To explore the safety of orally delivered rhIL-11 in patients with mild to moderate left-sided ulcerative colitis.

To explore the effects of orally administered rhIL-11 on pharmacogenomics in blood samples and in colonic biopsy tissue samples.

Condition	Treatment or Intervention	Phase
Ulcerative Colitis	Drug: rhIL-11	Phase I

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• 1. Documented, signed informed consent to participate in this study
• 2. Age greater than or equal to 18 years
• 3. Documented diagnosis of ulcerative colitis by standard clinical criteria, including endoscopy (either flexible sigmoidoscopy or colonoscopy, sufficient to define the proximal limit of disease) with biopsy
• 4. Mild to moderate ulcerative colitis, according to the Physician's Global Assessment of the MUCSS
• 5. Hematocrit (HCT) greater than or equal to 30%
• 6. Platelet count greater than or equal to 100,000 and less than or equal to 600,000/mm3
• 7. Fibrinogen less than or equal to 600 mg/dL
• 8. Baseline values within the following normal laboratory ranges:

White blood cell count greater than or equal to 4,000 and less than or equal to 12,000 cells/mL

Absolute neutrophil count greater than or equal to 1,500 cells/mL

Hemoglobin >10 g per dL

Urinalysis, within normal limits

• 9. Adequate renal and hepatic function, defined as:

Serum creatinine less than or equal to 1.50 x upper limit of normal (ULN)

Alanine aminotransferase (ALT, serum glutamic oxaloacetic transaminase (SGPT) less than or equal to 2.0 x ULN

Aspartate aminotransferase (AST, SGOT) less than or equal to 2.0 x ULN

Total bilirubin less than or equal to 1.25 x ULN

Alkaline phosphatase less than or equal to 1.5 x ULN

• 10. A negative stool sample must be available prior to randomization for Salmonella, Shigella, Yersinia, and Campylobacter species, Clostridium difficile, parasites, and ova.
• 11. Men and women are eligible for this study. Male and female patients who are neither surgically sterile nor postmenopausal must use a medically acceptable form of hormonal or non hormonal birth control during and for 30 days after the study (eg, oral contraceptives, cervical cap, diaphragm, condoms with spermicide, or intrauterine device).
• 12. Female patients of childbearing potential (women who are not surgically sterile or postmenopausal) must have a negative serum beta human chorionic gonadotropin (hCG) prior to randomization.
• 13. Patients receiving the following medications must fall within the specified stabilization periods for dosing:

Azathioprine, 6-MP, or 6-TG for greater than or equal to 12 weeks prior to randomization and have been on stable doses for greater than or equal to 8 weeks before randomization.

Oral mesalamine, sulfasalazine, olsalazine, balsalazide or any other 5-ASA compound for greater than or equal to 6 weeks prior to randomization and have been on stable doses for greater than or equal to 2 weeks before randomization.

Anti-diarrheal agents (Imodium® when taken as no more than 8 tablets per day; Imodium® AD when taken as no more than either 40 ml or 4 tablets per day; or Lomotil® when taken as no more than 8 tablets per day) for greater than or equal to 1 week prior to randomization

Antibiotic therapy (prescribed for ulcerative colitis) for greater than or equal to 2 weeks prior to randomization

Exclusion Criteria:

• 1. Use of the following medications within the specified time period:

Within 48 hours before randomization: NSAIDs (including COX-2 inhibitors and >500 mg/day acetylsalicylic acid)

Within 1 week before randomization: 5-ASA (enemas and suppositories)

Within 2 weeks before randomization: Mesalamine (topical), Corticosteroids (topical, oral, or parenteral)

Within 4 weeks before randomization: Other biological agents, Methotrexate, Tacrolimus (FK506), Cyclosporine A (oral or parenteral), Other investigational drugs

Within 4 months before randomization: Monoclonal antibodies to TNF (eg, Remicade®, CDP-571, CDP-870), Enbrel®, Thalidomide

• 2. Crohn's disease
• 3. Ulcerative proctitis
• 4. Ulcerative colitis extending beyond the splenic flexure
• 5. Cushing’s Disease
• 6. Clinically significant electrocardiogram (ECG) abnormalities
• 7. Clinically significant chest X-ray abnormalities
• 8. History of angina or cardiac arrhythmia requiring drug or device intervention or other clinically significant heart disease
• 9. History of myocardial infarction within the last 12 months
• 10. Breastfeeding women
• 11. Known human immunodeficiency virus (HIV) infection, symptoms or signs suggestive of HIV infection
• 12. Acute systemic infection and/or intestinal infection requiring antibiotic therapy at time of screening
• 13. History or evidence of chronic hepatitis B or C viral infection
• 14. Decompensated liver disease
• 15. History of cancer (other than resected cutaneous basal or squamous cell carcinoma or in situ cervical cancer) or clinically significant lymphoproliferative disease with less than 5 years documentation of a disease-free state
• 16. History of thromboembolic disease (eg, phlebitis, pulmonary embolus) or known congenital or acquired prothrombic disorder (eg, protein C deficiency)
• 17. Congestive heart failure or history of congestive heart failure
• 18. Bowel obstruction or any condition that may predispose to its development (eg, clinically significant unresolved intestinal stricture, adhesions, or any other condition that would place the patient at risk for developing overt bowel obstruction), intestinal perforation, or significant gastrointestinal hemorrhage
• 19. Any other major illness or condition that, in the investigator’s opinion, places the patient at undue risk by participating in the study

North Carolina
      Wake Research Associates, Raleigh,  North Carolina,  27612,  United States; Recruiting
Ohio
      The Cleveland Clinic Foundation, Cleveland,  Ohio,  44195-0001,  United States; No longer recruiting
      Consultants for Clinical Research, Cincinnati,  Ohio,  45219,  United States; No longer recruiting
Tennessee
      Summit Research Solutions, PPLC, Memphis,  Tennessee,  38120,  United States; Terminated
Virginia
      Charlottesville Medical Research, Charlottesville,  Virginia,  22902,  United States; No longer recruiting

Study ID Numbers:  3067K5-114-US
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  June 5, 2002
ClinicalTrials.gov Identifier:  NCT00038922
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08