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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
Are there results?
Not yet: the study is under way

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.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

39 sites in 11 countries

United States11 sites, 11 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

    Recruiting

Other trials in United States

Poland5 sites, 5 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

    Recruiting

Other trials in Poland

Colombia4 sites, 4 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

    Recruiting

Other trials in Colombia

United Kingdom4 sites, 4 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

    Recruiting

Other trials in United Kingdom

Canada3 sites, 3 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

    Recruiting

Other trials in Canada

South Korea3 sites, 3 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

    Recruiting

Other trials in South Korea

France2 sites, 2 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

    Recruiting

Other trials in France

Germany2 sites, 2 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

    Recruiting

Other trials in Germany

Greece2 sites, 2 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

    Recruiting

Other trials in Greece

Netherlands2 sites, 2 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

    Recruiting

Other trials in Netherlands

Italy1 site, 1 recruiting

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

    Bologna, Emilia-Romagna, 40138

    Study Coordinator, +39 0512144134

    Recruiting

Other trials in Italy

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.

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 groups in NCT07463183
Study groupRoleWhat they receive
Period 1: MK-8690ExperimentalParticipants will receive MK-8690 via subcutaneous injection for 12 weeks.
Receives: Drug: MK-8690
Period 1: PlaceboPlacebo comparatorParticipants will receive placebo via subcutaneous injection for 12 weeks.
Receives: Other: Placebo
Period 2: MK-8690ExperimentalParticipants 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-8690ExperimentalParticipants 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.

  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.

    Measured: Week 12

Secondary outcomes (6)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted11 Mar 2026
  2. Study start24 Mar 2026
  3. Primary completion28 Oct 2027 (estimated)
  4. Study completion21 Dec 2028 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States, Poland, Colombia, United Kingdom, Canada and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07463183.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.

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