Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New pill could ease ulcerative colitis symptoms

NCT ID NCT04857112

Disease control Sponsor: Bausch Health Americas, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested an oral drug called amiselimod (MT-1303) in 322 adults with mild to moderate ulcerative colitis. Participants received either a low dose, high dose, or placebo for 12 weeks, with an optional 36-week open-label period. The goal was to see if the drug could reduce disease activity and improve endoscopic findings.

What this could mean

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

Active substance
Amiselimod (MT-1303)
What this could lead to
If it works, this could point toward a new oral treatment option for people with mild to moderate ulcerative colitis.
What could go wrong
This is a Phase 2 trial, so it is still early. The drug may not prove effective or could have side effects. Results may not apply to all patients.

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

322 people

The number who actually took part.

Started

Sep 2021

Finished

Nov 2024

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.

Inclusion Criteria: * Subjects will be eligible if they are male or female aged between 18 to 75 years at time of consent (inclusive) with normal vital signs and a diagnosis of active mild ulcerative colitis (UC) (modified Mayo Score of 3 or 4) or moderate UC (modified Mayo Score of 5 to 8) confirmed at least 12 weeks prior to randomization by clinical and endoscopic evidence and corroborated by a histopathology report. * Subjects must have an endoscopic subscore of ≥2 from and evidence of active UC extending ≥15 cm from the anal verge confirmed by a screening colonoscopy. * If subjects are receiving oral or rectal 5-aminosalicylates (5-ASAs) or oral corticosteroids (≤20 mg prednisolone equivalent) for treatment of their UC, they must be on a stable dose for at least 28 days prior to randomization. * Subjects who complete the Double-Blind Period of the study who, in the opinion of the Investigator, would benefit from continued treatment, may participate in the Open Label Extension (OLE) Period. Exclusion Criteria: * Any of the following: a diagnosis of Crohn's disease, indeterminate colitis, colitis (pseudomembranous, microscopic, or ischemic) or coeliac disease, current or recent (within 12 weeks prior to randomization) evidence of fulminant colitis, proctitis (defined as a rectal inflammation within 15 cm from the anal verge), abdominal abscess, toxic megacolon, bowel obstruction, or bowel perforation; a history or evidence of any colonic resection or subtotal or total colectomy, ileostomy, colostomy, known fixed symptomatic stenosis of the intestine, unresected adenomatous colonic polyps, or colonic mucosal dysplasia. * Clinically significant infections (e.g., pneumonia, pyelonephritis, or septicemia) within 4 weeks prior to randomization or previous clinically significant infections requiring hospitalization within 6 months prior to randomization, active or latent tuberculosis, infections of hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or previous shingles outbreak. * Active SARS-CoV-2 infection or complications related to COVID-19. * A history of, or currently active, primary or secondary immunodeficiency, presence of progressive multifocal leukoencephalopathy (PML), or presence of demyelinating diseases. * A history or evidence of two or more failures with biologic treatment for UC. * Currently taking any medication for treatment of UC other than oral or rectal 5-ASAs (5-aminosalicylic acids) or oral corticosteroids (≤20 mg prednisolone equivalent) * Been taking enemas or suppositories (other than stable dose of 5-ASA) for treatment of UC within 2 weeks prior to the Screening Visit. * Been taking an unstable dose of probiotics or antidiarrheals 2 weeks prior to the Screening Visit. * Had recent myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure with hospitalization, Class III/IV heart failure, Mobitz Type II 2nd degree or 3rd degree atrioventricular (AV) block, sick sinus syndrome, prolonged QT interval, Wolff Parkinson White or other conduction abnormalities, low heart rate, ongoing treatment with Class I or Class III anti-arrhythmic drugs, heart-rate-lowering calcium-channel blockers, β blockers or with any other drugs which can reduce the heart rate, have known high risk for QT/QTc prolongation, or have clinically significant abnormal findings in 12-lead ECG that the Investigator considers may jeopardize the subject's health. * Forced expiratory volume in one second (FEV1) or forced expiratory vital capacity (FVC) \<70% of predicted values at screening. For sites where DLCO (diffusing capacity of the lungs for carbon monoxide) will be assessed, the value (mL/min/mmHg) is \< 80% of the predicted normal value for age, height, and gender. * Macular oedema as assessed by OCT (Optical Coherence Tomography). * History of non-response or treatment failure with MT-1303 or other sphingosine 1 phosphate (S1P) receptor modulators. * Fecal microbiota transplantation (FMT) within 12 months prior to the Screening Visit. * Any of the following laboratory abnormalities: * Hemoglobin (Hb) \<9.0 g/dL. * White blood cell (WBC) count \<3.50 × 109/L (\<3,500/µL). * Neutrophil count \<1.50 × 109/L (\<1,500/µL). * Lymphocyte count \<0.80 × 109/L (\<800/µL). * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2 × the upper limit of normal (ULN). * Bilirubin \>1.5 x the ULN; subjects with Gilbert's syndrome may be enrolled with total bilirubin up to 5.0 mg/dl. * Positive stool tests for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile (C. difficile) during the Screening Period. If subject has a history of recent C. difficile infection (within 60 days prior to Screening Visit), they should not be considered for study enrollment until subject has been treated for C. difficile and is symptom free for at least 14 days prior to the Screening Visit. * Any physical or mental conditions which would interfere with the study participation, collection of data, or study completion as determined by the Investigator.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Ulcerative colitis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

Ulcerative colitis

Contacts and locations

Locations

  • Bausch Health Site 1401

    Prague, 130 00, Czechia

  • Bausch Health Site 1402

    Slaný, 274 01, Czechia

  • Bausch Health Site 1403

    Olomouc, 779 00, Czechia

  • Bausch Health Site 1404

    Brno, 615 00, Czechia

  • Bausch Health Site 1405

    Hradec Králové, 500 12, Czechia

  • Bausch Health Site 1406

    Pardubice, 532 03, Czechia

  • Bausch Health Site 1601

    Tbilisi, 0172, Georgia

  • Bausch Health Site 1602

    Tbilisi, 0131, Georgia

  • Bausch Health Site 1603

    Tbilisi, 0160, Georgia

  • Bausch Health Site 1604

    Tbilisi, 0160, Georgia

  • Bausch Health Site 1605

    Tbilisi, 0160, Georgia

  • Bausch Health Site 1606

    Tbilisi, 0160, Georgia

  • Bausch Health Site 1701

    Tübingen, 72076, Germany

  • Bausch Health Site 1702

    Nordhausen, 99734, Germany

  • Bausch Health Site 1703

    Wipperfürth, 51688, Germany

  • Bausch Health Site 1705

    Berlin, 10117, Germany

  • Bausch Health Site 1706

    Kiel, 24105, Germany

  • Bausch Health Site 1707

    Frankfurt am Main, 60594, Germany

  • Bausch Health Site 1708

    Cologne, 51103, Germany

  • Bausch Health Site 1709

    Remscheid, 42589, Germany

  • Bausch Health Site 1710

    Dresden, 01307, Germany

  • Bausch Health Site 1712

    Mainz, 55122, Germany

  • Bausch Health Site 1713

    Mannheim, 68167, Germany

  • Bausch Health Site 1714

    Rostock, 18057, Germany

  • Bausch Health Site 1716

    Berlin, 14050, Germany

  • Bausch Health Site 1717

    Brandenburg, 14770, Germany

  • Bausch Health Site 1718

    Augsburg, 86156, Germany

  • Bausch Health Site 1801

    Mohács, 7700, Hungary

  • Bausch Health Site 1802

    Székesfehérvár, H-8000, Hungary

  • Bausch Health Site 1803

    Kistarcsa, H-2143, Hungary

  • Bausch Health Site 1805

    Békéscsaba, H-5600, Hungary

  • Bausch Health Site 1901

    Milan, 20157, Italy

  • Bausch Health Site 1903

    Turin, 10128, Italy

  • Bausch Health Site 1904

    Messina, 98125, Italy

  • Bausch Health Site 1906

    Florence, 50134, Italy

  • Bausch Health Site 1907

    Padova, 35128, Italy

  • Bausch Health Site 1908

    Monza, 20900, Italy

  • Bausch Health Site 1909

    Milan, 20142, Italy

  • Bausch Health Site 2002

    Miyagi, 983-8520, Japan

  • Bausch Health Site 2003

    Tokyo, 192-0032, Japan

  • Bausch Health Site 2004

    Chiba, 260-8677, Japan

  • Bausch Health Site 2005

    Hiroshima, 734-8551, Japan

  • Bausch Health Site 2006

    Ōita, 870-0823, Japan

  • Bausch Health Site 2007

    Saga, 849-8501, Japan

  • Bausch Health Site 2008

    Nagasaki, 852-8102, Japan

  • Bausch Health Site 2009

    Hokkaido, 004-0041, Japan

  • Bausch Health Site 2010

    Tokyo, 169-0073, Japan

  • Bausch Health Site 2011

    Fukuoka, 814-0180, Japan

  • Bausch Health Site 2012

    Tokyo, 108-8642, Japan

  • Bausch Health Site 2013

    Iwata, 020-8505, Japan

  • Bausch Health Site 2014

    Chiba, 285-8741, Japan

  • Bausch Health Site 2016

    Hyōgo, 663-8501, Japan

  • Bausch Health Site 2017

    Mie, 510-0016, Japan

  • Bausch Health Site 2018

    Tokyo, 113-0034, Japan

  • Bausch Health Site 2019

    Hokkaido, 060-8543, Japan

  • Bausch Health Site 2020

    Kagawa, 252-0375, Japan

  • Bausch Health Site 2021

    Tokyo, 181-8611, Japan

  • Bausch Health Site 2022

    Kamakura, 247-0056, Japan

  • Bausch Health Site 2023

    Takayama, 506-8550, Japan

  • Bausch Health Site 2101

    Seoul, 05278, South Korea

  • Bausch Health Site 2102

    Seoul, 06591, South Korea

  • Bausch Health Site 2103

    Seoul, 06973, South Korea

  • Bausch Health Site 2105

    Daegu, 41944, South Korea

  • Bausch Health Site 2106

    Wŏnju, 26426, South Korea

  • Bausch Health Site 2107

    Seoul, 03080, South Korea

  • Bausch Health Site 2108

    Seoul, South Korea

  • Bausch Health Site 2109

    Busan, 48108, South Korea

  • Bausch Health Site 2110

    Seoul, 06351, South Korea

  • Bausch Health Site 2112

    Daegu, 41404, South Korea

  • Bausch Health Site 2113

    Suwon, 442-723, South Korea

  • Bausch Health Site 2114

    Daegu, 42601, South Korea

  • Bausch Health Site 2201

    Chisinau, MD2025, Moldova

  • Bausch Health Site 2202

    Chisinau, 2005, Moldova

  • Bausch Health Site 2203

    Chisinau, MD2025, Moldova

  • Bausch Health Site 2204

    Chisinau, MD2025, Moldova

  • Bausch Health Site 2205

    Chisinau, MD-2068, Moldova

  • Bausch Health Site 2301

    Krakow, 30-363, Poland

  • Bausch Health Site 2302

    Szczecin, 71-434, Poland

  • Bausch Health Site 2303

    Warsaw, 00-728, Poland

  • Bausch Health Site 2304

    Sopot, 81-756, Poland

  • Bausch Health Site 2305

    Oświęcim, 32-600, Poland

  • Bausch Health Site 2306

    Krakow, 31-156, Poland

  • Bausch Health Site 2307

    Wroclaw, 51-162, Poland

  • Bausch Health Site 2308

    Warsaw, 03-580, Poland

  • Bausch Health Site 2309

    Bydgoszcz, 85-794, Poland

  • Bausch Health Site 2310

    Wierzchosławice, 33-122, Poland

  • Bausch Health Site 2311

    Warsaw, 00-635, Poland

  • Bausch Health Site 2313

    Wroclaw, 50-414, Poland

  • Bausch Health Site 2314

    Lodz, 93-357, Poland

  • Bausch Health Site 2315

    Tychy, 43-100, Poland

  • Bausch Health Site 2316

    Rzeszów, 35-302, Poland

  • Bausch Health Site 2317

    Wroclaw, 50-449, Poland

  • Bausch Health Site 2318

    Nowy Targ, 34-400, Poland

  • Bausch Health Site 2319

    Wroclaw, 60-309, Poland

  • Bausch Health Site 2320

    Bialystok, 15-322, Poland

  • Bausch Health Site 2321

    Staszów, 28-200, Poland

  • Bausch Health Site 2322

    Warsaw, 02-665, Poland

  • Bausch Health Site 2323

    Elblag, 82-300, Poland

  • Bausch Health Site 2401

    Veliky Novgorod, 173008, Russia

  • Bausch Health Site 2402

    Saint Petersburg, 197110, Russia

  • Bausch Health Site 2403

    Barnaul, 656015, Russia

  • Bausch Health Site 2405

    Nizhny Novgorod, 603140, Russia

  • Bausch Health Site 2406

    Moscow, 115516, Russia

  • Bausch Health Site 2408

    Saint Petersburg, 191015, Russia

  • Bausch Health Site 2409

    Saint Petersburg, 191015, Russia

  • Bausch Health Site 2410

    Tomsk, 634050, Russia

  • Bausch Health Site 2411

    Novosibirsk, 630005, Russia

  • Bausch Health Site 2413

    Pyatigorsk, 357502, Russia

  • Bausch Health Site 2415

    Saint Petersburg, 195257, Russia

  • Bausch Health Site 2416

    Chelyabinsk, 454076, Russia

  • Bausch Health Site 2417

    Chita, 672090, Russia

  • Bausch Health Site 2419

    Moscow, 115419, Russia

  • Bausch Health Site 2421

    Orenburg, 460050, Russia

  • Bausch Health Site 2422

    Samara, 443041, Russia

  • Bausch Health Site 2423

    Yekaterinburg, 620109, Russia

  • Bausch Health Site 2501

    Belgrade, 11 000, Serbia

  • Bausch Health Site 2502

    Belgrade, 11 000, Serbia

  • Bausch Health Site 2503

    Belgrade, 11 000, Serbia

  • Bausch Health Site 2504

    Pančevo, 260 00, Serbia

  • Bausch Health Site 2505

    Kragujevac, 34 000, Serbia

  • Bausch Health Site 2601

    Banská Bystrica, 975 17, Slovakia

  • Bausch Health Site 2602

    Prešov, 080 01, Slovakia

  • Bausch Health Site 2603

    Košice, 040 13, Slovakia

  • Bausch Health Site 2604

    Bratislava, 820 07, Slovakia

  • Bausch Health Site 2605

    Brezno, 97701, Slovakia

  • Bausch Health Site 2606

    Rimavská Sobota, 979 01, Slovakia

  • Bausch Health Site 2701

    Taichung, 404327, Taiwan

  • Bausch Health Site 2702

    Taichung, 40201, Taiwan

  • Bausch Health Site 2703

    Kaohsiung City, 807377, Taiwan

  • Bausch Health Site 2704

    Tainan, 704302, Taiwan

  • Bausch Health Site 2801

    Khmelnytskyi, 29000, Ukraine

  • Bausch Health Site 2802

    Zhytomyr, 10008, Ukraine

  • Bausch Health Site 2803

    Kharkiv, 61037, Ukraine

  • Bausch Health Site 2804

    Kyiv, 01030, Ukraine

  • Bausch Health Site 2805

    Odesa, 65025, Ukraine

  • Bausch Health Site 2806

    Kyiv, 04078, Ukraine

  • Bausch Health Site 2807

    Kyiv, 02091, Ukraine

  • Bausch Health Site 2808

    Zaporizhia, 69065, Ukraine

  • Bausch Health Site 2810

    Lviv, 79010, Ukraine

  • Bausch Health Site 2811

    Lutsk, 43005, Ukraine

  • Bausch Health Site 2812

    Zaporizhia, 69005, Ukraine

  • Bausch Health Site 2814

    Kyiv, Ukraine

  • Bausch Health Site 2815

    Ivano-Frankivsk, 76008, Ukraine

  • Bausch Health Site 2816

    Vinnytsia, 21028, Ukraine

  • Bausch Site 008

    Lafayette, Louisiana, 70503, United States

  • Bausch Site 011

    Chicago, Illinois, 60637, United States

  • Bausch Site 012

    Suffolk, Virginia, 23435, United States

  • Bausch Site 013

    Maitland, Florida, 32751, United States

  • Bausch Site 014

    El Paso, Texas, 79905, United States

  • Bausch Site 017

    Mentor, Ohio, 44060, United States

  • Bausch Site 018

    Houston, Texas, 77030, United States

  • Bausch Site 019

    Houston, Texas, 77030, United States

  • Bausch Site 020

    Glenview, Illinois, 60026, United States

  • Bausch Site 021

    Oklahoma City, Oklahoma, 73101, United States

  • Bausch Site 022

    Metairie, Louisiana, 70006, United States

  • Bausch Site 024

    Miami, Florida, 33174, United States

  • Bausch Site 025

    Chandler, Arizona, 85225, United States

  • Bausch Site 1101

    Homyel, 246029, Belarus

  • Bausch Site 1103

    Mogilev, 212018, Belarus

  • Bausch Site 1104

    Minsk, 220096, Belarus

  • Bausch Site 1105

    Vitebsk, 210002, Belarus

  • Bausch Site 1301

    Sofia, 1233, Bulgaria

  • Bausch Site 1302

    Sofia, 1527, Bulgaria

  • Bausch Site 1303

    Sofia, 1784, Bulgaria

  • Bausch Site 1304

    Sofia, 1407, Bulgaria

  • Bausch Site 1305

    Stara Zagora, 6000, Bulgaria

  • Bausch Site 1306

    Varna, 9002, Bulgaria

  • Bausch Site 1307

    Sofia, 1680, Bulgaria

  • Bausch Site 1501

    Tallinn, 10138, Estonia

  • Bausch Site 1502

    Tallinn, 10617, Estonia

  • Bausch Site 1503

    Pärnu, 80010, Estonia

  • Bausch site 026

    Orlando, Florida, 32807, United States

  • Bausch site 1001

    Brisbane, 4010, Australia

  • Bausch site 1002

    South Brisbane, 4101, Australia

  • Bausch site 1005

    Adelaide, 5112, Australia

  • Bausch site 1006

    Epping, 3076, Australia

  • Bausch site 1007

    Woolloongabba, 4102, Australia

  • Salix Site 001

    Shreveport, Louisiana, 71103, United States

  • Salix Site 002

    Freehold, New Jersey, 07728, United States

  • Salix Site 003

    Rancho Cucamonga, California, 91730, United States

  • Salix Site 004

    Los Angeles, California, 90048, United States

  • Salix Site 005

    Miramar, Florida, 33027, United States

  • Salix Site 006

    Ventura, California, 93003, United States

  • Salix Site 007

    Rialto, California, 92377, United States

  • Salix Site 010

    Snellville, Georgia, 30078, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.