findmyKOL
Clinical trialNCT05535946Active, not recruitingPhase 3Interventional

ABTECT - Maintenance

SponsorAbivax S.A.Enrollment1,116Ulcerative Colitis
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This is a multicenter, randomized, placebo-controlled study to evaluate the long-term efficacy and safety of ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies \[corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)\] and/or advanced therapies \[biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors\]. This study is the maintenance phase of both previous induction studies ABX464-105 and ABX464-106.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

413 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Argentina
  • Instituto de Investigaciones Clinicas Quilmes

    Quilmes, Buenos Aires, Argentina

  • Hospital Privado Centro Medico de Cordoba S.A

    Córdoba, Córdoba Province, Argentina

  • Centro de Investigacion Cice

    San Miguel de Tucumán, Tucumán Province, Argentina

  • Hospital Britanico de Buenos Aires

    Buenos Aires, Argentina

  • Stat Research S.A.

    Buenos Aires, Argentina

Australia
  • Concord Repatriation General Hospital

    Concord, New South Wales, Australia

  • St Vincent'S Hospital Melbourne

    Fitzroy, Victoria, Australia

  • the Alfred Hospital

    Melbourne, Victoria, Australia

  • Royal Melbourne Hospital

    Parkville, Victoria, Australia

Austria
  • Lkh - Universitaetsklinikum Graz

    Graz, Austria

  • Medizinische Universität Innsbruck

    Innsbruck, Austria

  • Lkh - Universitätsklinikum Der Pmu Salzburg

    Salzburg, Austria

  • Kh Der Barmherzigen Brüder St.Veit An Der Glan

    Sankt Veit an der Glan, Austria

Belgium
  • C. H. U. St-Pierre

    Brussels, Belgium

  • Az Maria Middelares

    Ghent, Belgium

  • Az Sint-Lucas

    Ghent, Belgium

  • Uz Leuven

    Leuven, Belgium

  • Clinique Chc Montlégia

    Liège, Belgium

  • Az Delta

    Roeselare, Belgium

  • Chu Ucl Namur

    Yvoir, Belgium

Brazil
  • Hospital Aliança

    Salvador, Estado de Bahia, Brazil

  • L2ip - Instituto de Pesquisas Clínicas Ltda.

    Brasília, Federal District, Brazil

  • Cdc - Centro Digestivo de Curitiba

    Curitiba, Paraná, Brazil

  • Instituto de Pesquisas Em Saúde - Fundação Universidade de Caxias Do Sul (ips/fucs)

    Caxias do Sul, Rio Grande do Sul, Brazil

  • Unesp - Faculdade de Medicina Da Universidade Estadual Paulista - Campus Botucatu

    Botucatu, São Paulo, Brazil

  • Cecip - Centro de Estudos Clínicos Do Interior Paulista

    Jaú, São Paulo, Brazil

  • Pesquisare Saúde

    Santo André, São Paulo, Brazil

  • Irmandade Da Santa Casa Da Misericórdia de Santos

    Santos, São Paulo, Brazil

  • Hepatogastro

    São Paulo, São Paulo, Brazil

Bulgaria
  • Medical Center Medconsult Pleven Ood

    Pleven, Bulgaria

  • Dcc "alexandrovska", Eood

    Sofia, Bulgaria

  • Umhatem 'N.I. Pirogov', Ead

    Sofia, Bulgaria

  • Mc Medica Plus

    Veliko Tarnovo, Bulgaria

Canada
  • Gastroenterology and Internal Medicine Research Institute (giri)

    Edmonton, Alberta, Canada

  • (g.I.R.I.) Gi Research Institute

    Vancouver, British Columbia, Canada

  • London Health Sciences Centre (lhsc) - Victoria Hospital

    London, Ontario, Canada

  • Toronto Immune & Digestive Health Institute

    North York, Ontario, Canada

China
  • Yijishan Hospital of Wannan Medical College

    Wuhu, Anhui, China

  • Peking University First Hospital

    Beijing, Beijing Municipality, China

  • the First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, China

373 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

ABX464Placebo
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
16 Jan 2023
Primary completion
28 Apr 2026
Completion
31 May 2030
Last update posted
7 Jul 2026
Registered enrollment
1,116
Registry id
NCT05535946
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.