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En studie för att utvärdera effektivitet och säkerhet av MK-8690 hos deltagare med måttligt till svårt aktiv ulcerös kolit (MK-8690-002)

9 november 2026 uppdaterad av: Merck Sharp & Dohme LLC

En fas 2a randomiserad, dubbelblind, placebokontrollerad studie för att utvärdera effektiviteten och säkerheten hos MK-8690 hos vuxna deltagare med måttligt till svårt aktiv ulcerös kolit

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

100

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Chile
    • Biobio
      • Concepción, Biobio, Chile, 4070022
        • Rekrytering
        • Hospital Clinico Regional Dr. Guillermo Grant Benavente ( Site 1129)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +56957585657
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7650568
        • Rekrytering
        • Clinica Alemana de Santiago ( Site 1124)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +56992794676
      • Santiago, Region M. de Santiago, Chile, 7691236
        • Rekrytering
        • Clínica MEDS La Dehesa ( Site 1123)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +56992000269
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 050001
        • Rekrytering
        • Servicios de Salud IPS Suramericana S.A.S. - IPS Sura Industriales Medellín ( Site 1163)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +57 3134673355
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 080020
        • Rekrytering
        • Clinica de la Costa S.A.S. ( Site 1161)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +573006528529
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 110111
        • Rekrytering
        • Fundacion Santa Fe de Bogota ( Site 1165)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +57 3165243088
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia, 760032
        • Rekrytering
        • Fundación Valle del Lili ( Site 1162)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +573146824542
  • Frankrike
    • Pas-de-Calais
      • Lens, Pas-de-Calais, Frankrike, 62300
        • Rekrytering
        • Centre Hospitalier Dr Schaffner ( Site 1288)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +33321691306
    • Pays de la Loire Region
      • Nantes, Pays de la Loire Region, Frankrike, 44300
        • Rekrytering
        • Clinique Jules Verne ( Site 1284)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +33251171652
  • Förenta staterna
    • California
      • Anaheim, California, Förenta staterna, 92805
        • Rekrytering
        • Clinnova Research ( Site 1042)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 949-889-0249
      • Coronado, California, Förenta staterna, 92118
        • Rekrytering
        • Southern California Research Center ( Site 1044)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 619-522-0330
    • Colorado
      • Colorado Springs, Colorado, Förenta staterna, 80907
        • Rekrytering
        • Peak Gastroenterology Associates ( Site 1052)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 719-636-1201
      • Englewood, Colorado, Förenta staterna, 80113
        • Rekrytering
        • South Denver Gastroenterology, PC ( Site 1068)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 303-406-4288
    • Florida
      • Inverness, Florida, Förenta staterna, 34452
        • Rekrytering
        • Nature Coast Clinical Research ( Site 1045)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 352-341-2100
      • Miami, Florida, Förenta staterna, 33134
        • Rekrytering
        • Research Associates of South Florida - Miami - Southwest 8th Street ( Site 1072)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 786-476-8790
      • Orlando, Florida, Förenta staterna, 32803
        • Rekrytering
        • AdventHealth Orlando ( Site 1074)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 407-303-9921
    • Georgia
      • Macon, Georgia, Förenta staterna, 31201
        • Rekrytering
        • Gastroenterology Associates of Central Georgia ( Site 1060)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 478-464-2600
    • Kansas
      • Kansas City, Kansas, Förenta staterna, 66160
        • Rekrytering
        • University of Kansas Medical Center ( Site 1077)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 913-588-6019
    • Louisiana
      • New Orleans, Louisiana, Förenta staterna, 70112
        • Rekrytering
        • Tulane University School of Medicine-Gastroenterology and Hepatology ( Site 1073)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 504-988-5110
    • Missouri
      • Liberty, Missouri, Förenta staterna, 64068
        • Rekrytering
        • BVL Research - Kansas ( Site 1054)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 816-222-4241
  • Grekland
    • Attica
      • Athens, Attica, Grekland, 10676
        • Rekrytering
        • Evangelismos General Hospital of Athens ( Site 1362)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +306977617000
      • Athens, Attica, Grekland, 115 27
        • Rekrytering
        • THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 1361)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +302107763359
  • Italien
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italien, 40138
        • Rekrytering
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1404)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +39 0512144134
    • Milano
      • Rozzano, Milano, Italien, 20089
        • Rekrytering
        • Istituto Clinico Humanitas-IBD center ( Site 1401)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +390282248282
  • Kanada
    • Alberta
      • Lethbridge, Alberta, Kanada, T1J 4G9
        • Rekrytering
        • Prairie Institute of Liver and Luminal Advanced Research ( Site 1008)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: (587) 691 3756
    • Ontario
      • Toronto, Ontario, Kanada, M5T 2S8
        • Rekrytering
        • Toronto Western Hospital ( Site 1006)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 416-603-5949
    • Quebec
      • Montreal, Quebec, Kanada, H2X 0C1
        • Rekrytering
        • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 1001)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 514-890-8000
  • Nederländerna
    • Gelderland
      • Nijmegen, Gelderland, Nederländerna, 6525 GA
        • Rekrytering
        • Radboudumc ( Site 1650)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 0031 24-3619190
    • North Holland
      • Amsterdam, North Holland, Nederländerna, 1081 HZ
        • Rekrytering
        • Amsterdam UMC, locatie VUmc ( Site 1651)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 020-4446630
  • Polen
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Polen, 31-513
        • Rekrytering
        • Promed P. Lach R. Glowacki s.j. Centrum Medyczne Promed ( Site 1447)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +48124111398
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Polen, 53-611
        • Rekrytering
        • Melita Medical Sp Zoo ( Site 1442)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +48717072111
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polen, 00-189
        • Rekrytering
        • EB Group Sp. Z o.o. Centrum Zdrowia MDM ( Site 1449)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +48783959687
      • Warsaw, Masovian Voivodeship, Polen, 04-501
        • Rekrytering
        • Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś ( Site 1448)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +48507091469
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Polen, 71-434
        • Rekrytering
        • Twoja Przychodnia - Szczeciskie Centrum Medyczne ( Site 1450)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +48914332919
  • Storbritannien
    • Cambridgeshire
      • Cambridge, Cambridgeshire, Storbritannien, CB2 0QQ
        • Rekrytering
        • Addenbrooke's Hospital ( Site 1525)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +4401223596461
    • Lancashire
      • Bury, Lancashire, Storbritannien, BL9 7TD
        • Rekrytering
        • Fairfield General Hospital ( Site 1524)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +4401617783879
    • London, City of
      • London, London, City of, Storbritannien, SE1 9RT
        • Rekrytering
        • Guys and St Thomas NHS Foundation Trust ( Site 1523)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 020 7188 8315
    • York
      • Huddersfield, York, Storbritannien, HD3 3EA
        • Rekrytering
        • Huddersfield Royal Infirmary ( Site 1522)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +4401484355434
  • Sydkorea
      • Seoul, Sydkorea, 03181
        • Rekrytering
        • Kangbuk Samsung Hospital ( Site 1601)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +82-2-2001-8556
    • Kang-won-do
      • Wŏnju, Kang-won-do, Sydkorea, 26426
        • Rekrytering
        • Wonju Severance Christian Hospital ( Site 1602)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +82 33 741 0505
    • Kyonggi-do
      • Ansan-si, Kyonggi-do, Sydkorea, 15355
        • Rekrytering
        • Korea University Ansan Hospital ( Site 1603)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +82314127674
  • Tyskland
      • Brandenburg, Tyskland, 14770
        • Rekrytering
        • Universitätsklinikum Brandenburg an der Havel ( Site 1323)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +493381412679
    • Baden-Wurttemberg
      • Ulm, Baden-Wurttemberg, Tyskland, 89081
        • Rekrytering
        • Universitaetsklinikum Ulm. ( Site 1324)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +4973150044727

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Period 1: MK-8690

Participants will receive MK-8690 via subcutaneous injection for 12 weeks.
Läkemedel: MK-8690

Solution for subcutaneous injection

Andra namn:
  • PRA052
Placebo-jämförare: Period 1: Placebo

Participants will receive placebo via subcutaneous injection for 12 weeks.
Övrig: Placebo

Solution for subcutaneous injection
Experimentell: 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.
Läkemedel: MK-8690

Solution for subcutaneous injection

Andra namn:
  • PRA052
Experimentell: 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.
Läkemedel: MK-8690

Solution for subcutaneous injection

Andra namn:
  • PRA052

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants With One or More Adverse Events (AEs)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Merck Sharp & Dohme LLC

Utredare

  • Studierektor: Medical Director, Merck Sharp & Dohme LLC

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

24 mars 2026

Primärt slutförande (Beräknad)

28 oktober 2027

Avslutad studie (Beräknad)

21 december 2028

Studieregistreringsdatum

Först inskickad

4 mars 2026

Först inskickad som uppfyllde QC-kriterierna

4 mars 2026

Första postat (Faktisk)

11 mars 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 8690-002
  • MK-8690-002 (Annan identifierare: MSD)
  • U1111-1326-7763 (Registeridentifierare: UTN)
  • 2025-523479-49-00 (Registeridentifierare: EU CT)
  • 2025 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera