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

R

Resolve Therapeutics

Status and phase

Completed
Phase 2

Conditions

Systemic Lupus Erythematosus

Treatments

Drug: Placebo
Drug: RSLV-132

Study type

Interventional

Funder types

Industry

Identifiers

NCT02660944
132-03

Details and patient eligibility

About

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

Enrollment

64 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

64 participants in 2 patient groups, including a placebo group

RSLV-132
Experimental group
Description:
10 mg/kg RSLV-132
Treatment:
Drug: RSLV-132
Placebo
Placebo Comparator group
Description:
Saline placebo
Treatment:
Drug: Placebo

Trial documents
2

Trial contacts and locations

16

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Data sourced from clinicaltrials.gov

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