The Immunological and Blood Effects of STA-5326 Mesylate on Patients With Crohn's Disease

Completed · Phase 2

Conditions studied: Crohn's Disease

In brief

This study will test whether a new experimental drug called STA-5326 mesylate will decrease inflammatory chemicals called cytokines in patients with Crohn's disease. The drug has prevented gut inflammation in mice and rats and has improved symptoms in humans with active Crohn's disease. Patients with Crohn's Disease between 18 and 75 years of age and who have active disease symptoms may be eligible for this study. Candidates are screened with a review of their medical records, a medical history and physical examination, electrocardiogram, blood and urine tests, chest x-ray and tuberculin skin test. They fill out diary cards for 7 days (measuring their symptoms on the Crohn's Disease Activity Index, or CDAI) and complete a 32-item Inflammatory Bowel Disease Questionnaire (IBDQ) that surveys how their disease affects their live and activities. Participants have a colonoscopy (an examination of the colon using a lighted tube) before starting the study medication. Colon tissue samples are biopsied during the procedure. Following the colonoscopy, patients are randomly assigned to receive either STA-5326 mesylate or placebo (sugar or dummy pill). They take four tablets a day and are seen in the clinic once a week (days 1, 8, 15, 22 and 29) for the following tests and procedures: * Physical examination - Days 1, 8, 15, 22, 29 * Blood tests - Days 1, 8, 15, 22, 29 * Pharmacodynamic study (blood collected before the first dose of medicine and again after 1, 2, 4, 6 and 8 hours to measure levels of the drug in the blood) - Day 1 * CDAI and IBDQ - Days 1, 15, 29 * Review of medications and symptoms - Days 1, 8, 15, 22, 29 * EKG - Days 8, 29 * Pregnancy test for women of child-bearing potential - Days 15, 29 * Urine test - Day 29 After patients complete the above treatment and tests, they undergo a second colonoscopy within 48 hours of their last dose of study medication and may be offered another 1-week supply of medication. Those for whom additional treatment is deemed potentially beneficial are offered another 4-week course of drug or placebo (continuing whichever they took the first 4 weeks). They come to the clinic for two visits 2 weeks apart (days 43 and 57) for a physical examination, blood tests, EKG, pregnancy test for women, CDAI, IBDQ and review of medications and symptoms. A urine sample is collected only on day 57. A third colonoscopy is done after all the tests are completed on day 57, within 48 hours after the last dose of study medication. Patients return to the clinic about 1 week after their final dose of study medication (day 36 for patients who complete only 1 month of treatment and day 64 for those who complete a second month of treatment) for a limited physical examination, blood tests, pregnancy test for women, CDAI and IBDQ, and a review of their medications and symptoms.

Key facts

Study ID: NCT00250198
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 12
Starts: 2005-11-03
Expected to finish: 2006-09-05
Last updated by the study team: 2017-07-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

A subject is excluded from the study if any of the following criteria are met:
General criteria:
Has any clinically significant disease (eg, renal, hepatic, neurological, cardiovascular, pulmonary, endocrinologic, psychiatric, hematologic, urologic, or other acute or chronic illness) that in the opinion of the investigator would make the subject an unsuitable candidate for this trial.
Is a woman who has a positive pregnancy test or who is breast-feeding
Is a woman of childbearing potential or a man who does not agree to use 2 forms of contraception during the course of the study and Follow-up period.
Has hypersensitivity to any of the components of STA 5326 mesylate drug product.
Has any of the following clinical chemistry values:
AST greater than 2.0 x ULN.
ALT greater than 2.0 x ULN.
Serum bilirubin greater than 1.5 x ULN.
Serum creatinine greater than 1.5 x ULN.
Alkaline phosphatase greater than 2.5 x ULN.
Has a hemoglobin level less than 9 g/dL or hematocrit less than 30%.
Has a PT INR greater than 1.3 or PTT of 3 or more seconds longer than control values.
Has the following cell counts (cells/microliter):
Platelets less than 100,000 or greater than 800,000.
White blood count less than 3,500.
Neutrophils less than 2000.
Has a history of any infection requiring intravenous antibiotics, a serious local infection (eg, cellulitis, abscess) or systemic infection (eg, pneumonia, septicemia) that occurred within 3 months of randomization.
Has a history of cancer within the past 5 years, with the exception of excised basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ.
Had a dependency for any illicit drug, chemical, or alcohol within the past 5 years.
Has a history of active tuberculosis, a positive PPD skin test, acute or chronic hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
Gastrointestinal criteria:
Has a current ileostomy or colostomy.
Has a proctocolectomy or total colectomy.

Where it is running

National Institute of Allergy and Infectious Diseases (NIAID) — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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