Befejeződött2. fázis
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants with Moderate to Severe Ulcerative Colitis
Key facts
- Where
- Bydgoszcz, Cracow, Ilawa, Kielce, Knurów, Leczna, Lodz, Lublin, Nowy Targ, Opole, Pabianice, Piotrkow Trybunalski, Poznan, Sopot, Szczecin, Tarnow, Wadowice, Warsaw, Warszawa, Wroclaw, Wrocław és Zamość, LengyelországSee the 31 sites
- Phase
- 2. fázis
Where in Lengyelország
- Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.Bydgoszcz, LengyelországNo longer taking part
- Manermed Sp. z o.o.Bydgoszcz, LengyelországNo longer taking part
- Topolowa Medicenter Ryszawa & Wspolnicy Sp. j.Cracow, LengyelországNo longer taking part
- Osrodek Badan Klinicznych Bd Research Sp. z o.o.Ilawa, LengyelországNo longer taking part
- Santa Sp. z o.o. sp.k.Kielce, LengyelországNo longer taking part
- MZ Badania Slowik Zymla Sp.j.Knurów, LengyelországNo longer taking part
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej W LecznejLeczna, LengyelországNo longer taking part
- Bonifraterskie Centrum Medyczne sp. z o.oLodz, LengyelországNo longer taking part
- Clinical Trials Umed Sp. z o.o.Lodz, LengyelországNo longer taking part
- 1. Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej w LublinieLublin, LengyelországNo longer taking part
- Medrise Sp. z o.o.Lublin, LengyelországNo longer taking part
- Allmedica Badania Kliniczne Sp. z o.o.Nowy Targ, LengyelországNo longer taking part
- Twoja Przychodnia Opolskie Centrum MedyczneOpole, LengyelországNo longer taking part
- Eskulap Pabianice Sp. z o.o.Pabianice, LengyelországNo longer taking part
- Trialmed Sp. z o. o.Piotrkow Trybunalski, LengyelországNo longer taking part
- Rivermed Sp. z o.o.Poznan, LengyelországNo longer taking part
- Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.Poznan, LengyelországNo longer taking part
- Endoskopia Sp z o.o.Sopot, LengyelországNo longer taking part
- Sonomed Sp. z o.o.Szczecin, LengyelországNo longer taking part
- Centrum Medyczne Uno-Med Sp. z o.o.Tarnow, LengyelországNo longer taking part
- NZOZ FOR MED sp. z o.o.Wadowice, LengyelországNo longer taking part
- Eb Group Sp. z o.o.Warsaw, LengyelországNo longer taking part
- Medical Network Sp z o oWarsaw, LengyelországNo longer taking part
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i AdministracjiWarsaw, LengyelországNo longer taking part
- Wsd Medi Clinical Sp. z o.o.Warsaw, LengyelországNo longer taking part
- Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga MieczWarszawa, LengyelországNo longer taking part
- PlanetMed Sp. z o.o.Wroclaw, LengyelországNo longer taking part
- Vistamed & Vertigo Sp Z O OWroclaw, LengyelországNo longer taking part
- EuroMediCare Szpital Specjalistyczny z PrzychodniaWrocław, LengyelországNo longer taking part
- Melita Medical Sp. z o.o.Wrocław, LengyelországNo longer taking part
- Etg Zamosc Sp. z o.o.Zamość, LengyelországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Genentech Inc.
- Trial code
- EU 2023-506655-19-00
- Record updated
- 2025. július 14.
- Original description
To evaluate the efficacy of vixarelimab compared to placebo in the induction of clinical remission at Week 12Read full original descriptionShow less
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
To evaluate the efficacy of vixarelimab compared to placebo in the induction of clinical remission at Week 12
Inclusion: 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.
Exclusion: 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; Diagnosis of Crohn’s disease or indeterminate colitis.