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TerminatedNCT01747538EYEGUARD™-CUpdated Jul 12, 2016

Safety and Efficacy Study of Gevokizumab to Treat Non-infectious Uveitis Controlled With Systemic Treatment

A Phase 3 interventional study of Placebo and Dose 1 gevokizumab in Uveitis, sponsored by XOMA (US) LLC. Terminated at 115 sites in 22 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-12.

Sponsored by XOMA (US) LLC · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
281
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Uveitis

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Keywords

  • Uveitis
  • Non-infectious Uveitis
  • Intermediate Uveitis
  • Posterior Uveitis
  • Panuveitis
03

In context

Uveitis

335 studies on the registry are indexed under Uveitis; 37 are open to participants now.

This study's enrollment of 281 is above the median of 30 across 208 interventional studies indexed under Uveitis.

Browse Uveitis studies →

Lead sponsor

XOMA (US) LLC is the lead sponsor of 25 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
281 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    Dose 1 gevokizumab

    Drug: Dose 1 gevokizumab

  • Experimental
    Dose 2 gevokizumab

    Drug: Dose 2 gevokizumab

Interventions

  • DrugPlacebo

    Solution for subcutaneous injection

  • DrugDose 1 gevokizumab

    Solution for subcutaneous injection

  • DrugDose 2 gevokizumab

    Solution for subcutaneous injection

06

What researchers measure

Primary outcomes

  1. Proportion of subjects with an occurrence of uveitic disease through Day 168

    Time frame: Day 0 through Day 168

Secondary outcomes

  1. Time to first occurrence of uveitic disease

    Time frame: Day 0 through Day 168

07

Study locations

115 sites
  • Chandler, Arizona, United States
  • Phoenix, Arizona, United States
  • Beverly Hills, California, United States
  • Los Angeles, California, United States
  • Redlands, California, United States
  • Sacramento, California, United States
  • San Luis Obispo, California, United States
  • Santa Ana, California, United States
  • Victorville, California, United States
  • Golden, Colorado, United States
  • Littleton, Colorado, United States
  • Bridgeport, Connecticut, United States
  • Washington, District of Columbia, United States
  • Lakeland, Florida, United States
  • St. Petersburg, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Indianapolis, Indiana, United States
  • Iowa City, Iowa, United States
  • Ellsworth, Maine, United States
  • Baltimore, Maryland, United States
  • Cambridge, Massachusetts, United States
  • Waltham, Massachusetts, United States
  • Detroit, Michigan, United States
  • Jackson, Michigan, United States
  • Royal Oak, Michigan, United States
  • Rochester, Minnesota, United States
  • St. Louis, Missouri, United States
  • Omaha, Nebraska, United States
  • Bloomfield, New Jersey, United States
  • Palisades Park, New Jersey, United States
  • Teaneck, New Jersey, United States
  • Belmont, North Carolina, United States
  • Charlotte, North Carolina, United States
  • Winston-Salem, North Carolina, United States
  • Fargo, North Dakota, United States
  • Beachwood, Ohio, United States
  • Cleveland, Ohio, United States
  • Middleburg Heights, Ohio, United States
  • Ashland, Oregon, United States
  • Philadelphia, Pennsylvania, United States
  • Knoxville, Tennessee, United States
  • Memphis, Tennessee, United States
  • Austin, Texas, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Mission, Texas, United States
  • San Antonio, Texas, United States
  • Salt Lake City, Utah, United States
  • Norfolk, Virginia, United States
  • Olivos, Buenos Aires, Argentina
  • Rosaria, Santa Fe, Argentina
  • Buenos Aires, Argentina
  • Yerevan, Armenia
  • Sydney, New South Wales, Australia
  • East Melbourne, Victoria, Australia
  • Nedlands, Western Australia, Australia
  • Darlinghurst, New South Wales, Australia
  • Belo Horizonte, MG, Brazil
  • Rio de Janeiro, Brazil
  • San Paulo, Brazil
  • Ottawa, Ontario, Canada
  • Montréal, Quebec, Canada
  • Beijing, China
  • Chongqing, China
  • Hong Kong, China
  • Lyon, France
  • Nantes, France
  • Paris, France
  • Berlin, Germany
  • Chemnitz, Germany
  • Heidelberg, Germany
  • Muenster, Germany
  • Tüebingen, Germany
  • Mezourlo, Larissa, Greece
  • Jerusalem, Israel
  • Petoch Tikvah, Israel
  • Tel Aviv, Israel
  • Ancona, Marche, Italy
  • Genova, Italy
  • Milano, Italy
  • Padova, Italy
  • Padua, Italy
  • Romagna, Italy
  • Distrito Federal, Mexico
  • Mexico City, Mexico
  • Nuevo Leon, Mexico
  • Tijuana, Mexico
  • Gdansk, Poland
  • Katowice, Poland
  • Lublin, Poland
  • Warszawa, Poland
  • Braga, Portugal
  • Coimbra, Portugal
  • Lisboa, Portugal
  • Khabarovsk, Russian Federation
  • Novosibirsk, Russian Federation
  • Saint-Petersburg, Russian Federation
  • Durban, South Africa

Showing the first 100 of 115 sites across 22 countries.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01747538
Lead sponsor
XOMA (US) LLC
Collaborators
Institut de Recherches Internationales Servier
Responsible party
Sponsor
First posted
Dec 11, 2012
Start date
Oct 2012
Primary completion
Jun 2016
Last update
Jul 12, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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