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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
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

  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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
RSLV-132
10 mg/kg RSLV-132
  • Drug: RSLV-132
    RNase-Fc fusion protein
Placebo Comparator
Placebo
Saline placebo
  • Drug: Placebo
    Saline placebo

More Details

Status
Completed
Sponsor
Resolve Therapeutics

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.