Study Evaluating Safety of Ragweed Mix Given by Intralymphatic Node Injections

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Allergic Conjunctivitis, Allergic Rhinitis

In brief

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.

Key facts

Study ID

NCT03038971

Run by

Woodmont Pharmaceuticals, Inc.

People needed

2

Starts

2017-03-30

Expected to finish

2017-04-29

Last updated by the study team

2018-02-26

Who can join

Age: 16 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Andover Eye Associates — Andover, Massachusetts, United States

Full record on ClinicalTrials.gov

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