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Sponsored by: |
Allergy Therapeutics |
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Information provided by: | Allergy Therapeutics |
ClinicalTrials.gov Identifier: | NCT00258635 |
The purpose of this study is to assess the immunological differences between three RagweedMATAMPL treatment arms compared to placebo with respect to immunoglobulin levels.
In addition, the study will assess the reduced allergenicity of modified Ragweed Pollen contained in RagweedMATAMPL compared to unmodified native allergen using skin prick testing.
Condition | Intervention | Phase |
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Type I Hypersensitivity |
Biological: RagweedMATAMPL |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
Official Title: | A Double-Blind Phase IIb Study to Evaluate the Safety and Efficacy of Different Doses of Tyrosine Adsorbed Ragweed Allergoid With MPL® With a Single-Blind Portion to Evaluate the Residual Allergenicity in Skin Test in Patients Sensitized to Ragweed Pollen. |
Enrollment: | 69 |
Study Start Date: | November 2005 |
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Males or non-pregnant, non-lactating females who are post-menopausal or naturally or surgically sterile (hysterectomy; bilateral oophorectomy; bilateral tubal ligation with surgery at least 6 weeks prior to study initiation).
Females of childbearing potential have a confirmed absence of pregnancy according to a negative urine pregnancy test and must be using one of the following acceptable birth control methods:
Exclusion Criteria:
United States, Michigan | |
Michigan Respiratory Health and Research Institute | |
Novi, Michigan, United States, 48375 | |
United States, Minnesota | |
Clinical Research Institute | |
Minneapolis, Minnesota, United States, 55402 | |
United States, North Carolina | |
Regional Allergy & Asthma Consultants | |
Asheville, North Carolina, United States, 28801 | |
United States, Texas | |
Lovelace Scientific Resources | |
Austin, Texas, United States, 78759 |
Study Chair: | Karl Jürgen Fischer von Weikersthal-Drachenberg, MD | Allergy Therapeutics |
Study ID Numbers: | RagweedMATAMPL203 |
Study First Received: | November 25, 2005 |
Last Updated: | September 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00258635 |
Health Authority: | United States: Food and Drug Administration |
Allergy Specific Immunotherapy |
Hypersensitivity Hypersensitivity, Immediate |
Immune System Diseases |