Systemic Lupus ErythematosusPhase 2NCT00390091
Study of LJP 394 (Abetimus Sodium) in Lupus Patients
A Phase 2 study testing abetimus sodium (LJP 394) in people with Systemic Lupus Erythematosus, run by La Jolla Pharmaceutical Company at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- abetimus sodium (LJP 394)
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2006to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Wallace Rheumatic Study Center
Los Angeles, California, 90048
About this study
Official title: 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.
Read the detailed description
STUDY NOW INCORPORATED INTO PHASE 3 STUDY NCT00089804.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- abetimus sodium (LJP 394)
- Keywords
- Lupus, Nephritis, Kidney, SLE, Systemic Lupus Erythematosus, Nephritis, Lupus
- Medical subject headings
- Lupus Erythematosus, Systemic, Nephritis, Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abetimus sodium (LJP 394)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The assessment of the safety and pharmacodynamic effect of abetimus sodium at
doses of 100mg, 300mg, and 900mg in reducing the anti-dsDNA antibody levels in
patients with SLE will be based on laboratory data from the central laboratory
and confirmed by supporting data. The pharmacodynamic effic will be assessed
using historical placebo effect as a control.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2006 (estimated)
- Study startSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- La Jolla Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Matthew D Linnik, PhD, Study chair, La Jolla Pharmaceutical Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00390091
- Sponsor's protocol ID
- LJP 394-90-16
- Status last verified
- Feb 2007
- First submitted
- 17 Oct 2006
- Last updated
- 1 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Study to Evaluate the Safety, Pharmacokinetic and Pharmacodynamic Effects of Abetimus Sodium in Patients With Systemic Lupus Erythematosus (SLE)
- ClinicalTrials.gov ID
- NCT00390091
- Acronym / sponsor ID
- LJP 394-90-16
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Lupus, Nephritis, Kidney, SLE, Systemic Lupus Erythematosus, Nephritis, Lupus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- La Jolla Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- First posted
- 19 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
STUDY NOW INCORPORATED INTO PHASE 3 STUDY NCT00089804.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abetimus sodium (LJP 394) | Drug | – |
Primary outcome
The assessment of the safety and pharmacodynamic effect of abetimus sodium at
doses of 100mg, 300mg, and 900mg in reducing the anti-dsDNA antibody levels in
patients with SLE will be based on laboratory data from the central laboratory
and confirmed by supporting data. The pharmacodynamic effic will be assessed
using historical placebo effect as a control.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
- Sponsor's websiteLink provided by the sponsor.
- STUDY NOW INCORPORATED INTO PHASE 3 STUDY NCT00089804Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew D Linnik, PhD study chair
La Jolla Pharmaceutical Company
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing abetimus sodium (LJP 394) in people with Systemic Lupus Erythematosus, run by La Jolla Pharmaceutical Company at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The assessment of the safety and pharmacodynamic effect of abetimus sodium at. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2015.