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NI-0401 in Active Crohn's Disease

NCT00630643 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2008-03-07

No results posted yet for this study

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.

Conditions

  • Moderate to Severe Crohn's Disease

Interventions

BIOLOGICAL

NI-0401 (anti-CD3 mAB)

0.05 mg up to 10 mg

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Light Chain Bioscience - Novimmune SA

    lead INDUSTRY

Principal Investigators

  • Janeeke Van der Woude, MD · Erasmus Medisch Centrum

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2007-12-31
Completion
2007-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00630643 on ClinicalTrials.gov