Colitis UlcerativePhase 2NCT07463183
A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-8690-002)
A Phase 2 study testing MK-8690 in people with Colitis Ulcerative and Ulcerative Colitis, run by Merck Sharp & Dohme LLC at 39 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colitis Ulcerative, Ulcerative Colitis
- What is being tested?
- MK-8690
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 39 sitesin 11 countries
- Study dates
- 24 Mar 2026to 21 Dec 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
39 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
39 sites in 11 countries
United States11 sites, 11 recruiting
- Recruiting
Clinnova Research ( Site 1042)
Anaheim, California, 92805
Study Coordinator, 949-889-0249
- Recruiting
Peak Gastroenterology Associates ( Site 1052)
Colorado Springs, Colorado, 80907
Study Coordinator, 719-636-1201
- Recruiting
Southern California Research Center ( Site 1044)
Coronado, California, 92118
Study Coordinator, 619-522-0330
- Recruiting
South Denver Gastroenterology, PC ( Site 1068)
Englewood, Colorado, 80113
Study Coordinator, 303-406-4288
- Recruiting
Nature Coast Clinical Research ( Site 1045)
Inverness, Florida, 34452
Study Coordinator, 352-341-2100
- Recruiting
University of Kansas Medical Center ( Site 1077)
Kansas City, Kansas, 66160
Study Coordinator, 913-588-6019
- Recruiting
BVL Research - Kansas ( Site 1054)
Liberty, Missouri, 64068
Study Coordinator, 816-222-4241
- Recruiting
Gastroenterology Associates of Central Georgia ( Site 1060)
Macon, Georgia, 31201
Study Coordinator, 478-464-2600
- Recruiting
Research Associates of South Florida - Miami - Southwest 8th Street ( Site 1072)
Miami, Florida, 33134
Study Coordinator, 786-476-8790
- Recruiting
Tulane University School of Medicine-Gastroenterology and Hepatology ( Site 1073)
New Orleans, Louisiana, 70112
Study Coordinator, 504-988-5110
- Recruiting
AdventHealth Orlando ( Site 1074)
Orlando, Florida, 32803
Study Coordinator, 407-303-9921
Poland5 sites, 5 recruiting
- Recruiting
PROMED P. LACH R. GLOWACKI SP. J. ( Site 1447)
Krakow, Lesser Poland Voivodeship, 31-513
Study Coordinator, +48124111398
- Recruiting
Twoja Przychodnia - Szczeciskie Centrum Medyczne ( Site 1450)
Szczecin, West Pomeranian Voivodeship, 71-434
Study Coordinator, +48914332919
- Recruiting
EB Group Sp. Z o.o. Centrum Zdrowia MDM ( Site 1449)
Warsaw, Masovian Voivodeship, 00-189
Study Coordinator, +48783959687
- Recruiting
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś ( Site 1448)
Warsaw, Masovian Voivodeship, 04-501
Study Coordinator, +48507091469
- Recruiting
Melita Medical Sp Zoo ( Site 1442)
Wroclaw, Lower Silesian Voivodeship, 53-611
Study Coordinator, +48717072111
Colombia4 sites, 4 recruiting
- Recruiting
Clinica de la Costa S.A.S. ( Site 1161)
Barranquilla, Atlántico, 080020
Study Coordinator, +573006528529
- Recruiting
Fundacion Santa Fe de Bogota ( Site 1165)
Bogota, Cundinamarca, 110111
Study Coordinator, +57 3165243088
- Recruiting
Fundación Valle del Lili ( Site 1162)
Cali, Valle del Cauca Department, 760032
Study Coordinator, +573146824542
- Recruiting
Servicios de Salud IPS Suramericana S.A.S. - IPS Sura Industriales Medellín ( Site 1163)
Medellín, Antioquia, 050001
Study Coordinator, +57 3134673355
United Kingdom4 sites, 4 recruiting
- Recruiting
Fairfield General Hospital ( Site 1524)
Bury, Lancashire, BL9 7TD
Study Coordinator, +4401617783879
- Recruiting
Addenbrooke's Hospital ( Site 1525)
Cambridge, Cambridgeshire, CB2 0QQ
Study Coordinator, +4401223596461
- Recruiting
Huddersfield Royal Infirmary ( Site 1522)
Huddersfield, York, HD3 3EA
Study Coordinator, +4401484355434
- Recruiting
Guys and St Thomas NHS Foundation Trust ( Site 1523)
London, London, City of, SE1 9RT
Study Coordinator, 020 7188 8315
Canada3 sites, 3 recruiting
- Recruiting
Prairie Institute of Liver and Luminal Advanced Research ( Site 1008)
Lethbridge, Alberta, T1J 4G9
Study Coordinator, (587) 691 3756
- Recruiting
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 1001)
Montreal, Quebec, H2X 0C1
Study Coordinator, 514-890-8000
- Recruiting
Toronto Western Hospital ( Site 1006)
Toronto, Ontario, M5T 2S8
Study Coordinator, 416-603-5949
South Korea3 sites, 3 recruiting
- Recruiting
Korea University Ansan Hospital ( Site 1603)
Ansan-si, Kyonggi-do, 15355
Study Coordinator, +82314127674
- Recruiting
Kangbuk Samsung Hospital ( Site 1601)
Seoul, 03181
Study Coordinator, +82-2-2001-8556
- Recruiting
Wonju Severance Christian Hospital ( Site 1602)
Wŏnju, Kang-won-do, 26426
Study Coordinator, +82 33 741 0505
France2 sites, 2 recruiting
- Recruiting
Centre Hospitalier Dr Schaffner ( Site 1288)
Lens, Pas-de-Calais, 62300
Study Coordinator, +33321691306
- Recruiting
Clinique Jules Verne ( Site 1284)
Nantes, Pays de la Loire Region, 44300
Study Coordinator, +33251171652
Germany2 sites, 2 recruiting
- Recruiting
Universitätsklinikum Brandenburg an der Havel ( Site 1323)
Brandenburg, 14770
Study Coordinator, +493381412679
- Recruiting
Universitaetsklinikum Ulm. ( Site 1324)
Ulm, Baden-Wurttemberg, 89081
Study Coordinator, +4973150044727
Greece2 sites, 2 recruiting
- Recruiting
Evangelismos General Hospital of Athens ( Site 1362)
Athens, Attica, 10676
Study Coordinator, +306977617000
- Recruiting
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 1361)
Athens, Attica, 115 27
Study Coordinator, +302107763359
Netherlands2 sites, 2 recruiting
- Recruiting
Amsterdam UMC, locatie VUmc ( Site 1651)
Amsterdam, North Holland, 1081 HZ
Study Coordinator, 020-4446630
- Recruiting
Radboudumc ( Site 1650)
Nijmegen, Gelderland, 6525 GA
Study Coordinator, 0031 24-3619190
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1404)
Bologna, Emilia-Romagna, 40138
Study Coordinator, +39 0512144134
About this study
Official title: A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-8690 in Adult Participants With Moderately to Severely Active Ulcerative 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.
- Conditions
- Colitis Ulcerative, Ulcerative Colitis
- Being tested
- MK-8690, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-8690Drug
Also called PRA052
Solution for subcutaneous injection
PlaceboOther
Solution for subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Period 1: MK-8690 | Experimental | Participants will receive MK-8690 via subcutaneous injection for 12 weeks. Receives: Drug: MK-8690 |
| Period 1: Placebo | Placebo comparator | Participants will receive placebo via subcutaneous injection for 12 weeks. Receives: 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. Receives: 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. Receives: Drug: MK-8690 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12
Secondary outcomes (6)
Percentage of Participants With One or More Adverse Events (AEs)
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.
Measured: Up to approximately 12 months
Percentage of Participants Who Discontinued Study Intervention Due to an AE
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.
Measured: Up to approximately 12 months
Percentage of Participants Achieving Clinical Response Per 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: 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.
Measured: Week 12
Percentage of Participants With Endoscopic Improvement at 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.
Measured: Week 12
Percentage of Participants Achieving Clinical Remission Per Partial Modified Mayo Score (pMMS) at 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.
Measured: Week 12
Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement (HEMI) at 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).
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start24 Mar 2026
- Primary completion28 Oct 2027 (estimated)
- Study completion21 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis UlcerativeStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants in Period 1 will have parallel assignment.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463183
- Sponsor's protocol ID
- 8690-002
- Other IDs
- MK-8690-002, U1111-1326-7763, 2025-523479-49-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 4 Mar 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf