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

• Status: Terminated
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Pharmaceutical Industries

Criteria

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.