Seasonal Allergic RhinitisPhase 3NCT02245360
Study Immunology and Safety of 60-day Treatment of SQ Grass SLIT (Sublingual Immunotherapy)-Tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis
A Phase 3 study testing Phleum pratense grass pollen allergen extract in people with Seasonal Allergic Rhinitis, run by Abbott at 15 sites in Russia.
Trial summary
To investigate the immunologic effects and safety of 60-day treatment of the Standardized Quality units (SQ) grass Sublingual immunotherapy (SLIT)-tablet in adult subjects with grass pollen-induced allergic rhinoconjunctivitis in a double-blind, placebo-controlled study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Phleum pratense grass pollen allergen extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 15 sitesRussia
- Study dates
- Oct 2014to Mar 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- clinical history consistent with grass pollen-induced allergic rhinoconjunctivitis.
- Use of symptomatic treatment of grass pollen-induced allergic rhinoconjunctivitis.
- Positive skin prick test response (wheal diameter ≥3 mm) to Phleum pratense.
- If asthma, daily use of Inhaled corticosteroid (ICS) should be ≤400 microgram budesonide or equivalent
- Moderate or higher level of Phleum pratense specific IgE (Immunoglobulin E) (defined as ≥IgE Class 2; or ≥0.70 Kilo Units/liter (kU/L))
Who cannot join
- Reduced lung function (defined as FEV1 < 70% (FEV1=Forced Expiratory Volume in 1 second) of predicted value after adequate pharmacologic treatment) measured at Visit 1 and Visit 2
- Clinical history of uncontrolled asthma within 3 months prior to the screening visit
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Russia15 sites
Research facility ID ORG-001086
Moscow, 105077
Research facility ID ORG-001018
Moscow, 115446
Research facility ID ORG-001005
Moscow, 115478
Research facility ID ORG-001009
Moscow, 119333
Research facility ID ORG-001016
Moscow, 119991
Research facility ID ORG-001006
Moscow, 123182
Research facility ID ORG-001085
Moscow, 123182
Research facility ID ORG-001014
Moscow, 142190
Research facility ID ORG-001007
Saint Petersburg, 193231
Research facility ID ORG-001019
Saint Petersburg, 195030
Research facility ID ORG-001008
Saint Petersburg, 198216
Research facility ID ORG-001015
Samara, 443099
Research facility ID ORG-001021
Saratov, 410028
Research facility ID ORG-001017
Smolensk, 214019
Research facility ID ORG-001020
Ufa, 450000
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the SQ Grass SLIT-tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis
To investigate the immunologic effects and safety of 60-day treatment of the Standardized Quality units (SQ) grass Sublingual immunotherapy (SLIT)-tablet in adult subjects with grass pollen-induced allergic rhinoconjunctivitis in a double-blind, placebo-controlled study.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Phleum pratense grass pollen allergen extract, placebo
- Keywords
- GRAZAX
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phleum pratense grass pollen allergen extractDrug
Also called GRAZAX/GRASTEK
Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days
placeboDrug
placebo tablet given once daily over 60 days
| Study group | Role | What they receive |
|---|---|---|
| Grass tablet 75,000 SQ-T | Experimental | Grass tablet 75,000 Standardized Quality units Tablet (SQ-T) Receives: Drug: Phleum pratense grass pollen allergen extract |
| Placebo | Placebo comparator | Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum
measurement of IgG4 in serum
Measured: baseline versus end of treatment (approx. 60 days)
Secondary outcomes (1)
Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment
measurement of IgE in serum
Measured: baseline versus end of treatment (approx. 60 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Seasonal Allergic RhinitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dmitri Kazei, MD PhD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245360
- Sponsor's protocol ID
- GRAS3001
- Status last verified
- Dec 2015
- First submitted
- 17 Sep 2014
- Last updated
- 11 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the SQ Grass SLIT-tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT02245360
- Acronym / sponsor ID
- GRAS3001
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- GRAZAX
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 19 Sep 2014 (estimated)
- Results
- Posted 8 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the immunologic effects and safety of 60-day treatment of the Standardized Quality units (SQ) grass Sublingual immunotherapy (SLIT)-tablet in adult subjects with grass pollen-induced allergic rhinoconjunctivitis in a double-blind, placebo-controlled study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grass tablet 75,000 SQ-T | Experimental | Drug: Phleum pratense grass pollen allergen extractGrass tablet 75,000 Standardized Quality units Tablet (SQ-T) |
| Placebo | Placebo comparator | Drug: placeboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- clinical history consistent with grass pollen-induced allergic rhinoconjunctivitis.
- Use of symptomatic treatment of grass pollen-induced allergic rhinoconjunctivitis.
- Positive skin prick test response (wheal diameter ≥3 mm) to Phleum pratense.
- If asthma, daily use of Inhaled corticosteroid (ICS) should be ≤400 microgram budesonide or equivalent
- Moderate or higher level of Phleum pratense specific IgE (Immunoglobulin E) (defined as ≥IgE Class 2; or ≥0.70 Kilo Units/liter (kU/L))
Key exclusion criteria (2 listed)
- Reduced lung function (defined as FEV1 < 70% (FEV1=Forced Expiratory Volume in 1 second) of predicted value after adequate pharmacologic treatment) measured at Visit 1 and Visit 2
- Clinical history of uncontrolled asthma within 3 months prior to the screening visit
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 |
|---|---|---|
| Phleum pratense grass pollen allergen extractAlso: GRAZAX/GRASTEKAllergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days | Drug | Grass tablet 75,000 SQ-T |
| placeboplacebo tablet given once daily over 60 days | Drug | Placebo |
Primary outcome
The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum
Time frame: baseline versus end of treatment (approx. 60 days)
measurement of IgG4 in serum
1 secondary outcome
Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment
Time frame: baseline versus end of treatment (approx. 60 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Dmitri Kazei, MD PhD study director
Abbott
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Phleum pratense grass pollen allergen extract in people with Seasonal Allergic Rhinitis, run by Abbott at 15 sites in Russia.
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 5 inclusion and 2 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 11 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 15 sites in Russia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum (time frame: baseline versus end of treatment (approx. 60 days)). 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 11 Jan 2016.