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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03038971

Enrollment

Registered

2017-02-01

Start date

2017-03-30

Completion date

2017-04-29

Last updated

2018-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Conjunctivitis, Allergic Rhinitis

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.

Interventions

BIOLOGICALDose Level 1

Short and Tall Ragweed Mix

BIOLOGICALDose Level 2

Short and Tall Ragweed Mix

BIOLOGICALPlacebo

Saline with 0.4% Phenol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Other

Measure	Time frame
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
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026