This study is in progress, not accepting new patients

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

a study on Lupus

Summary

for people ages 18-70 (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

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.

Official Title

A Phase 2a, Double-blind, Placebo-Controlled Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)

Keywords

Systemic Lupus Erythematosus Lupus Erythematosus, Systemic Immunoglobulin G RSLV-132

Eligibility

You can join if…

Open to people ages 18-70

  • CLASI score greater than or equal to 10 at Baseline
  • Positive for one or more RNA autoantibodies

You CAN'T join 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.

Locations

  • University of California San Diego
    La Jolla California 92093 United States
  • TriWest Research Associates
    El Cajon California 92020 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Resolve Therapeutics
ID
NCT02660944
Phase
Phase 2
Study Type
Interventional
Last Updated