A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)
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
- Systemic Lupus Erythematosus
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
- 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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental RSLV-132 |
10 mg/kg RSLV-132 |
|
|
Placebo Comparator Placebo |
Saline placebo |
|
More Details
- Status
- Completed
- Sponsor
- Resolve Therapeutics