Study Evaluating Safety of Ragweed Mix Given by Intralymphatic Node Injections

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03038971
• Other study ID #: 16-290-0010
• Status: Terminated
• Phase: Phase 1
• First received: October 7, 2016
• Last updated: February 21, 2018
• Start date: March 30, 2017
• Est. completion date: April 29, 2017

Study information

• Verified date: February 2018
• Source: Woodmont Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Allergic Rhinitis
• Conjunctivitis
• Conjunctivitis, Allergic
• Rhinitis
• Rhinitis, Allergic

Intervention

Biological:
• Dose Level 1
Short and Tall Ragweed Mix
• Dose Level 2
Short and Tall Ragweed Mix
• Placebo
Saline with 0.4% Phenol

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Woodmont Pharmaceuticals, Inc.	ORA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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