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 enrollmentMay 19, 2008

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: ovImmune S.A.
Enrollment: 60
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 19, 2008

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

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 and having exhausted all other possible treatment options.
•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. Women of childbearing potential and their partners are required to use two forms of contraception. Men with partners of child bearing potential are required to use barrier contraception, in addition to their partners using another method. Acceptable forms of contraception are as follows:
•\- Barrier methods: condoms, diaphragms, cervical caps
•\- Hormonal contraceptives: combination or progesterone only; includes depot contraceptives
•\- Intrauterine methods: intrauterine devices or systems
•7\. If using oral corticosteroids, mesalazine, or sulfasalazine, the start\-date must be at least 4 weeks prior to study day 1\. The dose of oral corticosteroids, mesalazine and/or sulfasalazine must be stable over the 2 weeks preceding study day 1\. The daily dose of systemic corticosteroids should not be greater than 20 mg of prednisone equivalent or 9 mg budesonide. If using azathioprine, 6\-mercaptopurine or methotrexate the dose must have been stable over the 8 weeks preceding study day 1\.

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