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

Non-infectious Uveitis Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00646425
• Other study ID #: BSX-003
• Status: Terminated
• Phase: Phase 2
• First received: March 26, 2008
• Last updated: August 17, 2010
• Start date: May 2008
• Est. completion date: November 2008

Study information

• Verified date: August 2010
• Source: Cerimon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Non-infectious Uveitis
• Uveitis

Intervention

Drug:
• Basiliximab
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
• Placebo
Placebo to match basiliximab

Locations

Country	Name	City	State
United States	Southeast Clinical Research Associates	Belmont	North Carolina
United States	Ocular Immunology & Uveitis Foundation	Cambridge	Massachusetts
United States	University of Texas Medical Branch	Galveston	Texas
United States	Vitreoretinal Consultants	Houston	Texas
United States	Tauber Eye Center	Kansas City	Missouri
United States	New York Eye and Ear Infirmary	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Cerimon Pharmaceuticals	PPD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		The primary outcome will be assessed at Week 16	Yes
Secondary	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		These measures will be assessed at Week 16	No