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A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus

NCT01283139 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 834

Last updated 2018-04-19

Study results available
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Summary

To evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with moderately to severely active Systemic Lupus Erythematosus (SLE).

Conditions

Interventions

BIOLOGICAL

Sifalimumab 200 mg

Sifalimumab 200 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses.

BIOLOGICAL

Sifalimumab 600 mg

Sifalimumab 600 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses.

BIOLOGICAL

Sifalimumab 1,200 mg

Sifalimumab 1,200 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses.

OTHER

Placebo

IV Placebo every 2 weeks for 4 weeks and then monthly for 44 weeks

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Gabor Illei, MD · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-11-14
Completion
2014-04-17

Countries

  • United States
  • Argentina
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • France
  • Germany
  • Hungary
  • India
  • Italy
  • Jamaica
  • Mexico
  • Netherlands
  • Peru
  • Philippines
  • Poland
  • Romania
  • South Africa
  • Spain
  • Thailand
  • United Kingdom

Study Locations

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Entities

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 NCT01283139 on ClinicalTrials.gov