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NI-0401 in Active Crohn's Disease

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: March 7, 2008
Last Update Posted: March 7, 2008
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.
Information provided by:
NovImmune SA
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 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by NovImmune SA:

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

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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00630643

Sponsors and Collaborators
NovImmune SA
Principal Investigator: Janeeke Van der Woude, MD Erasmus Medisch Centrum
  More Information

Responsible Party: Dr Janeke Van der Woude, Erasmus Medisch Centrum
ClinicalTrials.gov Identifier: NCT00630643     History of Changes
Other Study ID Numbers: NI-0401-01
First Submitted: February 28, 2008
First Posted: March 7, 2008
Last Update Posted: March 7, 2008
Last Verified: February 2008

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases