Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Resolve Therapeutics
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
CLASI score greater than or equal to 10 at Baseline
Positive for one or more RNA autoantibodies
You may not be if
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.
