Allergic ConjunctivitisPhase 2NCT02082899
A Single Center Study for the Treatment of Moderate to Severe Allergic Conjunctivitis (EBI-005-AC-1)
A Phase 2 study testing Active Comparator EBI-005 5 mg/mL in people with Allergic Conjunctivitis, run by Eleven Biotherapeutics at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- Active Comparator EBI-005 5 mg/mL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to Jul 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Allergic Conjunctivitis
- Being tested
- Active Comparator EBI-005 5 mg/mL, Placebo Comparator
- Keywords
- Allergic Conjunctivitis, Interleukin 1 Receptor Inhibitor, Environmental Exposure Chamber, Conjunctival Allergen Provocation Test
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator EBI-005 5 mg/mLDrug
Placebo ComparatorDrug
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator EBI-005 5 mg/mL | Active comparator | Administered 3 times per day Receives: Drug: Active Comparator EBI-005 5 mg/mL |
| Placebo Comparator | Placebo comparator | Administered 3 times per day Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular itching in EEC arm at a specific visit comparing EBI-005 vs vehicle
Measured: 17 days
Secondary outcomes (3)
Evaluation of Adverse Events.
Frequency, severity and relationship to study medication of all Adverse Events occurring during the study.
Measured: up to 45 days
Evaluation of antibodies to EBI-005.
Number and percent of subjects who develop drug antibodies over time
Measured: up to 45 days
Evaluation of ocular changes
Changes in ophthalmic examinations over time.
Measured: up to 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic ConjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eleven Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Goldstein, MD, Study director, Eleven Biotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082899
- Sponsor's protocol ID
- EBI-005-AC-1
- Status last verified
- Jul 2014
- First submitted
- 4 Mar 2014
- Last updated
- 11 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02082899
- Acronym / sponsor ID
- EBI-005-AC-1
- Conditions
- Allergic Conjunctivitis
- Keywords
- Allergic Conjunctivitis, Interleukin 1 Receptor Inhibitor, Environmental Exposure Chamber, Conjunctival Allergen Provocation Test
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Eleven BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 10 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator EBI-005 5 mg/mL | Active comparator | Drug: Active Comparator EBI-005 5 mg/mLAdministered 3 times per day |
| Placebo Comparator | Placebo comparator | Drug: Placebo ComparatorAdministered 3 times per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Comparator EBI-005 5 mg/mL | Drug | Active Comparator EBI-005 5 mg/mL |
| Placebo Comparator | Drug | Placebo Comparator |
Primary outcome
Ocular itching in EEC arm at a specific visit comparing EBI-005 vs vehicle
Time frame: 17 days
3 secondary outcomes
Evaluation of Adverse Events.
Time frame: up to 45 days
Evaluation of antibodies to EBI-005.
Time frame: up to 45 days
Evaluation of ocular changes
Time frame: up to 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Goldstein, MD study director
Eleven Biotherapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Active Comparator EBI-005 5 mg/mL in people with Allergic Conjunctivitis, run by Eleven Biotherapeutics at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular itching in EEC arm at a specific visit comparing EBI-005 vs vehicle (time frame: 17 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2014.