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

NCT00646425 | Terminated Phase 2

• 1 other identifier: BSX-003
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 6

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.

Conditions

Non-infectious Uveitis

Keywords

Non-infectious uveitis

Outcome Measures

Primary Outcomes (1)

• 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

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

  These measures will be assessed at Week 16

Study Arms (2)

1

EXPERIMENTAL

Basiliximab

Drug: Basiliximab

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Basiliximab DRUG

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

Also known as: Simulect

1

Placebo DRUG

Placebo to match basiliximab

2

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cerimon Pharmaceuticals: lead
• PPD Development, LP: collaborator

Study Sites (6)

Ocular Immunology & Uveitis Foundation

Cambridge, Massachusetts, 02142, United States

Location

Tauber Eye Center

Kansas City, Missouri, 64111, United States

Location

New York Eye and Ear Infirmary

New York, New York, 10003, United States

Location

Southeast Clinical Research Associates

Belmont, North Carolina, 28012, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Vitreoretinal Consultants

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Basiliximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Shaily Reichert

  Cerimon Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 26, 2008
• First Posted: March 28, 2008
• Study Start: May 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: August 19, 2010

Record last verified: 2010-08

Locations

US (6)