A Randomized, Double-blind, Placebo-controlled Clinical Study of the Oral IL-12/23 Inhibitor, STA-5326 mesylate, for the Induction of Clinical Response in Patients with Crohn’s Disease

• Conditions: Moderate to severe, active Crohn’s disease; MedDRA version: 3.2Level: LLTClassification code 10011401

• Registration Number: EUCTR2005-002857-29-HU
• Lead Sponsor: Synta Pharmaceutical Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 282

Inclusion Criteria

A patient is eligible for the study if all of the following criteria are met:
1. Has given written informed consent prior to Screening.
2. Is male or female aged 18 through 75 years.
3. Has Crohn’s disease diagnosed definitively prior to Screening (based upon clinical, endoscopic, radiologic imaging, or histological assessments).
4. Has a CDAI score of 220 to 450, inclusive at Baseline.
5. 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.
6. If taking azathioprine, 6-mercaptopurine, or methotrexate, must have been using continuously for at least 3 months prior to randomization and at stable doses for at least 1 month prior to randomization.
7. If taking oral antibiotics chronically, must have been using continuously for at least 1 month prior to randomization and at stable doses for at least 2 weeks prior to randomization.
8. If taking corticosteroids, must have been using prednisone =20 mg daily (or equivalents), or budesonide =9 mg daily for at least 2 months prior to randomization and at stable doses for at least 2 weeks prior to randomization.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Main criteria for exclusion:
A patient is excluded from the study if any of the following criteria are met:
General criteria
1. 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 patient an unsuitable candidate for this study.
2. Is a woman who has a positive pregnancy test, who is breast-feeding, or who is sexually active without using birth control during the course of the study and Follow-up period.
3. 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.
4. Has hypersensitivity to any of the components of STA 5326 mesylate drug product.
5. Has any of the following clinical chemistry values:
• Aspartate aminotransferase (AST) >2.0 x ULN
• Alanine aminotransferase (ALT) >2.0 x ULN
• Serum bilirubin >1.5 x ULN
• Serum creatinine >1.5 x ULN
• Alkaline phosphatase >2.5 x ULN
6. Has a hemoglobin level <9 g/dL or hematocrit <30%.
7. Has any of the following cell counts (cells/µL):
• Platelets <100,000 or >800,000
• White blood count <3,500
• Neutrophils <2000
8. 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.
9. 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;
10. Had a dependency for any illicit drug, chemical, or alcohol within the past 5 years;
11. Has an abnormal chest x-ray determined to be clinically significant by the investigator
12. Has a history of active tuberculosis, acute or chronic hepatitis B, hepatitis C, human immunodeficiency virus, or Listeria.
Gastrointestinal criteria
13. Has a current ileostomy or colostomy.
14. Has a proctocolectomy or total colectomy.
15. Has short bowel syndrome requiring enteral or parenteral nutrition supplementation or total parenteral nutrition.
16. Has a stool sample positive for gastrointestinal infection (e.g. Clostridium difficile toxin, etc.) during Screening.
17. Has a history or diagnosis of ulcerative or indeterminate colitis.
18. Had bowel surgery in the previous 3 months.
19. Had severe intestinal tract stenosis or fixed strictures causing symptomatic obstruction within 6 months prior to randomization.
Prior medication criteria relative to randomization (see Section 10.5 for details)
20. Received parenteral corticosteroids or corticotropin within 1 month prior to randomization.
21. Has had regular use of aspirin or other non-steroidal anti-inflammatory drugs within 2 weeks prior to randomization (other than use of chronic low dose aspirin [80 mg per day] for cardioprotective effects).
22. Received any investigational drug within 3 months prior to randomization.
23. Received cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 2 months prior to randomization.
24. Received any biological product (eg, infliximab, adalimumab, natalizumab, etc.) within 3 months prior to randomization.
25. Ever received treatment with STA-5326 free base or mesylate, anti-IL 12 antibodies, or other specific IL 12 inhibitors.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified