Study on the Effectiveness and Safety of JNJ-77242113 for Patients with Moderate to Severe Ulcerative Colitis

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What is this study about?

This clinical trial is focused on studying the treatment of Ulcerative Colitis, a condition that causes inflammation and sores in the digestive tract, specifically affecting the innermost lining of the large intestine and rectum. The study will evaluate a new medication known by its code name, JNJ-77242113, to see how effective and safe it is for people with moderately to severely active ulcerative colitis. Participants in the study will receive either the medication or a placebo, which is a substance with no active drug, to compare the effects.

The purpose of the study is to assess whether JNJ-77242113 can help reduce the symptoms of ulcerative colitis. The study will last for a period of 76 weeks, during which participants will be monitored for their response to the treatment. The medication will be administered in the form of a film-coated tablet taken orally. Throughout the study, participants will have regular check-ups to track their progress and any changes in their condition.

In addition to JNJ-77242113, the study will also involve other medications that are commonly used to manage ulcerative colitis, such as Mercaptopurine, Methotrexate, and Azathioprine. These medications are known to help control inflammation and immune system activity. The study aims to provide valuable information on the potential benefits of JNJ-77242113 in improving the quality of life for those living with ulcerative colitis.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing the diagnosis of ulcerative colitis, which must have been documented at least 12 weeks prior to this assessment.

A video endoscopy is performed to obtain an endoscopy subscore, which must be 2 or higher. This score is part of the modified Mayo score, which ranges from 5 to 9 for moderately to severely active ulcerative colitis.

2 baseline colonoscopy

Participants with extensive ulcerative colitis for 8 years or more, or disease limited to the left side of the colon for 10 years or more, must undergo a complete colonoscopy to check for dysplasia.

Participants aged 45 or older must have had a colonoscopy within the last 5 years to check for adenomatous polyps, or they must undergo one during the screening period. Any polyps found must be removed before starting the study treatment.

3 treatment phase

The treatment phase involves the administration of the study medication, JNJ-77242113, which is provided in the form of a film-coated tablet for oral use.

The study is designed to evaluate the efficacy of JNJ-77242113 compared to a placebo in inducing a clinical response in participants with moderately to severely active ulcerative colitis.

4 evaluation of clinical response

The primary endpoint of the study is to assess the clinical response at Week 12. This involves evaluating the improvement in symptoms and overall condition of the ulcerative colitis.

Who Can Join the Study?

  • You must be 18 years old or older, or the legal age of consent in your area.
  • You need to have a documented diagnosis of Ulcerative Colitis (UC) for at least 12 weeks before the screening. This means your condition should have been confirmed in the past through tests like X-rays, tissue samples, or a camera examination of the colon.
  • Your UC should be moderately to severely active. This is determined by a specific score (modified Mayo score) between 5 to 9, which is based on a video examination of your colon.
  • You need to have a score of 2 or more on a part of the examination called the endoscopy subscore, which is reviewed during the screening.
  • If you have had extensive UC for 8 years or more, or if your disease is limited to the left side of the colon for 10 years or more, you must have had a complete colon examination within the last year to check for abnormal cell growth (dysplasia). Alternatively, you can have this examination during the screening period according to local guidelines.
  • If you are 45 years old or older, you must have had a full colon examination within the last 5 years to check for growths called adenomatous polyps, or you can have this examination during the screening. Any polyps found must be removed before starting the study treatment.

Who Cannot Join the Study?

  • Patients who have a different condition than Ulcerative Colitis cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are not part of the specified clinical trial group cannot participate.
  • Patients who are not female or male cannot participate.
  • Patients who are considered part of a vulnerable population cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Other Sites

Site Name City Country Status
Ospedale San Raffaele S.r.l. Milan Italy
Semmelweis University Budapest Hungary
Centre Hospitalier Universitaire De Nice Nice France
Assistance Publique Hopitaux De Paris Paris France
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
AZ Sint-Lucas & Volkskliniek Gent Belgium
Adulqrd Orutlpthvkt dm Penpuh Padua Italy
Udikxozeix Oh Dlggjead Debrecen Hungary
Hxmayvo Hetzi Maaqjl &teeoev 1 rfe Gihaani Eldigu Creteil France
Fprliroyno Iivkk Cy Gebyav Opfgxsdt Maydaykd Pwcsyrpwnyp Milan Italy
Ckjjlx Hujqgyqxmof Unwhpycpkmdmr Dz Tjihdccz Toulouse France
Ulqcmbdwyfkh Da Simoewmk Dp Cdimuurxfe Santiago De Compostela Spain
Cfph Do Nzyxk Vandoeuvre Les Nancy France
Crttmd Hrlolduvygi Ufzvlyblnhmxu Dg Nbzgh Nimes France
Cexcyu hsdtwnqknpi uhxkzqwukxdol dd Lbktx Liege Belgium
Secteivnctnh Kiyaffqp Lixzxdgpv ghdbw Lueneburg Germany
Uguimktlexxr Zyfqqznlrb Guus Gent Belgium
Uczolrxmmaaulzknklbld Simjdoawpugwzrkyqj Aep Kiel Germany
Cbsgch Hldellodvjt Likt Snh Pierre Benite France
Hueorlrq Ubalewztcrnth Pgufkg Dt Hmsxdf Dx Mpyheslxycv Majadahonda Spain
Fhzlocuby Pdbn Li Izgcctfwirfcz Bicyzxpvk Dgm Hwolcjps Ujodekbrhkjzq Lr Prf Madrid Spain
Dcnkg Hluguo Ccsg Suvioi Bucharest Romania
Votyt Sint-Niklaas Belgium
Cwkgaslp Hpklyfmbgwih Uhexiucqnfgky Dy Vmrx Vigo Spain
Bqvknzksqq Sso z ocbc sdujw Warsaw Poland
Nyhxejdko Sgdlm Slany Czechia
Cubalyy Mccnupkp Lkvtalm Jxdlho Łcsk Chojnice Poland
Intkhytr da Cvjbtgnbdsvv Hvnadwbbwrn Ulfztpgfuthcp dx Sttat Egjjjuc (kvqszkf Saint Priest En Jarez France
Peozzvfoqmz Ejsgvrbxdfvh Wroclaw Poland
Mzmdjgxm Sk z olum Bydgoszcz Poland
Innez Oplzqykl Sbdxv Czpua Dyp Cukmjotx Negrar di Valpolicella Italy
Nmwhzisrs Cthgc Bjfejwwidi aoyi Ceske Budejovice Czechia
Bngyiofh Ukxnakumty Hycalypj Cvlomp Besançon France
Huzkrytq Usztrehlpkobu Vktplp Dy Vccnm Sevilla Spain
Pwxjbaeij Izwlkkij Meexdxmn Mosnberjvvsq Shwuv Wkytpxebjvay I Aqteqvpralhoy Warsaw Poland
Schedmvuow Uzzgugnmqh Budapest Hungary
Hvzyrcxpmfvoateqhmvigklh He srysgj Hradec Kralove Czechia
Hhkhhruo Ujlidcfbtjvnw Da Cwcnzdcp Gijon Spain
Gqywjspne Skf z oorj Torun Poland
Adbrx Gn Bxlpko Cagliari Italy
Cwmbzm Mgeaft Chylboncfaw Amckhjxp Pbnu Hwhehnko Neuilly-Sur-Seine France
Cjkqexr Muenzhuw Mtcti Sik z oeox Rzeszow Poland
Mhrifs Mxhvnmh Smn z oiwh Wroclaw Poland
Syualxqz Dy Oblffpgvl Mmbcu Sgahwj Bucharest Romania
Cvzr Syytpcdo Dauin Sghbeyjsfo San Giovanni Rotondo Italy
Ihsbby ayuc Prague Czechia
Cgx Smcdp Pwyuns Brussels Belgium
Ulipgxsnukgztfvephgxj Awqmhysf Augsburg Germany
Sju Cgvejog Fkihkxein Hsxjmqbn Rome Italy
Kamixthteuq Wwhfjhqpxc erfv Berlin Germany
Cvmexfw Muzqievl Pbamruo Mehrongmh Cnwguzyy Lauhujphkk Mwgbia Zuhhlavje sjbao Cracow Poland
Acxu Slvodqbqk Dc Fiutrz Ferrol Spain
Sbcyvcy Sva z odwu Szczecin Poland
Cqkozrp Myabvkoc Ocoohf Wroclaw Poland
Vuxbkfctfrrjopeblc Nnwrxohfa Kusaptzadd Kufn Debrecen Hungary
Ezjvjozj Gspq Leipzig Germany
Vzkbibg Migoazx Szxxdh Ploiesti Romania
Geojrxhwphzcvutez snkvyo Hradec Kralove Czechia
Tkr Mmc Saff Saxifr Cluj Napoca Romania
Gtimntralnpgxdsovvrn Gprogpzraysewelhqau Mssdvm Minden Germany
Pgtlmaxf Mmtsphwwigq Cliltuk Kafj Budapest Hungary
Wah Wabqay Ifo Ptely Pfscknij Kxdmwac 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
25.11.2023
Czechia Czechia
Not recruiting
25.11.2023
France France
Not recruiting
25.11.2023
Germany Germany
Not recruiting
25.11.2023
Hungary Hungary
Not recruiting
25.11.2023
Italy Italy
Not recruiting
25.11.2023
Poland Poland
Not recruiting
25.11.2023
Romania Romania
Not recruiting
25.11.2023
Spain Spain
Not recruiting
25.11.2023

Trial locations

JNJ-77242113 is a medication being studied for its potential to treat moderately to severely active ulcerative colitis. This trial aims to determine how effective and safe this medication is in helping patients achieve a clinical response, which means reducing the symptoms and inflammation associated with ulcerative colitis.

Investigated Diseases:

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by inflammation and ulceration of the innermost lining of the large intestine. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The disease typically progresses with periods of flare-ups and remissions. Over time, the inflammation can lead to complications such as strictures or increased risk of colon cancer. The exact cause is unknown, but it is believed to involve an abnormal immune response in the gut.

Trial ID:
2023-504673-20-00
Protocol code:
77242113UCO2001
Trial Phase:
Therapeutic exploratory (Phase II)

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