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

NCT02082899 | Completed Phase 2

• 1 other identifier: EBI-005-AC-1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Allergic Conjunctivitis

Keywords

Allergic Conjunctivitis; Interleukin 1 Receptor Inhibitor; Environmental Exposure Chamber; Conjunctival Allergen Provocation Test

Outcome Measures

Primary Outcomes (1)

• Ocular itching in EEC arm at a specific visit comparing EBI-005 vs vehicle

  17 days

Secondary Outcomes (3)

• Evaluation of Adverse Events.

  up to 45 days

• Evaluation of antibodies to EBI-005.

  up to 45 days

• Evaluation of ocular changes

  up to 45 days

Study Arms (2)

Active Comparator EBI-005 5 mg/mL

ACTIVE COMPARATOR

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

Interventions

Active Comparator EBI-005 5 mg/mL DRUG

Active Comparator EBI-005 5 mg/mL

Placebo Comparator DRUG

Placebo Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eleven Biotherapeutics: lead

Study Sites (1)

Investigation Site

Mississauga, Ontario, L4W 1A2, Canada

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Michael Goldstein, MD

  Eleven Biotherapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 10, 2014
• Study Start: February 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 11, 2014

Record last verified: 2014-07

Locations

CA (1)