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| Name | Class |
|---|---|
| PPD Development, LP | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Basiliximab |
|
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shaily Reichert | Cerimon Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ocular Immunology & Uveitis Foundation | Cambridge | Massachusetts | 02142 | United States | ||
| Tauber Eye Center |
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| Placebo | Drug | Placebo to match basiliximab |
|
| Kansas City |
| Missouri |
| 64111 |
| United States |
| New York Eye and Ear Infirmary | New York | New York | 10003 | United States |
| Southeast Clinical Research Associates | Belmont | North Carolina | 28012 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| Vitreoretinal Consultants | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D000077552 | Basiliximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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