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2025-524404-29-00RecruitingPhase 2

A study of LY4268989 in participants with Moderately to Severely Active Ulcerative Colitis (EMERALD-3)

J6E-MC-KWAM: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Development Program to Evaluate the Efficacy and Safety of LY4268989 (MORF-057) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis (EMERALD-3)

Source: EU CTIS (euclinicaltrials.eu) · Last updated 21 Oct 2026

Next steps

Brief summary (registry, in English)

-To evaluate if the 10-week induction efficacy of LY4268989 is superior to placebo as assessed by clinical remission in participants with moderately to severely active UC -To evaluate if the maintenance efficacy of LY4268989 is superior to placebo at Week 52 (Visit 208) as assessed by clinical remission among participants who achieve clinical response with LY4268989 at Week 10

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
104 (estimated)
First submitted
25 Feb 2026
Start date
24 Jun 2026
Lead sponsor
Eli Lilly & Co.
EU CT number
2025-524404-29-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 104
  • 61 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with moderately to severely active ulcerative colitis who did not respond well to, lost response to, or could not tolerate earlier treatment.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Ulcerative colitis diagnosed at least 3 months ago, moderately to severely active (Modified Mayo Score 5 to 9, Endoscopic Score of at least 2, rectal bleeding of at least 1), reaching beyond the rectum.
Earlier treatment
Inadequate response, loss of response or intolerance to at least one conventional medicine (including corticosteroids) or one advanced therapy (biologics, JAK inhibitors or S1P immunomodulators). People with inadequate response to vedolizumab cannot join.

Main reasons for not taking part

  • Crohn's disease, unclassified inflammatory bowel disease or primary sclerosing cholangitis
  • Inherited immune deficiency or a known single-gene cause of colitis
  • Bowel resection or intestinal or abdominal surgery, past or needed
  • Toxic megacolon, abdominal abscess, or narrowing of the bowel
  • Cancer of the digestive tract, or other cancer within 5 years before randomization

Read by machine on 9 Nov 2026.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Have had or will need bowel resection or intestinal or intra-abdominal surgery
  • Have any prior or current evidence of cancer of the the gastrointestinal (GI) tract, or specified lesions with increased risk of GI malignancie

Other illness

  • Have a current diagnosis of • Crohn’s disease • Inflammatory Bowel Disease (IBD unclassified) (formerly known as indeterminate colitis), or • primary sclerosing cholangitis
  • Have an inherited immunodeficiency syndrome or known monogenic cause of UC-like colonic inflammation
  • Have a diagnosis or history of malignant disease within 5 years prior to randomization

Other

  • Have evidence of toxic megacolon, intra-abdominal abscess, or stricture or stenosis within small bowel or colon that cannot be traversed by a colonoscope or that are symptomat

Who the study is looking for

  • Have had an established diagnosis of ulcerative colitis (UC) for ≥3 months prior to randomization, which includes endoscopic evidence of UC
  • Have moderately to severely active UC defined by a Modified Mayo Score (mMS) of 5 to 9 with an Endoscopic Score (ES)≥2 confirmed by central reader and rectal bleeding (RB)≥1
  • Have evidence of UC extending proximal to the rectum
  • Have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization, if the participant has a history of UC symptoms for more than 8 years
  • Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators). Participants with inadequate response to vedolizumab are excluded
  • Must meet contraception requirements

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (61)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hepato-Gastroenterologie HK, s.r.o.Hradec KrálovéCzechiaRecruiting
Nemocnice Pardubickeho kraje a.s.PardubiceCzechiaRecruiting
ISCARE a.s.PragueCzechiaRecruiting
MEDICON a.s.Prague 4CzechiaRecruiting
Clinoxus s.r.o.Prague 4CzechiaRecruiting
Nemocnice SlanySlanýCzechiaRecruiting
AGEL Stredomoravska nemocnicni a.s.SternberkCzechiaRecruiting
Clinical Trials Service s.r.o.Uherské HradištěCzechiaRecruiting
GASTRO NELL s.r.o.VsetinCzechiaRecruiting
Centre Medico Chirurgical Ambroise Pare HartmannNeuilly-Sur-SeineFranceRecruiting
Centre Hospitalier Universitaire de BordeauxPessacFranceRecruiting
Hospices Civils de LyonPierre-BéniteFranceRecruiting
Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9FranceRecruiting
Evangelismos S AAthensGreeceRecruiting
Thoracic General Hospital of Athens "I Sotiria"AthensGreeceRecruiting
University General Hospital of HeraklionHeraklionGreeceRecruiting
Ippokratio General Hospital of ThessalonikiThessalonikiGreeceRecruiting
Opca Bolnica Dr. Andelko Visic BjelovarBjelovarCroatiaRecruiting
Poliklinika Borzan d.o.o.OsijekCroatiaRecruiting
University hospital of SplitSplitCroatiaRecruiting
University Hospital Center ZagrebZagrebCroatiaRecruiting
Obudai Egeszseguegyi Centrum Kft.Budapest IIIHungaryRecruiting
Semmelweis UniversityBudapest VIIIHungaryRecruiting
Clinexpert Gyoengyoes Kft.GyongyosHungaryRecruiting
Komarom-Esztergom Varmegyei Szent Borbala KorhazTatabányaHungaryRecruiting
Ospedale San Raffaele S.r.l.MilanItalyRecruiting
Azienda Socio Sanitaria Territoriale RhodenseRhoItalyRecruiting
Ospedale Isola Tiberina - Gemelli IsolaRomeItalyRecruiting
San Camillo Forlanini HospitalRomeItalyRecruiting
Azienda Ospedaliera Policlinico Universitario Tor VergataRomeItalyRecruiting
Humanitas Mirasole S.p.A.RozzanoItalyRecruiting
Policlinico San Donato S.p.A.San Donato MilaneseItalyRecruiting
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikosKaunasLithuaniaRecruiting
Klaipėdos Miesto poliklinikaKlaipedaLithuaniaRecruiting
Klaipedos universiteto ligonine VšĮKlaipedaLithuaniaRecruiting
Veselibas centru apvieniba ASRigaLatviaRecruiting
Pauls Stradins Clinical University HospitalRigaLatviaRecruiting
M2M Med. Sp. z o.o. Sp. j.ChorzowPolandRecruiting
R57 Sp. z o.o.CracowPolandRecruiting
Gyncentrum Sp. z o.o.KatowicePolandRecruiting
Polimedica PTG KielceKielcePolandRecruiting
Santa SP. z o.oLodzPolandRecruiting
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o. oMalborkPolandRecruiting
Allmedica Badania Kliniczne Sp. z o.o.Nowy TargPolandRecruiting
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.PoznanPolandRecruiting
Lukmed 2 Sp. z o.o.SiedlcePolandRecruiting
Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.SzczecinPolandRecruiting
Sonomed Sp. z o.o.SzczecinPolandRecruiting
H-T. Centrum Medyczne Sp. z o.o. Sp.k.TychyPolandRecruiting
Clinical Best Solutions Sp. Z O.O. Sp.K.WarsawPolandRecruiting
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor KierkuśWarszawaPolandRecruiting
Etg Zamosc Sp. z o.o.ZamośćPolandRecruiting
CCAB Centro Clinico Academico Braga AssociacaoBragaPortugalRecruiting
Unidade Local De Saude De Santa Maria E.P.E.LisbonPortugalRecruiting
Hospital da Luz, S.ALisbonPortugalRecruiting
Unidade Local De Saude De Entre O Douro E Vouga E.P.E.Santa Maria Da FeiraPortugalRecruiting
Cliniq s.r.o.BratislavaSlovakiaRecruiting
Gastroentero s.r.o.BratislavaSlovakiaRecruiting
GASTRO I., s.r.o.PrešovSlovakiaRecruiting
Penta hospitals SK, a.s.Rimavská SobotaSlovakiaRecruiting
Accout Center s.r.o.ŠahySlovakiaRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.