Et studie til evaluering af effekt og sikkerhed af MK-8690 hos deltagere med moderat til svært aktiv ulcerøs colitis (MK-8690-002)
9. november 2026 opdateret af: Merck Sharp & Dohme LLC
En fase 2a randomiseret, dobbeltblind, placebo-kontrolleret undersøgelse til evaluering af effektivitet og sikkerhed af MK-8690 hos voksne deltagere med moderat til svært aktiv ulcerøs colitis
The purpose of this protocol is to evaluate the efficacy of MK-8690 in participants with moderately to severely active ulcerative colitis. The primary hypothesis is that MK-8690 is superior to placebo with respect to the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12.
Studieoversigt
Status
Status
Rekruttering
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
Tilmelding
100
Fase
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
Studiekontakt
- Navn: Toll Free Number
- Telefonnummer: 1-888-577-8839
- E-mail: Trialsites@msd.com
Studiesteder
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Alberta
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Lethbridge, Alberta, Canada, T1J 4G9
- Rekruttering
- Prairie Institute of Liver and Luminal Advanced Research ( Site 1008)
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Kontakt:
- Study Coordinator
- Telefonnummer: (587) 691 3756
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Ontario
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Toronto, Ontario, Canada, M5T 2S8
- Rekruttering
- Toronto Western Hospital ( Site 1006)
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Kontakt:
- Study Coordinator
- Telefonnummer: 416-603-5949
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Quebec
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Montreal, Quebec, Canada, H2X 0C1
- Rekruttering
- Centre Hospitalier de l Universite de Montreal - CHUM ( Site 1001)
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Kontakt:
- Study Coordinator
- Telefonnummer: 514-890-8000
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Biobio
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Concepción, Biobio, Chile, 4070022
- Rekruttering
- Hospital Clinico Regional Dr. Guillermo Grant Benavente ( Site 1129)
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Kontakt:
- Study Coordinator
- Telefonnummer: +56957585657
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Region M. de Santiago
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Santiago, Region M. de Santiago, Chile, 7650568
- Rekruttering
- Clinica Alemana de Santiago ( Site 1124)
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Kontakt:
- Study Coordinator
- Telefonnummer: +56992794676
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Santiago, Region M. de Santiago, Chile, 7691236
- Rekruttering
- Clínica MEDS La Dehesa ( Site 1123)
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Kontakt:
- Study Coordinator
- Telefonnummer: +56992000269
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Antioquia
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Medellín, Antioquia, Colombia, 050001
- Rekruttering
- Servicios de Salud IPS Suramericana S.A.S. - IPS Sura Industriales Medellín ( Site 1163)
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Kontakt:
- Study Coordinator
- Telefonnummer: +57 3134673355
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Atlántico
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Barranquilla, Atlántico, Colombia, 080020
- Rekruttering
- Clinica de la Costa S.A.S. ( Site 1161)
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Kontakt:
- Study Coordinator
- Telefonnummer: +573006528529
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Cundinamarca
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Bogota, Cundinamarca, Colombia, 110111
- Rekruttering
- Fundacion Santa Fe de Bogota ( Site 1165)
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Kontakt:
- Study Coordinator
- Telefonnummer: +57 3165243088
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Valle del Cauca Department
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Cali, Valle del Cauca Department, Colombia, 760032
- Rekruttering
- Fundación Valle del Lili ( Site 1162)
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Kontakt:
- Study Coordinator
- Telefonnummer: +573146824542
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Cambridgeshire
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Cambridge, Cambridgeshire, Det Forenede Kongerige, CB2 0QQ
- Rekruttering
- Addenbrooke's Hospital ( Site 1525)
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Kontakt:
- Study Coordinator
- Telefonnummer: +4401223596461
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Lancashire
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Bury, Lancashire, Det Forenede Kongerige, BL9 7TD
- Rekruttering
- Fairfield General Hospital ( Site 1524)
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Kontakt:
- Study Coordinator
- Telefonnummer: +4401617783879
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London, City of
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London, London, City of, Det Forenede Kongerige, SE1 9RT
- Rekruttering
- Guys and St Thomas NHS Foundation Trust ( Site 1523)
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Kontakt:
- Study Coordinator
- Telefonnummer: 020 7188 8315
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York
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Huddersfield, York, Det Forenede Kongerige, HD3 3EA
- Rekruttering
- Huddersfield Royal Infirmary ( Site 1522)
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Kontakt:
- Study Coordinator
- Telefonnummer: +4401484355434
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California
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Anaheim, California, Forenede Stater, 92805
- Rekruttering
- Clinnova Research ( Site 1042)
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Kontakt:
- Study Coordinator
- Telefonnummer: 949-889-0249
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Coronado, California, Forenede Stater, 92118
- Rekruttering
- Southern California Research Center ( Site 1044)
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Kontakt:
- Study Coordinator
- Telefonnummer: 619-522-0330
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Colorado
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Colorado Springs, Colorado, Forenede Stater, 80907
- Rekruttering
- Peak Gastroenterology Associates ( Site 1052)
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Kontakt:
- Study Coordinator
- Telefonnummer: 719-636-1201
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Englewood, Colorado, Forenede Stater, 80113
- Rekruttering
- South Denver Gastroenterology, PC ( Site 1068)
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Kontakt:
- Study Coordinator
- Telefonnummer: 303-406-4288
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Florida
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Inverness, Florida, Forenede Stater, 34452
- Rekruttering
- Nature Coast Clinical Research ( Site 1045)
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Kontakt:
- Study Coordinator
- Telefonnummer: 352-341-2100
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Miami, Florida, Forenede Stater, 33134
- Rekruttering
- Research Associates of South Florida - Miami - Southwest 8th Street ( Site 1072)
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Kontakt:
- Study Coordinator
- Telefonnummer: 786-476-8790
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Orlando, Florida, Forenede Stater, 32803
- Rekruttering
- AdventHealth Orlando ( Site 1074)
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Kontakt:
- Study Coordinator
- Telefonnummer: 407-303-9921
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Georgia
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Macon, Georgia, Forenede Stater, 31201
- Rekruttering
- Gastroenterology Associates of Central Georgia ( Site 1060)
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Kontakt:
- Study Coordinator
- Telefonnummer: 478-464-2600
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160
- Rekruttering
- University of Kansas Medical Center ( Site 1077)
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Kontakt:
- Study Coordinator
- Telefonnummer: 913-588-6019
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70112
- Rekruttering
- Tulane University School of Medicine-Gastroenterology and Hepatology ( Site 1073)
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Kontakt:
- Study Coordinator
- Telefonnummer: 504-988-5110
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Missouri
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Liberty, Missouri, Forenede Stater, 64068
- Rekruttering
- BVL Research - Kansas ( Site 1054)
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Kontakt:
- Study Coordinator
- Telefonnummer: 816-222-4241
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Pas-de-Calais
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Lens, Pas-de-Calais, Frankrig, 62300
- Rekruttering
- Centre Hospitalier Dr Schaffner ( Site 1288)
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Kontakt:
- Study Coordinator
- Telefonnummer: +33321691306
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Pays de la Loire Region
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Nantes, Pays de la Loire Region, Frankrig, 44300
- Rekruttering
- Clinique Jules Verne ( Site 1284)
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Kontakt:
- Study Coordinator
- Telefonnummer: +33251171652
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Attica
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Athens, Attica, Grækenland, 10676
- Rekruttering
- Evangelismos General Hospital of Athens ( Site 1362)
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Kontakt:
- Study Coordinator
- Telefonnummer: +306977617000
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Athens, Attica, Grækenland, 115 27
- Rekruttering
- THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 1361)
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Kontakt:
- Study Coordinator
- Telefonnummer: +302107763359
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Gelderland
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Nijmegen, Gelderland, Holland, 6525 GA
- Rekruttering
- Radboudumc ( Site 1650)
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Kontakt:
- Study Coordinator
- Telefonnummer: 0031 24-3619190
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North Holland
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Amsterdam, North Holland, Holland, 1081 HZ
- Rekruttering
- Amsterdam UMC, locatie VUmc ( Site 1651)
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Kontakt:
- Study Coordinator
- Telefonnummer: 020-4446630
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Emilia-Romagna
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Bologna, Emilia-Romagna, Italien, 40138
- Rekruttering
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1404)
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Kontakt:
- Study Coordinator
- Telefonnummer: +39 0512144134
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Milano
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Rozzano, Milano, Italien, 20089
- Rekruttering
- Istituto Clinico Humanitas-IBD center ( Site 1401)
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Kontakt:
- Study Coordinator
- Telefonnummer: +390282248282
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polen, 31-513
- Rekruttering
- Promed P. Lach R. Glowacki s.j. Centrum Medyczne Promed ( Site 1447)
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Kontakt:
- Study Coordinator
- Telefonnummer: +48124111398
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Lower Silesian Voivodeship
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Wroclaw, Lower Silesian Voivodeship, Polen, 53-611
- Rekruttering
- Melita Medical Sp Zoo ( Site 1442)
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Kontakt:
- Study Coordinator
- Telefonnummer: +48717072111
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polen, 00-189
- Rekruttering
- EB Group Sp. Z o.o. Centrum Zdrowia MDM ( Site 1449)
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Kontakt:
- Study Coordinator
- Telefonnummer: +48783959687
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Warsaw, Masovian Voivodeship, Polen, 04-501
- Rekruttering
- Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś ( Site 1448)
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Kontakt:
- Study Coordinator
- Telefonnummer: +48507091469
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West Pomeranian Voivodeship
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Szczecin, West Pomeranian Voivodeship, Polen, 71-434
- Rekruttering
- Twoja Przychodnia - Szczeciskie Centrum Medyczne ( Site 1450)
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Kontakt:
- Study Coordinator
- Telefonnummer: +48914332919
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Seoul, Sydkorea, 03181
- Rekruttering
- Kangbuk Samsung Hospital ( Site 1601)
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Kontakt:
- Study Coordinator
- Telefonnummer: +82-2-2001-8556
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Kang-won-do
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Wŏnju, Kang-won-do, Sydkorea, 26426
- Rekruttering
- Wonju Severance Christian Hospital ( Site 1602)
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Kontakt:
- Study Coordinator
- Telefonnummer: +82 33 741 0505
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Kyonggi-do
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Ansan-si, Kyonggi-do, Sydkorea, 15355
- Rekruttering
- Korea University Ansan Hospital ( Site 1603)
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Kontakt:
- Study Coordinator
- Telefonnummer: +82314127674
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Brandenburg, Tyskland, 14770
- Rekruttering
- Universitätsklinikum Brandenburg an der Havel ( Site 1323)
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Kontakt:
- Study Coordinator
- Telefonnummer: +493381412679
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Baden-Wurttemberg
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Ulm, Baden-Wurttemberg, Tyskland, 89081
- Rekruttering
- Universitaetsklinikum Ulm. ( Site 1324)
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Kontakt:
- Study Coordinator
- Telefonnummer: +4973150044727
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
The main inclusion criteria include but are not limited to the following:
- Has had ulcerative colitis (UC) (from onset of symptoms) for at least 3 months before Randomization
- Has moderately to severely active UC
- Has a weight ≥40 kg
- Satisfies at least 1 of the criteria: Has had an inadequate response or loss of response to 1 or more protocol-specified treatments; protocol specified corticosteroid dependence; has been intolerant to 1 or more protocol-specified UC treatments
- Is on treatment with any protocol-specified drugs during the study and meets drug stabilization requirements, as applicable
The main exclusion criteria include but are not limited to the following:
- Has a diagnosis of Crohn's Disease (CD) or indeterminate colitis (inflammatory bowel disease (IBD)-undefined) or other types of colitis or enteritis that may confound efficacy assessment
- Has a current diagnosis of fulminant colitis and/or toxic megacolon
- Has UC limited to the rectum
- Has a current or impending need for colostomy or ileostomy
- Has had a total proctocolectomy or partial colectomy
- Has UC exacerbation requiring hospitalization within 2 weeks before Screening
- Has any active infection as specified in the protocol
- Is known to be infected with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
- Has evidence of active tuberculosis (TB) or meets TB exclusionary parameters
- Has a history of cancer (except fully treated nonmelanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years before Randomization or has a history of colorectal cancer at any time
- Has prior or current evidence of definite colonic dysplasia except for low-grade dysplasia that has been completely removed
- Has had major surgery within 3 months before Screening or has a major surgery (ie, surgical procedure requiring general anesthesia) planned during the study
- Has received protocol-specified prohibited medications
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Antal våben
4
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Period 1: MK-8690
Participants will receive MK-8690 via subcutaneous injection for 12 weeks. |
Solution for subcutaneous injection
Andre navne:
|
|
Placebo komparator: Period 1: Placebo
Participants will receive placebo via subcutaneous injection for 12 weeks. |
Solution for subcutaneous injection |
|
Eksperimentel: Period 2: MK-8690
Participants who do not respond to treatment in Period 1 (regardless of treatment assignment in Period 1) will receive MK-8690 via subcutaneous injection for 12 weeks. |
Solution for subcutaneous injection
Andre navne:
|
|
Eksperimentel: Period 3: MK-8690
Participants who respond to treatment in either Period 1 or Period 2 will receive additional MK-8690 via subcutaneous injection for up to approximately 42 weeks. |
Solution for subcutaneous injection
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12
Tidsramme: Week 12
|
The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1 with no friability, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS. |
Week 12
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants With One or More Adverse Events (AEs)
Tidsramme: Up to approximately 12 months
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience an AE will be reported. |
Up to approximately 12 months
|
|
Percentage of Participants Who Discontinued Study Intervention Due to an AE
Tidsramme: Up to approximately 12 months
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study treatment due to an AE will be reported. |
Up to approximately 12 months
|
|
Percentage of Participants Achieving Clinical Response Per MMS at Week 12
Tidsramme: Week 12
|
The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as an MMS reduction of 2 or more points and 30% or more from baseline, plus a reduction of 1 or more points in RBS or an absolute RBS of 0 or 1. |
Week 12
|
|
Percentage of Participants With Endoscopic Improvement at Week 12
Tidsramme: Week 12
|
Endoscopic improvement is defined as ES of 0 or 1 with no friability. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity. |
Week 12
|
|
Percentage of Participants Achieving Clinical Remission Per Partial Modified Mayo Score (pMMS) at Week 12
Tidsramme: Week 12
|
pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant) and RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical remission per pMMS is defined as an RBS of 0 and SFS of less than or equal to 1. |
Week 12
|
|
Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement (HEMI) at Week 12
Tidsramme: Week 12
|
HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1 with no friability. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). |
Week 12
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
24. marts 2026
Primær færdiggørelse (Anslået)
Primær færdiggørelse
28. oktober 2027
Studieafslutning (Anslået)
Studieafslutning
21. december 2028
Datoer for studieregistrering
Først indsendt
Først indsendt
4. marts 2026
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
4. marts 2026
Først opslået (Faktiske)
Først opslået
11. marts 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
12. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. november 2026
Sidst verificeret
Sidst verificeret
1. november 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 8690-002
- MK-8690-002 (Anden identifikator: MSD)
- U1111-1326-7763 (Registry Identifier: UTN)
- 2025-523479-49-00 (Registry Identifier: EU CT)
- 2025 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .