Type I HypersensitivityPhase 2NCT00387478
Investigation of Efficacy and Safety of Tree MATAMPL,Tree MATA, and Placebo in Patients With Birch-Induced Seasonal Allergic Rhinitis
A Phase 2 study testing Tree MATA MPL or Tree MATA in people with Type I Hypersensitivity, run by Allergy Therapeutics at 1 site in Canada.
Trial summary
Tree MATAMPL has been developed to provide pre-seasonal specific immunotherapy for patients with hypersensitivity to Tree (birch, alder, hazel) pollen (hay fever). This novel formulation is designed to provide a vaccine that will be efficacious with only four escalating dose injections administered before the start of… 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?
- Tree MATA MPL or Tree MATA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2006to Jul 2007
- 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
- Patients must be male or female and aged 18 to 50 years inclusive.
- Patients must have at least a two-year clinical history of SAR due to birch pollen allergy.
- Patients must have allergy to tree pollen allergen, defined by positive case history and positive skin prick test for tree pollen allergen (wheals of ≥ 5 mm (birch) and ≥ 3 mm (hazel and alder) greater than the negative control after skin prick testing) at Visit 1. Patients who will be skin tested at Visit 1 must adhere to the washout time for antihistamines.
- Specific IgE for birch tree pollen as documented by a radioallergosorbent test (RAST), or equivalent test, with class ≥ 2.
- Patients must obtain minimum qualifying symptom scores on the final two pre-treatment birch pollen exposure sessions (Visits 4 and 5) to be enrolled into the study. Minimum qualifying symptom scores are defined as a TSS of at least 12 out of a possible 24 and a NSS of at least 7 out of a possible 12 on at least one symptom diary card on each of Visits 4 and 5. Furthermore, a minimum priming criteria for NSS of 7 out of a possible 12, including a score of at least 2 for runny nose, on two diary cards during each of Visits 4 and 5, must be obtained.
- Patients must observe the drug washout times prior to Screening (Visit 1). The use of other medications will be permitted if they are not expected to interfere with the ability of the patient to participate in the study and provided they have been on a stable regimen (i.e., the same dosage and administration) for six weeks prior to Screening.
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- Males or non-pregnant, non-lactating females who are post-menopausal or naturally or surgically sterile (hysterectomy; bilateral oophorectomy; bilateral tubal ligation with surgery at least 6 weeks prior to study initiation). Postmenopausal is defined as at least 12 months natural spontaneous amenorrhea, or at least six weeks following surgical menopause (bilateral oophorectomy). Females of childbearing potential should be using one of the following acceptable birth control methods:Intrauterine device (IUD) in place for at least 3 months;Barrier method (condom or diaphragm) with spermicide; Stable hormonal contraceptive for at least 3 months prior to study and through study completion;Abstinence; Non-heterosexual lifestyle.
- Patients who are normally active and otherwise judged to be in good health on the basis of medical history, physical examination and routine laboratory tests.
- Patients must be willing and able to give written informed consent and must provide this consent.
- Patients must be willing and able to attend required study visits. 11.Patients must be able to follow instructions.
Who cannot join
- A patient will not be included in this study if one or more of the following criteria apply:
- Have a positive skin prick test [wheal (longest diameter) ≥ 3 mm greater than the negative control] at Visit 1 to any of the following perennial allergens: house dust mites (Dermatophagoides pteronyssinus and Dermatophagoides farinae), molds (Cladosporium cladosporioides, Alternaria alternata, Penicillium chyrsogenum (notatum), and Aspergillus fumigatus), or epithelia (cat, dog, and horse). In these cases, a careful history is to be taken and if moderate or severe symptoms are reported when exposed to the aforementioned allergens, the subject is to be excluded. Exception: the source of the allergen (cat, dog, horse) can be avoided for the entire study. Subjects with mild or no symptoms when exposed to the aforementioned allergens during the 3 years prior to Visit 1 will be allowed to enroll. Mild symptoms are defined as: sign/symptom clearly present, but minimal awareness, easily tolerated.
- Concurrent disease that might complicate or interfere with investigation or evaluation of the study medications or the skin prick test result, such as:
- Rhinitis medicamentosa; Large obstructive nasal polyps; Documented evidence of acute or significant chronic sinusitis, or upper respiratory tract infection as determined by the individual Investigator; Asthma, with the exception of mild intermittent asthma, to lessen confounding by asthma medications; History of hospitalization for asthma; History or presence of acute or subacute atopic dermatitis, chronic dermatitis, urticaria factitia, or urticaria due to physical/chemical influence.
- Current diagnosis of seasonal asthma caused by tree pollen exposure.
- Concurrent use or inadequate washout of any prohibited medication.
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- Chronic or intermittent use of inhaled, nasal, ocular, oral, intramuscular, intravenous, or potent or super-potent topical corticosteroids (as assessed by the Investigator).
- Chronic use of long acting antihistamines and other concomitant medications (e.g., tricyclic antidepressants) that would affect assessment of the effectiveness of study drug(s).
- Are pregnant or lactating.
- Any systemic disorder that could interfere with the evaluation of the study medication(s).
- Upper or lower respiratory infection requiring antibiotics within 14 days of Visit 2.
- Diagnosis of sinusitis within 30 days of Visit 2.
- Any ocular disorder (other than allergic conjunctivitis) including presumed infectious ocular disease (bacterial, fungal, viral, etc.), which could interfere with the evaluation of the study medication.
- Hypersensitivity to the study drug(s) excipients.
- Patients with active or quiescent tuberculous infection of the respiratory tract, untreated local or systemic fungal or bacterial or systemic viral infections or parasitic or ocular herpes simplex.
- Patients who have experienced nasal septal ulcers, nasal surgery or nasal trauma within 90 days of enrollment into this study.
- Clinical history of anaphylaxis or idiopathic anaphylaxis.
- Patients with a clinical history of immunodeficiency, including those who are on immunosuppressant therapy.
- Patients with an auto-immune disease (e.g. of liver, kidney, thyroid, nervous system)
- Patients with a history of angioedema
- Patients in whom tyrosine metabolism is disturbed, especially in the case of tyrosinemia and alkaptonuria.
- Patients with contraindications to adrenaline.
- Patients taking β-blockers, including eye drops, for any indication.
- Patients taking Monoamine Oxidase Inhibitors
- Current diagnosis of chickenpox or measles.
- Clinical history of drug or alcohol abuse which would, at the Investigator's discretion, interfere with the patient's participation in the study.
- Clinical history of severe or uncontrolled cardiovascular, pulmonary, hepatic, renal and/or other disease/illness that could be expected to interfere with the study.
- Clinical history, or evidence, of nasolacrimal drainage system malfunction.
- Study site staff or immediate relatives of study site staff or other individuals who would have access to the clinical study protocol.
- Patient that has received TreeMATAMPL in any previous clinical trial.
- History of immunotherapy with tree pollen extract, except if treatment was successfully completed 3 years prior to Visit 1 and SAR symptoms had reappeared prior to Visit 1.
- Patient received treatment with preparation containing MPL during the past 12 months.
- Participation in any other investigational study within 30 days before Visit 1 or concomitantly with this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind Study to Investigate the Clinical Efficacy and Safety of TreeMATAMPL (Allergy Therapeutics, (UK) Ltd.), TreeMATA (Allergy Therapeutics, (UK) Ltd.) and Placebo in Patients With Seasonal Allergic Rhinitis Due to Birch Pollen Allergy, in an Environmental Exposure Chamber (EEC) Model When Exposed to Birch Pollen and Oak Pollen
Tree MATAMPL has been developed to provide pre-seasonal specific immunotherapy for patients with hypersensitivity to Tree (birch, alder, hazel) pollen (hay fever). This novel formulation is designed to provide a vaccine that will be efficacious with only four escalating dose injections administered before the start of the pollen season. In this Study the Efficacy will be assessed by exposing allergic subjects to birch pollen in an environmental exposure chamber EEC. Patient symptomatic response to birch pollen and patient quality of life in the EEC will be determined.
- Conditions
- Type I Hypersensitivity
- Being tested
- Tree MATA MPL or Tree MATA
- Keywords
- Allergy, Specific Immunotherapy, Tree, Environmental Exposure Chamber
- 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.
Tree MATA MPL or Tree MATABiological
4 injections of increasing dose strength for Tree MATA MPL or Tree MATA:
- 600 SU/0.5 ml
- 1600 SU/0.5 ml
- 4000 SU/0.5 ml
- 4000 SU/0.6 ml
4 injections of 0.5 mL of 2% w/v L-tyrosine for Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | modified Tree pollen allergen absorbed to Tyrosine and containing MPL adjuvant Receives: Biological: Tree MATA MPL or Tree MATA |
| 2 | Experimental | modified Tree pollen allergen absorbed to Tyrosine Receives: Biological: Tree MATA MPL or Tree MATA |
| Placebo | Placebo comparator | 4 injections of placebo 0.5 ml (2% tyrosine) Receives: Biological: Tree MATA MPL or Tree MATA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the clinical efficacy as measured by Total Symptom Scores (TSS) of TreeMATAMPL versus placebo in reducing Allergic Rhinitis (AR) symptoms caused by birch tree pollen in an Environmental Exposure Chamber (EEC) Model.
Measured: about 10 weeks
Secondary outcomes (8)
Assess the clinical efficacy of TreeMATAMPL versus placebo and TreeMATA in reducing AR symptoms caused by birch and oak tree pollen in an EEC model
Measured: about 10 weeks
Assess the responder/non-responder rate in TSS, NSS and NNSS of TreeMATAMPL versus placebo and TreeMATAMPL versus TreeMATA
Measured: about 10 weeks
Evaluate the correlation between TSS obtained during the baseline birch EEC session compared to baseline oak EEC session
Measured: about 10 weeks
Evaluate the correlation between the TSS change observed (baseline to post treatment) during the birch EEC sessions compared to oak EEC sessions
Measured: about 10 weeks
Assess the correlation between the percentage of positive skin prick test results between birch pollen and the following tree pollen: Oak, ash, red maple, poplar, black walnut, beech, sycamore and American elm
Measured: during screening period (normally 1 day)
Assess the immunological response to TreeMATAMPL versus placebo and for TreeMATAMPL versus TreeMATA immunotherapy in patients with SAR.
Measured: IgG (IgG/IgG4) levels will be assessed after V1, 14, 21
Evaluate the impact of TreeMATAMPL versus placebo and for TreeMATAMPL versus TreeMATA on quality-of-life in patients with SAR using the Rhinoconjunctivitis Quality of Life Questionnaire for use in the EEC.
Measured: about 10 weeks
Assess the safety and tolerability of TreeMATAMPL versus placebo and TreeMATAMPL versus TreeMATA in patients with SAR.
Measured: about 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionJul 2007
- Study completionJul 2007
Why it stopped: Enrollement target could not be achieved, study will not resume
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
- Who is masked
- Participant, Investigator
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergy Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Deepen Patel, MD, CCFP, Principal investigator, Allied Research International Inc, Mississauga, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00387478
- Sponsor's protocol ID
- TreeMATAMPL204
- Other IDs
- P2DP06002
- Status last verified
- Nov 2020
- First submitted
- 12 Oct 2006
- Last updated
- 30 Nov 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Study to Investigate the Clinical Efficacy and Safety of TreeMATAMPL (Allergy Therapeutics, (UK) Ltd.), TreeMATA (Allergy Therapeutics, (UK) Ltd.) and Placebo in Patients With Seasonal Allergic Rhinitis Due to Birch Pollen Allergy, in an Environmental Exposure Chamber (EEC) Model When Exposed to Birch Pollen and Oak Pollen
- ClinicalTrials.gov ID
- NCT00387478
- Acronym / sponsor ID
- TreeMATAMPL204
- Conditions
- Type I Hypersensitivity
- Keywords
- Allergy, Specific Immunotherapy, Tree, Environmental Exposure Chamber
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollement target could not be achieved, study will not resume
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Allergy TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2006 (actual)
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 13 Oct 2006 (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.
Tree MATAMPL has been developed to provide pre-seasonal specific immunotherapy for patients with hypersensitivity to Tree (birch, alder, hazel) pollen (hay fever). This novel formulation is designed to provide a vaccine that will be efficacious with only four escalating dose injections administered before the start of the pollen season. In this Study the Efficacy will be assessed by exposing allergic subjects to birch pollen in an environmental exposure chamber EEC. Patient symptomatic response to birch pollen and patient quality of life in the EEC will be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Tree MATA MPL or Tree MATAmodified Tree pollen allergen absorbed to Tyrosine and containing MPL adjuvant |
| 2 | Experimental | Biological: Tree MATA MPL or Tree MATAmodified Tree pollen allergen absorbed to Tyrosine |
| Placebo | Placebo comparator | Biological: Tree MATA MPL or Tree MATA4 injections of placebo 0.5 ml (2% tyrosine) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Patients must be male or female and aged 18 to 50 years inclusive.
- Patients must have at least a two-year clinical history of SAR due to birch pollen allergy.
- Patients must have allergy to tree pollen allergen, defined by positive case history and positive skin prick test for tree pollen allergen (wheals of ≥ 5 mm (birch) and ≥ 3 mm (hazel and alder) greater than the negative control after skin prick testing) at Visit 1. Patients who will be skin tested at Visit 1 must adhere to the washout time for antihistamines.
- Specific IgE for birch tree pollen as documented by a radioallergosorbent test (RAST), or equivalent test, with class ≥ 2.
- Patients must obtain minimum qualifying symptom scores on the final two pre-treatment birch pollen exposure sessions (Visits 4 and 5) to be enrolled into the study. Minimum qualifying symptom scores are defined as a TSS of at least 12 out of a possible 24 and a NSS of at least 7 out of a possible 12 on at least one symptom diary card on each of Visits 4 and 5. Furthermore, a minimum priming criteria for NSS of 7 out of a possible 12, including a score of at least 2 for runny nose, on two diary cards during each of Visits 4 and 5, must be obtained.
Key exclusion criteria (33 listed)
- A patient will not be included in this study if one or more of the following criteria apply:
- Have a positive skin prick test [wheal (longest diameter) ≥ 3 mm greater than the negative control] at Visit 1 to any of the following perennial allergens: house dust mites (Dermatophagoides pteronyssinus and Dermatophagoides farinae), molds (Cladosporium cladosporioides, Alternaria alternata, Penicillium chyrsogenum (notatum), and Aspergillus fumigatus), or epithelia (cat, dog, and horse). In these cases, a careful history is to be taken and if moderate or severe symptoms are reported when exposed to the aforementioned allergens, the subject is to be excluded. Exception: the source of the allergen (cat, dog, horse) can be avoided for the entire study. Subjects with mild or no symptoms when exposed to the aforementioned allergens during the 3 years prior to Visit 1 will be allowed to enroll. Mild symptoms are defined as: sign/symptom clearly present, but minimal awareness, easily tolerated.
- Concurrent disease that might complicate or interfere with investigation or evaluation of the study medications or the skin prick test result, such as:
- Rhinitis medicamentosa; Large obstructive nasal polyps; Documented evidence of acute or significant chronic sinusitis, or upper respiratory tract infection as determined by the individual Investigator; Asthma, with the exception of mild intermittent asthma, to lessen confounding by asthma medications; History of hospitalization for asthma; History or presence of acute or subacute atopic dermatitis, chronic dermatitis, urticaria factitia, or urticaria due to physical/chemical influence.
- Current diagnosis of seasonal asthma caused by tree pollen exposure.
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 |
|---|---|---|
| Tree MATA MPL or Tree MATA4 injections of increasing dose strength for Tree MATA MPL or Tree MATA: 1. 600 SU/0.5 ml 2. 1600 SU/0.5 ml 3. 4000 SU/0.5 ml 4. 4000 SU/0.6 ml 4 injections of 0.5 mL of 2% w/v L-tyrosine for Placebo | Biological | 1, 2, Placebo |
Primary outcome
Assess the clinical efficacy as measured by Total Symptom Scores (TSS) of TreeMATAMPL versus placebo in reducing Allergic Rhinitis (AR) symptoms caused by birch tree pollen in an Environmental Exposure Chamber (EEC) Model.
Time frame: about 10 weeks
8 secondary outcomes
Assess the clinical efficacy of TreeMATAMPL versus placebo and TreeMATA in reducing AR symptoms caused by birch and oak tree pollen in an EEC model
Time frame: about 10 weeks
Assess the responder/non-responder rate in TSS, NSS and NNSS of TreeMATAMPL versus placebo and TreeMATAMPL versus TreeMATA
Time frame: about 10 weeks
Evaluate the correlation between TSS obtained during the baseline birch EEC session compared to baseline oak EEC session
Time frame: about 10 weeks
Evaluate the correlation between the TSS change observed (baseline to post treatment) during the birch EEC sessions compared to oak EEC sessions
Time frame: about 10 weeks
Assess the correlation between the percentage of positive skin prick test results between birch pollen and the following tree pollen: Oak, ash, red maple, poplar, black walnut, beech, sycamore and American elm
Time frame: during screening period (normally 1 day)
Assess the immunological response to TreeMATAMPL versus placebo and for TreeMATAMPL versus TreeMATA immunotherapy in patients with SAR.
Time frame: IgG (IgG/IgG4) levels will be assessed after V1, 14, 21
Evaluate the impact of TreeMATAMPL versus placebo and for TreeMATAMPL versus TreeMATA on quality-of-life in patients with SAR using the Rhinoconjunctivitis Quality of Life Questionnaire for use in the EEC.
Time frame: about 10 weeks
Assess the safety and tolerability of TreeMATAMPL versus placebo and TreeMATAMPL versus TreeMATA in patients with SAR.
Time frame: about 10 weeks
Results and safety
The study was stopped early (reason given: Enrollement target could not be achieved, study will not resume). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
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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.
Deepen Patel, MD, CCFP principal investigator
Allied Research International Inc, Mississauga, Canada
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 Tree MATA MPL or Tree MATA in people with Type I Hypersensitivity, run by Allergy Therapeutics 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 10 inclusion and 33 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 30 Nov 2020. 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: Enrollement target could not be achieved, study will not resume). 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?
Assess the clinical efficacy as measured by Total Symptom Scores (TSS) of TreeMATAMPL versus placebo in reducing Allergic Rhinitis (AR) symptoms caused by birch tree pollen in an Environmental Exposure Chamber (EEC) Model. (time frame: about 10 weeks). 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 30 Nov 2020.