drugset
drugset / Trial / NCT01838694

Double-Blinded, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Biochemical Activity of Intravenous Cpn10 Administration in Subjects With Mild to Moderate SLE.

NCT01838694 ↗

Phase 1/2 Completed 30 enrolled Invion, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of the study is to evaluate the safety, tolerability, and efficacy of 4 weeks intravenous treatment with Cpn10 in subjects with mild to moderate active SLE.

Timeline

Start
2013-07
Primary completion
2015-08
Completion
2015-08

Outcome

Met primary endpoint

release “the study ha s met its objectives and supports the continued development of INV103 (ala-Cpn10)” inviongroup.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ala-Cpn10 Protein / enzyme biologic 10 mg Intravenous
Subject Ala-Cpn10 Protein / enzyme biologic 100 mg Intravenous

Indications

systemic lupus erythematosus