UveitisPhase 3EYEGUARD™-CNCT01747538
Safety and Efficacy Study of Gevokizumab to Treat Non-infectious Uveitis Controlled With Systemic Treatment
A Phase 3 study testing Dose 1 gevokizumab and Dose 2 gevokizumab in people with Uveitis, run by XOMA (US) LLC at 115 sites in 22 countries.
Trial summary
The purpose of this study is to evaluate the efficacy of gevokizumab in reducing the risk of recurrent uveitic disease in subjects with non-infectious uveitis whose disease is currently controlled with systemic treatment. 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
- 281 participants
- Where
- 115 sitesin 22 countries
- Study dates
- Oct 2012to Jun 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
- Controlled uveitic disease in both eyes
- Stable dose of oral corticosteroids in combination with selected stable immunosuppressive therapy
- Effective contraceptive measures
Who cannot join
- Infectious uveitis and masquerade syndromes
- Isolated anterior uveitis
- Contraindication to mydriatics
- Active tuberculosis disease
- History of allergic or anaphylactic reactions to monoclonal antibodies
- 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
115 sites in 22 countries.
115 sites in 22 countries
United States51 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, Michigan
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
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
Italy6 sites
Study site
Ancona, Marche
Study site
Genova
Study site
Milan
Study site
Padova
Study site
Padua
Study site
Romagna
Germany5 sites
Study site
Berlin
Study site
Chemnitz
Study site
Heidelberg
Study site
Münster
Study site
Tüebingen
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
Mexico City
Study site
Nuevo León
Study site
Tijuana
Poland4 sites
Study site
Gdansk
Study site
Katowice
Study site
Lublin
Study site
Warsaw
Spain4 sites
Study site
Barcelona
Study site
Granada
Study site
Madrid
Study site
Málaga
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
Rosaria, 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
Turkey (Türkiye)3 sites
Study site
Ankara
Study site
Cerrahpasa, Istanbul
Study site
Faith, Istanbul
About this study
Official title: A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Subjects With Non-infectious Intermediate, Posterior, or Pan-uveitis Currently Controlled With Systemic Treatment
The purpose of this study is to evaluate the efficacy of gevokizumab in reducing the risk of recurrent uveitic disease in subjects with non-infectious uveitis whose disease is currently controlled with systemic treatment.
- 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.
Proportion of subjects with an occurrence of uveitic disease through Day 168
Measured: Day 0 through Day 168
Secondary outcomes (1)
Time to first occurrence of uveitic disease
Measured: Day 0 through Day 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionJun 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
- 281 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
- NCT01747538
- Sponsor's protocol ID
- X052131/CL3-78989-006
- Other IDs
- 2012-001609-25, U1111-1135-1462
- Acronym
- EYEGUARD™-C
- Status last verified
- Jul 2016
- First submitted
- 7 Dec 2012
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 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 Subjects With Non-infectious Intermediate, Posterior, or Pan-uveitis Currently Controlled With Systemic Treatment
- ClinicalTrials.gov ID
- NCT01747538
- Acronym / sponsor ID
- EYEGUARD™-C / X052131/CL3-78989-006
- Conditions
- Uveitis
- Keywords
- Uveitis, Non-infectious Uveitis, Intermediate Uveitis, Posterior Uveitis, Panuveitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 281 participants (actual)
- Lead sponsor
- XOMA (US) LLCIndustry (pharma, biotech, devices)
- Collaborators
- Institut de Recherches Internationales Servier
- Study start
- Oct 2012
- Primary completion
- Jun 2016 (actual)
- First posted
- 11 Dec 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 reducing the risk of recurrent uveitic disease in subjects with non-infectious uveitis whose disease is currently controlled with systemic treatment.
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
- Controlled uveitic disease in both eyes
- Stable dose of oral corticosteroids in combination with selected stable immunosuppressive therapy
- Effective contraceptive measures
Key exclusion criteria (8 listed)
- Infectious uveitis and masquerade syndromes
- Isolated anterior uveitis
- Contraindication to mydriatics
- Active tuberculosis disease
- History of allergic or anaphylactic reactions to monoclonal antibodies
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
Proportion of subjects with an occurrence of uveitic disease through Day 168
Time frame: Day 0 through Day 168
1 secondary outcome
Time to first occurrence of uveitic disease
Time frame: Day 0 through Day 168
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 12 Jul 2016.
Related trials for Uveitis
RecruitingPhase 3
A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
Behçet's Disease, Juvenile Psoriatic Arthritis
Not yet recruiting
Efficacy and Safety of Adalimumab for the Treatment of Ocular Inflammation
Non-infectious Anterior Uveitis, Non-infectious Intermediate Uveitis
RecruitingObservational study
A Study of Uveitis in Children <18 Years of Age
Uveitis
Active, not recruitingPhase 2
Multicenter Study on the Efficacy and Safety of OCS-01 in Subjects With Uveitis Related and Post Surgical Macular Edema
Uveitis Related Cystoid Macular Edema, Cystoid Macular Edema, Postoperative
RecruitingPhase 1
A Proof-of-concept Trial to EvaluAte the efficaCy and Safety Of Cell Therapy TRX103 in Patients With Active, Non-infectious Uveitis
Non Infectious Uveitis
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.
115 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 115 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 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 115 sites in United States, Italy, Germany, Australia, Mexico 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?
Proportion of subjects with an occurrence of uveitic disease through Day 168 (time frame: Day 0 through Day 168). 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 12 Jul 2016.