A Single Center Study for the Treatment of Moderate to Severe Allergic Conjunctivitis (EBI-005-AC-1)

A Single Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel, Group Study to Assess the Efficacy of EBI-005 Topical Ophthalmic Solution for the Treatment of Moderate to Severe Allergic Conjunctivitis Using an Environmental Exposure Chamber (EEC) Model and Conjunctival Allergen Provocation Test (CAPT) Model

This is a Phase II Single Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel, Group Study to Assess the Efficacy of EBI-005 Topical Ophthalmic Solution for the Treatment of Moderate to Severe Allergic Conjunctivitis Using an Environmental Exposure Chamber (EEC) Model and Conjunctival Allergen Provocation Test (CAPT) Model. Approximately 150 subjects will be enrolled and randomized in one study center in Canada for a duration of 0.33 years.

Study Overview

• Status: Completed
• Conditions: Allergic Conjunctivitis
• Intervention / Treatment: Drug: Placebo Comparator; Drug: Active Comparator EBI-005 5 mg/mL

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada, L4W 1A2
      • Investigation Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Provide written informed consent prior to any study-related procedures.
• Be 18 years of age or older.
• Have at least a 2 year history of moderate to severe allergic conjunctivitis.
• Have a positive skin prick test to ragweed within the past 12 months of Screening (Visit 1A).
• Have a score of ≥ 2 for staff-assessed ocular redness in at least one region (nasal or temporal) in each eye and ≥ 2 for subject-assessed ocular itching within the 3.5-hour period of allergen exposure in the EEC at Visit 1B.
• Have required more than one anti-allergy pharmaceutical treatments in the past 2 years to treat ocular symptoms (including oral, topical, nasal treatments).
• Be able to self-administer topical ophthalmic drops.
• Avoid any topical or systemic ocular medications during the entire study period.
• Are willing and able to follow instructions and can be present for the required study visits for the duration of the study.

Exclusion Criteria:

• Are female and of childbearing potential and unwilling to remain abstinent through 30 days following the last dose of study drug or not willing to use acceptable birth control methods.
• Have previously used an IL-1 blocker (e.g., Anakinra, Rilonacept, or Ilaris).
• Have a known contraindication or hypersensitivities to Anakinra (Kineret®) or any therapeutic agent targeted to IL-1 or any component of study drug formulation.
• Current participation in another clinical study involving an experimental treatment or participation in such a study within 30 days prior to study entry.
• Require concomitant use of TNF-blocking agents (e.g., Etanercept, Adalimumab, Infliximab).
• Have a history of glaucoma or intraocular pressure (IOP) > 25 mmHg at the Visit 1A (Medical Screening) or a history of elevated IOP within the past year.
• Have had ocular surgery including laser procedures within the past 12 months of Visit 1A (Medical Screening).
• Have had contact lens wear within 4 weeks prior to Visit 1A (Medical Screening) or unwilling to discontinue wear during the study period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Active Comparator EBI-005 5 mg/mL; Administered 3 times per day	Drug: Active Comparator EBI-005 5 mg/mL
PLACEBO_COMPARATOR: Placebo Comparator; Administered 3 times per day	Drug: Placebo Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ocular itching in EEC arm at a specific visit comparing EBI-005 vs vehicle	17 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Adverse Events.	Frequency, severity and relationship to study medication of all Adverse Events occurring during the study.	up to 45 days
Evaluation of antibodies to EBI-005.	Number and percent of subjects who develop drug antibodies over time	up to 45 days
Evaluation of ocular changes	Changes in ophthalmic examinations over time.	up to 45 days

Collaborators and Investigators

• Sponsor: Eleven Biotherapeutics

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): July 1, 2014

Study Registration Dates

• First Submitted: March 4, 2014
• First Submitted That Met QC Criteria: March 6, 2014
• First Posted (ESTIMATE): March 10, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): July 11, 2014
• Last Update Submitted That Met QC Criteria: July 10, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Environmental Exposure Chamber; Allergic Conjunctivitis; Interleukin 1 Receptor Inhibitor; Conjunctival Allergen Provocation Test
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic
• Other Study ID Numbers: EBI-005-AC-1