CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 834 enrolled
Drug / intervention
Sifalimumab 200 mg +3 morebiological
Likely dose
Sifalimumab 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01283139
NCT01283139Phase 2Completed
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A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus

MedImmune LLC·interventional·Posted Jan 25, 2011·Updated Apr 19, 2018

In Brief

A Phase 2 clinical trial evaluating Sifalimumab 200 mg, Sifalimumab 600 mg, and 2 other interventions for Systemic Lupus Erythematosus. Completed, enrolled 834 participants across 107 sites in 22 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus
CountriesArgentina, Brazil, Bulgaria, Canada, Chile, France, Germany, Hungary, India, Italy, Jamaica, Mexico, Netherlands, Peru, Philippines, Poland, Romania, South Africa, Spain, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 25, 2011
Enrollment StartMar 31, 2011
Primary CompletionNov 14, 2013
Study CompletionApr 17, 2014
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 15.4 years ago

Interventions

Sifalimumab 200 mgbiological

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

Sifalimumab 600 mgbiological

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

Sifalimumab 1,200 mgbiological

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

Placeboother

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