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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RagweedMATAMPL | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| To assess immunological differences between three Ragweed MATA MPL treatment arms compared to placebo with respect to immunoglobulin levels (ragweed spec. IgG, IgG1, IgG4,IgE). | 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Residual allergenicity of modified Ragweed pollen in RagweedMATAMPL compared to unmodified native allergen using Skin Prick Test; | 20 minutes and 6 hours after skin prick test | |
| Tolerability of native, modified allergens and tyrosine adsorbents with and without MPL® using Skin Prick Test; |
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Inclusion Criteria:
Patients must be male or female aged 18-50 years, inclusive.
Patients must have a positive skin prick test for ragweed allergen (wheal that is ≥5 mm larger than the negative control).
Positive skin prick test to positive histamine control with a wheal (longest) diameter ≥3 mm.
Negative skin prick test to negative control (redness, but no wheal is acceptable).
Specific IgE for ragweed 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 ragweed as derived from the allergic history.
Patients must score in the disease severity questionnaire as moderate or severe.
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:
Patients who are normally active and otherwise judged to be in good health on the basis of medical history, physical examination, and routine laboratory tests.
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 for this study. Consent must be obtained prior to initiation of any washout period.
Spirometry at Screening demonstrates FEV1 ≥ 80% predicted and FEV1/FVC ≥70%, when applicable
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karl Jürgen Fischer von Weikersthal-Drachenberg, MD | Allergy Therapeutics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan Respiratory Health and Research Institute | Novi | Michigan | 48375 | United States | ||
| Clinical Research Institute |
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| 20 minutes and 6 hours after skin prick test |
| Tolerability of different subcutaneous doses; | 9 weeks |
| Tolerability of the cumulative subcutaneous doses; | 9 weeks |
| Clinical chemistry, hematology and urinalysis; | 9 weeks |
| Number of Adverse Events (AEs); | 9 weeks |
| Number of Adverse Reactions; | 9 weeks |
| Minneapolis |
| Minnesota |
| 55402 |
| United States |
| Regional Allergy & Asthma Consultants | Asheville | North Carolina | 28801 | United States |
| Lovelace Scientific Resources | Austin | Texas | 78759 | United States |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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