Study Evaluating The SBI-087 In Subjects With Systemic Lupus Erythematosus
| Status: | Completed |
|---|---|
| Conditions: | Lupus |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 12/9/2018 |
| Start Date: | March 2009 |
| End Date: | September 2012 |
An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Sbi-087 Administered To Subjects With Systemic Lupus Erythematosus.
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).
and pharmacodynamics (PD) of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE).
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.
We found this trial at
6
sites
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Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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