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
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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2147 Northeast Coachman Road
Clearwater, Florida 33765
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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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Great Neck, NY
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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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Los Angeles, California 90048
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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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