A Phase 2 interventional study of Grass MATA MPL 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 2021-07-13.
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. GrassMATAMPL has been developed to provide pre-seasonal specific immunotherapy for patients with an allergy to grass and rye pollen (hay fever).
The tolerability and immunogenicity of GrassMATA (allergen modified with glutaraldehyde and adsorbed to tyrosine) with and without MPL adjuvant (monophosphoryl lipid A, extracted from a bacterial cell surface) was investigated in this double-blind, randomized Phase IIa study in volunteers allergic to grass and rye pollen.
Additionally, this study assessed residual allergenicity of the modified grass and rye pollen in the product GrassMATAMPL using skin prick testing in volunteers allergic to grass and rye pollen.
Double-blind Phase IIa study with a single-blind component, to evaluate skin tests allergenicity and to demonstrate the contribution of MPL® to tyrosine adsorbed grass/rye pollen allergoid (Grass MATA) in volunteers allergic to grass and rye pollen. Volunteers underwent skin prick tests with 12 different solutions and then were randomized to receive 3 subcutaneous injections of either Grass MATA MPL or Grass MATA over approximately 14-day intervals for total study duration of approximately 67 days.
Enrollment was planned for 40 patients, 20 in each active treatment group. Data from 41 patients who completed the single blind portion of the study and from 40 randomized patients who took part in the double blind portion of the study were analyzed and included in the study. Screening was performed at Visit 0, then subjects fulfilling all inclusion/exclusion criteria underwent a series of skin prick tests to evaluate the tolerability of native allergen, modified allergen and tyrosine adsorbates with and without MPL® (Visit 1, single-blind portion of the study).
At Visit 2, subjects were randomized 1:1 to receive either Grass MATA MPL or Grass MATA and received the first injection of treatment. The dosing regimen consisted of three 0.5 mL subcutaneous injections of increasing strengths and was the same for both treatment groups. Patients were asked to remain in the clinic for an observation period of 30 to 45 minutes following study drug administration in order to record adverse reactions associated. The second and third injections of treatment were administered at Visit 4 and Visit 6. Each dosing visit occurred at least 14 days after the previous one.
Safety follow-up were performed 7-8 days after each dosing, at Visit 3, 5 and 7.
Subjects terminated the study after completion of Visit 8 (Post-treatment visit).
To assess the immunological response to Grass MATA MPL versus Grass MATA blood test were performed at baseline (Visit 0), after the first administration (Visit 3) and at the end of the study (Visit 8). Safety and tolerability of the different allergens used during prick test and of Grass MATA MPL versus Grass MATA were also be evaluated.
82 studies on the registry are indexed under Hypersensitivity, Immediate; 7 are open to participants now.
This study's enrollment of 41 is below 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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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Males or non-pregnant, non-lactating females who are or naturally or surgically sterile (hysterectomy; bilateral oophorectomy; bilateral tubal ligation with surgery at least 6 weeks prior to study initiation). Postmenopausal was defined as at least 12 months natural spontaneous amenorrhea, or at least 6 weeks following surgical menopause (bilateral oophorectomy). Females of were required to have a confirmed absence of pregnancy according to a negative urine pregnancy test and were required to be using one of the following acceptable methods:
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
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.
300 SU/0.5 mL Grass MATA MPL (Visit 2); 800 SU/0.5 mL Grass MATA MPL (Visit 4); 2000 SU/0.5 mL Grass MATA MPL (Visit 6)
Biological: Grass MATA MPL
300 SU/0.5 mL Grass MATA (Visit 2); 800 SU/0.5 mL Grass MATA (Visit 4); 2000 SU/0.5 mL Grass MATA (Visit 6);
Biological: Grass MATA MPL
Immunological response to GrassMATAMPL versus GrassMATA (grass specific)
Immunoglobulin levels: Timothy Grass specific IgG, Timothy Grass specific IgG1, Timothy Grass specific IgG4, and Timothy Grass specific IgE
Time frame: 14 days
Immunological response to Grass MATA MPL versus Grass MATA in volunteers allergic to grass and rye pollen
immunoglobulin levels: rye specific IgG, rye specific IgG1, rye specific IgG4, and rye specific IgE; June grass specific IgG, June Grass specific IgG1, June Grass specific IgG4, and June Grass specific IgE
Time frame: up to 10 weeks
Tolerability of native allergen, modified allergen and tyrosine adsorbents with and without MPL® in the skin prick tests
Time frame: >= 30 min to 6 hours post application
Tolerability of the cumulative subcutaneous doses compared between Grass MATA MPL and Grass MATA.
The rate of Adverse events reported by subjects in the two groups was compared.
Time frame: 6 weeks
Tolerability of the different dose steps compared between GrassMATAMPL and GrassMATA treatment groups.
The rate of local or systemic Adverse Events occurring within a 24-hour after any injection with study drug in subjects of the two groups was compared.
Time frame: Up to 24 hours post-administration
Measure of concentration of Albumin (g/L)
Time frame: 10 Weeks
Measure of concentration of Alkaline Phospatase, ALT, AST and LDH (U/L)
Time frame: 10 Weeks
Measure of concentration of Bilirubin Total and Creatinine (µmol/L)
Time frame: 10 Weeks
Measure of concentration of Calcium, Glucose, Phosphorus, Potassium, Sodium and Urea (mmol/L).
Time frame: 10 weeks
Measure of concentration of Red Blood Cells (10E12/L)
Time frame: 10 weeks
Measure of concentration of White Blood Cells, Neutrophils, Lymphocytes, Basophils, Eosinophils, Monocytes and Platelets (10E9/L)
Time frame: 10 weeks
Measure of concentration of Haemoglobin (g/L)
Time frame: 10 weeks
Measure of concentration of Haematocrit (L/L)
Time frame: 10 weeks
Vital signs - Blood pressure
Assessment of Sistolic (SBP) and diastolic (DBP) blood pressure.
Time frame: 10 weeks
Vital signs - Pulse
Time frame: 10 weeks
Vital signs - Temperature
Time frame: 10 weeks
12-lead electrocardiogram (ECG)
ECG evaluations by parameter (QRS interval, PR interval, QT interval, and QTc interval) and overall ECG results (normal, abnormal non clinical significant, abnormal clinical significant).
Time frame: 10 weeks
Number of adverse events
Time frame: Up to 10 weeks
Number of adverse reactions
The total of local or systemic events occurring in one patient within a 24-hour period after any one injection
Time frame: Up to 24 hours post-injection
Ran from Sep 2005 to primary completion in Nov 2005, 2 months.
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This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Grass MATA MPL