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A Study to Evaluate the Efficacy and Safety of CEP-33457 in Participants With Systemic Lupus Erythematosus (SLE)

NCT01135459 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2022-12-16

Study results available
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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.

Conditions

Interventions

DRUG

CEP-33457

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Cephalon, Inc.

    lead INDUSTRY

Principal Investigators

  • Teva Medical Expert · Teva Branded Pharmaceutical Products R&D, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-06-24
Primary Completion
2012-01-31
Completion
2012-06-30

Countries

  • United States
  • Belgium
  • Czechia
  • France
  • Germany
  • Hungary
  • Poland
  • Portugal
  • Spain
  • Ukraine
  • United Kingdom

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 NCT01135459 on ClinicalTrials.gov