Back to resultsStudy Evaluating Safety of Ragweed Mix Given by Intralymphatic Node Injections
Primary Purpose
Allergic Conjunctivitis, Allergic Rhinitis
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dose Level 1
Dose Level 2
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis
Eligibility Criteria
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
Sites / Locations
- Andover Eye Associates
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Concentration 1: Short and Tall Ragweed Mix
Concentration 2: Short and Tall Ragweed Mix
Placebo: Saline with 0.4% Phenol
Arm Description
Outcomes
Primary Outcome Measures
Adverse events (reported, elicited and observed)
Local Injection Site Tolerability and Reactivity; pain will be assessed using 0-4 scale
Local Injection Site Tolerability and Reactivity; tenderness will be assessed using 0-4 scale
Local Injection Site Tolerability and Reactivity; redness will be assessed using 0-4 scale
Local Injection Site Tolerability and Reactivity; swelling will be assessed using 0-4 scale
Secondary Outcome Measures
Full Information
NCT ID
NCT03038971
First Posted
October 7, 2016
Last Updated
February 21, 2018
Sponsor
Woodmont Pharmaceuticals, Inc.
Collaborators
ORA, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03038971
Brief Title
Study Evaluating Safety of Ragweed Mix Given by Intralymphatic Node Injections
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
Sponsor withdrew IND from FDA
Study Start Date
March 30, 2017 (Actual)
Primary Completion Date
April 29, 2017 (Actual)
Study Completion Date
April 29, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Woodmont Pharmaceuticals, Inc.
Collaborators
ORA, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis, Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Concentration 1: Short and Tall Ragweed Mix
Arm Type
Other
Arm Title
Concentration 2: Short and Tall Ragweed Mix
Arm Type
Other
Arm Title
Placebo: Saline with 0.4% Phenol
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
Dose Level 1
Intervention Description
Short and Tall Ragweed Mix
Intervention Type
Biological
Intervention Name(s)
Dose Level 2
Intervention Description
Short and Tall Ragweed Mix
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Saline with 0.4% Phenol
Primary Outcome Measure Information:
Title
Adverse events (reported, elicited and observed)
Time Frame
47 weeks
Title
Local Injection Site Tolerability and Reactivity; pain will be assessed using 0-4 scale
Time Frame
47 weeks
Title
Local Injection Site Tolerability and Reactivity; tenderness will be assessed using 0-4 scale
Time Frame
47 weeks
Title
Local Injection Site Tolerability and Reactivity; redness will be assessed using 0-4 scale
Time Frame
47 weeks
Title
Local Injection Site Tolerability and Reactivity; swelling will be assessed using 0-4 scale
Time Frame
47 weeks
Other Pre-specified Outcome Measures:
Title
Conjunctival Allergen Challenge (CAC) Outcome; concentration of allergen required to elicit a positive ocular allergic reaction will be compared from baseline to 24 weeks
Time Frame
Baseline and up to 24 weeks
Title
Nasal Allergen Challenge (NAC) Outcome; concentration of allergen required to elicit a positive nasal allergic reaction will be compared from baseline to 24 weeks
Time Frame
Baseline and up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Schoemmell
Organizational Affiliation
ORA, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Study Evaluating Safety of Ragweed Mix Given by Intralymphatic Node Injections
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