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
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.
- Diseases
- Ulcerative colitis
- 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
Sites (61)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hepato-Gastroenterologie HK, s.r.o. | Hradec Králové | Czechia | Recruiting |
| Nemocnice Pardubickeho kraje a.s. | Pardubice | Czechia | Recruiting |
| ISCARE a.s. | Prague | Czechia | Recruiting |
| MEDICON a.s. | Prague 4 | Czechia | Recruiting |
| Clinoxus s.r.o. | Prague 4 | Czechia | Recruiting |
| Nemocnice Slany | Slaný | Czechia | Recruiting |
| AGEL Stredomoravska nemocnicni a.s. | Sternberk | Czechia | Recruiting |
| Clinical Trials Service s.r.o. | Uherské Hradiště | Czechia | Recruiting |
| GASTRO NELL s.r.o. | Vsetin | Czechia | Recruiting |
| Centre Medico Chirurgical Ambroise Pare Hartmann | Neuilly-Sur-Seine | France | Recruiting |
| Centre Hospitalier Universitaire de Bordeaux | Pessac | France | Recruiting |
| Hospices Civils de Lyon | Pierre-Bénite | France | Recruiting |
| Centre Hospitalier Universitaire De Toulouse | Toulouse Cedex 9 | France | Recruiting |
| Evangelismos S A | Athens | Greece | Recruiting |
| Thoracic General Hospital of Athens "I Sotiria" | Athens | Greece | Recruiting |
| University General Hospital of Heraklion | Heraklion | Greece | Recruiting |
| Ippokratio General Hospital of Thessaloniki | Thessaloniki | Greece | Recruiting |
| Opca Bolnica Dr. Andelko Visic Bjelovar | Bjelovar | Croatia | Recruiting |
| Poliklinika Borzan d.o.o. | Osijek | Croatia | Recruiting |
| University hospital of Split | Split | Croatia | Recruiting |
| University Hospital Center Zagreb | Zagreb | Croatia | Recruiting |
| Obudai Egeszseguegyi Centrum Kft. | Budapest III | Hungary | Recruiting |
| Semmelweis University | Budapest VIII | Hungary | Recruiting |
| Clinexpert Gyoengyoes Kft. | Gyongyos | Hungary | Recruiting |
| Komarom-Esztergom Varmegyei Szent Borbala Korhaz | Tatabánya | Hungary | Recruiting |
| Ospedale San Raffaele S.r.l. | Milan | Italy | Recruiting |
| Azienda Socio Sanitaria Territoriale Rhodense | Rho | Italy | Recruiting |
| Ospedale Isola Tiberina - Gemelli Isola | Rome | Italy | Recruiting |
| San Camillo Forlanini Hospital | Rome | Italy | Recruiting |
| Azienda Ospedaliera Policlinico Universitario Tor Vergata | Rome | Italy | Recruiting |
| Humanitas Mirasole S.p.A. | Rozzano | Italy | Recruiting |
| Policlinico San Donato S.p.A. | San Donato Milanese | Italy | Recruiting |
| Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos | Kaunas | Lithuania | Recruiting |
| Klaipėdos Miesto poliklinika | Klaipeda | Lithuania | Recruiting |
| Klaipedos universiteto ligonine VšĮ | Klaipeda | Lithuania | Recruiting |
| Veselibas centru apvieniba AS | Riga | Latvia | Recruiting |
| Pauls Stradins Clinical University Hospital | Riga | Latvia | Recruiting |
| M2M Med. Sp. z o.o. Sp. j. | Chorzow | Poland | Recruiting |
| R57 Sp. z o.o. | Cracow | Poland | Recruiting |
| Gyncentrum Sp. z o.o. | Katowice | Poland | Recruiting |
| Polimedica PTG Kielce | Kielce | Poland | Recruiting |
| Santa SP. z o.o | Lodz | Poland | Recruiting |
| Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o. o | Malbork | Poland | Recruiting |
| Allmedica Badania Kliniczne Sp. z o.o. | Nowy Targ | Poland | Recruiting |
| Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o. | Poznan | Poland | Recruiting |
| Lukmed 2 Sp. z o.o. | Siedlce | Poland | Recruiting |
| Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o. | Szczecin | Poland | Recruiting |
| Sonomed Sp. z o.o. | Szczecin | Poland | Recruiting |
| H-T. Centrum Medyczne Sp. z o.o. Sp.k. | Tychy | Poland | Recruiting |
| Clinical Best Solutions Sp. Z O.O. Sp.K. | Warsaw | Poland | Recruiting |
| Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś | Warszawa | Poland | Recruiting |
| Etg Zamosc Sp. z o.o. | Zamość | Poland | Recruiting |
| CCAB Centro Clinico Academico Braga Associacao | Braga | Portugal | Recruiting |
| Unidade Local De Saude De Santa Maria E.P.E. | Lisbon | Portugal | Recruiting |
| Hospital da Luz, S.A | Lisbon | Portugal | Recruiting |
| Unidade Local De Saude De Entre O Douro E Vouga E.P.E. | Santa Maria Da Feira | Portugal | Recruiting |
| Cliniq s.r.o. | Bratislava | Slovakia | Recruiting |
| Gastroentero s.r.o. | Bratislava | Slovakia | Recruiting |
| GASTRO I., s.r.o. | Prešov | Slovakia | Recruiting |
| Penta hospitals SK, a.s. | Rimavská Sobota | Slovakia | Recruiting |
| Accout Center s.r.o. | Šahy | Slovakia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.