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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

Next steps

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
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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (155)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Medizinische Universitaet InnsbruckInnsbruckAustriaRecruiting
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbHSalzburgAustriaRecruiting
Medical University of ViennaViennaAustriaRecruiting
Universitair Ziekenhuis GentGentBelgiumRecruiting
UZ LeuvenLeuvenBelgiumRecruiting
Algemeen Ziekenhuis DeltaRoeselareBelgiumRecruiting
Pratia Czech s.r.o.Brno-StredCzechiaRecruiting
Vojenska Nemocnice BrnoBrno-ZideniceCzechiaRecruiting
Hepato-Gastroenterologie HK, s.r.o.Hradec KrálovéCzechiaRecruiting
ISCARE a.s.PragueCzechiaRecruiting
Institute for Clinical and Experimental MedicinePragueCzechiaRecruiting
Nemocnice SlanySlanýCzechiaRecruiting
Charite Universitaetsmedizin Berlin KöRBerlinGermanyRecruiting
Universitaetsklinikum Brandenburg an der Havel GmbHBrandenburg An Der HavelGermanyRecruiting
Medizinisches Versorgungszentrum fuer spezialaerztliche Versorgung Professor Dr. Friedrichs GmbHDuisburgGermanyRecruiting
Medizinische Hochschule HannoverHanoverGermanyRecruiting
Universitaetsklinikum Schleswig-Holstein AöRKielGermanyRecruiting
Universitaetsklinikum Leipzig AorLeipzigGermanyRecruiting
St. Marien und St. AnnastiftskrankenhausLudwigshafen am RheinGermanyRecruiting
Staedtisches Klinikum Lueneburg gGmbHLueneburgGermanyRecruiting
Gastroenterologische Gemeinschaftspraxis MindenMindenGermanyRecruiting
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)MunichGermanyRecruiting
LMU Klinikum Muenchen AöRMunichGermanyRecruiting
Siloah St Trudpert KlinikumPforzheimGermanyRecruiting
Magen-Darm-Zentrum RemscheidRemscheidGermanyRecruiting
Rostock University Medical CenterRostockGermanyRecruiting
Universitaetsklinikum Ulm AoRUlmGermanyRecruiting
Region HovedstadenHerlevDenmarkRecruiting
Odense University HospitalOdense CDenmarkRecruiting
Hospital Germans Trias i PujolBadalonaSpainRecruiting
Hospital Clinic de BarcelonaBarcelonaSpainRecruiting
Area Sanitaria De FerrolFerrolSpainRecruiting
Hospital Universitario La PazMadridSpainRecruiting
Hospital Universitario Puerta de Hierro de MajadahondaMadridSpainRecruiting
Complexo Hospitalario Universitario de PontevedraPontevedraSpainRecruiting
Hospital Universitario Nuestra Señora de CandelariaSanta Cruz de TenerifeSpainRecruiting
Hospital Universitario de TorrejonTorrejón de ArdozSpainRecruiting
Hospital Universitario Y Politecnico La FeValenciaSpainRecruiting
Hospital Clinico Universitario de ValenciaValenciaSpainRecruiting
Hospital Universitario Miguel ServetZaragozaSpainRecruiting
North Ka­re­lia Cent­ral Hos­pi­talJoensuuFinlandRecruiting
Tampere University HospitalTampereFinlandRecruiting
Turku University HospitalTurkuFinlandRecruiting
Centre Hospitalier Universitaire Amiens PicardieAmiens Cedex 1FranceRecruiting
CHU BesançonBesançonFranceRecruiting
Assistance Publique Hopitaux De ParisClichyFranceRecruiting
Assistance Publique Hopitaux De ParisCreteil CedexFranceRecruiting
Centre Hospitalier Universitaire de DijonDijonFranceRecruiting
Clinique des CèdresÉchirollesFranceRecruiting
Assistance Publique Hopitaux De ParisLe Kremlin-BicetreFranceRecruiting
Centre Hospitalier Universitaire De LilleLille CedexFranceRecruiting
Centre Hospitalier Regional De MarseilleMarseilleFranceRecruiting
Centre Hospitalier Universitaire de NantesNantesFranceRecruiting
Centre Medico Chirurgical Ambroise Pare HartmannNeuilly-Sur-SeineFranceRecruiting
Centre Hospitalier Universitaire de NiceNiceFranceRecruiting
Centre Hospitalier Universitaire De NimesNimes Cedex 9FranceRecruiting
Assistance Publique Hopitaux de ParisParisFranceRecruiting
Hospices Civils de LyonPierre-BéniteFranceRecruiting
Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9FranceRecruiting
CHRU De NancyVandoeuvre Les NancyFranceRecruiting
Thoracic General Hospital of Athens "I Sotiria"AthensGreeceRecruiting
Evangelismos S AAthensGreeceRecruiting
University General Hospital of HeraklionHeraklionGreeceRecruiting
Hippokration HospitalThessalonikiGreeceRecruiting
Geniko Nosokomeio Nikaias Peiraia Ag. Panteleimon Geniko Nosokomeio Dytikis Attikis IΝikaiaGreeceRecruiting
Poliklinika BatesGrad ZagrebCroatiaRecruiting
Poliklinika Solmed d.o.o.Grad ZagrebCroatiaRecruiting
Poliklinika Borzan d.o.o.OsijekCroatiaRecruiting
University Hospital Centre ZagrebZagrebCroatiaRecruiting
Klinicka bolnica MerkurZagrebCroatiaRecruiting
Bekes Varmegyei Koezponti KorhazBekescsabaHungaryRecruiting
Semmelweis UniversityBudapestHungaryRecruiting
Clinexpert Kft.Budapest IIIHungaryRecruiting
Central Hospital Of Northern Pest Military HospitalBudapest VIHungaryRecruiting
Pannonia Maganorvosi Centrum Kft.Budapest XIIIHungaryRecruiting
Heves Varmegyei Markhot Ferenc Oktatokorhaz Es RendelointezetEgerHungaryRecruiting
Gyoengyosi Bugat Pal KoerhazGyongyosHungaryRecruiting
Komarom-Esztergom Varmegyei Szent Borbala KorhazTatabányaHungaryRecruiting
VeszLife Kft.VeszpremHungaryRecruiting
Beaumont HospitalDublin 9IrelandCompleted
Azienda Universitaria Ospedaliera Consorziale Policlinico BariBariItalyRecruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBolognaItalyRecruiting
Azienda Ospedaliero-Universitaria CareggiFlorenceItalyRecruiting
Azienda Ospedaliera Universitaria Gaetano Martino MessinaMessinaItalyRecruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilanItalyRecruiting
Ospedale San Raffaele S.r.l.MilanItalyRecruiting
Azienda Ospedaliero-Universitaria Di CagliariMonserratoItalyRecruiting
Azienda Ospedaliera dei ColliNaplesItalyRecruiting
IRCCS Ospedale Sacro Cuore Don CalabriaNegrarItalyRecruiting
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - CervelloPalermoItalyRecruiting
Azienda Unita' Sanitaria Locale Toscana Nord OvestPontederaItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCSRomeItalyRecruiting
Humanitas Mirasole S.p.A.RozzanoItalyRecruiting
Azienda Ospedaliera Ordine Mauriziano di TorinoTurinItalyRecruiting
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikosKaunasLithuaniaRecruiting
Vilniaus universiteto ligonine Santaros klinikos VšĮVilniusLithuaniaRecruiting
M & M centrs SIAAdaziLatviaRecruiting
Pauls Stradins Clinical University HospitalRigaLatviaRecruiting
Amsterdam UMC StichtingAmsterdamNetherlandsRecruiting
Universitair Medisch Centrum GroningenGroningenNetherlandsRecruiting
Radboud universitair medisch centrum StichtingNijmegenNetherlandsRecruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)RotterdamNetherlandsRecruiting
Sint Franciscus Vlietland Groep StichtingRotterdamNetherlandsRecruiting
Stichting Elisabeth-TweeSteden ZiekenhuisTilburgNetherlandsRecruiting
Bernhoven B.V.UdenNetherlandsRecruiting
Universitair Medisch Centrum UtrechtUtrechtNetherlandsRecruiting
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.BydgoszczPolandRecruiting
M2M Med. Sp. z o.o. Sp. j.ChorzowPolandRecruiting
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.CracowPolandRecruiting
Promed P.Lach R.Glowacki Sp. j.CracowPolandRecruiting
Centrum Medyczne Med-Gastr Sp. z o.o.LodzPolandRecruiting
Amicare Sp. z o.o. S.K.LodzPolandRecruiting
IP Clinic Sp. z o.o.LodzPolandRecruiting
Medrise Sp. z o.o.LublinPolandRecruiting
Uniwersytecki Szpital Kliniczny nr 4 w LublinieLublinPolandRecruiting
Allmedica Badania Kliniczne Sp z o.o. Sp K.Nowy TargPolandRecruiting
NOVAMED ROBERT KOTERASOpolePolandRecruiting
Medicome Sp. z o.o.OswiecimPolandRecruiting
Pratia S.A.PoznanPolandRecruiting
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.PoznanPolandRecruiting
Endoskopia Sp z o.o.SopotPolandRecruiting
Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.SzczecinPolandRecruiting
Sonomed Sp. z o.o.SzczecinPolandRecruiting
GASTROMED Sp. z o.o.TorunPolandRecruiting
H-T. Centrum Medyczne Sp. z o.o. Sp.k.TychyPolandRecruiting
Eb Group Sp. z o.o.WarsawPolandRecruiting
Etg Warszawa Sp. z o.o.WarsawPolandRecruiting
Vivamed Sp. z o.o.WarsawPolandRecruiting
Medical Network Sp z o oWarsawPolandRecruiting
Melita Medical Sp. z o.o.WroclawPolandRecruiting
PlanetMed Sp. z o.o.WroclawPolandRecruiting
EMC Instytut Medyczny S.A.WroclawPolandRecruiting
Vistamed & Vertigo Sp Z O OWroclawPolandRecruiting
Etg Zamosc Sp. z o.o.ZamośćPolandRecruiting
Unidade Local De Saude Do Alto Ave E.P.E.GuimaraesPortugalRecruiting
Unidade Local De Saude Da Regiao De Leiria E.P.E.LeiriaPortugalRecruiting
Lusiadas S.A.LisbonPortugalRecruiting
Hospital da Luz, S.ALisbonPortugalRecruiting
Unidade Local de Saude do Algarve E.P.E.PortimaoPortugalRecruiting
Unidade Local De Saude Do Alto Minho E.P.E.Viana do CasteloPortugalRecruiting
Unidade Local De Saude De Viseu Dao-Lafoes E.P.E.ViseuPortugalRecruiting
Monza-Ares S.R.L.BucharestRomaniaRecruiting
Dermastyle S.R.L.BucharestRomaniaRecruiting
Institutul Clinic FundeniBucharestRomaniaRecruiting
Gastro Med S R LCluj-NapocaRomaniaRecruiting
Spitalul Clinic Judeţean MureşTârgu MureşRomaniaRecruiting
Asociatia OncohelpTimișoaraRomaniaRecruiting
Danderyds Sjukhus ABDanderydSwedenRecruiting
Region OestergoetlandLinkopingSwedenRecruiting
Karolinska University HospitalSolnaSwedenRecruiting
F D Roosevelt University General Hospital Of Banska BystricaBanska BystricaSlovakiaRecruiting
Cliniq s.r.o.BratislavaSlovakiaRecruiting
KM Management spol. s r.o.NitraSlovakiaRecruiting
Gastro LM s.r.o.PrešovSlovakiaRecruiting
GASTRO I., s.r.o.PrešovSlovakiaRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.