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

• Status: Completed
• Trial end date: 2020-08-10
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Resolve Therapeutics

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.