A Study of Tolerability and Safety of Two New Doses of Grass MATA MPL
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|ClinicalTrials.gov Identifier: NCT02557633|
Recruitment Status : Completed
First Posted : September 23, 2015
Last Update Posted : March 3, 2017
There is increasing evidence that the effectiveness of allergy immunotherapy to control symptoms of rhinoconjunctivitis is related to the cumulative dose of allergen or allergoid administered during a single regimen of subcutaneous (SC) injections or of sublingual administration.
Two new cumulative doses of the Grass MATA MPL 10200 and 18200 SU (Standardized Units) are being developed to compare with the current dose of 5100 SU. The purpose of this study is to evaluate the tolerability and safety of these two new cumulative dose regimens of Grass MATA MPL compared with placebo in patients with seasonal allergic rhinoconjunctivitis (SAR) due to grass pollen, to enable selection of the best dose to go into a larger scale study to assess the efficacy and safety of the higher cumulative doses.
|Condition or disease||Intervention/treatment||Phase|
|Allergic Rhinitis||Biological: Grass MATA MPL 10200 Biological: Grass MATA MPL 18200 Biological: Placebo||Phase 1|
Structure: Single center, parallel group, single-blind, randomized study There will be three treatment groups, two groups receiving a different, cumulative dose of Grass MATA MPL and the third group receiving placebo only.
Duration: The duration of the study from screening to final visit after treatment is expected to be approximately 7 weeks. There will be a telephone follow up at 1, 3, 6 and 12 months after treatment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Pre-season, Single Site, Single-blind, Parallel Group, Randomized Study to Determine the Tolerability and Safety of Two New Cumulative Doses of Modified Grass Allergens Adsorbed to L-tyrosine With Monophosphoryl Lipid A Adjuvant (Corixa), Phenol Preserved (Grass MATA MPL); Allergy Therapeutics, (UK) Ltd., Compared With Placebo in Patients With Seasonal Allergic Rhinoconjunctivitis Due to Grass Pollen Allergy.|
|Study Start Date :||August 2015|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2016|
Placebo Comparator: Placebo
2% w/v L-Tyrosine
Experimental: Grass MATA MPL 10200 SU
Grass MATA MPL cumulative dose 10200 SU given as six injections of placebo, placebo, 600SU, 1600SU, 4000SU and 4000SU.
Biological: Grass MATA MPL 10200
Experimental: Grass MATA MPL 18200 SU
Grass MATA MPL cumulative dose 18200 SU given as six injections of 600SU, 1600SU, 4000SU, 4000SU, 4000SU and 4000SU.
Biological: Grass MATA MPL 18200
- Number of AEs [ Time Frame: 8 weeks ]Aggregate of the number of AEs, adverse reaction complexes (ARCs; the total of treatment related injection site and systemic AEs experienced by a patient within a 24-hour period after an injection)
- Premature discontinuation [ Time Frame: 8 weeks ]The frequency of premature discontinuation from treatment or study due to AEs between the treatment groups
- AEs of special interest [ Time Frame: one year ]The number and frequency of neuro-inflammatory or new onset autoimmune disease.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557633
|United States, New Jersey|
|Inflamax Research, Inc.|
|Neptune, New Jersey, United States, 07753|
|Newark, New Jersey, United States, 07105|
|Study Director:||Tim Higenbottam, DSc MD FRCP FFPM||Allergy Therapeutics|