Study of GL701 in Men With Systemic Lupus Erythematosus

Genelabs Technologies

Status and phase

Unknown

Phase 3

Conditions

Systemic Lupus Erythematosus

Treatments

Drug: GL701

Study type

Interventional

Funder types

Industry

Identifiers

NCT00037128

GL97-01

Details and patient eligibility

About

Lupus flares and other symptoms associated with systemic lupus erythematosus (SLE) may be caused by a deficiency of dehydroepiandrosterone (DHEA). GL701 is an investigational new drug meant to enhance DHEA levels. This study is designed to evaluate both the safety and efficacy of GL701 in male lupus patients.

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Patient must have a diagnosis of SLE > 6 months according to the 1989 revised ACR criteria. Patient must meet at least four of the eleven ACR criteria for systemic lupus
Patient must have a modified SLEDAI score > 3 at both screening and qualifying visits (Appendix A-2)
Patient must be treated for SLE with doses of prednisone < 30 mg/day (including those on NO glucocorticoid therapy) unchanged for > 6 weeks prior to study entry (including both screening and qualifying visits). Prednisone dose in patient's receiving alternate day therapy will be the mean daily prednisone dose
Patient treated with azathioprine, methotrexate, or hydrochloroquine must be on a stable dose with no change in dose for at least 6 weeks preceding the study
Patient must be able to read and speak English and willing to sign an informed consent in English

Exclusion Criteria

Patient with a history of prostate cancer
Patient with elevated Prostate Specific Antigen (PSA)
Patient diagnosed with liver disease, defined as AST or ALT > 3x the upper limit of normal
Patient ingesting body building/anabolic steroids within the last 6 months preceding the study
Patient with end stage renal disease or receiving hemodialysis treatment
Patient with serum creatinine > 2 mg/dl or creatinine clearance < 60 ml/min
Patient receiving treatment with ACTH within the 3 months preceding study entry
Patient receiving androgens, immunoglobulins, cyclophosphamide, cyclosporin A, or other immunosuppressive agents, except azathioprine, methotrexate, and hydrochloroquine within the last 3 months
Patient with known hypersensitivity to DHEA or the inactive ingredients used in the GL70l formulation (cornstarch, lactose, and magnesium stearate)
Patient who participated in any prior DHEA study or administration of DHEA within the past 3 months
Patient using any investigational agents within the longer of 30 days or 10 half-lives of the agent
Patient with any condition which in the Investigator's or sponsor's opinion is sufficient to prevent adequate compliance with the study or likely to confuse follow-up evaluation (e.g.. alcoholism, drug addiction, acute withdrawal from chemical dependency, psychiatric disease)
Patient requires treatment/medication prohibited by protocol
Patient with any serious EKG abnormality as determined by the Investigator