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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 183 participants |
| Start Date | 2010-06-24 |
| Est. Completion | 2012-06-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗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.
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