Clinical Trials Logo
  1. Home
  2. Systemic Lupus Erythematosus
  3. NCT02554019

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
See also
  Status Clinical Trial Phase
Terminated NCT03843125 - A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE) Phase 3
Recruiting NCT05698173 - Systemic Lupus Erythematosus and Accelerated Aging N/A
Active, not recruiting NCT01649765 - Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy Phase 2
Recruiting NCT05704153 - Modelling and Control of Non-invasive Vagus Nerve Stimulation for Autoimmune Diseases (1A) N/A
Completed NCT05048238 - Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus Phase 1
Recruiting NCT06056778 - The Prevalence Evaluation of Systemic Lupus Erythematosus in Russian Patients With Reproductive Issues (PRISMA)
Completed NCT04358302 - Individual Patient Exposure and Response in Pediatric Lupus N/A
Completed NCT03802578 - The Impact of Exercise on Hand Function, Daily Activities Performance and Quality of Life of SLE' Patients N/A
Recruiting NCT04835883 - Exploring the Efficacy and Safety of CS20AT04 (Allogenic Bone Marrow-Derived Stem Cell) in Systemic Lupus Erythematosus Patients Phase 2
Terminated NCT02665364 - Phase IIb Study of IFN-K in Systemic Lupus Erythematosus Phase 2
Completed NCT00278538 - Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus Erythematosus Phase 2
Completed NCT00069342 - Health Beliefs and Health Behaviors Among Minorities With Rheumatic Diseases
Completed NCT03252587 - An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus Phase 2
Terminated NCT02066311 - Nelfinavir in Systemic Lupus Erythematosus Phase 2
Recruiting NCT01892748 - Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus. N/A
Terminated NCT01689025 - An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE) Phase 1
Completed NCT01475149 - Effect of HCQ on AnxA5 Resistance Assay in Antiphospholipid (aPL) Positive Patients With and Without Systemic Lupus Erythematosus (SLE) N/A
Unknown status NCT01712529 - Physical Exercise, Endothelial Function and Progenitor Endothelial Cells in Systemic Lupus Erythematosus Patients N/A
Completed NCT00962832 - A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus Phase 2
Recruiting NCT00747578 - Health-Related Quality of Life and Disease-Related Costs: Comparison Between Ankylosing Spondylitis, Rheumatoid Arthritis and Systemic Lupus Erythematosus in Taiwan N/A