A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-8690-002)

NCT07463183 | Recruiting Phase 2 DMC FDA Drug

• 5 other identifiers: 8690-002MK-8690-002U1111-1326-77632025-523479-49-002025
• Study Type: interventional
• Target: 100
• Locations: 11 countries
• Sites: 38

Brief Summary

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.

Conditions

Colitis Ulcerative; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at 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

Secondary Outcomes (6)

• Percentage of Participants With One or More Adverse Events (AEs)

  Up to approximately 12 months

• Percentage of Participants Who Discontinued Study Intervention Due to an AE

  Up to approximately 12 months

• Percentage of Participants Achieving Clinical Response Per MMS at Week 12

  Week 12

• Percentage of Participants With Endoscopic Improvement at Week 12

  Week 12

• Percentage of Participants Achieving Clinical Remission Per Partial Modified Mayo Score (pMMS) at Week 12

  Week 12

Study Arms (4)

Period 1: MK-8690

EXPERIMENTAL

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

Drug: MK-8690

Period 1: Placebo

PLACEBO COMPARATOR

Participants will receive placebo via subcutaneous injection for 12 weeks.

Other: Placebo

Period 2: MK-8690

EXPERIMENTAL

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.

Drug: MK-8690

Period 3: MK-8690

EXPERIMENTAL

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.

Drug: MK-8690

Interventions

MK-8690 DRUG

Solution for subcutaneous injection

Also known as: PRA052

Period 1: MK-8690; Period 2: MK-8690; Period 3: MK-8690

Placebo OTHER

Solution for subcutaneous injection

Period 1: Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (38)

Clinnova Research ( Site 1042)

Anaheim, California, 92805, United States

RECRUITING

Southern California Research Center ( Site 1044)

Coronado, California, 92118, United States

RECRUITING

Peak Gastroenterology Associates ( Site 1052)

Colorado Springs, Colorado, 80907, United States

RECRUITING

South Denver Gastroenterology, PC ( Site 1068)

Englewood, Colorado, 80113, United States

RECRUITING

Nature Coast Clinical Research ( Site 1045)

Inverness, Florida, 34452, United States

RECRUITING

Research Associates of South Florida - Miami - Southwest 8th Street ( Site 1072)

Miami, Florida, 33134, United States

RECRUITING

AdventHealth Orlando ( Site 1074)

Orlando, Florida, 32803, United States

RECRUITING

Gastroenterology Associates of Central Georgia ( Site 1060)

Macon, Georgia, 31201, United States

RECRUITING

University of Kansas Medical Center ( Site 1077)

Kansas City, Kansas, 66160, United States

RECRUITING

Tulane University School of Medicine-Gastroenterology and Hepatology ( Site 1073)

New Orleans, Louisiana, 70112, United States

RECRUITING

BVL Research - Kansas ( Site 1054)

Liberty, Missouri, 64068, United States

RECRUITING

Prairie Institute of Liver and Luminal Advanced Research ( Site 1008)

Lethbridge, Alberta, T1J 4G9, Canada

RECRUITING

Toronto Western Hospital ( Site 1006)

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 1001)

Montreal, Quebec, H2X 0C1, Canada

RECRUITING

Servicios de Salud IPS Suramericana S.A.S. - IPS Sura Industriales Medellín ( Site 1163)

Medellín, Antioquia, 050001, Colombia

RECRUITING

Clinica de la Costa S.A.S. ( Site 1161)

Barranquilla, Atlántico, 080020, Colombia

RECRUITING

Fundacion Santa Fe de Bogota ( Site 1165)

Bogota, Cundinamarca, 110111, Colombia

RECRUITING

Fundación Valle del Lili ( Site 1162)

Cali, Valle del Cauca Department, 760032, Colombia

RECRUITING

Centre Hospitalier Dr Schaffner ( Site 1288)

Lens, Pas-de-Calais, 62300, France

RECRUITING

Clinique Jules Verne ( Site 1284)

Nantes, Pays de la Loire Region, 44300, France

RECRUITING

Universitaetsklinikum Ulm. ( Site 1324)

Ulm, Baden-Wurttemberg, 89081, Germany

RECRUITING

Evangelismos General Hospital of Athens ( Site 1362)

Athens, Attica, 10676, Greece

RECRUITING

THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 1361)

Athens, Attica, 115 27, Greece

RECRUITING

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1404)

Bologna, Emilia-Romagna, 40138, Italy

RECRUITING

Radboudumc ( Site 1650)

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

Amsterdam UMC, locatie VUmc ( Site 1651)

Amsterdam, North Holland, 1081 HZ, Netherlands

RECRUITING

PROMED P. LACH R. GLOWACKI SP. J. ( Site 1447)

Krakow, Lesser Poland Voivodeship, 31-513, Poland

RECRUITING

Melita Medical Sp Zoo ( Site 1442)

Wroclaw, Lower Silesian Voivodeship, 53-611, Poland

RECRUITING

EB Group Sp. Z o.o. Centrum Zdrowia MDM ( Site 1449)

Warsaw, Masovian Voivodeship, 00-189, Poland

RECRUITING

Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś ( Site 1448)

Warsaw, Masovian Voivodeship, 04-501, Poland

RECRUITING

Twoja Przychodnia - Szczeciskie Centrum Medyczne ( Site 1450)

Szczecin, West Pomeranian Voivodeship, 71-434, Poland

RECRUITING

Wonju Severance Christian Hospital ( Site 1602)

Wŏnju, Kang-won-do, 26426, South Korea

RECRUITING

Korea University Ansan Hospital ( Site 1603)

Ansan-si, Kyonggi-do, 15355, South Korea

RECRUITING

Kangbuk Samsung Hospital ( Site 1601)

Seoul, 03181, South Korea

RECRUITING

Addenbrooke's Hospital ( Site 1525)

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

RECRUITING

Fairfield General Hospital ( Site 1524)

Bury, Lancashire, BL9 7TD, United Kingdom

RECRUITING

Guys and St Thomas NHS Foundation Trust ( Site 1523)

London, London, City of, SE1 9RT, United Kingdom

RECRUITING

Huddersfield Royal Infirmary ( Site 1522)

Huddersfield, York, HD3 3EA, United Kingdom

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Period 1 is double-blind. Period 2 and Period 3 are open-label.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants in Period 1 will have parallel assignment.

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 11, 2026
• Study Start: March 24, 2026
• Primary Completion (Estimated): October 28, 2027
• Study Completion (Estimated): December 21, 2028
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

PL (5); GB (4); GR (2); CA (3); US (11); NL (2); KR (3); FR (2); CO (4); DE (1); IT (1)