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B-GT/21: Regulatory and clinical data
(Authors: M. Sneyers and M. Goossens - Last revised:
September 16, 2009
)
Title |
A phase 2a randomized, placebo-controlled, double-blind, multi-center dose escalation study, to evaluate the safety, tolerability, pharmacodynamics and efficacy pf AG011, in subjects with moderately active ulcerative colitis. | |||||
Company or sponsor |
ActoGenix NV. | |||||
Pharmaceutical study code |
AG011-MDUC-201 | |||||
| EudraCT number | #2008-000967-40 | |||||
Phase |
phase II | |||||
Unicenter/multicenter study |
multicenter | |||||
| Clinical data | see table 2 | |||||
Installation |
UZ Gasthuisberg, Leuven | UZ Antwerpen | UZ Gent | Imelda VZW | AZ Groeninge | UCL St Luc |
Authorisation procedure 1 |
contained use, subsequent use (see relevant regulation) | contained use, subsequent use (see relevant regulation) | contained use, subsequent use (see relevant regulation) | contained use, subsequent use (see relevant regulation) | contained use, subsequent use (see relevant regulation) | contained use, first use (see relevant regulation) |
Application number |
219 2008/0875 |
219 2008/1074 | 219 2008/1106 | 219 2008/1200 | 219 2009/0114a,b | 219 2009/0208 |
User(s) |
Dr. Severine Vermeire | Dr. Tom Moreels | Prof. Dr. Martine De Vos | Dr. G. D'Haens | Dr. P. Vergauwe | Dr. Olivier Dewit |
Receipt date |
10/07/2008 | 22/08/2008 | 11/09/2008 | 11/09/2008 | 09/02/2009 | 05/03/2009 |
| Authorisation date | 04/08/2008 | 12/09/2008 | 16/10/2008 | 16/10/2008 | 18/02/2008 | 19/03/2009 |
| Authorisation procedure 2 | deliberate release for research and development purposes (see regulation in French - in Dutch) | |||||
| Application number | B/BE/07/BVW1 | |||||
| 18/01/2008 | ||||||
Authorisation date |
April 2008 |
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Status |
trial completed |
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