A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)
Status: | Recruiting |
---|---|
Conditions: | Lupus |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 6/6/2018 |
Start Date: | January 2016 |
End Date: | September 2019 |
Contact: | James Posada, Ph.D. |
Email: | jp@resolvebio.com |
Phone: | 208 727 7010 |
A Phase 2a, Double-blind, Placebo-Controlled Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)
This study evaluates the impact of 13 bi-weekly intravenous infusions of RSLV-132 on the
cutaneous manifestations in subjects with systemic lupus erythematosus.
cutaneous manifestations in subjects with systemic lupus erythematosus.
Inclusion Criteria:
- CLASI score greater than or equal to 10 at Baseline
- Positive for one or more RNA autoantibodies
Exclusion Criteria:
1. severe, active central nervous system (CNS) involvement at Screening;
2. severe renal involvement at Screening (urine protein/creatinine ratio of >200 mg/mmol,
or an estimated creatinine clearance of <30 mL/min);
3. use of cyclophosphamide within 3 months of the Baseline visit;
4. use of rituximab within 6 months of the Baseline visit;
5. use of belimumab within 3 months of the Baseline visit;
6. use of background medications within 1 month of Baseline in excess of: i.
mycophenolate mofetil > 3 g/day; ii. azathioprine > 200 mg/day; iii. methotrexate > 25
mg/day; iv. hydroxychloroquine > 400 mg/day; v. prednisone (or equivalent) > 15
mg/day;
7. use of an intravenous steroid "pulse" within 2 months of Baseline;
8. use of an intramuscular steroid injection within 1 month of Baseline;
9. change in SLE medications within 1 month of Baseline;
10. the presence of a clinically significant infection in the judgement of the
Investigator within seven days prior to the receipt of the first dose of study drug;
11. positive viral load test for hepatitis B, C, or HIV at Screening;
12. participation in another clinical trial with receipt of an investigational product
within 3 months or 5 half- lives, of last administration (whichever is longer) from
Baseline;
13. positive pregnancy test at Screening or at Baseline;
14. female subjects currently breast feeding at Baseline;
15. inability or unwillingness to comply with protocol-specified procedures which, in the
opinion of the Investigator, would make the subject unsuitable for study
participation.
We found this trial at
16
sites
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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Temple University Temple University is many things to many people. A place to pursue life's...
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