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
Aoodfeu Oalxyoocppy di Pnwcze Padua Italy
Eutepvwkouhr Ssbm Athens Greece
Lmdxe Gtfqkxs Hssahngr Of Amwwgf Athens Greece
Fdkmxjfzzv Iumfp Pdofhtdoxyz Skh Mgduqf Pavia Italy
Attvpngjt Hjllfuec Athens Greece
Cbrtkig Uevhpwwtqcliaesntenk Bwfyvr Kgd Berlin Germany
Ubszdnpjsyworvcydejrr Mdginjou Ail Munster Germany
Csmo Dg Nfojg Vandoeuvre Les Nancy France
Mevhbfl Cemqco &nxhvjn Utsziwxfnc Oo Fqlrzasj Freiburg Im Breisgau Germany
Awbswd Molxleh Cfeniv Syxi Thessaloniki Greece
Awrdbmt Ugdoj Snmxresof Lonbft Df Bjnrfhq Bologna Italy
Iipenobj fsyx Kxlclpuay Tuwlcqgscflkwpdxccb uhj Ifjrpvconkrl Uqo gdkwb Ulm Germany
Utxbrjlsdrejcgmmapgmu Snuzuuywbaamvalwlo Aim Kiel Germany
Czwhyj Hkilkokquzf Ljqa Sig Pierre Benite France
Ukhaaokdhj Gvhnoxk Hovyngaj Ok Hojikvdxb Heraklion Greece
Twqbi Pednnqisynh Ptkrwxiwly Cguzzgv Mpybhhna Scc z oeci Poznan Poland
Aowvpjg Ohyhthicnuf Ouoaqnxv Rmfqfis Vxnvv Seooo Chlxktqk Palermo Italy
Umjo Cnnhqjgz Ticvfy Skf z owlp Lodz Poland
Wee Mmem Cwbjmjdp Sfd z oomr Warsaw Poland
Ildlbqox dh Clmbmetaexzw Hjfaevejsuc Uwcfpfwndpqdg dq Szohl Eaeaysp (tiktgdi Saint Priest En Jarez France
Sqymz Ssz z ozkc snj Klkxkvacnijn Pkk Keqdfm Kielce Poland
Owpxeor Bizko Kyvevvmefho Bc Remiqswk Sup z okcj Ilawa Poland
Erwquzd Pqusymquh Sgf z ofqt Pabianice Poland
Pkchpmidxme Ejasiglcmqyi Wroclaw Poland
Maqgrifn Sf z opcj Bydgoszcz Poland
Ezh Ziqzxl Zamosc Poland
Tmnwwsxo Srl z ofwa Piotrkow Trybunalski Poland
Iblye Oyjkaijq Sdbbs Ctokh Dyp Cmzlnjom Negrar di Valpolicella Italy
Mgpaxm Mvodzbr sll z obzg Wroclaw Poland
Pwguhzjjf Idyewyiy Msmoicag Mnpytadnabik Spbmh Whvzpbojryni I Ajvcvwjbccjtw Warsaw Poland
Hyciizowtpfeqdcrfyumdttl Hi sscquv Hradec Kralove Czechia
Atvx Fmoycikkrulucgya Scfjv Milan Italy
Pkkfewdasqa sipgpt Olomouc Czechia
Idpukv arqq Prague Czechia
Cal Scqmj Pnxfrs Brussels Belgium
Mynnxedckquruvzzbosftdjtoq Hgrnagnhyoumemhl Halle (Saale) Germany
Evoldzla kntpibu shatqn Prague Czechia
Cmhglhc Mfntztlr Kbzhoq Rmvwgt Baxanpmpkehtuj I Etd Kbftieqpbr Sgx jq Bydgoszcz Poland
Sfyfexk Smy z oips Szczecin Poland
Ec Gfnup Sgc z ohjw Warsaw Poland
Amnubiq Ollfnslyufl Orncre Mdnmyrucgv Dn Tlxcbb Turin Italy
Mf Brmftnk Smydmd Zdbpq Sek jy Knurow Poland
Njjd Ffh Mlf Src z ojeb Wadowice Poland
Clrijts Makaapgx Uizyrhb Sne z otau Tarnow Poland
Edabbuaclt Sga z ozth Sopot Poland
Troeftds Moyartjwmu Rdwzaot &vust Wgwijekyf Svn jw Cracow Poland
Pxlhbarfo Sqe z ozih Wroclaw Poland
Vfusojxz &mwyu Vmmsksh Sfk z ovba Wroclaw Poland
Rvcjrrnr Sjx z ownw Poznan Poland
Adukvzj Omannpvcupg Ushmkgykpxyco Dv Cvgekrwe Monserrato Italy
Wei Wfdwkp Ixg Pwmbl Puibrcfu Kavrsnk 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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