Last updated 4 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
- Subjects must have completed the induction treatment study (ABX464-105 or ABX464-106), and patients' clinical response status must be available.Subjects with a valid endoscopy performed at the end of the induction study and results from central reader available at Day 1.Subjects must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures. For under-aged subjects, national requirements regarding consent should also be met.Women of childbearing potential (WOCBP) subjects and male subjects with WOCBP partner must agree to use highly effective contraception methods as stated in Section 4.4. (Contraception) of this protocol.Subjects must be able and willing to comply with study visits and procedures as per protocol.Subjects should be affiliated to a health insurance policy whenever required by a participating country or state
- Subjects who permanently discontinued the study treatment during the induction study (either ABX464-105 or ABX464-106).Subjects who have developed any major illness/condition or evidence of an unstable clinical condition (except UC) during the induction study that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study.Subjects who plan to participate in other investigational studies during the maintenance study.Male or female planning a pregnancy within the coming 12 months
Sites
Instituto de Investigaciones Clínicas Quilmes
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires
Hospital Británico de Buenos Aires - CABA
STAT Research - CABA
Recruiting
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Centro de Investigaciones Médicas Tucumán
Hospital Privado de Córdoba
L2IP Instituto de Pesquisas Clínicas
Hospital Felício Rocho
SponsorAbivax S.A.
Conditions
Moderate/severe ulcerative colitis
Requirements
From 16 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05535946
