Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

NI-0401 in Active Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00630643
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : March 7, 2008
Information provided by:
Light Chain Bioscience - Novimmune SA

Brief Summary:
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 or disease Intervention/treatment Phase
Moderate to Severe Crohn's Disease Biological: NI-0401 (anti-CD3 mAB) Drug: Placebo Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : January 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Placebo Comparator: 1 Drug: Placebo

Experimental: 2 Biological: NI-0401 (anti-CD3 mAB)
0.05 mg up to 10 mg

Primary Outcome Measures :
  1. Safety and tolerability of intravenous NI-0401 . [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Immunological response defined as the percent change in the modulation of the CD3 complex on T-cells

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Main Inclusion Criteria:

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

Main 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. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00630643

Sponsors and Collaborators
Light Chain Bioscience - Novimmune SA
Layout table for investigator information
Principal Investigator: Janeeke Van der Woude, MD Erasmus Medisch Centrum
Layout table for additonal information
Responsible Party: Dr Janeke Van der Woude, Erasmus Medisch Centrum Identifier: NCT00630643    
Other Study ID Numbers: NI-0401-01
First Posted: March 7, 2008    Key Record Dates
Last Update Posted: March 7, 2008
Last Verified: February 2008
Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents