2 years with placebo and a third year with active therapy (Grazax®) and active group will continue the active treatment in the third year. In the last year, all placebo patients will be changed to active group and active and placebo patients will be informed about, but the trial will not be unblinded until the end of the third year and patients won´t know what treatment they were assigned to during the first 2 years.
Detailed description
There is a first stage of clinical trial (GT-20) in which ALK- Abelló is directly working into the MEICA project to explore human immunological mechanisms of SIT (observed after Grazax® treatment). In this trial, different potential biomarkers of early and sustained effect of specific immunotherapy have been identified. Therefore, for a further research, it was necessary to carry on a new clinical double blind placebo control trial to evaluate a selected panel of biomarkers that can be applied in the selection and monitoring of patients during immunotherapy. They can be of value in the evaluation of future product candidates for specific immunotherapy. For this purpose, it is necessary that the Biomarkers selected, clearly differentiate between active and placebo treated groups. Moreover, specific immunological changes differences between active and placebo patients during pollen seasons are unknown. This first study allowed us identifying a potential set of biomarkers and time points for each of them that might correlate with treatment effect. This second study is needed to evaluate the potential of these biomarkers to discriminate placebo treated patients and it is a necessary step before incorporating them in big prospective efficacy studies.
A third year in an active IMP design after the two years in a double blind placebo setup is included as a way to validate the differences observed intergroup during the first year of therapy. This is needed as pollen seasons significantly differ in strength and duration. Moreover, there is a unique opportunity of analysing immunological changes of the intervention before a careful baseline monitoring of patients undergoing placebo treatment, with the opportunity of understanding immunological clues in the natural evolution of allergy disease.
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 |
|---|---|---|
| GRAZAX | Active comparator | Drug: GrazaxTablet 75.000SQ-T once daily |
| Placebo | Placebo comparator | Other: PlaceboTablet with no active grass component |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A history of grass pollen allergy
- Positive skin prick test to grass
- Positive specific IgE against Phl p 5
- Written informed consent before entering the trial.
- Female subjects who are fertile must have a negative pregnancy test and be willing to practise appropriate contraceptive methods.
Key exclusion criteria (15 listed)
- Previous treatment by immunotherapy with grass allergen extracts.
- Ongoing treatment with any allergen specific immunotherapy product.
- Previous or ongoing treatment with Omalizumab, mono amine oxidase (MAO) inhibitors or tricyclic antidepressant medication.
- Use of medication at the screening visit which can interfere with SPT results
- A clinical history of symptomatic perennial allergic rhinitis or asthma.
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 |
|---|---|---|
| GrazaxGRAZAX | Drug | GRAZAX |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Cellular populations (neutrophils, eosinophils, basophils, monocytes, DCs and lymphocytes populations)
Time frame: 2 years
2 secondary outcomes
Global improvement on the Visual Analogue Scale
Time frame: 2 years
Number of participants with IMP related adverse events
Time frame: 2 years
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 28 Jun 2017.
- Individual participant dataSharing planned: No
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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.
CARLOS BLANCO, MD principal investigator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Grazax in people with Allergic Rhinitis Due to Grass Pollens, run by ALK-Abelló A/S at 2 sites 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 6 inclusion and 15 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 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Cellular populations (neutrophils, eosinophils, basophils, monocytes, DCs and lymphocytes populations) (time frame: 2 years). 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 28 Jun 2017.