A Phase I/IIa, Double-blind, Randomized, Placebo-controlled, Dose-Escalation Study of NI-0401 in Patients with Moderate to Severe Active Crohn´s Disease

ovImmune S.A.0 sites60 target enrollmentJune 21, 2006

ConditionsModerate to Severe Active Crohn´s Disease

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Moderate to Severe Active Crohn´s Disease
Sponsor: ovImmune S.A.
Enrollment: 60
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 21, 2006

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ovImmune S.A.

Eligibility Criteria

Inclusion Criteria

•1\. Men and women ³ 18 and \< 70 years of age.
•2\. Crohn’s Disease Activity Index (CDAI) of \>220 to \<450\.
•3\. Detectable plasma CRP level.
•4\. Endoscopic inflammation defined as the presence of any inflammatory mucosal lesion.
•5\. Crohn’s disease of at least 6 months duration, with colitis, ileitis, or ileocolitis, confirmed by endoscopy and histology within 28 days of study day 1\.
•6\. Men and women of childbearing potential must use adequate birth control measures until 6 month after receiving study drug.
•7\. If using oral corticosteroids, mesalazine, or sulfasalazine, the start\-date must be at least 4 weeks prior to randomization. The dose of oral corticosteroids, mesalazine and/or sulfasalazine must be stable over the 2 weeks preceding randomization. The daily dose of systemic corticosteroids should not be greater than 20 mg of prednisone equivalent or 9 mg budesonide. If using azathioprine or 6\-mercaptopurine, the dose must have been stable over the 8 weeks preceding randomization.
•8\. If not using corticosteroids, azathioprine/6\-mercaptopurine (6\-MP), mycophenolate mofetil, methotrexate at the time of screening, the stop\-date for any previous use of these agents must be at least 4 weeks prior to randomization.
•9\. Patients who have received anti\-TNF antibody therapy (infliximab, adalimumab, etanercept) must have received their last dosing at least 3 months prior to randomization.
•10\. Patients who have received tacrolimus or cyclosporine must have received their last dosing at least 4 weeks prior to randomization.

Exclusion Criteria

•1\. Have received or are planned to receive immunization with a live vaccine within 6 weeks prior to receiving study drug and 12 weeks after treatment cessation.
•2\. Isolated small bowel involvement not assessable by endoscopy.
•3\. Ileo\-/colostoma or extensive bowel resection (e.g., more than 100 cm of small bowel, proctocolectomy or colectomy with ileorectal anastomosis). Segmental colectomy is permitted.
•4\. Bowel surgery within the past three months, except for minor luminal surgery.
•5\. Immediate need for surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra\-abdominal or pancreatic abscess requiring surgical drainage.
•6\. Known fixed symptomatic stenosis of the small or large intestine.
•7\. Clinically significant abnormalities on chest X\-ray or electrocardiogram.
•8\. Concomitant disease:
•a. Current signs or symptoms of severe, progressive or uncontrolled renal (creatinine \> 250 mmol/L), hepatic (bilirubin \> 25 mmol/L), hematological, endocrine, pulmonary, cardiac, neurological or cerebral disease (including a history of seizure disorders or ongoing chronic active conditions such as chronic active hepatitis)
•b. Previous diagnosis of, or known, malignancies