Study Evaluating Safety of Ragweed Mix Given by Intralymphatic Node Injections

Phase 1

Terminated

• Conditions: Allergic Conjunctivitis; Allergic Rhinitis
• Interventions: Biological: Dose Level 1; Biological: Dose Level 2; Biological: Placebo

• Registration Number: NCT03038971
• Lead Sponsor: Woodmont Pharmaceuticals, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-07
• Study First Submitted QC: 2017-01-30
• Study First Posted: 2017-02-01
• Study Start: 2017-03-30
• Primary Completion: 2017-04-29
• Study Completion: 2017-04-29
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-21
• Last Update Posted: 2018-02-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Concentration 1: Short and Tall Ragweed Mix	Dose Level 1	-
Concentration 2: Short and Tall Ragweed Mix	Dose Level 2	-
Placebo: Saline with 0.4% Phenol	Placebo	-

Primary Outcome Measures

Name	Time	Method
Local Injection Site Tolerability and Reactivity; pain will be assessed using 0-4 scale	47 weeks
Adverse events (reported, elicited and observed)	47 weeks
Local Injection Site Tolerability and Reactivity; swelling will be assessed using 0-4 scale	47 weeks
Local Injection Site Tolerability and Reactivity; tenderness will be assessed using 0-4 scale	47 weeks
Local Injection Site Tolerability and Reactivity; redness will be assessed using 0-4 scale	47 weeks

Trial Locations

Locations (1)

Andover Eye Associates; 🇺🇸 Andover, Massachusetts, United States