A Study to Evaluate the Tolerability, Safety and Effectiveness of Edratide in the Treatment of Lupus

NCT00203151 ↗

Phase 2 Terminated 340 enrolled Teva Branded Pharmaceutical Products R&D, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

It is thought that Edratide may be able to reduce the symptoms of SLE.

Timeline

Start: 2005-07
Primary completion: 2007-02
Completion: 2007-02

Outcome

Missed primary endpoint

Stopped: “TV-4710/201 did not meet its primary endpoints in patients with SLE”

paper The primary endpoints based solely on SLEDAI-2K and AMS were not met. PMID 26301100 ↗

release “edratide (TV-4710), did not meet its primary endpoint in the PRELUDE trial, a Phase 2 clinical trial in patients with systemic lupus erythematosus (SLE).” tevapharm.com ↗

Publications

Urowitz MB, Isenberg DA, Wallace DJ. Safety and efficacy of hCDR1 (Edratide) in patients with active systemic lupus erythematosus: results of phase II study. Lupus Sci Med. 2015 Aug 11;2(1):e000104. doi: 10.1136/lupus-2015-000104. eCollection 2015.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	edratide	Protein / enzyme biologic	0.5 mg	Subcutaneous
Subject	edratide	Protein / enzyme biologic	1 mg	Subcutaneous
Subject	edratide	Protein / enzyme biologic	2.5 mg	Subcutaneous