A Study to Evaluate the Tolerability, Safety and Effectiveness of Edratide in the Treatment of Lupus

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2007-02-28

Brief Summary

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

It is thought that Edratide may be able to reduce the symptoms of SLE.

Related Clinical Trials

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

Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

NCT00383214

Systemic Lupus Erythematosus

TERMINATED PHASE3

Study of Epratuzumab in Systemic Lupus Erythematosus

NCT00383513

Systemic Lupus Erythematosus

COMPLETED PHASE2

Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease

NCT00624351

Systemic Lupus Erythematosus

COMPLETED PHASE2

Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

NCT00113971

Lupus Erythematosus, Systemic

TERMINATED PHASE2

A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus

NCT02349061

Lupus Erythematosus, Systemic

COMPLETED PHASE2

Detailed Description

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

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

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

edratide

Intervention Type DRUG

0.5 mg, 1.0 mg, 2.5 mg injection once weekly

2

Group Type PLACEBO_COMPARATOR

edratide

Intervention Type DRUG

0.5 mg, 1.0 mg, 2.5 mg injection once weekly

Interventions

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

edratide

0.5 mg, 1.0 mg, 2.5 mg injection once weekly

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

1. Willing and able to give written informed consent
2. Between the ages of 18 and 65 years (inclusive)
3. Fulfilled at least 4 ACR classification criteria
4. SLE patients with moderate, active disease
5. Subjects on stable dose of SLE medications for at least 4 weeks before randomization.
6. Women of child-bearing potential must practice a medically acceptable method of contraception..
7. Must understand the requirements of the study and agree to comply with the study protocol.

Exclusion Criteria

1. Any condition which the investigator feels may interfere with participation in the study.
2. Subjects having a history of chronic infection
3. Subjects with a history of immunodeficiency syndrome or malignancy,
4. Subjects who received any investigational medication (including DHEA) within 3 months prior to randomization,
5. Subjects treated with any cytotoxic agents in the 3 months prior to randomization.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No