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
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.
- Diseases
- Ulcerative colitis
- 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
Sites (66)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Saint-Pierre | Brussels | Belgium | Completed |
| UZ Leuven | Leuven | Belgium | Completed |
| SurGal Clinic s.r.o. | Brno-Sever | Czechia | Completed |
| Vojenska Nemocnice Brno | Brno-Zidenice | Czechia | Completed |
| Hepato-Gastroenterologie HK, s.r.o. | Hradec Králové | Czechia | Completed |
| PreventaMed, s.r.o. | Olomouc | Czechia | Completed |
| ISCARE a.s. | Prague | Czechia | Completed |
| Endohope klinika s.r.o. | Prague | Czechia | Completed |
| Charite Universitaetsmedizin Berlin KöR | Berlin | Germany | Completed |
| Medical Center- University of Freiburg | Freiburg im Breisgau | Germany | Completed |
| Martin-Luther-Universitaet Halle-Wittenberg | Halle (Saale) | Germany | Completed |
| Universitaetsklinikum Schleswig-Holstein AöR | Kiel | Germany | Completed |
| Universitaet Muenster | Muenster | Germany | Completed |
| Universitaetsklinikum Ulm AoR | Ulm | Germany | Completed |
| Centre Hospitalier Universitaire de Nice | Nice | France | Completed |
| Hospices Civils de Lyon | Pierre-Bénite | France | Completed |
| Centre Hospitalier Universitaire de Saint Etienne | Saint-Priest-en-Jarez | France | Completed |
| CHRU De Nancy | Vandoeuvre Les Nancy | France | Completed |
| Alexandra Hospital | Athens | Greece | Completed |
| Thoracic General Hospital of Athens "I Sotiria" | Athens | Greece | Completed |
| Evangelismos S A | Athens | Greece | Completed |
| University General Hospital of Heraklion | Heraklion | Greece | Completed |
| Athens Medical Center S.A. | Paleo Faliro | Greece | Completed |
| Geniko Nosokomeio Peiraia Tzaneio | Piraeus | Greece | Completed |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico | Bologna | Italy | Completed |
| ASST Fatebenefratelli Sacco | Milan | Italy | Completed |
| Ospedale San Raffaele S.r.l. | Milan | Italy | Completed |
| Azienda Ospedaliero-Universitaria Di Cagliari | Monserrato | Italy | Completed |
| IRCCS Ospedale Sacro Cuore Don Calabria | Negrar | Italy | Completed |
| Azienda Ospedaliera di Padova | Padova | Italy | Completed |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello | Palermo | Italy | Completed |
| Fondazione IRCCS Policlinico San Matteo | Pavia | Italy | Completed |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Italy | Completed |
| Humanitas Research Hospital | Rozzano | Italy | Completed |
| Azienda Ospedaliera Ordine Mauriziano di Torino | Turin | Italy | Completed |
| Manermed Sp. z o.o. | Bydgoszcz | Poland | Completed |
| Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j. | Bydgoszcz | Poland | Completed |
| Topolowa Medicenter Ryszawa & Wspolnicy Sp. j. | Cracow | Poland | Completed |
| Osrodek Badan Klinicznych Bd Research Sp. z o.o. | Ilawa | Poland | Completed |
| Santa Sp. z o.o. sp.k. | Kielce | Poland | Completed |
| MZ Badania Slowik Zymla Sp.j. | Knurów | Poland | Completed |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Lecznej | Leczna | Poland | Completed |
| Clinical Trials Umed Sp. z o.o. | Lodz | Poland | Completed |
| Bonifraterskie Centrum Medyczne sp. z o.o | Lodz | Poland | Completed |
| 1. Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej w Lublinie | Lublin | Poland | Completed |
| Medrise Sp. z o.o. | Lublin | Poland | Completed |
| Allmedica Badania Kliniczne Sp. z o.o. | Nowy Targ | Poland | Completed |
| Twoja Przychodnia Opolskie Centrum Medyczne | Opole | Poland | Completed |
| Eskulap Pabianice Sp. z o.o. | Pabianice | Poland | Completed |
| Trialmed Sp. z o. o. | Piotrkow Trybunalski | Poland | Completed |
| Rivermed Sp. z o.o. | Poznan | Poland | Completed |
| Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o. | Poznan | Poland | Completed |
| Endoskopia Sp z o.o. | Sopot | Poland | Completed |
| Sonomed Sp. z o.o. | Szczecin | Poland | Completed |
| Centrum Medyczne Uno-Med Sp. z o.o. | Tarnow | Poland | Completed |
| NZOZ FOR MED sp. z o.o. | Wadowice | Poland | Completed |
| Eb Group Sp. z o.o. | Warsaw | Poland | Completed |
| Medical Network Sp z o o | Warsaw | Poland | Completed |
| Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji | Warsaw | Poland | Completed |
| Wsd Medi Clinical Sp. z o.o. | Warsaw | Poland | Completed |
| Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz | Warszawa | Poland | Completed |
| Vistamed & Vertigo Sp Z O O | Wroclaw | Poland | Completed |
| PlanetMed Sp. z o.o. | Wroclaw | Poland | Completed |
| Melita Medical Sp. z o.o. | Wrocław | Poland | Completed |
| EuroMediCare Szpital Specjalistyczny z Przychodnia | Wrocław | Poland | Completed |
| Etg Zamosc Sp. z o.o. | Zamość | Poland | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.