Type I HypersensitivityPhase 2NCT00133159
Different Doses of Tyrosine Adsorbed Grass Pollen Allergoid With Monophosphoryl Lipid A (MPL) in Patients Sensitized to Grass Pollen
A Phase 2 study testing Grass MATAMPL in people with Type I Hypersensitivity, run by Allergy Therapeutics at 3 sites in Canada.
Trial summary
Allergen-specific immunotherapy (SIT), the administration of gradually increasing quantities of an allergen extract to an allergic patient, is a curative approach which directly treats the underlying allergic disease. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Type I Hypersensitivity
- What is being tested?
- Grass MATAMPL
- How many people
- 68 participants
- Where
- 3 sitesCanada
- Study dates
- 12 Sep 2005to 8 Nov 2005
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- positive skin prick test for grass and rye allergen
- Specific IgE for grass and rye as documented by radioallergosorbent or equivalent test with class >= 2
- History of at least 1 season of moderate to severe seasonal rhinoconjunctivitis due to an IgE - mediated allergy to pollen from grass and rye
- Males or non-pregnant, non-lactating females who are post-menopausal or naturally or surgically sterile. Females of childbearing potential have a confirmed absence of pregnancy according to a negative urine pregnancy test and must be using an acceptable birth control method.
- Spirometry at Screening demonstrates FEV1 >= 80% predicted and FEV1/FVC >= 70%
Who cannot join
- Acute or subacute atopic dermatitis and/or urticaria factitia and/or urticaria due to physical or chemical influence and/or chronic dermatitis
- Patient has moderate to severe asthma
- Visual inspection of the forearms indicates potential problems with the conduct or interpretation of the skin prick test; both forearms must be available for testing
- History or presence of diabetes, cancer or any clinically significant cardiac, metabolic renal, hematologic diseases or disorders
- Recent clinically significant history (within 2 years) of hepatic gastrointestinal, dermatologic, venereal, neurologic or psychiatric diseases or disorders
- Any clinically significant (as determined by the investigator) abnormal laboratory value
Show all 25Show fewer
- Perennial allergens: clinically relevant sensitivity against house dust mites, molds, and epithelia
- Patient has clinically relevant sensitivity against the following summer/autumn season flowering plants: plantain, orache, nettle, mugwort, Bermuda grass, or ragweed.
- Secondary alteration at the affected organ
- History of autoimmune diseases and/or rheumatoid diseases
- Patient is taking b-blockers
- Patient who is not allowed to receive adrenalin
- Patients in whom tyrosine metabolism is disturbed
- Presence of a disease with a pathogenesis interfering with the immune response and patient has received medication which could influence the results of this study
- Documented evidence of acute or significant chronic infection
- History of anaphylaxis
- Documented history of angioedema
- Hypersensitivity to excipients in the study medications
- Previous or current immunotherapy with comparable grass/rye allergen extracts
- Currently using anti-allergy medication and other drugs with antihistaminic activity
- Patients currently participating in a clinical trial or who have been exposed to study medication within the last 30 days
- Patient is pregnant or planning pregnancy and/or lactating
- Patient has received treatment with preparation containing MPL® during the past 12 months
- Any systemic disorder that could interfere with the evaluation of the study medication(s)
- Clinical history of drug or alcohol abuse that would interfere with the patient's participation in the study
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Allied Research International Inc.
Mississauga, Ontario, L4W 1N2
Study site
Mississauga, Ontario, L5B 1N1
Ottawa Allergy Research Corporation
Ottawa, Ontario, K1Y 4G2
About this study
Official title: A Double-Blind Phase IIb Study to Evaluate the Safety and Efficacy of Different Doses of Tyrosine Adsorbed Grass/Rye Pollen Allergoid With MPL in Patients Sensitized to Grass and Rye Pollen
Allergen-specific immunotherapy (SIT), the administration of gradually increasing quantities of an allergen extract to an allergic patient, is a curative approach which directly treats the underlying allergic disease. GrassMATAMPL has been developed to provide pre-seasonal specific immunotherapy for patients with an allergy to grass pollen (hay fever). The purpose of this double-blind Phase IIb study is to assess the tolerability and immunogenicity of different doses of GrassMATAMPL in volunteers allergic to grasses and rye pollen.
- Conditions
- Type I Hypersensitivity
- Being tested
- Grass MATAMPL
- Keywords
- Allergy, Specific Immunotherapy
- Medical subject headings
- Hypersensitivity, Immediate, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grass MATAMPLBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
immunological response to the three GrassMATAMPL treatment arms compared to placebo (grass specific)
Secondary outcomes (6)
tolerability of different subcutaneous doses
tolerability of the cumulative subcutaneous doses
clinical chemistry and hematology
number of adverse events
number of adverse reactions
immunological response to the three GrassMATAMPL treatment arms compared to placebo (rye specific)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2005 (estimated)
- Study start12 Sep 2005
- Primary completion8 Nov 2005
- Study completion8 Nov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type I HypersensitivityStudies 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
- Double blind
- Enrolment
- 68 participants
Sponsor and investigators
- Lead sponsor
- Allergy Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kemi Oluwayi, MD, Study chair, Allergy Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133159
- Sponsor's protocol ID
- GrassMATAMPL203
- Other IDs
- P2DP5005
- Status last verified
- May 2021
- First submitted
- 22 Aug 2005
- Last updated
- 18 May 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Phase IIb Study to Evaluate the Safety and Efficacy of Different Doses of Tyrosine Adsorbed Grass/Rye Pollen Allergoid With MPL in Patients Sensitized to Grass and Rye Pollen
- ClinicalTrials.gov ID
- NCT00133159
- Acronym / sponsor ID
- GrassMATAMPL203
- Conditions
- Type I Hypersensitivity
- Keywords
- Allergy, Specific Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants
- Lead sponsor
- Allergy TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2005 (actual)
- Primary completion
- 8 Nov 2005 (actual)
- Study completion
- 8 Nov 2005 (actual)
- First posted
- 23 Aug 2005 (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.
Allergen-specific immunotherapy (SIT), the administration of gradually increasing quantities of an allergen extract to an allergic patient, is a curative approach which directly treats the underlying allergic disease. GrassMATAMPL has been developed to provide pre-seasonal specific immunotherapy for patients with an allergy to grass pollen (hay fever). The purpose of this double-blind Phase IIb study is to assess the tolerability and immunogenicity of different doses of GrassMATAMPL in volunteers allergic to grasses and rye pollen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- positive skin prick test for grass and rye allergen
- Specific IgE for grass and rye as documented by radioallergosorbent or equivalent test with class >= 2
- History of at least 1 season of moderate to severe seasonal rhinoconjunctivitis due to an IgE - mediated allergy to pollen from grass and rye
- Males or non-pregnant, non-lactating females who are post-menopausal or naturally or surgically sterile. Females of childbearing potential have a confirmed absence of pregnancy according to a negative urine pregnancy test and must be using an acceptable birth control method.
- Spirometry at Screening demonstrates FEV1 >= 80% predicted and FEV1/FVC >= 70%
Key exclusion criteria (25 listed)
- Acute or subacute atopic dermatitis and/or urticaria factitia and/or urticaria due to physical or chemical influence and/or chronic dermatitis
- Patient has moderate to severe asthma
- Visual inspection of the forearms indicates potential problems with the conduct or interpretation of the skin prick test; both forearms must be available for testing
- History or presence of diabetes, cancer or any clinically significant cardiac, metabolic renal, hematologic diseases or disorders
- Recent clinically significant history (within 2 years) of hepatic gastrointestinal, dermatologic, venereal, neurologic or psychiatric diseases or disorders
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 |
|---|---|---|
| Grass MATAMPL | Biological | – |
Primary outcome
immunological response to the three GrassMATAMPL treatment arms compared to placebo (grass specific)
6 secondary outcomes
tolerability of different subcutaneous doses
tolerability of the cumulative subcutaneous doses
clinical chemistry and hematology
number of adverse events
number of adverse reactions
immunological response to the three GrassMATAMPL treatment arms compared to placebo (rye specific)
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 18 May 2021.
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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.
Kemi Oluwayi, MD study chair
Allergy Therapeutics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Grass MATAMPL in people with Type I Hypersensitivity, run by Allergy Therapeutics at 3 sites 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 5 inclusion and 25 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 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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?
immunological response to the three GrassMATAMPL treatment arms compared to placebo (grass specific). 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 18 May 2021.