Phase 2 Study in Adults Sensitized to Short Ragweed

Study Overview
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Brief Summary
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The purpose of this study is to identify an effective dose of allergen-specific immunotherapy for short ragweed (Ambrosia artemisiifolia) administered by an oral/sublingual route.

Official Title
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A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging Study of Sublingual Immunotherapy in Adults Sensitized to the Standardized Allergenic Extract, Short Ragweed (Ambrosia Artemisiifolia)

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Biological: Standardized Allergenic Extract, Short Ragweed (Ambrosia artemisiifolia)
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Male and female patients between the ages of 18 and 55 years (inclusive. Written informed consent to participate in the study. Documented allergy to short ragweed pollen as demonstrated by a positive epicutaneous skin test (wheal >3 mm) and symptoms of allergic rhinitis during the two previous short ragweed seasons. Female subjects of childbearing potential, defined as not surgically sterile or at least 2 years postmenopausal, must agree to use one of the following forms of contraception from screening through the 4 week follow-up period following the last dose of Clinical Trial Material (CTM): hormonal (oral, implant, or injection) begun >30 days prior to screening, barrier (condom, diaphragm with spermicide), Intrauterine Device (IUD), or vasectomized partner (6 months minimum). No clinically significant abnormal findings on the physical examination, with the exception of head, eyes, ears, nose and throat (HEENT) findings consistent with allergic rhinitis, medical history, or clinical laboratory results during screening which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results Exclusion Criteria: Previous allergen immunotherapy (subcutaneous immunotherapy (SCIT), oral immunotherapy, sublingual immunotherapy (SLIT), or recombinant peptide) for short ragweed within 24 months of the Screening Visit. History of severe allergic reaction requiring medical intervention. Intolerance of or severe allergic reaction to previous immunotherapy (SCIT, oral immunotherapy, SLIT, or recombinant peptide). Allergy to any of the non-antigen ingredients in the study drug formulation, including, but not limited to, Food, Drug and Cosmetic (FD&C) Yellow #5, sodium chloride, sodium bicarbonate, and glycerine. History of asthma requiring daily medication. Subjects receiving anti-IgE monoclonal antibodies. Congenital immune deficiency or acquired immune suppression. Causes of acquired immune suppression may include, but are not limited to, systemic illnesses such as malignancy and infection, the use of medications such as corticosteroids and chemotherapeutic agents, and radiation therapy. History of organ transplant, hematologic malignancy, autoimmune disease, myocardial infarction, or congestive heart failure. History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, psychiatric, or cardiovascular disease, or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results. Inability or unwillingness to stop using drugs that may inhibit the wheal-and-flare reaction or rhinitic response prior to the study and for the duration of dosing CTM (with the exception of protocol-specified rescue medications provided by the study site for use after Study Day 0). Inability or unwillingness to stop using drugs that may inhibit the ability to treat a severe allergic adverse event. This includes, but is not limited to: beta blockers such as atenolol (Tenormin), metoprolol (Lopressor, Toprol-XL) and propranolol (Inderal, Inderal LA) for 14 days prior to Study Day 0 and for the duration of the study Female subjects who are trying to conceive, are pregnant, or are lactating. Positive serum pregnancy test at screening or a positive human chorionic gonadotropin (HCG) urine test on Study Day 0 prior to administration of study drug for women of childbearing potential. Positive blood screen for HIV, Hepatitis B surface antigen (HbSAg), or Hepatitis C. History of alcohol or drug abuse within the year prior to the Screening Visit, or current evidence of substance dependence or abuse. Participation in a clinical trial or receipt of a non-FDA approved therapy within 30 days prior to the Screening Visit.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dose Group A<br>Standardized Allergenic Extract, Short Ragweed (Ambrosia artemisiifolia) | Biological: Standardized Allergenic Extract, Short Ragweed (Ambrosia artemisiifolia)<br>* Sublingual drops<br>|
| Active Comparator: Dose Group B<br>Standardized Allergenic Extract, Short Ragweed (Ambrosia artemisiifolia) | Biological: Standardized Allergenic Extract, Short Ragweed (Ambrosia artemisiifolia)<br>* Sublingual drops<br>|
| Placebo Comparator: Placebo<br> | Biological: Placebo<br>* Sublingual drops<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average of Total Symptom Scores |  | 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SLIT, Immunotherapy, Short ragweed, SAR, Seasonal allergic rhinitis