NCT03038971

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 1, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 30, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2017

Completed
Last Updated

February 26, 2018

Status Verified

February 1, 2018

Enrollment Period

1 month

First QC Date

October 7, 2016

Last Update Submit

February 21, 2018

Conditions

Allergic ConjunctivitisAllergic Rhinitis

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (2)

  • 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

Study Arms (3)

Concentration 1: Short and Tall Ragweed Mix

OTHER
Biological: Dose Level 1

Concentration 2: Short and Tall Ragweed Mix

OTHER
Biological: Dose Level 2

Placebo: Saline with 0.4% Phenol

OTHER
Biological: Placebo

Interventions

Dose Level 1BIOLOGICAL

Short and Tall Ragweed Mix

Concentration 1: Short and Tall Ragweed Mix
Dose Level 2BIOLOGICAL

Short and Tall Ragweed Mix

Concentration 2: Short and Tall Ragweed Mix
PlaceboBIOLOGICAL

Saline with 0.4% Phenol

Placebo: Saline with 0.4% Phenol

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Conjunctivitis, AllergicRhinitis, Allergic

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic Diseases

Study Officials

  • Emily Schoemmell

    ORA, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2016

First Posted

February 1, 2017

Study Start

March 30, 2017

Primary Completion

April 29, 2017

Study Completion

April 29, 2017

Last Updated

February 26, 2018

Record last verified: 2018-02

Locations

US(1)