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2023-506655-19-00CompletedPhase 2

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants with Moderate to Severe Ulcerative Colitis

A Phase II, Multicenter Induction Study with an Active Treatment Extension to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Patients with Moderate to Severe Ulcerative Colitis

Source: EU CTIS (euclinicaltrials.eu) · Last updated 14 Jul 2025

Next steps

Brief summary (registry, in English)

To evaluate the efficacy of vixarelimab compared to placebo in the induction of clinical remission at Week 12

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
138 (actual)
First submitted
20 Dec 2023
Start date
16 May 2024
Lead sponsor
Genentech Inc.
EU CT number
2023-506655-19-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 138
  • 66 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Suspicion of ischemic, radiation, microscopic, or infectious colitis
  • Prior colectomy
  • Inadequate response to or loss of response to previous treatment of UC with Janus kinase (JAK) inhibitors.

Other illness

  • Diagnosis of Crohn’s disease or indeterminate colitis

Who the study is looking for

  • Diagnosis of UC for at least 3 months
  • Moderately to severely active UC, assessed by Modified Mayo Score (mMS)
  • Inadequate response, loss of response to, or intolerance to conventional or advanced therapies for UC

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (66)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
CHU Saint-PierreBrusselsBelgiumCompleted
UZ LeuvenLeuvenBelgiumCompleted
SurGal Clinic s.r.o.Brno-SeverCzechiaCompleted
Vojenska Nemocnice BrnoBrno-ZideniceCzechiaCompleted
Hepato-Gastroenterologie HK, s.r.o.Hradec KrálovéCzechiaCompleted
PreventaMed, s.r.o.OlomoucCzechiaCompleted
ISCARE a.s.PragueCzechiaCompleted
Endohope klinika s.r.o.PragueCzechiaCompleted
Charite Universitaetsmedizin Berlin KöRBerlinGermanyCompleted
Medical Center- University of FreiburgFreiburg im BreisgauGermanyCompleted
Martin-Luther-Universitaet Halle-WittenbergHalle (Saale)GermanyCompleted
Universitaetsklinikum Schleswig-Holstein AöRKielGermanyCompleted
Universitaet MuensterMuensterGermanyCompleted
Universitaetsklinikum Ulm AoRUlmGermanyCompleted
Centre Hospitalier Universitaire de NiceNiceFranceCompleted
Hospices Civils de LyonPierre-BéniteFranceCompleted
Centre Hospitalier Universitaire de Saint EtienneSaint-Priest-en-JarezFranceCompleted
CHRU De NancyVandoeuvre Les NancyFranceCompleted
Alexandra HospitalAthensGreeceCompleted
Thoracic General Hospital of Athens "I Sotiria"AthensGreeceCompleted
Evangelismos S AAthensGreeceCompleted
University General Hospital of HeraklionHeraklionGreeceCompleted
Athens Medical Center S.A.Paleo FaliroGreeceCompleted
Geniko Nosokomeio Peiraia TzaneioPiraeusGreeceCompleted
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBolognaItalyCompleted
ASST Fatebenefratelli SaccoMilanItalyCompleted
Ospedale San Raffaele S.r.l.MilanItalyCompleted
Azienda Ospedaliero-Universitaria Di CagliariMonserratoItalyCompleted
IRCCS Ospedale Sacro Cuore Don CalabriaNegrarItalyCompleted
Azienda Ospedaliera di PadovaPadovaItalyCompleted
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - CervelloPalermoItalyCompleted
Fondazione IRCCS Policlinico San MatteoPaviaItalyCompleted
Fondazione Policlinico Universitario Agostino Gemelli IRCCSRomeItalyCompleted
Humanitas Research HospitalRozzanoItalyCompleted
Azienda Ospedaliera Ordine Mauriziano di TorinoTurinItalyCompleted
Manermed Sp. z o.o.BydgoszczPolandCompleted
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.BydgoszczPolandCompleted
Topolowa Medicenter Ryszawa & Wspolnicy Sp. j.CracowPolandCompleted
Osrodek Badan Klinicznych Bd Research Sp. z o.o.IlawaPolandCompleted
Santa Sp. z o.o. sp.k.KielcePolandCompleted
MZ Badania Slowik Zymla Sp.j.KnurówPolandCompleted
Samodzielny Publiczny Zaklad Opieki Zdrowotnej W LecznejLecznaPolandCompleted
Clinical Trials Umed Sp. z o.o.LodzPolandCompleted
Bonifraterskie Centrum Medyczne sp. z o.oLodzPolandCompleted
1. Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej w LublinieLublinPolandCompleted
Medrise Sp. z o.o.LublinPolandCompleted
Allmedica Badania Kliniczne Sp. z o.o.Nowy TargPolandCompleted
Twoja Przychodnia Opolskie Centrum MedyczneOpolePolandCompleted
Eskulap Pabianice Sp. z o.o.PabianicePolandCompleted
Trialmed Sp. z o. o.Piotrkow TrybunalskiPolandCompleted
Rivermed Sp. z o.o.PoznanPolandCompleted
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.PoznanPolandCompleted
Endoskopia Sp z o.o.SopotPolandCompleted
Sonomed Sp. z o.o.SzczecinPolandCompleted
Centrum Medyczne Uno-Med Sp. z o.o.TarnowPolandCompleted
NZOZ FOR MED sp. z o.o.WadowicePolandCompleted
Eb Group Sp. z o.o.WarsawPolandCompleted
Medical Network Sp z o oWarsawPolandCompleted
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i AdministracjiWarsawPolandCompleted
Wsd Medi Clinical Sp. z o.o.WarsawPolandCompleted
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga MieczWarszawaPolandCompleted
Vistamed & Vertigo Sp Z O OWroclawPolandCompleted
PlanetMed Sp. z o.o.WroclawPolandCompleted
Melita Medical Sp. z o.o.WrocławPolandCompleted
EuroMediCare Szpital Specjalistyczny z PrzychodniaWrocławPolandCompleted
Etg Zamosc Sp. z o.o.ZamośćPolandCompleted

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