Uveitis, PosteriorPhase 3LUMINATENCT00404742
A Study of LX211 in Clinically Quiescent Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis
A Phase 3 study testing LX211 in people with Uveitis, Posterior and Uveitis, Intermediate, run by Lux Biosciences, Inc. at 41 sites in 7 countries.
Trial summary
The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with clinically quiescent non-infectious uveitis Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Uveitis, Posterior, Uveitis, Intermediate, Panuveitis
- What is being tested?
- LX211
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 232 participants
- Where
- 41 sitesin 7 countries
- Study dates
- Jan 2007to May 2009
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A documented history of non-infectious intermediate, anterior and intermediate, posterior or panuveitis.
- Minimum prescribed therapy upon enrollment is one or more of the following:
- systemic prednisone or equivalent averaging ≥ 10 mg/day
- at least 2 periocular/intravitreal corticosteroid administrations for control of inflammatory disease within the previous 8 months (but not within 6 weeks of randomization).
- at least one, but not more than 2 immunosuppressive drugs from among the following compounds: cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, methotrexate
- Subjects with clinically quiescent uveitis in both eyes at enrollment and who have been on a stable treatment regimen for a minimum of 6 weeks
- Best-corrected distance visual acuity in the worst involved eye of 20/400 or better (ETDRS logMAR <1.34)
- Subjects not planning to undergo elective ocular surgery during the study
Who cannot join
- Evidence of active, uncontrolled non-infectious uveitis
- Periocular administration of corticosteroids within the previous 6 weeks.
- Uveitis of infectious etiology
- Uncontrolled glaucoma
- Clinically suspected or confirmed central nervous system or ocular lymphoma
- History or diagnosis of Behçet's disease
- Primary diagnosis of anterior uveitis
Trial locations and contacts
41 sites in 7 countries.
41 sites in 7 countries
United States19 sites
Texas Retina Associates
Arlington, Texas, 76012
Brian B. Berger, MD, P.A.
Austin, Texas, 78705
Wilmer Eye Institute
Baltimore, Maryland
University of Alabama at Birmingham
Birmingham, Alabama
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts
Massachusetts Eye Research and Surgery Institute
Cambridge, Massachusetts, 02142
University of Illinois - Chicago
Chicago, Illinois, 60612
Texas Retina Associates
Dallas, Texas, 75231
Duke University Eye Center, Erwin Road
Durham, North Carolina
Associated Retinal Consultants, PC
Grand Rapids, Michigan, 49546
Vitreoretinal Consultants
Houston, Texas, 77030
Midwest Eye Institute
Indianapolis, Indiana, 46280
Tauber Eye Center
Kansas City, Missouri, 64111
New York Eye & Ear Hospital
New York, New York, 10003
UMDNJ-New Jersey Medical School, Ophthalmology Dept.
Newark, New Jersey, 07103
Viginia Eye Consultants
Norfolk, Virginia, 23502
Retinal Consultants of Arizona
Phoenix, Arizona, 85014
Oregon Health Sciences University
Portland, Oregon, 97201
Retina & Uveitis Consultants of Texas
San Antonio, Texas, 78240
India9 sites
Vittala International Institute of Ophthalmology
Bangalore
Consultant, Retina and Vitreous Services, Bhubaneswar L V Prasad Eye Institute
Bhubaneswar, Odisha
Advanced Eye Centre, Postgraduate Institute of Medical Education and Research (PGIMER)
Chandigarh
Department of Opthalmology, Sankara Nethralaya, Medical Research Foundation,
Chennai, Tamil Nadu
Aravind Eye Hospital, Uvea Clinic
Coimbatore
L V Prasad Eye Institute
Hyderabaad, Andhra Pradesh
Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology
Madurai, Tamil Nadu
Aditya Jyot Eye Hospital Pvt Ltd
Mumbai
Dr. R. P. Centre for Ophthalmic Sciences, All India Institute of Medical Sciences
New Delhi
Canada3 sites
Ivey Eye Institute
London, Ontario, N6A 4G5
McGill University Health Center
Montreal, Quebec, H3A 1A1
University of Ottawa Eye Institute
Ottawa, Ontario, K1H 8L6
Germany3 sites
Universitätsklinikum Freiburg
Freiburg im Breisgau
Augenklinik der Universität Heidelberg
Heidelberg
Universitätsklinikum Tübingen
Tübingen
United Kingdom3 sites
Bristol Eye Hospital and University of Bristol
Bristol
Royal Liverpool University Hospital
Liverpool
Moorfields Eye Hospital
London
Austria2 sites
Universitätsklinik für Augenheilkunde
Salzburg
Klinik für Augenheilkunde, Dept. of Ophthalmology
Vienna
France2 sites
Center Hospitalier Universitaire d' Angers, Service d'Opthalmologie
Angers
Hôpital Pitié Salpétrière, Service d'Ophtalmologie
Paris
About this study
Official title: A Double-Masked, Placebo-Controlled, Multi-Center, Parallel-Group, Dose-Ranging Study With an Optional Extension to Assess the Efficacy and Safety of LX211 as Therapy in Subjects With Clinically Quiescent Sight Threatening, Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis
The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with clinically quiescent non-infectious uveitis
- Conditions
- Uveitis, Posterior, Uveitis, Intermediate, Panuveitis
- Being tested
- Placebo, LX211
- Keywords
- uveitis, calcineurin
- Medical subject headings
- Uveitis, Posterior, Uveitis, Intermediate, Panuveitis, Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
PO BID
LX211Drug
0.2 mg/kg, twice a day (BID)
LX211Drug
0.4 mg/kg, twice a day (BID)
LX211Drug
0.6 mg/kg, twice a day (BID)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| LX211, 0.2 mg/kg | Active comparator | Not described Receives: Drug: LX211 |
| LX211, 0.4 mg/kg | Active comparator | Not described Receives: Drug: LX211 |
| LX211, 0.6 mg/kg | Active comparator | Not described Receives: Drug: LX211 |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of ocular inflammation
Measured: 26 weeks
Secondary outcomes (2)
BCVA
Measured: 26 weeks
systemic corticosteroid usage
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2006 (estimated)
- Study startJan 2007
- Primary completionNov 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveitis, PosteriorStudies 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
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lux Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eddy Anglade, M.D., Study chair, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00404742
- Sponsor's protocol ID
- LX211-02-UV
- Other IDs
- EudraCT No: 2006-006544-66
- Acronym
- LUMINATE
- Status last verified
- Jun 2012
- First submitted
- 27 Nov 2006
- Last updated
- 22 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Masked, Placebo-Controlled, Multi-Center, Parallel-Group, Dose-Ranging Study With an Optional Extension to Assess the Efficacy and Safety of LX211 as Therapy in Subjects With Clinically Quiescent Sight Threatening, Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis
- ClinicalTrials.gov ID
- NCT00404742
- Acronym / sponsor ID
- LUMINATE / LX211-02-UV
- Conditions
- Uveitis, Posterior, Uveitis, Intermediate, Panuveitis
- Keywords
- uveitis, calcineurin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Lux Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 29 Nov 2006 (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 evaluate the safety and efficacy of LX211 as therapy in subjects with clinically quiescent non-infectious uveitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| LX211, 0.2 mg/kg | Active comparator | Drug: LX211 |
| LX211, 0.4 mg/kg | Active comparator | Drug: LX211 |
| LX211, 0.6 mg/kg | Active comparator | Drug: LX211 |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- A documented history of non-infectious intermediate, anterior and intermediate, posterior or panuveitis.
- Minimum prescribed therapy upon enrollment is one or more of the following:
- Subjects with clinically quiescent uveitis in both eyes at enrollment and who have been on a stable treatment regimen for a minimum of 6 weeks
- Best-corrected distance visual acuity in the worst involved eye of 20/400 or better (ETDRS logMAR <1.34)
- Subjects not planning to undergo elective ocular surgery during the study
Key exclusion criteria (7 listed)
- Evidence of active, uncontrolled non-infectious uveitis
- Periocular administration of corticosteroids within the previous 6 weeks.
- Uveitis of infectious etiology
- Uncontrolled glaucoma
- Clinically suspected or confirmed central nervous system or ocular lymphoma
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 |
|---|---|---|
| PlaceboPO BID | Drug | Placebo |
| LX2110.2 mg/kg, twice a day (BID) | Drug | LX211, 0.2 mg/kg |
| LX2110.4 mg/kg, twice a day (BID) | Drug | LX211, 0.4 mg/kg |
| LX2110.6 mg/kg, twice a day (BID) | Drug | LX211, 0.6 mg/kg |
Primary outcome
recurrence of ocular inflammation
Time frame: 26 weeks
2 secondary outcomes
BCVA
Time frame: 26 weeks
systemic corticosteroid usage
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2012.
- Related InfoLink provided by the sponsor.
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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.
Eddy Anglade, M.D. study chair
Chief Medical Officer
41 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LX211 in people with Uveitis, Posterior and Uveitis, Intermediate, run by Lux Biosciences, Inc. at 41 sites in 7 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 8 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: finished, as of the sponsor's last update on 22 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, India, Canada, Germany, United Kingdom and 2 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
recurrence of ocular inflammation (time frame: 26 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 22 Jun 2012.