Study of LJP 394 (Abetimus Sodium) in Lupus Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy Study of LJP 394 (Abetimus Sodium) to Treat Lupus Kidney Disease

NCT00035308

Immunologic Diseases Autoimmune Diseases Systemic Lupus Erythematosus +2 more

COMPLETED PHASE3

Study of LJP 394 in Lupus Patients With History of Renal Disease

NCT00089804

Lupus Erythematosus, Systemic Lupus Nephritis

TERMINATED PHASE3

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-199 in Female Patients With Systemic Lupus Erythematosus (SLE)

NCT01686555

Lupus Erythematosus

COMPLETED PHASE1

A Study of LY2127399 in Participants With Systemic Lupus Erythematosus

NCT01196091

Systemic Lupus Erythematosus Connective Tissue Disease Autoimmune Disease

COMPLETED PHASE3

A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intravenous Infusions of ABBV-319 in Adult Participants With Systemic Lupus Erythematosus (SLE) and Sjogren's Disease (SjD)

NCT06977724

Dry Eye Syndrome Systemic Lupus Erythematosus

RECRUITING PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

STUDY NOW INCORPORATED INTO PHASE 3 STUDY NCT00089804.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Systemic Lupus Erythematosus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

abetimus sodium (LJP 394)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No