A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02660944 |
Recruitment Status :
Completed
First Posted : January 21, 2016
Last Update Posted : October 6, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Systemic Lupus Erythematosus | Drug: RSLV-132 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 64 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2a, Double-blind, Placebo-Controlled Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE) |
Actual Study Start Date : | January 3, 2016 |
Actual Primary Completion Date : | May 28, 2020 |
Actual Study Completion Date : | August 10, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: RSLV-132
10 mg/kg RSLV-132
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Drug: RSLV-132
RNase-Fc fusion protein |
Placebo Comparator: Placebo
Saline placebo
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Drug: Placebo
Saline placebo |
- Proportion of RSLV-132 treated subjects with cutaneous lupus erythematosus disease area and severity index (CLASI) improvement compared to placebo. [ Time Frame: 24 weeks ]
- Proportion of RSLV-132 treated subjects with steroid reduction as compared to placebo. [ Time Frame: 24 weeks ]
- Proportion of RSLV-132 treated subjects with improvement in FACIT-fatigue index as compared to placebo. [ Time Frame: 24 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- CLASI score greater than or equal to 10 at Baseline
- Positive for one or more RNA autoantibodies
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02660944
United States, California | |
TriWest Research Associates | |
El Cajon, California, United States, 92020 | |
University of California San Diego | |
La Jolla, California, United States, 92093 | |
Valerius Research Center | |
Los Alamitos, California, United States, 90720 | |
Wallace Rheumatic Study Center | |
Los Angeles, California, United States, 90048 | |
United States, Colorado | |
University of Colorado | |
Aurora, Colorado, United States, 80045 | |
United States, Florida | |
Clinical Research of West Florida | |
Clearwater, Florida, United States, 33765 | |
Center for Rheumatology, Immunology and Arthritis | |
Fort Lauderdale, Florida, United States, 33309 | |
Alper Research | |
Naples, Florida, United States, 34102 | |
United States, New York | |
Northwell Health/ Division of Rheumatology | |
Great Neck, New York, United States, 11042 | |
Feinstein Institute for Medical Research | |
Manhasset, New York, United States, 11030 | |
United States, North Carolina | |
DJL Clinical Research | |
Charlotte, North Carolina, United States, 28210 | |
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
Temple University | |
Philadelphia, Pennsylvania, United States, 19140 | |
United States, Tennessee | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37232 | |
United States, Texas | |
Metroplex Clinical Research Center | |
Dallas, Texas, United States, 75231 | |
Accurate Clinical Research | |
Sugar Land, Texas, United States, 77479 |
Study Chair: | James Posada, Ph.D. | Resolve Therapeutics |
Responsible Party: | Resolve Therapeutics |
ClinicalTrials.gov Identifier: | NCT02660944 |
Other Study ID Numbers: |
132-03 |
First Posted: | January 21, 2016 Key Record Dates |
Last Update Posted: | October 6, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |