UveitisPhase 3EYEGUARD™-ENCT02258854
An Open-label, Rollover Study Providing Continued Dosing of Gevokizumab in Order to Assess Long-term Gevokizumab Safety Data
A Phase 3 study testing Dose 2 gevokizumab in people with Uveitis, run by XOMA (US) LLC at 33 sites in United States.
Trial summary
The purpose of this study is to provide continued dosing of gevokizumab in order to obtain and assess long-term gevokizumab safety data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis
- What is being tested?
- Dose 2 gevokizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 33 sitesUnited States
- Study dates
- Mar 2014to Dec 2017
- Phase
- Phase 3
- 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
- Completed either the X052130/CL3-78989-005 or the X052131/CL3-78989-006 study's masked D392 or OL-224 completion day visits or had controlled ocular inflammation after having received study drug in Part 2 of study X052133
Who cannot join
- Discontinued from the previous study
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Study site
Baltimore, Maryland
Study site
Belmont, North Carolina
Study site
Beverly Hills, California
Study site
Bloomfield, New Jersey
Study site
Bridgeport, Connecticut
Study site
Cambridge, Massachusetts
Study site
Chandler, Arizona
Study site
Charlotte, North Carolina
Study site
Chicago, Illinois
Study site
Dallas, Texas
Study site
Ellsworth, Maine
Study site
Fargo, North Dakota
Study site
Golden, Colorado
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Jackson, Michigan
Study site
Lakeland, Florida
Study site
Littleton, Colorado
Study site
Norfolk, Virginia
Study site
Omaha, Nebraska
Study site
Phoenix, Arizona
Study site
Redlands, California
Study site
Riverside, California
Study site
Royal Oak, Michigan
Study site
Sacramento, California
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
Santa Ana, California
Study site
Tampa, Florida
Study site
Teaneck, New Jersey
Study site
Victorville, California
Study site
Waltham, Massachusetts
Study site
Winston-Salem, North Carolina
About this study
Official title: An Open-Label, Non-Randomized, Single-Arm, Rollover Study to Continue Dosing of Gevokizumab in Subjects With Non Infectious Intermediate-, Posterior-, or Pan-Uveitis Patients Who Each Successfully Completed Either the X052130/CL3-78989-005 (EYEGUARD™-A) or the X052131/CL3-78989-006 (EYEGUARD™-C) Study or Who Have Controlled Ocular Inflammation After Receiving Study Drug in Study X052133 (EYEGUARD™-US)
The purpose of this study is to provide continued dosing of gevokizumab in order to obtain and assess long-term gevokizumab safety data.
- Conditions
- Uveitis
- Being tested
- Dose 2 gevokizumab
- Keywords
- Uveitis, Non-infectious Uveitis, Intermediate Uveitis, Posterior Uveitis, Panuveitis, Behçet's disease uveitis
- Medical subject headings
- Uveitis, Uveitis, Intermediate, Uveitis, Posterior, Panuveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose 2 gevokizumabDrug
Solution for subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Dose 2 gevokizumab | Experimental | Not described Receives: Drug: Dose 2 gevokizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent Adverse Events
Measured: 108 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- XOMA (US) LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258854
- Sponsor's protocol ID
- X052132
- Acronym
- EYEGUARD™-E
- Status last verified
- Oct 2015
- First submitted
- 2 Oct 2014
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Non-Randomized, Single-Arm, Rollover Study to Continue Dosing of Gevokizumab in Subjects With Non Infectious Intermediate-, Posterior-, or Pan-Uveitis Patients Who Each Successfully Completed Either the X052130/CL3-78989-005 (EYEGUARD™-A) or the X052131/CL3-78989-006 (EYEGUARD™-C) Study or Who Have Controlled Ocular Inflammation After Receiving Study Drug in Study X052133 (EYEGUARD™-US)
- ClinicalTrials.gov ID
- NCT02258854
- Acronym / sponsor ID
- EYEGUARD™-E / X052132
- Conditions
- Uveitis
- Keywords
- Uveitis, Non-infectious Uveitis, Intermediate Uveitis, Posterior Uveitis, Panuveitis, Behçet's disease uveitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 69 participants (actual)
- Lead sponsor
- XOMA (US) LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 8 Oct 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.
The purpose of this study is to provide continued dosing of gevokizumab in order to obtain and assess long-term gevokizumab safety data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose 2 gevokizumab | Experimental | Drug: Dose 2 gevokizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Completed either the X052130/CL3-78989-005 or the X052131/CL3-78989-006 study's masked D392 or OL-224 completion day visits or had controlled ocular inflammation after having received study drug in Part 2 of study X052133
Key exclusion criteria (2 listed)
- Discontinued from the previous study
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| Dose 2 gevokizumabSolution for subcutaneous injection | Drug | Dose 2 gevokizumab |
Primary outcome
Treatment-emergent Adverse Events
Time frame: 108 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dose 2 gevokizumab in people with Uveitis, run by XOMA (US) LLC at 33 sites in United States.
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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 16 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early. Results are not available in the source record.
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?
Treatment-emergent Adverse Events (time frame: 108 weeks). 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 16 Oct 2015.