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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2016
• Main ID: NCT02483624
• Date of registration: 23/06/2015
• Prospective Registration: Yes
• Primary sponsor: North Shore Long Island Jewish Health System
• Public title: 3,3'-Diindolylmethane in Patients With Systemic Lupus Erythematosus
• Scientific title: A Single-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of 3,3'-Diindolylmethane (BR-DIM) in Patients With Systemic Lupus Erythematosus (SLE)
• Date of first enrolment: January 2016
• Target sample size: 6
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02483624
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
• Phase: Phase 1

Contacts

• Name: Richard Furie, MD
• Affiliation: NorthShore-LIJ Health System

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Female

Health Condition(s) or Problem(s) studied

SLE

Intervention(s)

Drug: BR-DIM

Drug: Placebo

Primary Outcome(s)

T and B Lymphocytes [Time Frame: 14 Months]

Autoantibody Production [Time Frame: 14 Months]

Estradiol Hydroxylation Pathways [Time Frame: 14 months]

Safety and Tolerability Routine clinical and laboratory parameters as well as SLE activity measurement with SELENA Systemic Lupus Erythematosus Disease Activity Index assessment. [Time Frame: 14 months]

Secondary ID(s)

06.02.107T

Source(s) of Monetary Support

Please refer to primary and secondary sponsors