Dose-escalation Study of NI-0401 (a Fully Human Anti-CD3 Monoclonal Antibody) in Patients with Moderate to Severe Active Crohn’s Disease

Phase I, Double-blind, Randomized, Placebo-controlled, Dose-escalation Study of NI-0401 (a Fully Human Anti-CD3 Monoclonal Antibody) in Patients with Moderate to Severe Active Crohn’s Disease C. Janneke van der Woude, MD,* Pieter Stokkers, MD, Ad A. van Bodegraven, MD, Gert Van Assche, MD, Zbigniew Hebzda, MD, Leszek Paradowski, MD,k Geert D’Haens, MD,** Subrata Ghosh, MD, Brian Feagan, MD, Paul Rutgeerts, MD, Gerard Dijkstra, MD, Dirk J. de Jong, MD, Bas Oldenburg, MD,*** Mahdi Farhan, MD, Tristan Richard, PhD, Yann Dean, PhD, and Daniel W. Hommes, MD, on behalf of the Initiative on Crohn’s and Colitis (ICC), The Netherlands