Study Evaluating Safety of Ragweed Mix Given by Intralymphatic Node Injections

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

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.

Study Overview

• Status: Terminated
• Conditions: Allergic Rhinitis; Allergic Conjunctivitis
• Intervention / Treatment: Biological: Dose Level 1; Biological: Dose Level 2; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Concentration 1: Short and Tall Ragweed Mix	Biological: Dose Level 1; Short and Tall Ragweed Mix
Other: Concentration 2: Short and Tall Ragweed Mix	Biological: Dose Level 2; Short and Tall Ragweed Mix
Other: Placebo: Saline with 0.4% Phenol	Biological: Placebo; Saline with 0.4% Phenol

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Woodmont Pharmaceuticals, Inc.
• Collaborators: ORA, Inc.
• Investigators: Study Director: Emily Schoemmell, ORA, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2017
• Primary Completion (Actual): April 29, 2017
• Study Completion (Actual): April 29, 2017

Study Registration Dates

• First Submitted: October 7, 2016
• First Submitted That Met QC Criteria: January 30, 2017
• First Posted (Estimate): February 1, 2017

Study Record Updates

• Last Update Posted (Actual): February 26, 2018
• Last Update Submitted That Met QC Criteria: February 21, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Conjunctival Diseases; Rhinitis; Rhinitis, Allergic; Conjunctivitis; Conjunctivitis, Allergic
• Other Study ID Numbers: 16-290-0010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No