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NCT01085097 · ClinicalTrials.gov registry record · Phase 2
A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis
A Phase 2 study of Lupus Nephritis, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
- 20
- Study locations
NCT01085097 is a Phase 2 study of Lupus Nephritis that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 46 participants, below the 309-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 13 states.
The verdict
NCT01085097, a Phase 2 study of Lupus Nephritis, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study aims to evaluate the safety and clinical effect of daily oral treatment with laquinimod capsules in active lupus nephritis participants. This study will assess Laquinimod doses of 0.5 milligrams (mg)/day and 1 mg/day in combination with standard of care treatment (mycophenolate mofetil \[MMF\] and corticosteroids). Laquinimod is a novel immunomodulating drug which is currently in advanced stages of development by Teva Pharmaceuticals Ltd. for Multiple Sclerosis.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Mycophenolate Mofetil
- DRUG Methylprednisolone
- DRUG Laquinimod
- DRUG Prednisolone/Prednisone
Study Locations (20)
New York
- Teva Investigational Site 1022 - Lake Success
- Teva Investigational Site 1018 - Manhasset
- Teva Investigational Site 1019 - New York
- Teva Investigational Site 1017 - New York
California
- Teva Investigational Site 1024 - La Jolla
- Teva Investigational Site 1028 - Los Angeles
- Teva Investigational Site 1025 - San Leandro
Other
- Teva Investigational Site 3510 - Lille
- Teva Investigational Site 3509 - Paris
- Teva Investigational Site 5006 - Kazan'
Arizona
- Teva Investigational Site 1032 - Phoenix
Maryland
- Teva Investigational Site 1031 - Baltimore
Minnesota
- Teva Investigational Site 1021 - Rochester
North Carolina
- Teva Investigational Site 1020 - Charlotte
Ohio
- Teva Investigational Site 1016 - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2010-09-01 |
| Est. Completion | 2012-10-24 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01085097
The ClinicalTrials.gov registry entry for NCT01085097 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 309-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (85% lower). The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 167 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lupus Nephritis appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT01085097 reports 20 study locations spanning 13 distinct geographic areas - top geographies include New York, California, Other.
Frequently Asked Questions
What is clinical trial NCT01085097 about?
NCT01085097 is a clinical study titled "A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis". The study aims to evaluate the safety and clinical effect of daily oral treatment with laquinimod capsules in active lupus nephritis participants. This study will assess Laquinimod doses of 0.5 milligrams (mg)/day and 1 mg/day in combination with standard of care treatment (mycophenolate mofetil \[M...
What is the current status of trial NCT01085097?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2010-09-01. Estimated completion is 2012-10-24.
What conditions does trial NCT01085097 study?
This clinical trial studies the following conditions: Lupus Nephritis.
What interventions are being tested in trial NCT01085097?
The interventions under investigation include: Placebo (DRUG), Mycophenolate Mofetil (DRUG), Methylprednisolone (DRUG), Laquinimod (DRUG), Prednisolone/Prednisone (DRUG).
Who is sponsoring clinical trial NCT01085097?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01085097 being conducted?
This trial has 20 study locations across Arizona, California, Maryland, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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