Noninfectious UveitisPhase 3NCT01243983
Efficacy and Safety of Voclosporin to Treat Active Noninfectious Uveitis
A Phase 3 study testing LX211 in people with Noninfectious Uveitis, run by Lux Biosciences, Inc. at 52 sites in 9 countries.
Trial summary
The primary objective of this study is to assess the safety and efficacy of voclosporin as therapy in subjects with active noninfectious uveitis involving the intermediate and/or posterior segments of the eye (i.e., anterior + intermediate-, intermediate-, posterior- or pan-uveitis). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Noninfectious Uveitis
- What is being tested?
- LX211
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 52 sitesin 9 countries
- Study dates
- Feb 2011to Dec 2012
- 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
- Active noninfectious uveitis involving the intermediate and/or posterior segment (i.e., anterior + intermediate-, intermediate-, posterior- or pan-uveitis) in at least one eye as evidenced by a vitreous haze grade of at least 2+ at the baseline visit. Subjects who also have anterior segment involvement need not be excluded if otherwise qualified.
- Subjects must be:
- Capable of understanding the purpose and risks of the study.
- Able to give written informed consent.
- Able to comply with all study requirements.
Who cannot join
- Ocular Disease/Conditions
- The following conditions are exclusionary if present:
- Uveitis limited to only the anterior segment of the study eye.
- Confirmed or suspected infectious uveitis in either eye.
- Prior and Current Treatment:
- As defined in the protocol
Show all 10Show fewer
- Extraocular Conditions:
- As defined in the protocol.
- Laboratory, Blood Pressure and ECG Evaluations:
- As defined in the protocol.
Trial locations and contacts
52 sites in 9 countries.
52 sites in 9 countries
United States28 sites
Study site
Arlington, Texas, 76012
Study site
Ashland, Oregon, 97520
Study site
Baltimore, Maryland, 21287
Study site
Belmont, North Carolina, 28012
Study site
Beverly Hills, California, 90211
Study site
Cambridge, Massachusetts, 02142
Study site
Cleveland, Ohio, 44122
Study site
Cleveland, Ohio, 44195
Study site
Dallas, Texas, 75231
Study site
Dublin, Ohio, 43016
Study site
Ellsworth, Maine, 04605
Study site
Houston, Texas, 77030
Study site
Indianapolis, Indiana, 46290
Study site
Ladson, South Carolina, 29456
Study site
Little Rock, Arkansas, 72205
Study site
Middleburg Heights, Ohio, 44130
Study site
Mountain View, California, 94040
Study site
Newark, New Jersey, 07103
Study site
Norfolk, Virginia, 23502
Study site
Peoria, Arizona, 85381
Study site
Philadelphia, Pennsylvania, 19107
Study site
Phoenix, Arizona, 85014
Study site
Richmond, Virginia, 23219
Study site
Sacramento, California, 95819
Study site
San Antonio, Texas, 78240
Study site
Santa Ana, California, 92705
Study site
Torrance, California, 90503
Study site
Winston-Salem, North Carolina, 27157
Italy5 sites
Study site
Bologna, 40138
Study site
Milan, 20132
Study site
Padova, 35128
Study site
Parma, 43126
Study site
Reggio Emilia, 42100
Czechia4 sites
Study site
Brno, 62500
Study site
Hradec Králové, 50005
Study site
Olomouc, 77520
Study site
Prague, 12808
France4 sites
Study site
Angers, 49933
Study site
Bordeaux, 33000
Study site
Paris, 75013
Study site
Paris, 75019
United Kingdom4 sites
Study site
Birmingham, B18 7QU
Study site
London, EC1V 2PD
Study site
London, SE1 7EH
Study site
York, YO31 8HE
Brazil3 sites
Study site
Recife, 50070-040, PE
Study site
Rio de Janeiro, 21941-913, RJ
Study site
São Paulo, 04023-062, SP
About this study
Official title: A Multi-Center, Double-Masked, Parallel-Group, Placebo-Controlled Study to Assess the Efficacy and Safety of Voclosporin as Therapy in Subjects With Active Noninfectious Uveitis Involving the Intermediate and/or Posterior Segments of the Eye
The primary objective of this study is to assess the safety and efficacy of voclosporin as therapy in subjects with active noninfectious uveitis involving the intermediate and/or posterior segments of the eye (i.e., anterior + intermediate-, intermediate-, posterior- or pan-uveitis).
- Conditions
- Noninfectious Uveitis
- Being tested
- LX211
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LX211Drug
Subjects will be sequentially assigned to one of the following treatment arms in a 1:1 ratio:
- Treatment Arm A: voclosporin 0.4 mg/kg p.o. b.i.d., not to exceed 40 mg p.o. b.i.d.
- Treatment Arm B: placebo p.o. b.i.d.
Dosage Form:
- Soft gelatin capsule
Duration of treatment:
- 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| LX211 | Experimental | Not described Receives: Drug: LX211 |
| Placebo | Placebo comparator | Not described Receives: Drug: LX211 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in graded vitreous haze in the study eye at 12 weeks of therapy or at the time of treatment failure, if earlier.
Measured: 12 weeks
Secondary outcomes (2)
Daily mean systemic corticosteroid dose used during Weeks 12-24
Measured: Weeks 12-24
Time to augmentation with corticosteroid therapy.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startFeb 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noninfectious 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
- 155 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
- NCT01243983
- Sponsor's protocol ID
- LX211-11
- Other IDs
- 2010-022128-63
- Status last verified
- Jan 2013
- First submitted
- 17 Nov 2010
- Last updated
- 10 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Masked, Parallel-Group, Placebo-Controlled Study to Assess the Efficacy and Safety of Voclosporin as Therapy in Subjects With Active Noninfectious Uveitis Involving the Intermediate and/or Posterior Segments of the Eye
- ClinicalTrials.gov ID
- NCT01243983
- Acronym / sponsor ID
- LX211-11
- Conditions
- Noninfectious Uveitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Lux Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 19 Nov 2010 (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 primary objective of this study is to assess the safety and efficacy of voclosporin as therapy in subjects with active noninfectious uveitis involving the intermediate and/or posterior segments of the eye (i.e., anterior + intermediate-, 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
- 2
| Arm | Type | Receives |
|---|---|---|
| LX211 | Experimental | Drug: LX211 |
| Placebo | Placebo comparator | Drug: LX211 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Active noninfectious uveitis involving the intermediate and/or posterior segment (i.e., anterior + intermediate-, intermediate-, posterior- or pan-uveitis) in at least one eye as evidenced by a vitreous haze grade of at least 2+ at the baseline visit. Subjects who also have anterior segment involvement need not be excluded if otherwise qualified.
- Subjects must be:
Key exclusion criteria (10 listed)
- Ocular Disease/Conditions
- The following conditions are exclusionary if present:
- Prior and Current Treatment:
- Extraocular Conditions:
- Laboratory, Blood Pressure and ECG Evaluations:
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 |
|---|---|---|
| LX211Subjects will be sequentially assigned to one of the following treatment arms in a 1:1 ratio: * Treatment Arm A: voclosporin 0.4 mg/kg p.o. b.i.d., not to exceed 40 mg p.o. b.i.d. * Treatment Arm B: placebo p.o. b.i.d. Dosage Form: • Soft gelatin capsule Duration of treatment: • 24 weeks | Drug | LX211, Placebo |
Primary outcome
The change from baseline in graded vitreous haze in the study eye at 12 weeks of therapy or at the time of treatment failure, if earlier.
Time frame: 12 weeks
2 secondary outcomes
Daily mean systemic corticosteroid dose used during Weeks 12-24
Time frame: Weeks 12-24
Time to augmentation with corticosteroid therapy.
Time frame: Week 24
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 10 Jan 2013.
Related trials for Noninfectious Uveitis
Not yet recruitingObservational study
The Microbiome in Uveitis and Pediatric Inflammatory Diseases
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Not yet recruitingPhase 2
A Clinical Trial Of Tulisokibart In Participants With Active, Non-Infectious Uveitis (MK-7240-019)
Noninfectious Intermediate, Posterior, or Panuveitis
Active, not recruitingPhase 3
A Phase 3 Study of VVN461 Ophthalmic Solution for Noninfectious Anterior Uveitis
Non-infectious Anterior Uveitis
Not yet recruitingObservational study
Frequency and Intensity of Inflammatory Relapses in Patients With Non-infectious Posterior Uveitis Treated With a Fluocinolone Acetonide Implant
Noninfectious Posterior Uveitis, Uveitis, Posterior
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
52 sites in 9 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 Noninfectious Uveitis, run by Lux Biosciences, Inc. at 52 sites in 9 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 5 inclusion and 10 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 10 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States, Italy, Czechia, France, United Kingdom and 4 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?
The change from baseline in graded vitreous haze in the study eye at 12 weeks of therapy or at the time of treatment failure, if earlier. (time frame: 12 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 10 Jan 2013.