A Phase 2 interventional study of Tree MATA MPL - Therapeutic Regimen and Tree MATA MPL - Intermediate dose in Type I Hypersensitivity, sponsored by Allergy Therapeutics. Completed at 1 site in Canada. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-02-09.
Sponsored by Allergy Therapeutics · Phase 2, Interventional, and Treatment
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.
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.
82 studies on the registry are indexed under Hypersensitivity, Immediate; 7 are open to participants now.
This study's enrollment of 68 is close to the median of 70 across 66 interventional studies indexed under Hypersensitivity, Immediate.
Browse Hypersensitivity, Immediate studies →Allergy Therapeutics is the lead sponsor of 27 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: Tree MATA MPL - Therapeutic Regimen
Biological: Tree MATA MPL - Intermediate dose
Biological: Tree MATA MPL - Low dose
Biological: Placebo
600, 1600, 4000, 4000 SU/0.5 mL
300, 600, 1600, 1600 SU/0.5 mL
300, 300, 300, 300 SU/0.5 mL
L-tyrosine 2% w/v , 4 injections
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.
Time frame: Up to two approximately 2 months
Tolerability of individual subcutaneous doses
Time frame: Up to two approximately 2 months
Tolerability of the cumulative subcutaneous doses
Time frame: Up to two approximately 2 months
safety laboratory evaluation - clinical chemistry
Time frame: Up to two approximately 2 months
safety laboratory evaluation - hematology
Time frame: Up to two approximately 2 months
safety laboratory evaluation - urinalysis
Time frame: Up to two approximately 2 months
Vital signs
Time frame: Up to two approximately 2 months
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
Time frame: Up to two approximately 2 months
12-Lead ECGs
QRS duration, PR interval, QT interval, and QTc
Time frame: Up to two approximately 2 months
number of adverse events
Time frame: Approximately 2 months
number of adverse reactions
Time frame: Up to two approximately 2 months
immunological response to the three Tree MATA MPL treatment arms compared to placebo (alder and hazel specific)
Time frame: Up to two approximately 2 months
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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