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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02660944
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Resolve Therapeutics
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	James Posada, Ph.D.
Principal Investigator Affiliation	Resolve Therapeutics
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Systemic Lupus Erythematosus

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

TriWest Research Associates, El Cajon, California

Status

Recruiting

Address

TriWest Research Associates

El Cajon, California, 92020

Site Contact

Diana Banales

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