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

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Azienda Ospedaliera di Padova Padua Italy
University Of Debrecen Debrecen Hungary
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Ospedale San Raffaele S.r.l. Milan Italy
Centre Hospitalier Universitaire De Toulouse Toulouse France
Semmelweis University Budapest Hungary
Universidade De Santiago De Compostela Santiago De Compostela Spain
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Universitaire De Nimes Nimes France
Centre hospitalier universitaire de Liege Liege Belgium
Staedtisches Klinikum Lueneburg gGmbH Lueneburg Germany
Universitair Ziekenhuis Gent Gent Belgium
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Delta Health Care S.R.L. Bucharest Romania
Vitaz Sint-Niklaas Belgium
Bodyclinic Sp. z o.o. sp.k. Warsaw Poland
Nemocnice Slany Slany Czechia
IRCCS Ospedale Sacro Cuore Don Calabria Negrar di Valpolicella Italy
Nemocnice Ceske Budejovice a.s. Ceske Budejovice Czechia
Assistance Publique Hopitaux De Paris Paris France
Hospital Universitario Virgen De Valme Sevilla Spain
Semmelweis University Budapest Hungary
Hepato-Gastroenterologie HK s.r.o. Hradec Kralove Czechia
Gastromed Sp. z o.o. Torun Poland
ARNAS G. Brotzu Cagliari Italy
Centre Medico Chirurgical Ambroise Pare Hartmann Neuilly-Sur-Seine France
Centrum Medyczne Medyk Sp. z o.o. Rzeszow Poland
Spitalul De Oncologie Monza S.R.L. Bucharest Romania
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy
Iscare a.s. Prague Czechia
CHU Saint Pierre Brussels Belgium
San Camillo Forlanini Hospital Rome Italy
Krankenhaus Waldfriede e.V. Berlin Germany
AZ Sint-Lucas & Volkskliniek Gent Belgium
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
Area Sanitaria De Ferrol Ferrol Spain
Sonomed Sp. z o.o. Szczecin Poland
Centrum Medyczne Oporow Wroclaw Poland
Vasutegeszseguegyi Nonprofit Koezhasznu Kft. Debrecen Hungary
Eugastro GmbH Leipzig Germany
Gastroenterologie s.r.o. Hradec Kralove Czechia
Tvm Med Serv S.R.L. Cluj Napoca Romania
Pannonia Maganorvosi Centrum Kft. Budapest Hungary
Hziiggv Hueuu Mnewqw &aleryf 1 rrw Gwsbgeb Eizoyv Creteil France
Cfcf Dd Nfjqn Vandoeuvre Les Nancy France
Fgvmwcwfy Phfk Ld Itxeazknwplyz Bmxkpzabp Ddq Hevzewwj Uznllmdgtlmrh Lc Pth Madrid Spain
Cosffaom Huxqmdnerjff Uzgdfpifungsq Du Veje Vigo Spain
Cqkpkpw Mxvbtrwq Lydchbi Jejtnv Łjbq Chojnice Poland
Izuwfjuf dy Csukklrycund Hgaonvvwdic Ujkjuiidwecnu do Sekyl Eeitdni (qtvxtaw Saint Priest En Jarez France
Pewfpaqults Emvbidcwkwzk Wroclaw Poland
Mlhixher Si z olvr Bydgoszcz Poland
Wfj Wmhaye Ioa Pibdh Pkuggusc Kgulihn Warsaw Poland
Bdzcmzrs Untjminbmg Hvmkqbgg Cenvte Besançon France
Pebcijjvc Ikwtenje Mzqizkjm Myplnkajlfxr Soble Wxeockutxaju I Ayqeemdeqcwkz Warsaw Poland
Hboplgcd Uxrrfkiqeqzmq Df Cjfwgoby Gijon Spain
Mcaosd Mzoptrn Svb z olra Wroclaw Poland
Uasqzqfmpyfzcehxzusdk Ajldledo Augsburg Germany
Vxbolfk Mkvopea Sfbldl Ploiesti Romania
Gcqgangrocpjspnjkbmd Gszkntjmlwjejwgrzdn Mmuplf Minden Germany

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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