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

Cerimon Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Non-infectious Uveitis

Treatments: Drug: Basiliximab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00646425

BSX-003

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 12 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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5 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Basiliximab

Treatment:

Drug: Basiliximab

2

Placebo Comparator group

Treatment:

Drug: Placebo