A Study to Evaluate the Efficacy and Safety of CEP-33457 in Participants With Systemic Lupus Erythematosus (SLE)
Public ClinicalTrials.gov record NCT01135459. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01135459
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 183 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 23, 2010
- Primary completion
- Jan 30, 2012
- Completion
- Jun 29, 2012
- Last update posted
- Dec 15, 2022
2010 – 2012
United States locations
- U.S. sites
- 40
- U.S. states
- 20
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Teva Investigational Site 27 | Birmingham | Alabama | 35233 | — |
| Teva Investigational Site 20 | Tucson | Arizona | 85715 | — |
| Teva Investigational Site 16 | Los Angeles | California | 90048 | — |
| Teva Investigational Site 5 | Los Angeles | California | 90095-1769 | — |
| Teva Investigational Site 7 | San Diego | California | 92161 | — |
| Teva Investigational Site 14 | San Leandro | California | 94578 | — |
| Teva Investigational Site 17 | Stanford | California | 94305 | — |
| Teva Investigational Site 30 | Aurora | Colorado | 80045 | — |
| Teva Investigational Site 4 | Aventura | Florida | 33180 | — |
| Teva Investigational Site 32 | Clearwater | Florida | 33765 | — |
| Teva Investigational Site 35 | Fort Lauderdale | Florida | 33334 | — |
| Teva Investigational Site 1 | Jupiter | Florida | 33458 | — |
| Teva Investigational Site 11 | Tampa | Florida | 33614 | — |
| Teva Investigational Site 8 | Atlanta | Georgia | 30322 | — |
| Teva Investigational Site 31 | Atlanta | Georgia | 30342 | — |
| Teva Investigational Site 38 | Stockbridge | Georgia | 30281 | — |
| Teva Investigational Site 23 | Coeur d'Alene | Idaho | 83814 | — |
| Teva Investigational Site 37 | Lexington | Kentucky | 40504 | — |
| Teva Investigational Site 36 | Baltimore | Maryland | 21231 | — |
| Teva Investigational Site 10 | Boston | Massachusetts | 02111 | — |
| Teva Investigational Site 22 | Ann Arbor | Michigan | 48109 | — |
| Teva Investigational Site 9 | Manhasset | New York | 11030 | — |
| Teva Investigational Site 3 | Chapel Hill | North Carolina | 27599-7600 | — |
| Teva Investigational Site 28 | Charlotte | North Carolina | 28210 | — |
| Teva Investigational Site 18 | Durham | North Carolina | 27710 | — |
| Teva Investigational Site 2 | Monroe | North Carolina | 28112 | — |
| Teva Investigational Site 21 | Oklahoma City | Oklahoma | 73103 | — |
| Teva Investigational Site 13 | Oklahoma City | Oklahoma | 73104 | — |
| Teva Investigational Site 25 | Duncansville | Pennsylvania | 16635 | — |
| Teva Investigational Site 26 | Pittsburgh | Pennsylvania | 15213 | — |
| Teva Investigational Site 15 | Charleston | South Carolina | 29425 | — |
| Teva Investigational Site 29 | Dallas | Texas | 75231 | — |
| Teva Investigational Site 40 | Houston | Texas | 77034 | — |
| Teva Investigational Site 6 | Houston | Texas | 77074 | — |
| Teva Investigational Site 39 | Mesquite | Texas | 75150 | — |
| Teva Investigational Site 34 | San Antonio | Texas | 78229 | — |
| Teva Investigational Site 24 | Temple | Texas | 76508 | — |
| Teva Investigational Site 19 | Arlington | Virginia | 22205 | — |
| Teva Investigational Site 12 | Seattle | Washington | 98104 | — |
| Teva Investigational Site 33 | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 46 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01135459, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 15, 2022 · Synced Sep 25, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01135459 live on ClinicalTrials.gov.