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New shot aims to tame ulcerative colitis Flare-Ups

NCT ID NCT07463183

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 18, 2026 · Updated 15 times

Summary

This study tests whether MK-8690, a drug given as a shot, can help people with moderate-to-severe ulcerative colitis achieve remission. About 100 adults who haven't responded well to other treatments will receive either MK-8690 or a placebo. The main goal is to see if more people on the drug reach clinical remission after 12 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MK-8690 (also called PRA052), a drug given as a shot under the skin
What this could lead to
If it works, this could point toward a new treatment option for people with moderate-to-severe ulcerative colitis who haven't responded to other therapies.
What could go wrong
This is an early Phase 2a trial with only 100 participants, so results may not apply to everyone. The drug could cause side effects or fail to show benefit over placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colitis ulcerative Ulcerative colitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    35 sites in 11 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AdventHealth Orlando ( Site 1074)

    RECRUITING

    Orlando, Florida, 32803, United States

  • Amsterdam UMC, locatie VUmc ( Site 1651)

    RECRUITING

    Amsterdam, North Holland, 1081 HZ, Netherlands

  • BVL Research - Kansas ( Site 1054)

    RECRUITING

    Liberty, Missouri, 64068, United States

  • Centre Hospitalier Dr Schaffner ( Site 1288)

    RECRUITING

    Lens, Pas-de-Calais, 62300, France

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

    RECRUITING

    Montreal, Quebec, H2X 0C1, Canada

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

    RECRUITING

    Barranquilla, Atlántico, 080020, Colombia

  • Clinique Jules Verne ( Site 1284)

    RECRUITING

    Nantes, Pays de la Loire Region, 44300, France

  • Clinnova Research ( Site 1042)

    RECRUITING

    Anaheim, California, 92805, United States

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

    RECRUITING

    Warsaw, Masovian Voivodeship, 00-189, Poland

  • Evangelismos General Hospital of Athens ( Site 1362)

    RECRUITING

    Athens, Attica, 10676, Greece

  • Fairfield General Hospital ( Site 1524)

    RECRUITING

    Bury, Lancashire, BL9 7TD, United Kingdom

  • Fundacion Santa Fe de Bogota ( Site 1165)

    RECRUITING

    Bogota, Cundinamarca, 110111, Colombia

  • Fundación Valle del Lili ( Site 1162)

    RECRUITING

    Cali, Valle del Cauca Department, 760032, Colombia

  • Gastroenterology Associates of Central Georgia ( Site 1060)

    RECRUITING

    Macon, Georgia, 31201, United States

  • Huddersfield Royal Infirmary ( Site 1522)

    RECRUITING

    Huddersfield, York, HD3 3EA, United Kingdom

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

    RECRUITING

    Bologna, Emilia-Romagna, 40138, Italy

  • Kangbuk Samsung Hospital ( Site 1601)

    RECRUITING

    Seoul, 03181, South Korea

  • Korea University Ansan Hospital ( Site 1603)

    RECRUITING

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

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

    RECRUITING

    Warsaw, Masovian Voivodeship, 04-501, Poland

  • Melita Medical Sp Zoo ( Site 1442)

    RECRUITING

    Wroclaw, Lower Silesian Voivodeship, 53-611, Poland

  • Nature Coast Clinical Research ( Site 1045)

    RECRUITING

    Inverness, Florida, 34452, United States

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

    RECRUITING

    Krakow, Lesser Poland Voivodeship, 31-513, Poland

  • Peak Gastroenterology Associates ( Site 1052)

    RECRUITING

    Colorado Springs, Colorado, 80907, United States

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

    RECRUITING

    Lethbridge, Alberta, T1J 4G9, Canada

  • Radboudumc ( Site 1650)

    RECRUITING

    Nijmegen, Gelderland, 6525 GA, Netherlands

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

    RECRUITING

    Miami, Florida, 33134, United States

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

    RECRUITING

    Medellín, Antioquia, 050001, Colombia

  • South Denver Gastroenterology, PC ( Site 1068)

    RECRUITING

    Englewood, Colorado, 80113, United States

  • Southern California Research Center ( Site 1044)

    RECRUITING

    Coronado, California, 92118, United States

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

    RECRUITING

    Athens, Attica, 115 27, Greece

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

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • Twoja Przychodnia - Szczeciskie Centrum Medyczne ( Site 1450)

    RECRUITING

    Szczecin, West Pomeranian Voivodeship, 71-434, Poland

  • Universitaetsklinikum Ulm. ( Site 1324)

    RECRUITING

    Ulm, Baden-Wurttemberg, 89081, Germany

  • University of Kansas Medical Center ( Site 1077)

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • Wonju Severance Christian Hospital ( Site 1602)

    RECRUITING

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

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