MedTrace Logo

CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus

NCT01395745 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 442

Last updated 2017-02-03

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of subcutaneous blisibimod administered in addition to standard therapy in subjects with active Systemic Lupus Erythematosus (SLE) disease as defined by SELENA-SLEDAI score ≥10 despite on-going stable corticosteroid therapy.

Conditions

Interventions

DRUG

blisibimod

blisibimod administered via subcutaneous injection every week for 52 weeks

DRUG

Placebo

Placebo will be administered weekly via subcutaneous injection for 52 weeks

Sponsors & Collaborators

  • Anthera Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2016-07-31
Completion
2016-10-31

Countries

  • Belarus
  • Brazil
  • Colombia
  • Georgia
  • Guatemala
  • Hong Kong
  • India
  • Malaysia
  • Mexico
  • Philippines
  • Russia
  • Singapore
  • South Korea
  • Sri Lanka
  • Taiwan
  • Thailand

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01395745 on ClinicalTrials.gov