2024-518296-56-00RecruitingPhase 3
A clinical study of MK-7240 for the treatment of Crohn’s disease (MK-7240-008)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderately to Severely Active Crohn’s Disease
Source: EU CTIS (euclinicaltrials.eu) · Last updated 8 Nov 2026
Brief summary (registry, in English)
1.Study 2: US/FDA: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving clinical remission per Crohn’s Disease Activity Index score (<150) at Week 12 2.Study 2: EU/EMA: Evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving clinical remission per stool frequency and abdominal pain score at Week 12 3.Study 2: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving endoscopic response at Week 12
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 567 (estimated)
- First submitted
- 13 May 2025
- Start date
- 29 Sept 2025
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Crohn's disease
- EU CT number
- 2024-518296-56-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 567
- 155 sites in 21 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults, and some adolescents, with moderately to severely active Crohn's disease who did not do well on earlier treatment.
- Age
- 18 years or older. Adolescents aged 16 to under 18 can join only if the country or health authority approves.
- Sex
- All sexes can join.
- Disease stage
- Crohn's disease diagnosed at least 3 months before the study, and moderately to severely active.
- Earlier treatment
- Earlier treatment with one or more drug types (oral locally acting steroids, systemic steroids, immunomodulators, biologic or small molecule advanced therapies) did not work well enough, stopped working, or was not tolerated. Earlier exposure to tulisokibart (MK-7240, PRA023) or another anti-TL1A antibody is not allowed.
Main reasons for not taking part
- Ulcerative colitis or indeterminate colitis
- Hepatitis B, hepatitis C or HIV infection, or active tuberculosis
- History of cancer, unless disease free for at least 5 years (some fully treated skin or cervical cancers excepted)
- Complications of Crohn's disease such as abscess, fulminant colitis, toxic megacolon or a stoma
- Bowel surgery within 3 months of the study
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody (Ab).
- Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
- Has surgical bowel resection within 3 months of study.
- Has prior or current gastrointestinal dysplasia.
Other illness
- Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- Has active tuberculosis.
- Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.
- Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides CD.
- Has chronic infection requiring ongoing antimicrobial treatment.
Age
- Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years.
Other
- Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.
- Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.
- Has current stoma or need for colostomy or ileostomy.
- Is missing >2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
Who the study is looking for
- Has had a diagnosis of Crohn’s disease (CD) at least 3 months before study.
- Has moderately to severely active CD.
- Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies.
- Adolescent participants ≥16 and <18 years of age can participate if approved by the country or regulatory/health authority.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (155)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medizinische Universitaet Innsbruck | Innsbruck | Austria | Recruiting |
| Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH | Salzburg | Austria | Recruiting |
| Medical University of Vienna | Vienna | Austria | Recruiting |
| Universitair Ziekenhuis Gent | Gent | Belgium | Recruiting |
| UZ Leuven | Leuven | Belgium | Recruiting |
| Algemeen Ziekenhuis Delta | Roeselare | Belgium | Recruiting |
| Pratia Czech s.r.o. | Brno-Stred | Czechia | Recruiting |
| Vojenska Nemocnice Brno | Brno-Zidenice | Czechia | Recruiting |
| Hepato-Gastroenterologie HK, s.r.o. | Hradec Králové | Czechia | Recruiting |
| ISCARE a.s. | Prague | Czechia | Recruiting |
| Institute for Clinical and Experimental Medicine | Prague | Czechia | Recruiting |
| Nemocnice Slany | Slaný | Czechia | Recruiting |
| Charite Universitaetsmedizin Berlin KöR | Berlin | Germany | Recruiting |
| Universitaetsklinikum Brandenburg an der Havel GmbH | Brandenburg An Der Havel | Germany | Recruiting |
| Medizinisches Versorgungszentrum fuer spezialaerztliche Versorgung Professor Dr. Friedrichs GmbH | Duisburg | Germany | Recruiting |
| Medizinische Hochschule Hannover | Hanover | Germany | Recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR | Kiel | Germany | Recruiting |
| Universitaetsklinikum Leipzig Aor | Leipzig | Germany | Recruiting |
| St. Marien und St. Annastiftskrankenhaus | Ludwigshafen am Rhein | Germany | Recruiting |
| Staedtisches Klinikum Lueneburg gGmbH | Lueneburg | Germany | Recruiting |
| Gastroenterologische Gemeinschaftspraxis Minden | Minden | Germany | Recruiting |
| Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) | Munich | Germany | Recruiting |
| LMU Klinikum Muenchen AöR | Munich | Germany | Recruiting |
| Siloah St Trudpert Klinikum | Pforzheim | Germany | Recruiting |
| Magen-Darm-Zentrum Remscheid | Remscheid | Germany | Recruiting |
| Rostock University Medical Center | Rostock | Germany | Recruiting |
| Universitaetsklinikum Ulm AoR | Ulm | Germany | Recruiting |
| Region Hovedstaden | Herlev | Denmark | Recruiting |
| Odense University Hospital | Odense C | Denmark | Recruiting |
| Hospital Germans Trias i Pujol | Badalona | Spain | Recruiting |
| Hospital Clinic de Barcelona | Barcelona | Spain | Recruiting |
| Area Sanitaria De Ferrol | Ferrol | Spain | Recruiting |
| Hospital Universitario La Paz | Madrid | Spain | Recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda | Madrid | Spain | Recruiting |
| Complexo Hospitalario Universitario de Pontevedra | Pontevedra | Spain | Recruiting |
| Hospital Universitario Nuestra Señora de Candelaria | Santa Cruz de Tenerife | Spain | Recruiting |
| Hospital Universitario de Torrejon | Torrejón de Ardoz | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe | Valencia | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia | Valencia | Spain | Recruiting |
| Hospital Universitario Miguel Servet | Zaragoza | Spain | Recruiting |
| North Karelia Central Hospital | Joensuu | Finland | Recruiting |
| Tampere University Hospital | Tampere | Finland | Recruiting |
| Turku University Hospital | Turku | Finland | Recruiting |
| Centre Hospitalier Universitaire Amiens Picardie | Amiens Cedex 1 | France | Recruiting |
| CHU Besançon | Besançon | France | Recruiting |
| Assistance Publique Hopitaux De Paris | Clichy | France | Recruiting |
| Assistance Publique Hopitaux De Paris | Creteil Cedex | France | Recruiting |
| Centre Hospitalier Universitaire de Dijon | Dijon | France | Recruiting |
| Clinique des Cèdres | Échirolles | France | Recruiting |
| Assistance Publique Hopitaux De Paris | Le Kremlin-Bicetre | France | Recruiting |
| Centre Hospitalier Universitaire De Lille | Lille Cedex | France | Recruiting |
| Centre Hospitalier Regional De Marseille | Marseille | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes | Nantes | France | Recruiting |
| Centre Medico Chirurgical Ambroise Pare Hartmann | Neuilly-Sur-Seine | France | Recruiting |
| Centre Hospitalier Universitaire de Nice | Nice | France | Recruiting |
| Centre Hospitalier Universitaire De Nimes | Nimes Cedex 9 | France | Recruiting |
| Assistance Publique Hopitaux de Paris | Paris | France | Recruiting |
| Hospices Civils de Lyon | Pierre-Bénite | France | Recruiting |
| Centre Hospitalier Universitaire De Toulouse | Toulouse Cedex 9 | France | Recruiting |
| CHRU De Nancy | Vandoeuvre Les Nancy | France | Recruiting |
| Thoracic General Hospital of Athens "I Sotiria" | Athens | Greece | Recruiting |
| Evangelismos S A | Athens | Greece | Recruiting |
| University General Hospital of Heraklion | Heraklion | Greece | Recruiting |
| Hippokration Hospital | Thessaloniki | Greece | Recruiting |
| Geniko Nosokomeio Nikaias Peiraia Ag. Panteleimon Geniko Nosokomeio Dytikis Attikis I | Νikaia | Greece | Recruiting |
| Poliklinika Bates | Grad Zagreb | Croatia | Recruiting |
| Poliklinika Solmed d.o.o. | Grad Zagreb | Croatia | Recruiting |
| Poliklinika Borzan d.o.o. | Osijek | Croatia | Recruiting |
| University Hospital Centre Zagreb | Zagreb | Croatia | Recruiting |
| Klinicka bolnica Merkur | Zagreb | Croatia | Recruiting |
| Bekes Varmegyei Koezponti Korhaz | Bekescsaba | Hungary | Recruiting |
| Semmelweis University | Budapest | Hungary | Recruiting |
| Clinexpert Kft. | Budapest III | Hungary | Recruiting |
| Central Hospital Of Northern Pest Military Hospital | Budapest VI | Hungary | Recruiting |
| Pannonia Maganorvosi Centrum Kft. | Budapest XIII | Hungary | Recruiting |
| Heves Varmegyei Markhot Ferenc Oktatokorhaz Es Rendelointezet | Eger | Hungary | Recruiting |
| Gyoengyosi Bugat Pal Koerhaz | Gyongyos | Hungary | Recruiting |
| Komarom-Esztergom Varmegyei Szent Borbala Korhaz | Tatabánya | Hungary | Recruiting |
| VeszLife Kft. | Veszprem | Hungary | Recruiting |
| Beaumont Hospital | Dublin 9 | Ireland | Completed |
| Azienda Universitaria Ospedaliera Consorziale Policlinico Bari | Bari | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico | Bologna | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Careggi | Florence | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Gaetano Martino Messina | Messina | Italy | Recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milan | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. | Milan | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Di Cagliari | Monserrato | Italy | Recruiting |
| Azienda Ospedaliera dei Colli | Naples | Italy | Recruiting |
| IRCCS Ospedale Sacro Cuore Don Calabria | Negrar | Italy | Recruiting |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello | Palermo | Italy | Recruiting |
| Azienda Unita' Sanitaria Locale Toscana Nord Ovest | Pontedera | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Italy | Recruiting |
| Humanitas Mirasole S.p.A. | Rozzano | Italy | Recruiting |
| Azienda Ospedaliera Ordine Mauriziano di Torino | Turin | Italy | Recruiting |
| Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos | Kaunas | Lithuania | Recruiting |
| Vilniaus universiteto ligonine Santaros klinikos VšĮ | Vilnius | Lithuania | Recruiting |
| M & M centrs SIA | Adazi | Latvia | Recruiting |
| Pauls Stradins Clinical University Hospital | Riga | Latvia | Recruiting |
| Amsterdam UMC Stichting | Amsterdam | Netherlands | Recruiting |
| Universitair Medisch Centrum Groningen | Groningen | Netherlands | Recruiting |
| Radboud universitair medisch centrum Stichting | Nijmegen | Netherlands | Recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) | Rotterdam | Netherlands | Recruiting |
| Sint Franciscus Vlietland Groep Stichting | Rotterdam | Netherlands | Recruiting |
| Stichting Elisabeth-TweeSteden Ziekenhuis | Tilburg | Netherlands | Recruiting |
| Bernhoven B.V. | Uden | Netherlands | Recruiting |
| Universitair Medisch Centrum Utrecht | Utrecht | Netherlands | Recruiting |
| Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j. | Bydgoszcz | Poland | Recruiting |
| M2M Med. Sp. z o.o. Sp. j. | Chorzow | Poland | Recruiting |
| Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. | Cracow | Poland | Recruiting |
| Promed P.Lach R.Glowacki Sp. j. | Cracow | Poland | Recruiting |
| Centrum Medyczne Med-Gastr Sp. z o.o. | Lodz | Poland | Recruiting |
| Amicare Sp. z o.o. S.K. | Lodz | Poland | Recruiting |
| IP Clinic Sp. z o.o. | Lodz | Poland | Recruiting |
| Medrise Sp. z o.o. | Lublin | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny nr 4 w Lublinie | Lublin | Poland | Recruiting |
| Allmedica Badania Kliniczne Sp z o.o. Sp K. | Nowy Targ | Poland | Recruiting |
| NOVAMED ROBERT KOTERAS | Opole | Poland | Recruiting |
| Medicome Sp. z o.o. | Oswiecim | Poland | Recruiting |
| Pratia S.A. | Poznan | Poland | Recruiting |
| Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o. | Poznan | Poland | Recruiting |
| Endoskopia Sp z o.o. | Sopot | Poland | Recruiting |
| Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o. | Szczecin | Poland | Recruiting |
| Sonomed Sp. z o.o. | Szczecin | Poland | Recruiting |
| GASTROMED Sp. z o.o. | Torun | Poland | Recruiting |
| H-T. Centrum Medyczne Sp. z o.o. Sp.k. | Tychy | Poland | Recruiting |
| Eb Group Sp. z o.o. | Warsaw | Poland | Recruiting |
| Etg Warszawa Sp. z o.o. | Warsaw | Poland | Recruiting |
| Vivamed Sp. z o.o. | Warsaw | Poland | Recruiting |
| Medical Network Sp z o o | Warsaw | Poland | Recruiting |
| Melita Medical Sp. z o.o. | Wroclaw | Poland | Recruiting |
| PlanetMed Sp. z o.o. | Wroclaw | Poland | Recruiting |
| EMC Instytut Medyczny S.A. | Wroclaw | Poland | Recruiting |
| Vistamed & Vertigo Sp Z O O | Wroclaw | Poland | Recruiting |
| Etg Zamosc Sp. z o.o. | Zamość | Poland | Recruiting |
| Unidade Local De Saude Do Alto Ave E.P.E. | Guimaraes | Portugal | Recruiting |
| Unidade Local De Saude Da Regiao De Leiria E.P.E. | Leiria | Portugal | Recruiting |
| Lusiadas S.A. | Lisbon | Portugal | Recruiting |
| Hospital da Luz, S.A | Lisbon | Portugal | Recruiting |
| Unidade Local de Saude do Algarve E.P.E. | Portimao | Portugal | Recruiting |
| Unidade Local De Saude Do Alto Minho E.P.E. | Viana do Castelo | Portugal | Recruiting |
| Unidade Local De Saude De Viseu Dao-Lafoes E.P.E. | Viseu | Portugal | Recruiting |
| Monza-Ares S.R.L. | Bucharest | Romania | Recruiting |
| Dermastyle S.R.L. | Bucharest | Romania | Recruiting |
| Institutul Clinic Fundeni | Bucharest | Romania | Recruiting |
| Gastro Med S R L | Cluj-Napoca | Romania | Recruiting |
| Spitalul Clinic Judeţean Mureş | Târgu Mureş | Romania | Recruiting |
| Asociatia Oncohelp | Timișoara | Romania | Recruiting |
| Danderyds Sjukhus AB | Danderyd | Sweden | Recruiting |
| Region Oestergoetland | Linkoping | Sweden | Recruiting |
| Karolinska University Hospital | Solna | Sweden | Recruiting |
| F D Roosevelt University General Hospital Of Banska Bystrica | Banska Bystrica | Slovakia | Recruiting |
| Cliniq s.r.o. | Bratislava | Slovakia | Recruiting |
| KM Management spol. s r.o. | Nitra | Slovakia | Recruiting |
| Gastro LM s.r.o. | Prešov | Slovakia | Recruiting |
| GASTRO I., s.r.o. | Prešov | Slovakia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.