CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 183 enrolled
Drug / intervention
CEP-33457 +1 moredrug
Likely dose
Not stated in 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/NCT01135459
NCT01135459Phase 2Completed
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A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus

Cephalon, Inc.·interventional·Posted Jun 2, 2010·Updated Dec 16, 2022

In Brief

A Phase 2 clinical trial evaluating CEP-33457 and Placebo for Systemic Lupus Erythematosus. Completed, enrolled 183 participants across 86 sites in 11 countries.

Detailed Summary

The primary objective of this study is to evaluate the efficacy of a 200 micrograms (mcg) dose of CEP-33457 compared with placebo in participants with active systemic lupus erythematosus (SLE) as assessed by the proportion of participants achieving a combined clinical response using the SLE responder index (SRI) at Week 24.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus
CountriesBelgium, Czechia, France, Germany, Hungary, Poland, Portugal, Spain, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2, 2010
Enrollment StartJun 24, 2010
Primary CompletionJan 31, 2012
Study CompletionJun 30, 2012
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 16.1 years ago

Interventions

CEP-33457drug

CEP-33457 will be administered per dose and schedule specified in the arm description.

Placebodrug

Placebo matching to CEP-33457 will be administered per schedule specified in the arm description.