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NCT01135459 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Cephalon.

Completed
Registry status
Phase 2
Development phase
183
Enrollment target

NCT01135459 is a Phase 2 study that has completed, run by Cephalon. The registered enrollment target is 183 participants.

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The verdict

NCT01135459, a Phase 2 study, has completed, sponsored by Cephalon.

COMPLETED
Registry status
Phase 2
Development phase
183 participants
Enrollment target

Study 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.

Interventions

  • DRUG Placebo
  • DRUG CEP-33457

Trial Details

FieldValue
Enrollment Target 183 participants
Start Date 2010-06-24
Est. Completion 2012-06-30
Phase Phase 2

Sponsor

Cephalon

64 total trials

What the Registry Record Tells You About NCT01135459

The ClinicalTrials.gov registry entry for NCT01135459 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 183 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cephalon, which has 64 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01135459 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01135459 about?

NCT01135459 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of CEP-33457 in Participants With Systemic Lupus Erythematosus (SLE)". 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 responde...

What is the current status of trial NCT01135459?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 183 participants. The study started on 2010-06-24. Estimated completion is 2012-06-30.

What interventions are being tested in trial NCT01135459?

The interventions under investigation include: Placebo (DRUG), CEP-33457 (DRUG).

Who is sponsoring clinical trial NCT01135459?

This trial is sponsored by Cephalon, which has 64 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.