NI-0401 in Active Crohn's Disease - Full Text View

Purpose

The purpose of the study is to assess the safety and tolerability of daily intravenous NI-0401 treatment, compared to matching placebo. And to assess the ability of NI-0401 to modulate the CD3 complex on T-cells.

Condition	Intervention	Phase
Moderate to Severe Crohn's Disease	Biological: NI-0401 (anti-CD3 mAB) Drug: Placebo	Phase I Phase II

Genetics Home Reference related topics:

Crohn disease

MedlinePlus related topics:

Crohn's Disease

Drug Information available for:

Visilizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study

Official Title:	A Phase I/IIa, Double-Blind, Placebo-Controlled, Dose-Escalation Study of NI-0401 in Patients With Moderate to Severe Active Crohn´s Disease

Further study details as provided by NovImmune SA:

Primary Outcome Measures:

Safety and tolerability of intravenous NI-0401 . [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Immunological response defined as the percent change in the modulation of the CD3 complex on T-cells [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	January 2006
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: Placebo Placebo
2: Experimental	Biological: NI-0401 (anti-CD3 mAB) 0.05 mg up to 10 mg

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Main Inclusion Criteria:

Men and women between 18 and 70 years of age.
Crohn's Disease Activity Index (CDAI) between 220 and 450.
Raised plasma CRP level.
Endoscopic inflammation.
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.

Main Exclusion criteria

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.
Concomitant disease:
- Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurological or cerebral disease (including a history of seizure disorders or ongoing chronic active conditions such as chronic active hepatitis)
- Previous diagnosis of, or known, malignancies
- Severe infections, such as hepatitis, pneumonia or pyelonephritis, in the past three months. Less serious infections in the past 3 months, such as acute upper respiratory tract infection (colds) or uncompliant urinary tract infection are permitted at the discretion of the investigator
- Active infection requiring antibiotic therapy
- Serum anti HCV positive, serum HBsAg positive, serum anti-HIV positive
- History of opportunistic infections such as herpes zoster within 2 months prior to screening, evidence of acute CMV or EBV, active Pneumocystic Carinii
- History of active tuberculosis (TB) or currently undergoing treatment for TB. Patients with a positive TB skin test or chest x-ray are ineligible. Patients with a history of bacille Calmette Guerin (BCG) vaccination and a newly positive TB skin test or a chest X-ray showing fibrotic lesions consistent with previous TB are ineligible. The PPD skin test must be read between 48 and 72 hours
- Stool examination positive for enteric pathogens, pathogenic ova or parasites, or Clostridium Difficile toxin within 4 weeks prior to Study Day 1

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630643

Sponsors and Collaborators

NovImmune SA

Investigators


Principal Investigator:	Janeeke Van der Woude, MD	Erasmus Medisch Centrum

More Information

Responsible Party:	Erasmus Medisch Centrum ( Dr Janeke Van der Woude )
Study ID Numbers:	NI-0401-01
First Received:	February 28, 2008
Last Updated:	March 6, 2008
ClinicalTrials.gov Identifier:	NCT00630643
Health Authority:	Belgium:DGMP; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Poland: CEBK

Study placed in the following topic categories:

Digestive System Diseases

Gastrointestinal Diseases

Crohn Disease

Inflammatory Bowel Diseases

Gastroenteritis

Intestinal Diseases

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	NovImmune SA
Information provided by:	NovImmune SA
ClinicalTrials.gov Identifier:	NCT00630643