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Type I HypersensitivityPhase 2NCT00118612

Different Doses of Tyrosine Adsorbed Tree Pollen Allergoid With Monophosphoryl Lipid A (MPL) in Patients Sensitized to Tree Pollen

A Phase 2 study testing Tree MATA MPL - Therapeutic Regimen, Tree MATA MPL - Intermediate dose and Tree MATA MPL - Low dose in people with Type I Hypersensitivity, run by Allergy Therapeutics at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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?
Tree MATA MPL - Therapeutic Regimen, Tree MATA MPL - Intermediate dose and Tree MATA MPL - Low dose
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
68 participants
Where
1 siteCanada
Study dates
7 Jul 2005to 15 Sep 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

  • Patients must have a positive skin prick test for birch and hazel and alder allergen.
  • Positive skin prick test to positive histamine control
  • Negative skin prick test to negative control
  • Specific IgE for birch 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 birch, hazel, and alder
  • Patients must score on the disease severity questionnaire as moderate or severe.
Show all 11Show fewer
  • Males or non-pregnant, non-lactating females
  • Patients who are normally active and otherwise judged to be in good health
  • Patients must be willing and able to attend required study visits.
  • Patients must be able to follow instructions.
  • Patients must be willing and able to give written informed consent and must provide this consent.

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
  • 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, or hematologic diseases or disorders
  • Recent clinically significant history of hepatic, gastrointestinal, dermatologic, venereal, neurologic or psychiatric diseases or disorders
  • Any clinically significant abnormal laboratory value at Visit 1
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  • Perennial allergens: clinically relevant sensitivity to house dust mites, molds, and epithelia
  • Patient has clinically relevant sensitivity to the following summer/autumn season flowering plants: plantain, orache, nettle, mugwort, Parietaria judaica, Bermuda grass, or ragweed.
  • Secondary alteration at the affected organ
  • History of autoimmune diseases and/or rheumatoid diseases
  • Patient is taking ß-blockers for any indication including eye drops
  • 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
  • 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 tree 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
  • Patients who cannot communicate reliably with the Investigator or who are not likely to cooperate with the requirements of the study
  • Patient is pregnant or planning pregnancy and/or lactating
  • Patient has received treatment with preparation containing MPL during the past 12 months
  • Concurrent use of any prohibited medication(s), as listed in the study protocol, or inadequate washout of any medication
  • Any systemic disorder that could interfere with the evaluation of the study medication(s)
  • Clinical history of drug or alcohol abuse, at the Investigator's discretion, that would interfere with the patient's participation in the study
  • Study site staff or immediate relatives of study site staff or other individuals who would have access to the clinical study protocol

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Allied Research International Inc.

    Mississauga, Ontario, L4W 1N2

Other trials in Canada

About this study

Official title: A DoubleBlind Phase 2b Study to Evaluate Safety & Efficacy of Different Doses of Tyrosine Adsorbed Birch+Hazel+Alder Pollen Allergoid With MPL® in Patients Sensitized to Birch, Hazel, Alder 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. Tree MATA MPL has been developed to provide pre-seasonal specific immunotherapy for patients with an allergy to tree pollen (hay fever).

The purpose of this double-blind Phase IIb study is to assess the tolerability and immunogenicity of different doses of Tree MATA MPL in volunteers allergic to birch, hazel and alder pollen.

Read the detailed description

Tree MATAMPL (tyrosine adsorbed tree pollen allergoid with monophosphoryl lipid A (MPL®)) has been developed to provide pre-seasonal specific immunotherapy for patients with proven type I hypersensitivity to cross-reacting tree pollens that cause rhinitis and/or conjunctivitis with or without mild to moderate asthma.

This was a phase IIb, double-blind, placebo-controlled study to assess the tolerability and immunogenicity of different doses of Tree MATA MPL in volunteers allergic to birch, hazel and alder pollen.

Sixty eight (68) volunteers were randomly assigned to one of three active treatments or placebo to receive up to 4 subcutaneous injections of either increasing doses of Tree MATAMPL or Placebo over 7 day (+1 day) interval.

The duration of the study from screening (Visit 1) to end of study (Visit 6, Post-Treatment Visit) was approximately 50 days.

Being tested
Tree MATA MPL - Therapeutic Regimen, Tree MATA MPL - Intermediate dose, Tree MATA MPL - Low dose, Placebo
Keywords
Allergy, Specific Immunotherapy, Allergy Vaccination, Allergenicity
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 - Therapeutic RegimenBiological

    600, 1600, 4000, 4000 SU/0.5 mL

  • Tree MATA MPL - Intermediate doseBiological

    300, 600, 1600, 1600 SU/0.5 mL

  • Tree MATA MPL - Low doseBiological

    300, 300, 300, 300 SU/0.5 mL

  • PlaceboBiological

    L-tyrosine 2% w/v , 4 injections

Study groups in NCT00118612
Study groupRoleWhat they receive
Therapeutic RegimenExperimentalNot described
Receives: Biological: Tree MATA MPL - Therapeutic Regimen
Intermediate doseExperimentalNot described
Receives: Biological: Tree MATA MPL - Intermediate dose
Low doseExperimentalNot described
Receives: Biological: Tree MATA MPL - Low dose
PlaceboPlacebo comparatorNot described
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immunological response to the three Tree MATA MPL treatment arms compared to placebo (birch specific)

    Efficacy was assessed based on the immunological differences between the three Tree MATA MPL treatment arms compared to placebo with respect to immunoglobulins (specific IgG, specific IgG1, specific IgG4, and specific IgE) for birch, alder, and hazel.

    Measured: Up to two approximately 2 months

Secondary outcomes (11)

  1. Tolerability of individual subcutaneous doses

    Measured: Up to two approximately 2 months

  2. Tolerability of the cumulative subcutaneous doses

    Measured: Up to two approximately 2 months

  3. safety laboratory evaluation - clinical chemistry

    Measured: Up to two approximately 2 months

  4. safety laboratory evaluation - hematology

    Measured: Up to two approximately 2 months

  5. safety laboratory evaluation - urinalysis

    Measured: Up to two approximately 2 months

  6. Vital signs

    Measured: Up to two approximately 2 months

  7. Physical examinations

    Abnormal physical examination findings were summarized by clinical significance(CS or NCS) using frequencies and percentages of patients for each body system and overall

    Measured: Up to two approximately 2 months

  8. 12-Lead ECGs

    QRS duration, PR interval, QT interval, and QTc

    Measured: Up to two approximately 2 months

  9. number of adverse events

    Measured: Approximately 2 months

  10. number of adverse reactions

    Measured: Up to two approximately 2 months

  11. immunological response to the three Tree MATA MPL treatment arms compared to placebo (alder and hazel specific)

    Measured: Up to two approximately 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2005 (estimated)
  2. Study start7 Jul 2005
  3. Primary completion15 Sep 2005
  4. Study completion15 Sep 2005

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00118612
Sponsor's protocol ID
TreeMATAMPL203
Other IDs
P2DP05003
Status last verified
Feb 2021
First submitted
1 Jul 2005
Last updated
9 Feb 2021
Results posted
No
FDA-regulated drug
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tree MATA MPL - Therapeutic Regimen, Tree MATA MPL - Intermediate dose and Tree MATA MPL - Low dose 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 28 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 9 Feb 2021. 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 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 Tree MATA MPL treatment arms compared to placebo (birch specific) (time frame: Up to two approximately 2 months). 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 NCT00118612.

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 9 Feb 2021.

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