A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)

Completed · Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

This study evaluates the impact of 13 bi-weekly intravenous infusions of RSLV-132 on the cutaneous manifestations in subjects with systemic lupus erythematosus.

Key facts

Study ID

NCT02660944

Run by

Resolve Therapeutics

People needed

64

Starts

2016-01-03

Expected to finish

2020-08-10

Last updated by the study team

2021-03-10

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• CLASI score greater than or equal to 10 at Baseline
• Positive for one or more RNA autoantibodies

You may not qualify if…

• severe, active central nervous system (CNS) involvement at Screening;
• severe renal involvement at Screening (urine protein/creatinine ratio of >200 mg/mmol, or an estimated creatinine clearance of <30 mL/min);
• use of cyclophosphamide within 3 months of the Baseline visit;
• use of rituximab within 6 months of the Baseline visit;
• use of belimumab within 3 months of the Baseline visit;
• 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;
• use of an intravenous steroid "pulse" within 2 months of Baseline;
• use of an intramuscular steroid injection within 1 month of Baseline;
• change in SLE medications within 1 month of Baseline;
• 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;
• positive viral load test for hepatitis B, C, or HIV at Screening;
• 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;
• positive pregnancy test at Screening or at Baseline;
• female subjects currently breast feeding at Baseline;
• inability or unwillingness to comply with protocol-specified procedures which, in the opinion of the Investigator, would make the subject unsuitable for study participation.

Where it is running

• TriWest Research Associates — El Cajon, California, United States
• University of California San Diego — La Jolla, California, United States
• Valerius Research Center — Los Alamitos, California, United States
• Wallace Rheumatic Study Center — Los Angeles, California, United States
• University of Colorado — Aurora, Colorado, United States
• Clinical Research of West Florida — Clearwater, Florida, United States
• Center for Rheumatology, Immunology and Arthritis — Fort Lauderdale, Florida, United States
• Alper Research — Naples, Florida, United States
• Northwell Health/ Division of Rheumatology — Great Neck, New York, United States
• Feinstein Institute for Medical Research — Manhasset, New York, United States
• DJL Clinical Research — Charlotte, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Temple University — Philadelphia, Pennsylvania, United States
• Vanderbilt University — Nashville, Tennessee, United States
• Metroplex Clinical Research Center — Dallas, Texas, United States
• Accurate Clinical Research — Sugar Land, Texas, United States

Full record on ClinicalTrials.gov

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