Allergic RhinoconjunctivitisPhase 4GT-20NCT02437786
Molecular and Cellular Mechanism in Rhinitis Allergic Patients Treated With GRAZAX®
A Phase 4 study testing GRAZAX in people with Allergic Rhinoconjunctivitis, run by ALK-Abelló A/S at 1 site in Spain.
Trial summary
The specific clinical trial is a part in which ALK- Abelló will directly work to explore human immunological mechanisms of SIT (observed after GRAZAX treatment). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinoconjunctivitis
- What is being tested?
- GRAZAX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2009to Dec 2014
- 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
- Written informed consent obtained before entering the trial.
- Male and female 18-65 years of age.
- A clinical history of relevant rhinitis or rhinoconjunctivitis (with/without concurrent asthma) to grass pollen of at least one year prior to trial entry.
- Documented positive specific IgE against grass pollen (IgE ≥ Class 2) into the 5 previous years.
- Positive Skin Prick Test response (wheal diameter ≥ 3 mm) to Phleum pratense.
- Negative pregnancy test for childbearing potential females.
- Willing and able to comply with the trial protocol regimen.
Who cannot join
- Previous treatment by immunotherapy with grass allergen extracts.
- A clinical history of symptomatic perennial allergic rhinitis or asthma.
- Patients with contraindications for immunotherapy as established by the IT subcommittee of the EAACI or in the Summary of Products Characteristics of GRAZAX®.
- Positive pregnancy test (in fertile females).
- 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
1 site in 1 country.
About this study
The specific clinical trial is a part in which ALK- Abelló will directly work to explore human immunological mechanisms of SIT (observed after GRAZAX treatment).
Read the detailed description
The main idea of the project was to address the study of some of the most important inflammatory diseases (psoriasis, rheumatoid arthritis, lupus, rhinitis/asthma… ) with the aim of identifying novel inflammatory markers.
- Conditions
- Allergic Rhinoconjunctivitis
- Being tested
- GRAZAX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRAZAXDrug
GRAZAX
| Study group | Role | What they receive |
|---|---|---|
| GRAZAX | Experimental | GRAZAX Receives: Drug: GRAZAX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in immunological markers (composite) measured in grass allergic subjects during treatment with Grazax®
Measured: 5 years
Secondary outcomes (1)
Number of participants with IMP related adverse events
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startSep 2009
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- CARLOS BLANCO, PhD, Principal investigator, HOSPITAL UNIVERSITARIO DE LA PRINCESA MADRID
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437786
- Sponsor's protocol ID
- GT-20
- Acronym
- GT-20
- Status last verified
- Jan 2018
- First submitted
- 5 Jan 2015
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Suarez-Fueyo A, Ramos T, Galan A, Jimeno L, Wurtzen PA, Marin A, de Frutos C, Blanco C, Carrera AC, Barber D, Varona R. Grass tablet sublingual immunotherapy downregulates the TH2 cytokine response followed by regulatory T-cell generation. J Allergy Clin Immunol. 2014 Jan;133(1):130-8.e1-2. doi: 10.1016/j.jaci.2013.09.043. Epub 2013 Nov 28.
PubMed 24290282
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
- Molecular and Cellular Mechanism in Rhinitis Allergic Patients Treated With GRAZAX®
- ClinicalTrials.gov ID
- NCT02437786
- Acronym / sponsor ID
- GT-20 / GT-20
- Conditions
- Allergic Rhinoconjunctivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 May 2015 (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 specific clinical trial is a part in which ALK- Abelló will directly work to explore human immunological mechanisms of SIT (observed after GRAZAX treatment).
Detailed description
The main idea of the project was to address the study of some of the most important inflammatory diseases (psoriasis, rheumatoid arthritis, lupus, rhinitis/asthma… ) with the aim of identifying novel inflammatory markers.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GRAZAX | Experimental | Drug: GRAZAXGRAZAX |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent obtained before entering the trial.
- Male and female 18-65 years of age.
- A clinical history of relevant rhinitis or rhinoconjunctivitis (with/without concurrent asthma) to grass pollen of at least one year prior to trial entry.
- Documented positive specific IgE against grass pollen (IgE ≥ Class 2) into the 5 previous years.
- Positive Skin Prick Test response (wheal diameter ≥ 3 mm) to Phleum pratense.
Key exclusion criteria (8 listed)
- Previous treatment by immunotherapy with grass allergen extracts.
- A clinical history of symptomatic perennial allergic rhinitis or asthma.
- Patients with contraindications for immunotherapy as established by the IT subcommittee of the EAACI or in the Summary of Products Characteristics of GRAZAX®.
- Positive pregnancy test (in fertile females).
- Being immediate family of the investigator or trial staff.
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 |
Primary outcome
Changes in immunological markers (composite) measured in grass allergic subjects during treatment with Grazax®
Time frame: 5 years
1 secondary outcome
Number of participants with IMP related adverse events
Time frame: 5 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 17 Jan 2018.
- Results publication: PubMed 24290282Suarez-Fueyo A, Ramos T, Galan A, Jimeno L, Wurtzen PA, Marin A, de Frutos C, Blanco C, Carrera AC, Barber D, Varona R. Grass tablet sublingual immunotherapy downregulates the TH2 cytokine response followed by regulatory T-cell generation. J Allergy Clin Immunol. 2014 Jan;133(1):130-8.e1-2. doi: 10.1016/j.jaci.2013.09.043. Epub 2013 Nov 28.
- 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, PhD principal investigator
HOSPITAL UNIVERSITARIO DE LA PRINCESA MADRID
1 site 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 Rhinoconjunctivitis, 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 7 inclusion and 8 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 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 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 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?
Changes in immunological markers (composite) measured in grass allergic subjects during treatment with Grazax® (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02437786, which also lists 1 linked publication.
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.