NCT00630643

NI-0401 in Active Crohn's Disease

A Phase I/IIa, Double-Blind, Placebo-Controlled, Dose-Escalation Study of NI-0401 in Patients With Moderate to Severe Active Crohn´s Disease

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Light Chain Bioscience - Novimmune SA · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
BIOLOGICAL	NI-0401 (anti-CD3 mAB)	0.05 mg up to 10 mg
DRUG	Placebo	Placebo

Timeline

• Start date: 2006-01-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2008-03-07
• Last updated: 2008-03-07