A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of Single Dose of AMG 623 in Subjects With Systemic Lupus Erythematosus

Phase 1 Completed 56 enrolled Amgen

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is to evaluate the safety of AMG 623 in subjects with systemic lupus erythematosus. The study consists of a 21 day screening period followed by administration of the investigational product and up to 70 day follow up period.

Timeline

Start: 2004-10
Primary completion: 2007-04
Completion: 2007-06

Publications

Stohl W, Merrill JT, Looney RJ, Buyon J, Wallace DJ, Weisman MH, Ginzler EM, Cooke B, Holloway D, Kaliyaperumal A, Kuchimanchi KR, Cheah TC, Rasmussen E, Ferbas J, Belouski SS, Tsuji W, Zack DJ. Treatment of systemic lupus erythematosus patients with the BAFF antagonist "peptibody" blisibimod (AMG 623/A-623): results from randomized, double-blind phase 1a and phase 1b trials. Arthritis Res Ther. 2015 Aug 20;17(1):215. doi: 10.1186/s13075-015-0741-z.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Blisibimod	Peptide	0.1 mg/kg	Subcutaneous
Subject	Blisibimod	Peptide	0.3 mg/kg	Subcutaneous
Subject	Blisibimod	Peptide	1 mg/kg	Subcutaneous
Subject	Blisibimod	Peptide	3 mg/kg	Subcutaneous
Subject	Blisibimod	Peptide	6 mg/kg	Subcutaneous

A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of Single Dose of AMG 623 in Subjects With Systemic Lupus Erythematosus

Summary

Timeline

Publications

Drugs

Indications