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

Teva Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: edratide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00203151

TV-4710/201

Details and patient eligibility

About

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

Enrollment: 340 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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340 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: edratide

2

Placebo Comparator group

Treatment:

Drug: edratide