UveitisPhase 3EYEGUARD™-ANCT01684345
Safety and Efficacy Study of Gevokizumab to Treat Active Non-infectious Uveitis
A Phase 3 study testing Dose 1 gevokizumab and Dose 2 gevokizumab in people with Uveitis, run by XOMA (US) LLC at 116 sites in 22 countries.
Trial summary
The purpose of this study is to evaluate the efficacy of gevokizumab in the treatment of active non-infectious intermediate, posterior, or pan- uveitis. 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 1 gevokizumab and Dose 2 gevokizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 116 sitesin 22 countries
- Study dates
- Aug 2012to Feb 2016
- 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
- Diagnosis of non-infectious intermediate, posterior, or pan- uveitis in at least one eye
- Active uveitic disease in at least one eye
- Currently on one of the following stable treatment regimens for uveitis: oral corticosteroids; systemic immunosuppressive medication; a combination of oral corticosteroids with at least one systemic immunosuppressive medication
- Effective contraceptive measures
Who cannot join
- Infectious uveitis and masquerade syndromes
- Isolated anterior uveitis
- Contraindication to mydriatics
- History of allergic or anaphylactic reactions to monoclonal antibodies
- Active tuberculosis disease
- History of recurrent infection or predisposition to infection; active ocular infection
- Pregnant or nursing women
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
116 sites in 22 countries.
116 sites in 22 countries
United States52 sites
Study site
Ashland, Oregon
Study site
Atlanta, Georgia
Study site
Austin, Texas
Study site
Baltimore, Maryland
Study site
Beachwood, Ohio
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
Cleveland, Ohio
Study site
Dallas, Texas
Study site
Detroit, Michigan
Study site
Ellsworth, Maine
Study site
Fargo, North Dakota
Study site
Golden, Colorado
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Iowa City, Iowa
Study site
Jackson, Mississippi
Study site
Knoxville, Tennessee
Study site
Lakeland, Florida
Study site
Littleton, Colorado
Study site
Los Angeles, California
Study site
Memphis, Tennessee
Study site
Middleburg Heights, Ohio
Study site
Mission, Texas
Study site
New York, New York
Study site
Norfolk, Virginia
Study site
Omaha, Nebraska
Study site
Palisades Park, New Jersey
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Redlands, California
Study site
Rochester, Minnesota
Study site
Royal Oak, Michigan
Study site
Sacramento, California
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
San Luis Obispo, California
Study site
Santa Ana, California
Study site
St Louis, Missouri
Study site
St. Petersburg, Florida
Study site
Tampa, Florida
Study site
Teaneck, New Jersey
Study site
Victorville, California
Study site
Waltham, Massachusetts
Study site
Washington D.C., District of Columbia
Study site
Winston-Salem, North Carolina
South Korea6 sites
Study site
Gangnam-gu, SEL
Study site
Jongno-gu, SEL
Study site
Secho-gu, SEL
Study site
Seodaemun-gu, SEL
Study site
Seoul
Study site
Songpa-g, SEL
Germany5 sites
Study site
Berlin
Study site
Chemnitz
Study site
Heidelberg
Study site
Münster
Study site
Tüebingen
Spain5 sites
Study site
Barcelona
Study site
Granada
Study site
León
Study site
Madrid
Study site
Málaga
Australia4 sites
Study site
Darlinghurst, New South Wales
Study site
East Melbourne, Victoria
Study site
Nedlands, Western Australia
Study site
Sydney, New South Wales
Mexico4 sites
Study site
Distrito Federal
Study site
León
Study site
Mexico City
Study site
Tijuana
Poland4 sites
Study site
Gdansk
Study site
Katowice
Study site
Lublin
Study site
Warsaw
United Kingdom4 sites
Study site
Bristol
Study site
Liverpool
Study site
London
Study site
Sunderland, Tyne and Wear
Argentina3 sites
Study site
Buenos Aires
Study site
Olivos, Buenos Aires
Study site
Rosario, Santa Fe Province
Brazil3 sites
Study site
Belo Horizonte, Minas Gerais
Study site
Rio de Janeiro
Study site
São Paulo
Russia3 sites
Study site
Khabarovsk
Study site
Novosibirsk
Study site
Saint Petersburg
About this study
Official title: A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Active Non-infectious Intermediate, Posterior, or Pan- Uveitis
The purpose of this study is to evaluate the efficacy of gevokizumab in the treatment of active non-infectious intermediate, posterior, or pan- uveitis.
- Conditions
- Uveitis
- Being tested
- Placebo, Dose 1 gevokizumab, Dose 2 gevokizumab
- Keywords
- Uveitis, Non-infectious Uveitis, Intermediate Uveitis, Posterior Uveitis, Panuveitis
- 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.
PlaceboDrug
Solution for subcutaneous injection
Dose 1 gevokizumabDrug
Solution for subcutaneous injection
Dose 2 gevokizumabDrug
Solution for subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Dose 1 gevokizumab | Experimental | Not described Receives: Drug: Dose 1 gevokizumab |
| 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.
The proportion of responders at Day 56
A response is defined as an improvement of the study eye without deterioration in the contralateral eye.
Measured: Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionFeb 2016
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- XOMA (US) LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut de Recherches Internationales Servier
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684345
- Sponsor's protocol ID
- X052130/CL3-78989-005
- Other IDs
- 2012-001610-42
- Acronym
- EYEGUARD™-A
- Status last verified
- Apr 2016
- First submitted
- 10 Sep 2012
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Active Non-infectious Intermediate, Posterior, or Pan- Uveitis
- ClinicalTrials.gov ID
- NCT01684345
- Acronym / sponsor ID
- EYEGUARD™-A / X052130/CL3-78989-005
- Conditions
- Uveitis
- Keywords
- Uveitis, Non-infectious Uveitis, Intermediate Uveitis, Posterior Uveitis, Panuveitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 200 participants (actual)
- Lead sponsor
- XOMA (US) LLCIndustry (pharma, biotech, devices)
- Collaborators
- Institut de Recherches Internationales Servier
- Study start
- Aug 2012
- Primary completion
- Feb 2016 (actual)
- First posted
- 12 Sep 2012 (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 evaluate the efficacy of gevokizumab in the treatment of active non-infectious intermediate, posterior, or pan- uveitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Dose 1 gevokizumab | Experimental | Drug: Dose 1 gevokizumab |
| 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 (4 listed)
- Diagnosis of non-infectious intermediate, posterior, or pan- uveitis in at least one eye
- Active uveitic disease in at least one eye
- Currently on one of the following stable treatment regimens for uveitis: oral corticosteroids; systemic immunosuppressive medication; a combination of oral corticosteroids with at least one systemic immunosuppressive medication
- Effective contraceptive measures
Key exclusion criteria (8 listed)
- Infectious uveitis and masquerade syndromes
- Isolated anterior uveitis
- Contraindication to mydriatics
- History of allergic or anaphylactic reactions to monoclonal antibodies
- Active tuberculosis disease
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 |
|---|---|---|
| PlaceboSolution for subcutaneous injection | Drug | Placebo |
| Dose 1 gevokizumabSolution for subcutaneous injection | Drug | Dose 1 gevokizumab |
| Dose 2 gevokizumabSolution for subcutaneous injection | Drug | Dose 2 gevokizumab |
Primary outcome
The proportion of responders at Day 56
Time frame: Day 56
A response is defined as an improvement of the study eye without deterioration in the contralateral eye.
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 8 Apr 2016.
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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.
116 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dose 1 gevokizumab and Dose 2 gevokizumab in people with Uveitis, run by XOMA (US) LLC at 116 sites in 22 countries.
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 4 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: stopped early, as of the sponsor's last update on 8 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 116 sites in United States, South Korea, Germany, Spain, Australia and 17 more countries. 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 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?
The proportion of responders at Day 56 (time frame: Day 56). 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 8 Apr 2016.