3,3'-Diindolylmethane in Patients With Systemic Lupus Erythematosus

• Status: Terminated
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a single center study of patients with inactive or mild SLE being performed to determine the safety, tolerability, and pharmacodynamics of DIM.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwell Health
• Treatments: 3,3'-diindolylmethane

Criteria

Inclusion Criteria:

• Stable SLE disease activity for a period of at least 2 months prior to the Screening visit, based on the clinical judgment of the investigators

• History of measurable anti-dsDNA, anti-Sm, RNP, SS-A (anti-Ro), or SS-B (anti-La) autoantibodies

• Age > 18 and < 50

• Ability to understand the requirements of the study, provide written consent, and comply with the study protocol procedures

• A negative pregnancy test

• The use of contraception by fertile females

• A serum creatinine <1.8 mg/dL

• Serum hepatic transaminases < 1.25 times the upper limits of normal

• Hemoglobin > 9.5, WBC > 3.0, neutrophils > 1.2; platelets > 90,000

Exclusion Criteria:

• Immunosuppressive therapy (e.g. cyclophosphamide, cyclosporine, azathioprine, mycophenolate mofetil) or intravenous gamma globulin within 6 months of study entry

• Prior receipt of biologic agents, unless 9 months or 4 half-lives, whichever is greater, have passed since the last dose

• Prednisone > 10 mg/day (or its pharmacologic equivalent) within 2 months of randomization

• Pregnancy or the intent to conceive during the study or 3 months after study completion

• Concurrent medications such as danazol, DHEA, or other medications that affect estrogen levels or metabolism

• Nursing mothers

• Oral contraceptive use

• The presence of infection

• A history of poor procedural compliance

• Receipt of an investigational drug within 60 days of baseline

• Malignancy (except for basal cell carcinoma)

• Dose changes of steroids, anti-malarial drugs, or NSAID's within 4 weeks of randomization

• Peri- or post-menopausal state

• History of clinical evidence of active significant acute or chronic diseases (i.e., cardiovascular, pulmonary, untreated hypertension, anemia, gastrointestinal, hepatic, renal, neurological, cancer, or infectious diseases) that could confound the results of the study or put the subject at undue risk

• History of any other medical disease, laboratory abnormalities, or conditions that would make the subject (in the opinion of the investigators) unsuitable for the study

• Current drug or alcohol addiction