A study to evaluate the efficacy and safety of vixarelimab in patients with moderate to severe ulcerative colitis

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What is this study about?

This study focuses on individuals living with Ulcerative Colitis, a long-term condition that causes inflammation and sores in the lining of the large intestine. The purpose of the study is to evaluate the efficacy of vixarelimab compared to a placebo in achieving clinical remission, which is a state where symptoms of the disease are significantly reduced or gone. Participants in the study may also be taking other medications as part of their usual care, such as azathioprine, adalimumab, methotrexate, golimumab, infliximab, mercaptopurine, corticosteroids, or aminosalicylates.

The study consists of an initial phase to see how well the treatment works to control symptoms, followed by an extension period to continue monitoring the effects. During the study, medical professionals will monitor the levels of vixarelimab in the blood and check for anti-drug antibodies, which are substances the body might create in response to a medication. The course of the study involves regular assessments to observe changes in symptoms and the condition of the intestinal lining.

Who Can Join the Study?

  • You must have been diagnosed with Ulcerative Colitis, which is a type of long-term inflammation in the lining of the large intestine, for at least 3 months.
  • Your condition must be moderately to severely active, meaning your symptoms are significant, as measured by a specific scale called the Modified Mayo Score (a tool doctors use to track the severity of inflammation and symptoms).
  • You must have had an inadequate response, a loss of response, or an intolerance to standard or advanced treatments, meaning your current medicines are either not working well enough or are causing side effects you cannot handle.
  • The study is open to both males and females.
  • Participants must be within the age range specified by the study (ages 3 to 17).

Who Cannot Join the Study?

  • You cannot join if you have been diagnosed with Crohn’s disease, which is a type of long-term inflammation in the digestive tract, or indeterminate colitis, a condition where it is unclear exactly what type of inflammation is in the colon.
  • You cannot participate if doctors suspect you have ischemic colitis (damage to the colon caused by low blood flow), radiation colitis (inflammation caused by radiation therapy), microscopic colitis (inflammation only visible under a microscope), or infectious colitis (inflammation caused by an infection).
  • You cannot take part if you have previously had a colectomy, which is a surgery to remove all or part of the large intestine.
  • You cannot join if your previous treatment for Ulcerative Colitis using Janus kinase (JAK) inhibitors—a specific type of medicine that helps block inflammation—did not work well enough or stopped working for you.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Wsd Medi Clinical Sp. z o.o. Warsaw Poland
ASST Fatebenefratelli Sacco Milan Italy
PreventaMed s.r.o. Olomouc Czechia
Iscare a.s. Prague Czechia
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
CHU Saint Pierre Brussels Belgium
University General Hospital Of Heraklion Heraklion Greece
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j. Bydgoszcz Poland
Sonomed Sp. z o.o. Szczecin Poland
Eb Group Sp. z o.o. Warsaw Poland
Azienda Ospedaliera Ordine Mauriziano Di Torino Turin Italy
Nzoz For Med Sp. z o.o. Wadowice Poland
Endoskopia Sp. z o.o. Sopot Poland
Topolowa Medicenter Ryszawa & Wspolnicy Sp. j. Cracow Poland
Planetmed Sp. z o.o. Wroclaw Poland
SurGal Clinic s.r.o. Brno-Sever Czechia
1 Wojskowy Szpital Kliniczny Z Poliklinika samodzielny publiczny zakład opieki zdrowotnej W Lublinie Lublin Poland
Rivermed Sp. z o.o. Poznan Poland
Melita Medical sp. z o.o. Wroclaw Poland
Mz Badania Slowik Zymla Sp. j. Knurow Poland
Centrum Medyczne Uno-Med Sp. z o.o. Tarnow Poland
Bonifraterskie Centrum Medyczne Sp. z o.o. Lodz Poland
Endohope klinika s.r.o. Prague Czechia
Azienda Ospedaliera di Padova Padua Italy
Evangelismos S.A. Athens Greece
Santa Sp. z o.o. sp. K.Polimedica PTG Kielce Kielce Poland
Ospedale San Raffaele S.r.l. Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Alexandra Hospital Athens Greece
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Hepato-Gastroenterologie HK s.r.o. Hradec Kralove Czechia
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centre Hospitalier Universitaire De Nice Nice France
Vojenska Nemocnice Brno Brno-Zidenice Czechia
Geniko Nosokomeio Peiraia Tzaneio Piraeus Greece
Medrise Sp. z o.o. Lublin Poland
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Azienda Ospedaliera Universitaria Di Cagliari Monserrato Italy
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o. Poznan Poland
IRCCS Ospedale Sacro Cuore Don Calabria Negrar di Valpolicella Italy
Allmedica Badania Kliniczne Sp. z o.o. Nowy Targ Poland
Uglv Cauptowx Tcteaj Sgy z otak Lodz Poland
Mzrwlrzkvowsfpowmxgogxidyp Hxtbfvmevkqzlhos Halle (Saale) Germany
Vfgxcpox &frqd Vdxemty Sgs z oljm Wroclaw Poland
Tmqtewoj Sdp z otyj Piotrkow Trybunalski Poland
Ebjudzn Pbbtmcufw Smw z oslz Pabianice Poland
Ozfbspp Bkwbj Krubhyhtizo Bu Ryzbdqlt Sah z ohxg Ilawa Poland
Lulwa Gdhhexc Hbfmwixi Ou Aqjbfd Athens Greece
Axfxlpl Oyoyeiosdie Owpczhvz Rmzhhht Vnggv Svmmy Cmuoweih Palermo Italy
Pqqhqzwtvgq Etniimrdgpcp Wroclaw Poland
Mlalgeim So z oipe Bydgoszcz Poland
Evr Zyrssr Zamosc Poland
Udfoyxajlmjbzebtqhtop Mgsmrodn Afz Munster Germany
Cjnk Dc Nvdsm Vandoeuvre Les Nancy France
Plebqbtui Izzdchsa Mnmfevto Mfrysotzynnn Scdqf Wyarmxuukpjv I Akonefrnmrugj Warsaw Poland
Asnffx Mdtoros Clnoir Sxmp Thessaloniki Greece
Apjpmvb Ugsre Sljbdhazu Lylayu Dq Bwxmovd Bologna Italy
Itixpedw dy Crxwbowdzrif Hwfbzxdpbhn Uiwklsjzaeifm dg Saxtj Evacbbj (obdpsuo Saint Priest En Jarez France
Www Wmqwje Ifl Pltic Pscwvarg Kygkvsl Warsaw Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
05.04.2024
Czechia Czechia
Not recruiting
05.04.2024
France France
Not recruiting
05.04.2024
Germany Germany
Not recruiting
05.04.2024
Greece Greece
Not recruiting
05.04.2024
Italy Italy
Not recruiting
05.04.2024
Poland Poland
Not recruiting
05.04.2024

Trial locations

Vixarelimab is the experimental medication being tested in this study to see if it can help induce remission in patients with moderate to severe ulcerative colitis.

Ulcerative colitis – This is a condition characterized by inflammation and sores in the inner lining of the large intestine and rectum. The inflammation typically affects only the innermost layer of the affected tissue. As the condition progresses, the inflammation may spread continuously from the rectum upward through the colon. This process can lead to increased swelling and irritation of the intestinal wall. Symptoms often involve changes in bowel habits and visible bleeding.

Trial ID:
2023-506655-19-00
Protocol code:
GA44839
Trial Phase:
Therapeutic exploratory (Phase II)

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