A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)
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ClinicalTrials.gov Identifier: NCT02660944 |
Recruitment Status :
Completed
First Posted : January 21, 2016
Results First Posted : March 10, 2021
Last Update Posted : March 10, 2021
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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
|
Drug: RSLV-132
RNase-Fc fusion protein |
Placebo Comparator: Placebo
Saline placebo
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Drug: Placebo
Saline placebo |
- Mean Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Improvement Compared to Placebo. [ Time Frame: Baseline and Days 29, 57, 85, 99, 113, 127, 141, 155, 169 ]
Mean change from baseline (from baseline to Day 85; or baseline to Day 169) in CLASI activity scores (Last Observation Carried Forward [LOCF] post censoring values).
The CLASI is a single-page tool that separately quantifies disease activity and damage. For the activity score, points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. The total score represents the sum of the individual scores and ranges from 0 to 70. Higher scores are awarded for more severe manifestations.
- Percentage of Participants Achieving a 50% Improvement in CLASI Activity Score [ Time Frame: Baseline and Days 29, 57, 85, 99, 113, 127, 141, 155, 169 ]Percentage of participants achieving a 50% improvement in CLASI activity score at Day 85 and Day 169 (LOCF post censoring due to use of exclusionary medications)

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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 |
Documents provided by Resolve Therapeutics:
Responsible Party: | Resolve Therapeutics |
ClinicalTrials.gov Identifier: | NCT02660944 |
Other Study ID Numbers: |
132-03 |
First Posted: | January 21, 2016 Key Record Dates |
Results First Posted: | March 10, 2021 |
Last Update Posted: | March 10, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |