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Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus — BT063 in SLE  

Systemic Lupus Erythematosus Clinical Trial

Official title:
A Prospective, Double-blind, Randomized, Placebo-controlled, Repeated Dose, Multicentre Phase IIa Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of repeated intravenous infusions of the study drug BT063 in patients with Systemic Lupus Erythematosus (SLE) compared with people who receive a placebo.

Clinical Trial Description

Study 990 is a Phase IIa, proof-of-concept study of BT063 in subjects with SLE. This study is divided into 2 parts. After Part I an interim analysis will be performed. Each Part will enrol 18 subjects. Subjects will be randomly assigned to receive BT063 or Placebo 8 times over 12 weeks and will be followed for 4 months after their last dose. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02554019
Study type Interventional
Source Biotest
Contact
Status Completed
Phase Phase 2
Start date September 28, 2015
Completion date October 25, 2017
View Details
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