Allergic Rhinitis Clinical Trial
Official title:
A Single-Center, Double-Blinded, Placebo-Controlled, Phase 1 Evaluation of the Safety of Ragweed Mix Given in Four Monthly Doses by Intralymphatic Node Injections for Inducing Tolerance in Subjects With Ragweed Induced Allergic Conjunctivitis and Allergic Rhinitis
Verified date | February 2018 |
Source | Woodmont Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A safety study conducted on subjects ≥16 years old evaluating the safety of 4 intralymphatic injections of 2 different dose levels of the investigational short and tall ragweed product. Biomarkers will be assessed at baseline and at multiple time points post-treatment.
Status | Terminated |
Enrollment | 2 |
Est. completion date | April 29, 2017 |
Est. primary completion date | April 29, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Between the ages of 16 and 65 years old - Seasonal Allergic Conjunctivitis (with or without Allergic Rhinitis) to ragweed pollen - Positive skin test reaction at screening visit to short ragweed extract - Avoid disallowed medications - Females of childbearing potential must have pregnancy test and must agree to use an acceptable method of birth control - Have blood and urine analysis within normal limits - Manifest a positive reaction to a conjunctival allergen challenge with ragweed pollen - Have a specific IgE = 0.70 kU/L to short ragweed Exclusion Criteria: - Have ocular or nasal conditions that could affect subject safety or trial parameters - Have a presence of an active sinus, nasal, or ocular infections - Have had allergy immunotherapy to ragweed pollen - Have a compromised lung function =80% of predicted |
Country | Name | City | State |
---|---|---|---|
United States | Andover Eye Associates | Andover | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Woodmont Pharmaceuticals, Inc. | ORA, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Conjunctival Allergen Challenge (CAC) Outcome; concentration of allergen required to elicit a positive ocular allergic reaction will be compared from baseline to 24 weeks | Baseline and up to 24 weeks | ||
Other | Nasal Allergen Challenge (NAC) Outcome; concentration of allergen required to elicit a positive nasal allergic reaction will be compared from baseline to 24 weeks | Baseline and up to 24 weeks | ||
Primary | Adverse events (reported, elicited and observed) | 47 weeks | ||
Primary | Local Injection Site Tolerability and Reactivity; pain will be assessed using 0-4 scale | 47 weeks | ||
Primary | Local Injection Site Tolerability and Reactivity; tenderness will be assessed using 0-4 scale | 47 weeks | ||
Primary | Local Injection Site Tolerability and Reactivity; redness will be assessed using 0-4 scale | 47 weeks | ||
Primary | Local Injection Site Tolerability and Reactivity; swelling will be assessed using 0-4 scale | 47 weeks |
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