Phase 2 N=64 Randomized Quadruple-blind Treatment

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

Systemic Lupus Erythematosus

Bottom Line

View on ClinicalTrials.gov: NCT02660944 ↗

Enrolled (actual)

Serious AEs

12.5%

Results posted

Mar 2021

Primary outcome: Primary: Mean Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Improvement Compared to Placebo. — -6.2; -6.5; -6.2; -5.7 Scores on a scale — p=0.845

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: RSLV-132 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Resolve Therapeutics
Primary completion: May 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Improvement Compared to Placebo.	-6.2; -6.5; -6.2; -5.7	0.845
SECONDARY Percentage of Participants Achieving a 50% Improvement in CLASI Activity Score	11; 2; 14; 5; 7; 3	—

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.

Eligibility Criteria

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;
severe renal involvement at Screening (urine protein/creatinine ratio of >200 mg/mmol, or an estimated creatinine clearance of 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;
use of an intravenous steroid "pulse" within 2 months of Baseline;
use of an intramuscular steroid injection within 1 month of Baseline;
change in SLE medications within 1 month of Baseline;
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;
positive viral load test for hepatitis B, C, or HIV at Screening;
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;
positive pregnancy test at Screening or at Baseline;
female subjects currently breast feeding at Baseline;
inability or unwillingness to comply with protocol-specified procedures which, in the opinion of the Investigator, would make the subject unsuitable for study participation.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02660944). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.