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The Safety and Efficacy of Basiliximab as Maintenance Therapy in Subjects With Stable, Noninfectious Uveitis (BSX-003)

Primary Purpose

Non-infectious Uveitis

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Basiliximab
Placebo
Sponsored by
Cerimon Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-infectious Uveitis focused on measuring Non-infectious uveitis

Eligibility Criteria

12 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Ocular Immunology & Uveitis Foundation
  • Tauber Eye Center
  • New York Eye and Ear Infirmary
  • Southeast Clinical Research Associates
  • University of Texas Medical Branch
  • Vitreoretinal Consultants

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Basiliximab

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 26, 2008
Last Updated
August 17, 2010
Sponsor
Cerimon Pharmaceuticals
Collaborators
PPD
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1. Study Identification

Unique Protocol Identification Number
NCT00646425
Brief Title
The Safety and Efficacy of Basiliximab as Maintenance Therapy in Subjects With Stable, Noninfectious Uveitis
Acronym
BSX-003
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Terminated
Study Start Date
May 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cerimon Pharmaceuticals
Collaborators
PPD

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-infectious Uveitis
Keywords
Non-infectious uveitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Basiliximab
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Basiliximab
Other Intervention Name(s)
Simulect
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match basiliximab
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaily Reichert
Organizational Affiliation
Cerimon Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Ocular Immunology & Uveitis Foundation
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02142
Country
United States
Facility Name
Tauber Eye Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
New York Eye and Ear Infirmary
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Southeast Clinical Research Associates
City
Belmont
State/Province
North Carolina
ZIP/Postal Code
28012
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Vitreoretinal Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Safety and Efficacy of Basiliximab as Maintenance Therapy in Subjects With Stable, Noninfectious Uveitis

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