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NI-0401 in Active Crohn's Disease

Primary Purpose

Moderate to Severe Crohn's Disease

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
NI-0401 (anti-CD3 mAB)
Placebo
Sponsored by
Light Chain Bioscience - Novimmune SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate to Severe Crohn's Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    1

    2

    Arm Description

    Outcomes

    Primary Outcome Measures

    Safety and tolerability of intravenous NI-0401 .

    Secondary Outcome Measures

    Immunological response defined as the percent change in the modulation of the CD3 complex on T-cells

    Full Information

    First Posted
    February 28, 2008
    Last Updated
    March 6, 2008
    Sponsor
    Light Chain Bioscience - Novimmune SA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00630643
    Brief Title
    NI-0401 in Active Crohn's Disease
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2006 (undefined)
    Primary Completion Date
    December 2007 (Actual)
    Study Completion Date
    December 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Light Chain Bioscience - Novimmune SA

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Moderate to Severe Crohn's Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Placebo Comparator
    Arm Title
    2
    Arm Type
    Experimental
    Intervention Type
    Biological
    Intervention Name(s)
    NI-0401 (anti-CD3 mAB)
    Intervention Description
    0.05 mg up to 10 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    Safety and tolerability of intravenous NI-0401 .
    Time Frame
    24 weeks
    Secondary Outcome Measure Information:
    Title
    Immunological response defined as the percent change in the modulation of the CD3 complex on T-cells

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janeeke Van der Woude, MD
    Organizational Affiliation
    Erasmus Medisch Centrum
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    NI-0401 in Active Crohn's Disease

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