Detail of the clinical trial

Title of the trial A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercapto
EudraCT number 2018-003558-26
Protocol number ABX464-103
Sponsor ABIVAX, 5 Rue de la Baume, Paris, 75008, France
Indications
Diagnosis moderate to severe ulcerative colitis
Population in clinical trial Adults (18-65 years)
Elderly ( > 65 years)
Male
Female
Patients
Year of receiving the request to Institute (SÚKL) 2019
Date of approval by Institute (SÚKL) 22.5.2019
Date of approval by EC 28.3.2019
Date of initiation CT in ČR 22.10.2019
Date of ending CT in ČR
Notice
Sites Nemocnice Slaný, Politických vězňů 576, Slaný, 274 01
Fakultní nemocnice u sv. Anny v Brně, Pekařská 53, Brno, 656 91
Fakultní nemocnice Ostrava,17.listopadu 1790, Ostrava, 708 52
Thomayerova nemocnice, Vídeňská 800, 140 59 Praha 4
ISCARE a.s., Ceskomoravská 2510/19, 190 00 Praha 9
Hepato-Gastroenterologie HK s.r.o., tř. Edvarda Beneše 1549, 500 12 Hradec Králové
MUDr. GREGAR s.r.o., Čajkovského 67/14, 779 00 Olomouc
Nemocnice Na Bulovce, I.interní oddělení, Budínova 67/2, 180 81 Praha 8

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