Type I HypersensitivityPhase 2NCT00325338
Follow-up Investigation of Efficacy of Ragweed MATAMPL,and Placebo in Patients With Ragweed-induced Seasonal Allergic Rhinitis
A Phase 2 study testing Ragweed MATAMPL in people with Type I Hypersensitivity, run by Allergy Therapeutics at 1 site in Canada.
Trial summary
Ragweed MATAMPL has been developed to provide pre-seasonal specific immunotherapy for patients with hypersensitivity to ragweed 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type I Hypersensitivity
- What is being tested?
- Ragweed MATAMPL
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- May 2006to Jul 2006
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have completed both EEC periods of study P2DP5001; have had received either placebo or the top dose if they had been treated with Ragweed MATA MPL; and have had no major changes in medical history or health status since completing the study.
- Patients must be willing and able to give written informed consent and provide this consent prior to initiation of any study procedures, including initiation of washout of any concomitant medications.
- Patients must be willing and able to attend all study visits.
- Patients must observe the drug washout times listed in Table 3.2.3 prior to Screening (Visit 1). The use of other concomitant medications will be permitted if they are not expected to interfere with the ability of the patient to participate in the study and provided that they have been on a stable regimen (i.e. the same dose and schedule of administration) for eight weeks prior to screening).
- Women of childbearing potential must be using one of the following acceptable birth control methods:
- Intrauterine device (IUD) in place for at least three months;
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- Barrier method (condom or diaphragm) with spermicide;
- Stable hormonal contraceptive for at least three months prior to study and through study completion;
- Abstinence;
- Not-heterosexual lifestyle.
- Patients must be able to follow instructions
Who cannot join
- Symptomatic for allergic rhinitis or allergic conjunctivitis from allergy to grass or trees at Visit 1.
- Symptomatic for significant perennial rhinitis at Visit 1, as judged by the Investigator.
- Concurrent disease that might complicate or interfere with investigation or evaluation of the study medication such as:
- Chronic use of antihistamines and other concomitant medications (e.g. tricyclic antidepressants) that would affect assessment of the effectiveness of study drug.
- Any systemic disorder that could interfere with the evaluation of the study medication.
- Upper or lower respiratory tract infection requiring antibiotics with 14 days of Visit 2.
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- 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 drug.
- Hypersensitivity to the study drug excipients.
- Patients with active or quiescent tuberculous infection of the respiratory tract, untreated local or systemic fungal infection or bacterial or systemic viral infections or parasitic or ocular herpes simplex.
- Patients who have experienced nasal ulcers, nasal surgery or nasal trauma within 90 days of enrollment into this study.
- Clinical history of anaphylaxis or idiopathic anaphylaxis.
- Patients with contraindications for allergy vaccines.
- Patients with a clinical history of immunodeficiency, including those who are on immunosuppressant therapy.
- Patients in whom tyrosine metabolism is disturbed, especially in the case of tyrosinemia and alkaptonuria.
- Patients with contraindication to adrenaline.
- Subjects who are taking β-blockers for any indication including eye drops.
- Current diagnosis of chickenpox or measles.
- Clinical history of drug or alcohol abuse, at the Investigator's discretion, that would interfere with the patient's participation in the study.
- Clinical history of severe or uncontrolled cardiovascular, hepatic, renal and/or other diseases/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 who have participated in any other investigational study within 30 days of Visit 1 or concomitant with this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follow-up Study to Evaluate the Sustained Clinical Efficacy of Ragweed MATA MPL (Allergy Therapeutics®) in Patients With Ragweed-induced Seasonal Allergic Rhinitis Upon Re-exposure to Ragweed Pollen in an Environmental Exposure Chamber (EEC) Model, Approximately One Year After Pre-seasonal Treatment in 2005
Ragweed MATAMPL has been developed to provide pre-seasonal specific immunotherapy for patients with hypersensitivity to ragweed 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 Follow-up Study the Efficacy will be assessed by exposing allergic subjects to Ragweed pollen in an environmental exposure chamber EEC. Patient symptomatic response to pollen and patient quality of life in the EEC will be determined. Patients who previously completed two EEC portions of study Ragweed MATAMPL 204 and who had been treated with either Ragweed MATA MPL or Placebo before the 2005 ragweed season will be enrolled.
- Conditions
- Type I Hypersensitivity
- Being tested
- Ragweed MATAMPL
- Keywords
- Allergy, Specific Immunotherapy, Ragweed, 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.
Ragweed MATAMPLBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
to assess whether the efficacy of RagweedMATAMPL is maintained approximately one year later during the first EEC period of 2006
Secondary outcomes (8)
Determine whether the lack of efficacy observed for Ragweed MATA MPL in 2005 will manifest itself approximately one year later
Determine whether the immunoglobulin levels measured after treatment with Ragweed MATA MPL in 2005 have changed approximately one year later.
Determine whether the responses to the RQLQ-EEC measured after treatment with Ragweed MATA MPL in 2005 have changed approximately one year later.
Determine whether a second treatment in 2006 will modify the efficacy observed in 2005 and maintained approximately one year later in patients who had been treated with Ragweed MATA MPL.
Determine whether a second treatment in 2006 will modify the efficacy observed in 2005 and partially or completely lost approximately one year later in patients who had been treated with Ragweed MATA MPL
Determine whether a second treatment in 2006 will confer or improve the efficacy in patients who moderately responded or did not respond to Ragweed MATA MPL in 2005
Determine whether a second treatment in 2006 will modify the extent of the immunoglobulin response observed in 2005 in patients who had been treated with Ragweed MATA MPL
Determine whether a second treatment in 2006 will modify the responses to the RQLQ-EEC recorded before and after treatment in 2005
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2006 (estimated)
- Study startMay 2006
- Study completionJul 2006
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
- Single blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Allergy Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Deepen Patel, MD, Principal investigator, Allied Research International Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00325338
- Sponsor's protocol ID
- RagweedMATAMPL205
- Other IDs
- P2DP05007
- Status last verified
- Jun 2010
- First submitted
- 11 May 2006
- Last updated
- 17 Jun 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Study to Evaluate the Sustained Clinical Efficacy of Ragweed MATA MPL (Allergy Therapeutics®) in Patients With Ragweed-induced Seasonal Allergic Rhinitis Upon Re-exposure to Ragweed Pollen in an Environmental Exposure Chamber (EEC) Model, Approximately One Year After Pre-seasonal Treatment in 2005
- ClinicalTrials.gov ID
- NCT00325338
- Acronym / sponsor ID
- RagweedMATAMPL205
- Conditions
- Type I Hypersensitivity
- Keywords
- Allergy, Specific Immunotherapy, Ragweed, Environmental Exposure Chamber
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Allergy TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Study completion
- Jul 2006
- First posted
- 12 May 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.
Ragweed MATAMPL has been developed to provide pre-seasonal specific immunotherapy for patients with hypersensitivity to ragweed 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 Follow-up Study the Efficacy will be assessed by exposing allergic subjects to Ragweed pollen in an environmental exposure chamber EEC. Patient symptomatic response to pollen and patient quality of life in the EEC will be determined. Patients who previously completed two EEC portions of study Ragweed MATAMPL 204 and who had been treated with either Ragweed MATA MPL or Placebo before the 2005 ragweed season will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must have completed both EEC periods of study P2DP5001; have had received either placebo or the top dose if they had been treated with Ragweed MATA MPL; and have had no major changes in medical history or health status since completing the study.
- Patients must be willing and able to give written informed consent and provide this consent prior to initiation of any study procedures, including initiation of washout of any concomitant medications.
- Patients must be willing and able to attend all study visits.
- Patients must observe the drug washout times listed in Table 3.2.3 prior to Screening (Visit 1). The use of other concomitant medications will be permitted if they are not expected to interfere with the ability of the patient to participate in the study and provided that they have been on a stable regimen (i.e. the same dose and schedule of administration) for eight weeks prior to screening).
- Women of childbearing potential must be using one of the following acceptable birth control methods:
Key exclusion criteria (23 listed)
- Symptomatic for allergic rhinitis or allergic conjunctivitis from allergy to grass or trees at Visit 1.
- Symptomatic for significant perennial rhinitis at Visit 1, as judged by the Investigator.
- Concurrent disease that might complicate or interfere with investigation or evaluation of the study medication such as:
- Chronic use of antihistamines and other concomitant medications (e.g. tricyclic antidepressants) that would affect assessment of the effectiveness of study drug.
- Any systemic disorder that could interfere with the evaluation of the study medication.
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 |
|---|---|---|
| Ragweed MATAMPL | Biological | – |
Primary outcome
to assess whether the efficacy of RagweedMATAMPL is maintained approximately one year later during the first EEC period of 2006
8 secondary outcomes
Determine whether the lack of efficacy observed for Ragweed MATA MPL in 2005 will manifest itself approximately one year later
Determine whether the immunoglobulin levels measured after treatment with Ragweed MATA MPL in 2005 have changed approximately one year later.
Determine whether the responses to the RQLQ-EEC measured after treatment with Ragweed MATA MPL in 2005 have changed approximately one year later.
Determine whether a second treatment in 2006 will modify the efficacy observed in 2005 and maintained approximately one year later in patients who had been treated with Ragweed MATA MPL.
Determine whether a second treatment in 2006 will modify the efficacy observed in 2005 and partially or completely lost approximately one year later in patients who had been treated with Ragweed MATA MPL
Determine whether a second treatment in 2006 will confer or improve the efficacy in patients who moderately responded or did not respond to Ragweed MATA MPL in 2005
Determine whether a second treatment in 2006 will modify the extent of the immunoglobulin response observed in 2005 in patients who had been treated with Ragweed MATA MPL
Determine whether a second treatment in 2006 will modify the responses to the RQLQ-EEC recorded before and after treatment in 2005
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 Jun 2010.
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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 principal investigator
Allied Research International Inc.
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 Ragweed MATAMPL 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 11 inclusion and 23 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 Jun 2010. 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. 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?
to assess whether the efficacy of RagweedMATAMPL is maintained approximately one year later during the first EEC period of 2006. 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 17 Jun 2010; AzTrials last refreshed its copy on 8 Nov 2026.