Study of LJP 394 (Abetimus Sodium) in Lupus Patients
August 31, 2015 updated by: La Jolla Pharmaceutical Company
A Randomized, Double-Blind Study to Evaluate the Safety, Pharmacokinetic and Pharmacodynamic Effects of Abetimus Sodium in Patients With Systemic Lupus Erythematosus (SLE)
The primary purpose of this study is to assess the safety and pharmacodynamic effect of LJP 394 at doses of 100 mg, 300 mg and 900 mg on anti-dsDNA antibody levels in patients with SLE.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
STUDY NOW INCORPORATED INTO PHASE 3 STUDY NCT00089804.
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90048
- Wallace Rheumatic Study Center
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Pennsylvania
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Duncansville, Pennsylvania, United States, 16635
- Altoona Center for Clinical Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males or females between 12 and 70 years old.
- Diagnosis of Systemic Lupus Erythematosus (SLE)
- Females must be non-pregnant and non-lactating. Females must agree to use adequate birth control methods during the course of the study.
- Ability to have weekly intravenous (IV) administration of study drug.
Exclusion Criteria:
- Prior exposure to abetimus sodium within 6 months prior to screening.
- Patients not on stable medications for 30 days prior to screening.
- Patients with acute or chronic infections.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The assessment of the safety and pharmacodynamic effect of abetimus sodium at
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doses of 100mg, 300mg, and 900mg in reducing the anti-dsDNA antibody levels in
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patients with SLE will be based on laboratory data from the central laboratory
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and confirmed by supporting data. The pharmacodynamic effic will be assessed
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using historical placebo effect as a control.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Matthew D Linnik, PhD, La Jolla Pharmaceutical Company
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion
December 7, 2022
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
October 17, 2006
First Submitted That Met QC Criteria
October 17, 2006
First Posted (Estimate)
October 19, 2006
Study Record Updates
Last Update Posted (Estimate)
September 1, 2015
Last Update Submitted That Met QC Criteria
August 31, 2015
Last Verified
February 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LJP 394-90-16
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.