Last updated on July 2020

Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis


Brief description of study

Phase IIb study to evaluate the efficacy and the safety of 3 dose-levels of ABX464, administered daily in patients with moderate to severe Ulcerative Colitis.

Detailed Study Description

This phase IIb study will evaluate the efficacy and the safety of 3 dose-levels of ABX464, administered daily in improving Modified Mayo Score (MMS) 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-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment .

Eligible patients will be randomized into 4 parallel intervention/treatment groups: 25mg q.d of ABX464, 50mg q.d of ABX464, 100mg q.d of ABX464, or matching placebo and will be treated for 16 weeks.

Clinical Study Identifier: NCT03760003

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UZA

Edegem, Belgium
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UZ Leuven

Leuven, Belgium
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Hopital Saint Eloi

Montpellier, France
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H pital de Brabois Adultes

Vandœuvre-lès-Nancy, France
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Trialmed CRS

Piotrkow Trybunalski, Poland
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Nzoz Vivamed

Warszawa, Poland
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LexMedica

Wroclaw, Poland
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Alian s.r.o.

Bardejov, Slovakia
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Cliniq s.r.o.

Bratislava, Slovakia
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Gastromedic, s.r.o.

Nové Zámky, Slovakia
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Endomed, s.r.o.

Vranov Nad Top?ou, Slovakia
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Guy's Hospital

London, United Kingdom
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H pital de Brabois Adultes

Vandœuvre-lès-Nancy, France
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Gastromedic, s.r.o.

Nové Zámky, Slovakia
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Endomed, s.r.o.

Vranov Nad Top?ou, Slovakia
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UCSD Health System

San Diego, CA United States
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Fakultni nemocnice Ostrava

Ostrava-Kunčice, Czechia
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H pital de Brabois Adultes

Vandœuvre-lès-Nancy, France
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Endomed, s.r.o.

Vranov Nad Topľou, Slovakia
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Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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