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Sponsored by: |
NovImmune SA |
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Information provided by: | NovImmune SA |
ClinicalTrials.gov Identifier: | NCT00630643 |
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 |
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Moderate to Severe Crohn's Disease |
Biological: NI-0401 (anti-CD3 mAB) Drug: Placebo |
Phase I Phase II |
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 |
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 |
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1: Placebo Comparator |
Drug: Placebo
Placebo
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2: Experimental |
Biological: NI-0401 (anti-CD3 mAB)
0.05 mg up to 10 mg
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
Main Exclusion criteria
Concomitant disease:
Responsible Party: | Erasmus Medisch Centrum ( Dr Janeke Van der Woude ) |
Study ID Numbers: | NI-0401-01 |
Study 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 |
Digestive System Diseases Gastrointestinal Diseases Crohn Disease |
Inflammatory Bowel Diseases Gastroenteritis Intestinal Diseases |