Non-infectious UveitisPhase 2BSX-003NCT00646425
The Safety and Efficacy of Basiliximab as Maintenance Therapy in Subjects With Stable, Noninfectious Uveitis
A Phase 2 study testing Basiliximab in people with Non-infectious Uveitis, run by Cerimon Pharmaceuticals at 6 sites in United States.
Trial summary
The objective of this trial is to assess if treatment with basiliximab allows subjects to taper off other immunosuppressive drug regimens without causing an increase in their uveitis. Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Non-infectious Uveitis
- What is being tested?
- Basiliximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 6 sitesUnited States
- Study dates
- May 2008to Nov 2008
- Phase
- Phase 2
- 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 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of noninfectious intermediate, posterior or panuveitis of at least 3 months duration
- Treatment with greater than or equal to 20 mg/day of Prednisone at baseline or immunosuppressive drug score of greater than or equal to 5 at baseline
- BCVA by ETDRS protocol better than or equal to 20/200
- Intraocular pressure of 24 mmHg or less
- Anterior chamber cells and vitreous haze of less than or equal to 1
- Male or females, aged 12 or greater, body weight of 40 kg or greater
Who cannot join
- Prior treatment with Retisert
- Primary diagnosis of anterior uveitis, uveitis of infectious etiology or Behcet's disease
- Pregnancy or breast-feeding
- Increase in systemic immunosuppressive treatment regimen within 6 weeks before baseline
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Southeast Clinical Research Associates
Belmont, North Carolina, 28012
Ocular Immunology & Uveitis Foundation
Cambridge, Massachusetts, 02142
University of Texas Medical Branch
Galveston, Texas, 77555
Vitreoretinal Consultants
Houston, Texas, 77030
Tauber Eye Center
Kansas City, Missouri, 64111
New York Eye and Ear Infirmary
New York, New York, 10003
About this study
Official title: Randomized, Double-Masked, Placebo-controlled Evaluation of the Safety and Efficacy of Basiliximab as Maintenance Therapy in Subjects With Stable, Noninfectious Uveitis Who Undergo Tapering of Concomitant Immunosuppressive Medications
The objective of this trial is to assess if treatment with basiliximab allows subjects to taper off other immunosuppressive drug regimens without causing an increase in their uveitis.
- Conditions
- Non-infectious Uveitis
- Being tested
- Basiliximab, Placebo
- Keywords
- Non-infectious uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BasiliximabDrug
Also called Simulect
40 mg basiliximab administered as short iv infusion once every 2 weeks for 3 doses and at Weeks 8 and 12 for a total of 5 doses
PlaceboDrug
Placebo to match basiliximab
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Basiliximab Receives: Drug: Basiliximab |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To prevent an increase in disease activity as measured by anterior cell count, vitreal haze and visual acuity while subjects with stable noninfectious uveitis undergo tapering of concomitant immunosuppressive medications
Measured: The primary outcome will be assessed at Week 16
Secondary outcomes (1)
Secondary objectives are to assess changes in visual acuity, retinal thickness, corticosteroid dose, and immunosuppressive drug score. Basiliximab pharmacokinetics and immunogenicity will also be assessed
Measured: These measures will be assessed at Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study startMay 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-infectious 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerimon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Investigators
- Shaily Reichert, Study director, Cerimon Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646425
- Sponsor's protocol ID
- BSX-003
- Acronym
- BSX-003
- Status last verified
- Aug 2010
- First submitted
- 26 Mar 2008
- Last updated
- 19 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Masked, Placebo-controlled Evaluation of the Safety and Efficacy of Basiliximab as Maintenance Therapy in Subjects With Stable, Noninfectious Uveitis Who Undergo Tapering of Concomitant Immunosuppressive Medications
- ClinicalTrials.gov ID
- NCT00646425
- Acronym / sponsor ID
- BSX-003 / BSX-003
- Conditions
- Non-infectious Uveitis
- Keywords
- Non-infectious uveitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Cerimon PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- May 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 28 Mar 2008 (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 trial is to assess if treatment with basiliximab allows subjects to taper off other immunosuppressive drug regimens without causing an increase in their 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 |
|---|---|---|
| 1 | Experimental | Drug: BasiliximabBasiliximab |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of noninfectious intermediate, posterior or panuveitis of at least 3 months duration
- Treatment with greater than or equal to 20 mg/day of Prednisone at baseline or immunosuppressive drug score of greater than or equal to 5 at baseline
- BCVA by ETDRS protocol better than or equal to 20/200
- Intraocular pressure of 24 mmHg or less
- Anterior chamber cells and vitreous haze of less than or equal to 1
Key exclusion criteria (4 listed)
- Prior treatment with Retisert
- Primary diagnosis of anterior uveitis, uveitis of infectious etiology or Behcet's disease
- Pregnancy or breast-feeding
- Increase in systemic immunosuppressive treatment regimen within 6 weeks before baseline
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 |
|---|---|---|
| BasiliximabAlso: Simulect40 mg basiliximab administered as short iv infusion once every 2 weeks for 3 doses and at Weeks 8 and 12 for a total of 5 doses | Drug | 1 |
| PlaceboPlacebo to match basiliximab | Drug | 2 |
Primary outcome
To prevent an increase in disease activity as measured by anterior cell count, vitreal haze and visual acuity while subjects with stable noninfectious uveitis undergo tapering of concomitant immunosuppressive medications
Time frame: The primary outcome will be assessed at Week 16
1 secondary outcome
Secondary objectives are to assess changes in visual acuity, retinal thickness, corticosteroid dose, and immunosuppressive drug score. Basiliximab pharmacokinetics and immunogenicity will also be assessed
Time frame: These measures will be assessed at Week 16
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 19 Aug 2010.
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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.
Shaily Reichert study director
Cerimon Pharmaceuticals
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Basiliximab in people with Non-infectious Uveitis, run by Cerimon Pharmaceuticals at 6 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 6 inclusion and 4 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 19 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To prevent an increase in disease activity as measured by anterior cell count, vitreal haze and visual acuity while subjects with stable noninfectious uveitis undergo tapering of concomitant immunosuppressive medications (time frame: The primary outcome will be assessed at Week 16). 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 19 Aug 2010.