Behcet's Disease UveitisPhase 3EYEGUARD™-USNCT02258867
Efficacy and Safety Study of Gevokizumab to Treat Behcet's Disease Uveitis
A Phase 3 study testing Gevokizumab in people with Behcet's Disease Uveitis, run by XOMA (US) LLC at 8 sites in United States.
Trial summary
The objective of this study is to assess the efficacy and safety of gevokizumab in treating Behcet's disease uveitis (BDU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Behcet's Disease Uveitis
- What is being tested?
- Gevokizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 8 sitesUnited States
- Study dates
- Nov 2014to Nov 2015
- 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
- Have characteristics of Behcet's disease consistent with International Criteria for Behcet's disease
- Have a documented history of active uveitis with or without retinal vasculitis within the past 12 months
- Best corrected visual acuity (BCVA) >= 20 ETDRS letters in both eyes at baseline
- Effective contraceptive measures
Who cannot join
- Infectious uveitis and masquerade syndromes
- End stage ocular disease
- 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
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Study site
Cambridge, Massachusetts
Study site
Chicago, Illinois
Study site
Ellsworth, Maine
Study site
Fargo, North Dakota
Study site
Houston, Texas
Study site
Royal Oak, Michigan
Study site
Santa Ana, California
Study site
Winston-Salem, North Carolina
About this study
Official title: A Randomized-Withdrawal, Double-Masked, Placebo-Controlled Study of the Efficacy and Safety of Gevokizumab in Treating Subjects With Behcet's Disease Uveitis
The objective of this study is to assess the efficacy and safety of gevokizumab in treating Behcet's disease uveitis (BDU).
- Conditions
- Behcet's Disease Uveitis
- Being tested
- Placebo, Gevokizumab
- Keywords
- Uveitis, Behcet's Disease Uveitis, Behcet's Disease
- Medical subject headings
- Uveitis, Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Solution for subcutaneous injection
GevokizumabDrug
Solution for subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Gevokizumab | Experimental | Not described Receives: Drug: Gevokizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first ocular exacerbation
Time to first ocular exacerbation is defined as the number of days from randomization to the first ocular exacerbation.
Measured: Randomization through Day 280
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 startNov 2014
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behcet's Disease 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
- 4 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
- NCT02258867
- Sponsor's protocol ID
- X052133
- Acronym
- EYEGUARD™-US
- Status last verified
- Dec 2015
- First submitted
- 2 Oct 2014
- Last updated
- 29 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized-Withdrawal, Double-Masked, Placebo-Controlled Study of the Efficacy and Safety of Gevokizumab in Treating Subjects With Behcet's Disease Uveitis
- ClinicalTrials.gov ID
- NCT02258867
- Acronym / sponsor ID
- EYEGUARD™-US / X052133
- Conditions
- Behcet's Disease Uveitis
- Keywords
- Uveitis, Behcet's Disease Uveitis, Behcet's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- XOMA (US) LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- 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 objective of this study is to assess the efficacy and safety of gevokizumab in treating Behcet's disease uveitis (BDU).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Gevokizumab | Experimental | Drug: 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)
- Have characteristics of Behcet's disease consistent with International Criteria for Behcet's disease
- Have a documented history of active uveitis with or without retinal vasculitis within the past 12 months
- Best corrected visual acuity (BCVA) >= 20 ETDRS letters in both eyes at baseline
- Effective contraceptive measures
Key exclusion criteria (7 listed)
- Infectious uveitis and masquerade syndromes
- End stage ocular disease
- History of allergic or anaphylactic reactions to monoclonal antibodies
- Active tuberculosis disease
- History of recurrent infection or predisposition to infection; active ocular infection
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 |
| GevokizumabSolution for subcutaneous injection | Drug | Gevokizumab |
Primary outcome
Time to first ocular exacerbation
Time frame: Randomization through Day 280
Time to first ocular exacerbation is defined as the number of days from randomization to the first ocular exacerbation.
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 29 Dec 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.
8 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 Gevokizumab in people with Behcet's Disease Uveitis, run by XOMA (US) LLC at 8 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 4 inclusion and 7 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 29 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. 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?
Time to first ocular exacerbation (time frame: Randomization through Day 280). 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 29 Dec 2015.