A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)
NCT ID: NCT02660944
Last Updated: 2021-03-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
64 participants
INTERVENTIONAL
2016-01-03
2020-08-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dose Escalation Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus
NCT02194400
A Study of SHR-2173 in Participants With Systemic Lupus Erythematosus
NCT07299422
A Study of RSLV-132 in Subjects With Primary Sjogren's Syndrome
NCT03247686
A Study of RSLV-132 in Females With Sjögren's Disease
NCT06440525
Determining the Responses and Impact of Rituximab-instigated Cell Depletion on T Cells in People With SLE
NCT01702038
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
RSLV-132
10 mg/kg RSLV-132
RSLV-132
RNase-Fc fusion protein
Placebo
Saline placebo
Placebo
Saline placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
RSLV-132
RNase-Fc fusion protein
Placebo
Saline placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Positive for one or more RNA autoantibodies
Exclusion Criteria
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.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Resolve Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
James Posada, Ph.D.
Role: STUDY_CHAIR
Resolve Therapeutics
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
132-03
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.