Last updated 2 months ago

ABTECT - Maintenance

1050 patients around the world
Available in Spain, United States, Mexico, Argentina, Brazil
All eligible subjects who have completed either one of the induction studies above mentioned, will be given the opportunity to take part in the present ABX464-107 study which consists of 2 treatment phases. This study consists of a 44-week maintenance treatment phase (Part 1 and Part 2), followed by a 4-year Long Term Extension (LTE) treatment phase and a 28-days follow-up period consisting in the End of Study (EOS) visit. The maintenance phase is a 44-week double blind, placebo-controlled, phase. Subjects who are clinical responders after 8 weeks induction will be randomized to Part 1, and those who are non-clinical responders will be randomized to Part 2. At the end of the 44-week maintenance phase, subjects will continue their allocated treatment until the maintenance phase is unblinded. Once the study is unblinded, all subjects receiving obefazimod will continue their allocated treatment. Subjects receiving placebo will be allocated to obefazimod 25 mg or can terminate the study.
Abivax S.A.
31Research sites
1050Patients around the world

This study is for people with

Ulcerative colitis
Moderate/severe ulcerative colitis

Requirements for the patient

From 16 Years
All Gender

Medical requirements

Sites

Instituto de Investigaciones Clínicas Quilmes
Instituto de Investigaciones Clínicas Quilmes
Sarmiento 315, Quilmes, Buenos Aires, Argentina
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
Av. Galvan 4102, CABA, Buenos Aires
Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires
Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires
Viamonte, Cdad. Autónoma de Buenos Aires, Argentina
Hospital Británico de Buenos Aires - CABA
Hospital Británico de Buenos Aires - CABA
Perdriel 74, CABA, Buenos Aires
STAT Research - CABA
STAT Research - CABA
Recruiting
Av. Callao 875, CABA, Buenos Aires
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Juan Domingo Perón 4190, Piso 1, Ciudad Autónoma de Buenos Aires, C1181ACH
Centro de Investigaciones Médicas Tucumán
Lavalle 506, T4000 San Miguel de Tucumán, Tucumán, Argentina
Hospital Privado de Córdoba
Naciones Unidas 346, Córdoba
L2IP Instituto de Pesquisas Clínicas
SGAS 613, Conj. E Bloco A , Sala 06 - Subsolo , Asa Sul - Brasília/DF, CEP: 70.200-730
Hospital Felício Rocho
Av. do Contorno, 9530 - Barro Preto, Belo Horizonte - MG, 30110-934
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