Study Evaluating The SBI-087 In Subjects With Systemic Lupus Erythematosus
This study has been completed.
Sponsor:
Pfizer
Collaborator:
Emergent Product Development Seattle LLC
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00714116
First received: July 8, 2008
Last updated: December 20, 2012
Last verified: December 2012
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Purpose
The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE).
| Condition | Intervention | Phase |
|---|---|---|
|
Lupus Erythematosus, Systemic |
Drug: SBI-087 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Subjects With Systemic Lupus Erythematosus |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Safety (physical examinations, laboratory tests, adverse events) and tolerability (dose-limiting toxicities) of ascending single doses of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Initial pharmacokinetic and pharmacodynamic profiles of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 30 |
| Study Start Date: | February 2009 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: SBI-087 |
Drug: SBI-087
Single IV or SC dose of SBI-087
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of SLE (by greater than or equal to 4 American College of Rheumatology [ACR] Revised Criteria) greater than 6 months before study day 1.
- History of a positive antinuclear antibody (ANA) titer greater than or equal to 1:160 or equivalent.
Exclusion Criteria:
- Treatment with more than 20 mg of prednisone per day.
- Evidence of unstable clinically significant disease (e.g., cardiovascular, cerebrovascular, respiratory, or renal disease, or any other unstable serious disorder) other than SLE.
- History of cancer (other than resected cutaneous basal and squamous cell carcinoma or in situ cervical cancer) with less than 5 years' documentation of a disease-free state.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00714116
Locations
| United States, Florida | |
| Pfizer Investigational Site | |
| Miami, Florida, United States, 33143 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Durham, North Carolina, United States, 27710 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Duncansville, Pennsylvania, United States, 16635 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75231 | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75235 | |
Sponsors and Collaborators
Pfizer
Emergent Product Development Seattle LLC
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00714116 History of Changes |
| Other Study ID Numbers: | 3227K2-1002, B2261004 |
| Study First Received: | July 8, 2008 |
| Last Updated: | December 20, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
safety pharmacokinetics |
Additional relevant MeSH terms:
|
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013