Clinical trial NCT03038971: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Allergic Conjunctivitis
Allergic Rhinitis
Lead sponsor: Woodmont Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2017-02-01
Enrollment: 2
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Adverse events (reported, elicited and observed)
timeFrame: 47 weeks
measure: Local Injection Site Tolerability and Reactivity; pain will be assessed using 0-4 scale
timeFrame: 47 weeks
measure: Local Injection Site Tolerability and Reactivity; tenderness will be assessed using 0-4 scale
timeFrame: 47 weeks
measure: Local Injection Site Tolerability and Reactivity; redness will be assessed using 0-4 scale
timeFrame: 47 weeks
measure: Local Injection Site Tolerability and Reactivity; swelling will be assessed using 0-4 scale
timeFrame: 47 weeks
Secondary outcomes:
Other outcomes:
measure: Conjunctival Allergen Challenge (CAC) Outcome; concentration of allergen required to elicit a positive ocular allergic reaction will be compared from baseline to 24 weeks
timeFrame: Baseline and up to 24 weeks
measure: Nasal Allergen Challenge (NAC) Outcome; concentration of allergen required to elicit a positive nasal allergic reaction will be compared from baseline to 24 weeks
timeFrame: Baseline and up to 24 weeks
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
affiliation: ORA, Inc.
name: Emily Schoemmell
role: STUDY_DIRECTOR
References: