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New pill shows promise for ulcerative colitis sufferers
NCT ID NCT05611671
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests three different doses of an experimental drug called MORF-057 in 280 adults with moderate to severe ulcerative colitis, a chronic inflammatory bowel disease. The goal is to see if the drug can safely help patients achieve remission, meaning less bleeding, more normal bowel movements, and healed gut lining. Participants are randomly assigned to receive either MORF-057 or a placebo, and neither they nor their doctors know which group they are in.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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280 people
The number who actually took part.
- Started
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Nov 2022
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
Inclusion Criteria: * Has signs/symptoms of moderate to severe UC for at least 3 months prior to Screening * Has evidence of UC extending at least 15 cm from the anal verge * Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Oral aminosalicylates (e.g., mesalamine, sulfasalazine, olsalazine, or balsalazide), corticosteroids, immunosuppressants (e.g., azathioprine, 6-mercaptopurine, or methotrexate), advanced therapies for UC (e.g., biologic agents, Janus kinase \[JAK\] antagonists, or sphingosine-1-phosphate \[S1P\] receptor agonists) * Subject has no prior exposure to approved or investigational anti-integrin therapies * Agrees to abide by the study guidelines and requirements * Capable of giving signed informed consent Exclusion Criteria: * Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or Crohn's disease or has clinical findings suggestive of Crohn's disease * Has positive findings on a subjective neurological screening questionnaire * Has a concurrent, clinically significant, serious, unstable comorbidity * Previous treatment with vedolizumab or other licensed or investigational integrin inhibitors * Participation in any other interventional study or received any investigational therapy within 30 days * Previous exposure to MORF-057 and/or a known hypersensitivity to drugs with a similar mechanism to MORF-057 * Unable to attend study visits or comply with study procedures
Get updates
Get notified about this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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"Vita Longa" Non-Public Healthcare Facility, Limited Liability Company
Katowice, 40-748, Poland
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Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda
Sofia, 1407, Bulgaria
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All India Institute of Medical Sciences
New Delhi, 110029, India
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Arizona Digestive Health - Sun City
Sun City, Arizona, 85351, United States
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Blacktown Hospital
Blacktown, 2148, Australia
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Bugat Pal Korhaz
Gyöngyös, 3200, Hungary
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CLINSANTE Clinical Research Centre Ewa Galczak-Nowak, Malgorzata Trzaska
Bydgoszcz, 85-794, Poland
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Center of Diagnosis and Treatment Provita
Bucharest, 21494, Romania
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Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
Nice, 06202, France
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Centrum Medyczne Reuma Park
Warsaw, 02-665, Poland
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Changhua Christian Hospital
Changhua, 50006, Taiwan
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Charite - University Hospital Berlin
Berlin, 10117, Germany
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Chia-Yi Christian Hospital
Chiayi City, 600, Taiwan
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China Medical University Hospital
Taichung, 404, Taiwan
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Clinical Hospital Center Bezanijska Kosa
Belgrade, 11000, Serbia
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Cliniq s.r.o.
Bratislava, 811 09, Slovakia
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Clinoxus s.r.o., Outpatient Clinic Budejovicka
Prague, 140 00, Czechia
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Colentina Clinical Hospital
Bucharest, 020125, Romania
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Concord Repatriation General Hospital
Concord, 2139, Australia
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Curatio, Jsc
Tbilisi, 0114, Georgia
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Dayanand Medical College and Hospital
Ludhiana, 141001, India
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Digestive Diseases Center "Gastro"
Riga, 1079, Latvia
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Dong-A University Hospital
Busan, 49201, South Korea
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EMC Medical Institute Joint Stock Company, "Certus" Private Healthcare Facility Hospital No. 1
Poznan, 60-309, Poland
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EMC Medical Institute Joint Stock Company, EuroMediCare Specialist Outpatient Clinics in Wroclaw
Wroclaw, 54-144, Poland
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ENDOMED s.r.o.
Košice, 04013, Slovakia
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ETG Lublin
Lublin, 20-412, Poland
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ETG Zamość
Zamość, 22-400, Poland
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East Tallinn Central Hospital
Tallinn, 10138, Estonia
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Eminat, LLC - Miramar
Miramar, Florida, 33027, United States
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Endoscopy Limited Liability Company
Sopot, 81-756, Poland
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Far Eastern Memorial Hospital
Taipei, 220, Taiwan
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Fejer County St. Gyorgy University Teaching Hospital
Székesfehérvár, H-8000, Hungary
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Fejér Megyei Szent György Egyetemi Oktató Kórház
Székesfehérvár, 8000, Hungary
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Fiona Stanley Hospital
Murdoch, 6150, Australia
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Fortis Hospital
Noida, 201301, India
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Fortis Memorial Research Institute(FMRI)
Gurgaon, 122002, India
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Gastro Care Institute
Lancaster, California, 93534, United States
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Gastro LM s.r.o.
Prešov, 08001, Slovakia
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General Hospital "Djordje Joanovic"
Zrenjanin, 23000, Serbia
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Gleneagles Hospital
Hyderabad, 500004, India
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Government Medical College
Thiruvananthapuram, 695011, India
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Great Lakes Gastroenterology
Mentor, Ohio, 44060, United States
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H-T. Medical Center
Tychy, 43-100, Poland
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Hospital of Padova
Padova, 35128, Italy
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IP Clinic
Lodz, 90-752, Poland
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IRCCS Istituto Clinico Humanitas- Centro Malattie Infiammatorie Intestinali
Rozzano, 20089, Italy
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IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, 71013, Italy
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IRCCS Ospedale San Raffaele
Segrate, 20132, Italy
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Innova Clinical Trials
Coral Gables, Florida, 33145, United States
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JSC Infectious Diseases, AIDS and Clinical Immunology Research Center
Tbilisi, 0159, Georgia
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Javorszky Odon Korhaz
Vác, 2600, Hungary
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Kaplan Medical Center, Institute of Gastroenterology and Liver Diseases
Rehovot, 7661041, Israel
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Krakow Medical Center
Krakow, 31-501, Poland
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Krankenhaus Waldfriede
Berlin, 14163, Germany
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Kyung Hee University Hospital
Seoul, 02447, South Korea
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LTD Aversi Clinic
Tbilisi, 0160, Georgia
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LTD The First Medical Center
Tbilisi, 0180, Georgia
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LV Venter OU
Pärnu, 80010, Estonia
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Liepaja Regional Hospital
Liepāja, LV-3414, Latvia
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Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC
Tbilisi, 0101, Georgia
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Mater Adult Hospital Brisbane
South Brisbane, 4101, Australia
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Medical Center "CITO" Ltd.
Tbilisi, 0179, Georgia
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Medical Center "Rusemed" EOOD
Rousse, 7005, Bulgaria
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Medical University of Vienna
Vienna, 1090, Austria
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National Taiwan University Hospital
Taipei, 10002, Taiwan
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New health-CK, Kieltucki and partners g.p.
Staszów, 28-200, Poland
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OU Innomedica
Tallinn, 10117, Estonia
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Order Hospital Linz Ltd. - Hospital of Sisters of Mercy
Linz, 4010, Austria
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Ospedale Luigi Sacco
Milan, 20157, Italy
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Pauls Stradins Clinical Univeristy Hospital
Riga, LV-1002, Latvia
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PreventaMed, s.r.o.
Olomouc, 77900, Czechia
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Republican Panevezys Hospital
Panevezys, 35144, Lithuania
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Robert Wood Johnson University Medical School
New Brunswick, New Jersey, 08901, United States
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Royal Brisbane and Women's Hospital
Herston, QLD 4029, Australia
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S R Kalla Memorial Gastro and General Hospital
Jaipur, 302006, India
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SIDS Hospital and Research Centre
Surat, 395002, India
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Salzburg Regional Hospital
Salzburg, 5020, Austria
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Sawai Man Singh Medical College Hospital (SMS Hospital)
Jaipur, 302004, India
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Second Multiprofile Hospital for Active Treatment - Sofia
Sofia, 2700, Bulgaria
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Semmelweis Medical University
Budapest, 1083, Hungary
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Semmelweis University, Department of Internal Medicine and Haematology, Division of Internal Medicine and Gastroenterology
Budapest, H-1088, Hungary
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Shaare Zedek Medical Center, Digestive Diseases Institute
Jerusalem, 91004, Israel
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St. John Paul 2nd Municipal Hospital in Elblag
Elblag, 82-300, Poland
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TLC Clinical Research Inc.
Los Angeles, California, 90048, United States
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Taipei Veterans General Hospital
Taipei, 112201, Taiwan
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The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
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Tri-Service General Hospital
Neihu Taipei, 11490, Taiwan
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Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, 71-434, Poland
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Twoja Przychodnia Opolskie Centrum Medyczne
Opole, 45 819, Poland
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Twoja Przychodnia Pcm
Poznan, 60-324, Poland
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University Hospital Schleswig-Holstein
Kiel, 24105, Germany
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University Hospital Ulm
Ulm, 89081, Germany
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University Multiprofile Hospital for Active Treatment "ACIBADEM City Clinic"
Sofia, 1202, Bulgaria
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University Teaching Hospital No. 4 in Lublin
Lublin, 20-090, Poland
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University of Tartu
Tartu, 51014, Estonia
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Vilnius University Hospital Santaros Klinikos
Vilnius, LT-08406, Lithuania
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WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 04-501, Poland
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West Tallinn Central Hospital
Tallinn, 10617, Estonia
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Yashoda Hospital
Secunderabad, 500003, India
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Yeungnam Univeristy Medical Center
Daegu, 42415, South Korea
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Zvezdara University Medical Center
Belgrade, 11 000, Serbia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a liquid diet calm Crohn's in kids?
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