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

Phase 2 Completed 64 enrolled Resolve Therapeutics

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2016-01-03
Primary completion: 2020-05-28
Completion: 2020-08-10

Outcome

Missed primary endpoint

registry analysis (superiority test); RSLV-132 vs Placebo; p = 0.845; Mean Difference (Final Values) 0.37 (95% CI -3.42 to 4.15); t-test, 2 sided NCT02660944 ↗

registry analysis (superiority test); RSLV-132 vs Placebo; p = 0.818; Mean Difference (Final Values) -0.48 (95% CI -4.66 to 3.70); t-test, 2 sided NCT02660944 ↗

Publications

Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	RSLV-132	Protein / enzyme biologic	10 mg/kg	Intravenous