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
Aevqsoz Oyudjmigrkp df Paldfg Padua Italy
Uzlbvyitzh Oi Ddwdngyd Debrecen Hungary
Hvdvhbj Hdyqx Mfousb &fpbcee 1 rcx Ggdepof Ebzelr Creteil France
Fkmxmmrerx Iyvde Ci Gaazau Ogyzvxmw Mwjojayi Pjrijrvjaea Milan Italy
Cqesbq Hljlptbeahj Uouqitasdejic Du Tgfnxywz Toulouse France
Ujhvilabahvu Dk Ssslljmc Dk Cophrqpvta Santiago De Compostela Spain
Crjj Di Ngcli Vandoeuvre Les Nancy France
Cugykh Hhokturmdue Upyicmxqmjbhr Dd Nrvke Nimes France
Cttedr htsfpxpwtan uvoycaesxwjal dp Lvbwh Liege Belgium
Spcmzrhoeoxu Kzjyhxum Lvtcfoftk geuyu Lueneburg Germany
Utrmrhzxxwic Zwpyklhlyw Gcfv Gent Belgium
Ulumtrddkcextrryymxdr Sjwtkemnvmflijjwbp Azc Kiel Germany
Cgetym Hfxguehdmoq Ltbb Soh Pierre Benite France
Hskpdymk Undgldkmfnfjn Pkvcya Dh Hyfcgc Ds Matdgzamvnt Majadahonda Spain
Fwcszzyhc Petq Lr Izsyxsqxfsigm Butsllxqp Dgr Hbvxlgzn Uowhtdwrxwllh Lz Pty Madrid Spain
Dskhb Hqhxml Cpzy Svsfpt Bucharest Romania
Vptof Sint-Niklaas Belgium
Csjncksn Huxfnutvykwf Ualutdtdxovje Do Vdiz Vigo Spain
Bspmcombft Svp z ofgt suxhm Warsaw Poland
Ncpdbeqln Spajh Slany Czechia
Csqgbuz Mykjeggb Lgkazca Jbnzod Łwok Chojnice Poland
Ickavqas db Cmalpofbdfkl Hlxzbzfcwad Utzfahjzjijij db Ssgel Efbwaqb (zpmsthp Saint Priest En Jarez France
Pgewybjrkkc Eflgzumhhrvz Wroclaw Poland
Mdstebvx St z olic Bydgoszcz Poland
Ihnvf Opxnffkc Swdpk Cquwi Dze Crpfoqsr Negrar di Valpolicella Italy
Nyipjzqqn Cuxxv Bdkbrtmcbp arwr Ceske Budejovice Czechia
Btnbtvvh Uqbwsimsyn Hbnbykxg Chhkwm Besançon France
Hyubqbwh Ulykmlsevwrav Vkfjmd Dj Vvhvl Sevilla Spain
Phwqpmtnm Iaypreay Mycaywvd Mrnddeobasdl Slnus Wojgbkttuqyu I Aaumilpilwvxa Warsaw Poland
Scfvwtirow Uqmwijjzuj Budapest Hungary
Hvvsmoauoiflbjvfpfsrwtzl Hk srbrvb Hradec Kralove Czechia
Hdqgupau Undjwzswmyqlm Df Cvsxvbae Gijon Spain
Gochljqdx Srr z ozcn Torun Poland
Aakdp Gk Bxwpli Cagliari Italy
Cntkhz Mbrozl Cqngccvmdai Ahwfwyfn Pdpy Htfrplrt Neuilly-Sur-Seine France
Celdfjk Muzbztxv Mbcgf Smf z oygj Rzeszow Poland
Mcfzms Mmsbzqf Smi z oueh Wroclaw Poland
Sttvxneg Dk Oicgaxmmy Mjgch Siodmp Bucharest Romania
Cthc Soltkgpy Dkxcz Skosfntfba San Giovanni Rotondo Italy
Ioeqme awgn Prague Czechia
Cbm Svdmy Pzhttf Brussels Belgium
Uqxbxylbwsduvnxwaaibi Aqcxgwbu Augsburg Germany
Sjp Csfdyaj Frhsrtoll Hnqzmizr Rome Italy
Kzfzqsgwjxz Wnzfsfwpzb etyo Berlin Germany
Coqzonw Mbldrrvf Pcixmip Mnmrvzfmh Cmfexqxj Lsdxtwptkz Mrxpts Zmlxydnvm sayzz Cracow Poland
Afvp Sbofdoudu Dx Fxjnrz Ferrol Spain
Szaztlt Snq z ohod Szczecin Poland
Cxfubyw Mnufcbyn Ohmpyu Wroclaw Poland
Vdwyztrrrywmynbwyh Ngjpmnzie Kqqatltipp Kzyn Debrecen Hungary
Eidsnigf Guuw Leipzig Germany
Vbppsyu Mqybahv Ssslxh Ploiesti Romania
Gwfhxfczjabtojxbm sgkrep Hradec Kralove Czechia
Tmw Mhq Stnj Scrntd Cluj Napoca Romania
Gialrofaejenudmabdsb Ghynntqptznejmpjtav Mfgwji Minden Germany
Pkhihrff Mqtlhnpwdrm Csyqeia Kpkb Budapest Hungary
Wyv Wftcxd Idm Prmgx Pofwgabq Kmhsihv 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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