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

NCT00250198 | Completed Phase 2

• 2 other identifiers: 06002106-I-0021
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Crohn's Disease

Keywords

T Cell; Lymphocyte; Lamina Propria; Colonoscopy; Placebo; Crohn's Disease; Crohns Disease

Interventions

STA-5326 DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A subject is eligible for the study if all of the following criteria are met:
• Has given written informed consent prior to Screening.
• Is male or female aged 18 through 75 years.
• Has CD diagnosed definitively prior to Screening (based upon clinical, endoscopic, radiologic imaging, or histological assessments).
• Has a CDAI score of 220 to 450, inclusive.
• If taking sulfasalazine or mesalamine, must have been using continuously for at least 2 months prior to randomization and at stable doses for at least 2 weeks prior to randomization.
• If taking azathioprine, 6-mercaptopurine, or methotrexate, must have used continuously for at least 3 months prior to randomization and at stable doses for at least 1 month prior to randomization.
• If taking oral antibiotics chronically, must have used continuously for at least 1 month prior to randomization and at stable doses for at least two weeks prior to randomization.
• If taking corticosteroids, must be taking prednisone less than or equal to 20 mg daily (or equivalent), or budesonide less than or equal to 9 mg daily for at least 2 months prior to randomization and at stable doses for at least 2 weeks prior to randomization.
• Not taking any potential CYP3A4 inhibitors/inducers (eg, macrolide antibiotics, HIV protease inhibitors, antifungals, grapefruit juice, St. John's Wort).

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):

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institute of Allergy and Infectious Diseases (NIAID)

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Larsson S, Linden M. Effects of a corticosteroid, budesonide, on production of bioactive IL-12 by human monocytes. Cytokine. 1998 Oct;10(10):786-9. doi: 10.1006/cyto.1998.0362.

  PMID: 9811532 BACKGROUND

MeSH Terms

Conditions

Crohn Disease

Interventions

apilimod

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 5, 2005
• First Posted: November 7, 2005
• Study Start: November 3, 2005
• Study Completion: September 5, 2006
• Last Updated: July 2, 2017

Record last verified: 2006-09-05

Locations

US (1)