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

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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.


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
Los Angeles, California 90048
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2147 Northeast Coachman Road
Clearwater, Florida 33765
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Aurora, Colorado 80045
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Charlotte, North Carolina 28210
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El Cajon, California 92020
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Fort Lauderdale, Florida 33334
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450 Lakeville Road
Great Neck, New York 11042
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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10861 Cherry Street
Los Alamitos, California 90720
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Manhasset, NY
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694 8th Street North
Naples, Florida 34102
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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1801 N Broad St
Philadelphia, Pennsylvania 19122
(215) 204-7000
Temple University Temple University is many things to many people. A place to pursue life's...
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2060 Space Park Drive
Sugar Land, Texas 77479
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