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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: Completed Phase 2 study, sponsored by Cephalon.
NCT01135459 is a Phase 2 study that has completed, run by Cephalon. The registered enrollment target is 183 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An SRI response was defined as a reduction from baseline in SLE Disease Activity Index 2000 (SLEDAI-2K) score of ≥4 points, no worsening in Physician Global Assessment (PhGA), no new British Isles Lupus Assessment Group (BILAG) A body system score, and ≤1 new BILAG B body system score from baseline. SLEDAI-2K includes 24 weighted clinical and laboratory variables. Total score = 0 to 105. A score of 6 to 10 = moderate disease activity, and a reduction of \>3 points = improvement. PhGA was complet
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 |
What the finished NCT01135459 record still lists
NCT01135459 is an interventional study that assigns participants to a tested intervention. The registered 183 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01135459 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01135459's enrollment target sits among peer trials
183 363rd of 2000 higher than 1,638 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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