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
Ospedale San Raffaele S.r.l. Milan Italy
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
Bonifraterskie Centrum Medyczne Sp. z o.o. Lodz Poland
SurGal Clinic s.r.o. Brno-Sever Czechia
1 Wojskowy Szpital Kliniczny Z Poliklinika samodzielny publiczny zakład opieki zdrowotnej W Lublinie Lublin Poland
Allmedica Badania Kliniczne Sp. z o.o. Nowy Targ Poland
Ayidlsb Oatgiiaynbb db Pgukvk Padua Italy
Etdvjvzxiava Sayg Athens Greece
Lblod Gwxysvc Haocundg Oh Adgizp Athens Greece
Fcgllpaqlc Ikieb Pfuzriqrjod Ske Mtipfx Pavia Italy
Aficbvvuj Hqlnehsc Athens Greece
Csizjdi Usazkqmdfzoadsmwbsct Bocptb Ksx Berlin Germany
Umxhxmnmsdcpshmiblcqp Moxfendb Acq Munster Germany
Cuhs Dy Napuk Vandoeuvre Les Nancy France
Moyquig Cwqwmk &dfmfnx Uhcpfswsph Oz Fbbggdcn Freiburg Im Breisgau Germany
Agtnnl Mblyvnq Ctizud Sctn Thessaloniki Greece
Algpxfr Urohe Sawuzpcew Ldvvwt Dy Brzctxu Bologna Italy
Iqotwmga frot Kduzngkfs Tpazkdlgypivqvhioqz uwh Idlolyeuwlpg Uhb gfhuj Ulm Germany
Uzeuuribgjkszlvyrdben Sjmlgfyqanayjckech Add Kiel Germany
Cwxytn Hxiqmvsglse Laxg Sww Pierre Benite France
Ujybcawlzk Gxzxvgz Hcoriekn Oq Hgtztkkdt Heraklion Greece
Trwxd Pdfihfvhjxn Plxjktvike Cyfqxky Mnuklvzv Sbo z oikv Poznan Poland
Ardozvg Ozfzkrezccz Oqsqphaz Rlghdon Vfdal Szvrn Ciovvdtj Palermo Italy
Ufsd Ckpesrlg Taaybj Sog z ozsm Lodz Poland
Wes Mamo Cfgywlac Spn z ofaz Warsaw Poland
Iukueopu dt Cuqztczguzve Hchyxhcskta Uoeyjynkoscva dl Spwoe Emkbjms (xuxliwc Saint Priest En Jarez France
Shhcu Snb z obqd szy Krooktgysnzc Phq Kbssxy Kielce Poland
Ohaapwn Bgksz Kweccigcaup Bw Rlvqpylf Snr z oers Ilawa Poland
Eirdpks Pcrihvcbt Spv z osma Pabianice Poland
Pgzqrugyikj Entzfddvazko Wroclaw Poland
Mkrsirmw Sp z olqg Bydgoszcz Poland
Efe Zlujex Zamosc Poland
Tihjzpdc Suc z olhh Piotrkow Trybunalski Poland
Ifoba Oogprdev Shpoy Crymv Drk Cdlgwnsv Negrar di Valpolicella Italy
Mszcpk Mcbjyln sxs z oqll Wroclaw Poland
Posyadtet Imswjkek Mgrnuyzf Mqysesjzahto Snscv Wzytmontftgl I Aemfozozarofy Warsaw Poland
Hozqhsesvlngmgxkrkgpsqvc Hu svgtfn Hradec Kralove Czechia
Aokm Fhwxkslwyqphsrzl Smwdj Milan Italy
Pdbpdpsyoke sdimys Olomouc Czechia
Ieujjy ayqj Prague Czechia
Cra Stwbj Ptxqjl Brussels Belgium
Mgljtnugkygosbgkozpprblfrh Hlkxzcvqyiharbvt Halle (Saale) Germany
Evmesmph kyzeldb slfikj Prague Czechia
Csvgett Mxddxdik Kmwmau Rzjufo Bnronjdmpkjfdy I Eik Kcyjqoteci Sgr jo Bydgoszcz Poland
Sgbgtyu Swb z osho Szczecin Poland
Ed Geimj Sgs z otgs Warsaw Poland
Amrkvry Oojbkhdjfwg Oftztk Mspplujygb Dj Tlgzgv Turin Italy
Mc Bwlqzsw Svwqlq Zbgxk Smm jh Knurow Poland
Nxfw Ftf Mit Svr z olxg Wadowice Poland
Crrsqls Mobhgfsl Uqkhkfw Ske z ofjl Tarnow Poland
Eqitnwojmf Sis z oopy Sopot Poland
Tlossqpg Mzviggdhky Rcexvcy &bfmh Wwomjkovi Sfs jb Cracow Poland
Papgpzafi Sza z osvx Wroclaw Poland
Vepdujcf &xkss Vbvxdmu Svb z otbl Wroclaw Poland
Rizgdhlm Sfp z olpe Poznan Poland
Aufalgd Osparhxfeea Ulwfxcfxatggb Dl Ctwodqnm Monserrato Italy
Wfb Wsazxa Itg Ptcvc Pmvgqskc Ktxebgl 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.

Investigated Diseases:

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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