Clinical Trial: Active Crohn's Disease Study

Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of Orally Administered Recombinant Human Interleukin-11 (rhIL-11) for the Treatment of Patients With Active Crohn’s Disease


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Sponsored by:	Wyeth-Ayerst Research
Information provided by:	Wyeth-Ayerst Research

Condition	Treatment or Intervention	Phase
Crohn Disease	Drug: Recombinant Human Interleukin-11 (rhIL-11)	Phase II

Inclusion Criteria:

Documented, signed and dated informed consent to participate in this trial prior to any study related procedures being performed.
Men and women age 16 years and over.
Diagnosis of Crohn’s disease for at least 6 months that has been appropriately documented and confirmed by radiological studies, endoscopy (with histological examination preferred), or surgical pathology. Patients with a diagnosis of Crohn’s disease for less than 6 months may be included if the diagnosis is confirmed by a biopsy characteristic of Crohn’s disease.
Baseline CDAI score of 220-400, with an abdominal pain rating of greater than or equal to 25 and/or a diarrhea rating of greater than or equal to 25
Male and female patients who are not surgically sterile or postmenopausal must use medically acceptable methods of birth control (hormonal or non-hormonal) during and for 30 days after the study (eg, abstinence, oral contraceptives, cervical cap, diaphragm, condoms with spermicide, or intrauterine device).
A negative stool sample must be available prior to randomization for enteric pathogens (including Salmonella, Shigella, Yersinia, and Campylobacter species), Clostridium difficile toxins A and B, ova, and parasites.

Patients receiving the following medications must have been receiving stable doses for the specified time periods:

Patients receiving azathioprine, 6-mercaptopurine (6-MP), and 6-thioguanine (6-TG) must have been receiving these drugs 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 prior to randomization.
Systemic corticosteroids (less than or equal to 20 mg/day prednisone or equivalent, 9 mg/day maximum for budesonide), any oral 5-aminosalicylate (5-ASA) compound, sulfasalazine, and/or balsalazide for greater than or equal to 4 weeks prior to randomization.
Antibiotic therapy for Crohn’s disease for greater than or equal to 2 weeks prior to randomization
HCT greater than or equal to 30%.
Platelet count greater than or equal to 100,000 and less than or equal to 600,000 mm3.
Fibrinogen less than or equal to 600 mg/dL.
Adequate renal function, defined as:
Serum creatinine less than or equal to 1.5 x upper limit of normal (ULN)
Blood urea nitrogen (BUN) less than or equal to 1.5 x ULN

Adequate hepatic function, defined as:

ALT/SGPT less than or equal to 2.0 x ULN
Aspartate aminotransferase (AST, serum glutamic oxaloacetic transaminase [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
Female patients of childbearing potential (women who are not surgically sterile or postmenopausal) must have a negative serum beta human chorionic gonadotropin (-hCG) test result prior to randomization.

Exclusion Criteria:

1. Use of the following medications within the specified time period prior to randomization:

Within 48 hours prior to randomization:

Nonsteroidal anti-inflammatory drugs (NSAIDs; including Cyclooxygenase-2 [COX-2] inhibitors and >500 mg/day acetylsalicylic acid)

Within 1 week prior to randomization:

Codeine-containing compounds
Corticosteroid enemas
5-ASA enemas and/or suppositories

Within 4 weeks prior to randomization:

Systemic corticosteroids >20 mg/day
Other biologics (other than monoclonal antibody therapy)
Methotrexate
Cyclosporine or tacrolimus (FK506)
Other investigational drugs

Within 4 months prior to randomization:

Monoclonal antibody therapy (including infliximab [Remicade], CDP-571, CDP-870)
Etanercept (Enbrel)
Thalidomide

2. Nutritionally compromised patients requiring enteral or parenteral therapy to maintain weight.

3. Ulcerative colitis.

4. Cushing’s syndrome.

5. Current ileostomy or colostomy.

6. Clinically significant electrocardiogram (ECG) abnormalities.

7. 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.

8. Known human immunodeficiency virus (HIV) infection, symptoms or signs suggestive of HIV infection.

9. Acute systemic infection and/or intestinal infection requiring antibiotic therapy at time of screening.

10. Evidence of chronic hepatitis B or C viral infection.

11. Decompensated liver disease.

12. Nursing women.

13. 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.

14. History of angina or cardiac arrhythmia requiring drug or device intervention or other clinically significant heart disease.

15. History of myocardial infarction within 12 months of screening.

16. History of thromboembolic disease (eg, phlebitis, pulmonary embolus) or known congenital or acquired prothrombotic disorder (eg, protein C deficiency).

17. Patients expected to require surgical therapy for Crohn’s disease or Crohn’s disease-related complications within 12 weeks of screening.

18. History of clinically significant congestive heart failure

19. Any condition, in the investigator’s opinion, that places the patient at undue risk by participating in the study.