Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis

NCT04857112 | Completed Phase 2 FDA Drug

• 1 other identifier: AMUC-2023
• Study Type: interventional
• Target: 322
• Locations: 19 countries
• Sites: 185

Brief Summary

The study will assess the efficacy and safety of oral MT-1303 compared to placebo at 12 weeks as the induction treatment in subjects with active mild to moderate ulcerative colitis (UC), as well as maintenance treatment with open-label MT-1303 for up to 36 weeks.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in the modified Mayo Score at Day 85

  The modified Mayo Score for ulcerative colitis disease activity provides an assessment of disease severity and can be used to monitor subjects during therapy. Scoring is accomplished by summation of subscores for endoscopic findings, stool frequency, and rectal bleeding, with higher scores indicating worse severity. Each subscore ranges from 0 to 3. The modified Mayo Score is defined as the sum of the endoscopy findings subscore + stool frequency subscore + rectal bleeding subscore, with a range from 0 to 9.

  Baseline to Day 85

Secondary Outcomes (3)

• The proportion of subjects with endoscopic improvement at Day 85

  Baseline to Day 85

• The change from Baseline in the 2-component Mayo Score at Day 85.

  Baseline to Day 85

• The proportion of subjects with clinical remission at Day 85 based on the modified Mayo Score

  Baseline to Day 85

Study Arms (4)

Low Dose

EXPERIMENTAL

MT-1303 loading dose of 0.4 mg once daily (QD) (Day 1-14) then maintenance dose of 0.2 mg QD (Day 15-85)

Drug: Low Dose MT-1303

High Dose

EXPERIMENTAL

MT-1303 loading dose of 0.8 mg QD (Day 1-14) then maintenance dose of 0.4 mg QD (Day 15-85)

Drug: High Dose MT-1303

Placebo

PLACEBO COMPARATOR

Matching placebo, QD (Day 1-85)

Drug: Placebo

Open Label Extension Period

OTHER

0.4 mg MT-1303 QD for 36 weeks for those participants who continue on to the OLE period from the double-blind portion of the clinical study

Drug: MT-1303

Interventions

Low Dose MT-1303 DRUG

MT-1303 loading dose of 0.4 mg once daily (QD) (Day 1-14) then maintenance dose of 0.2 mg QD (Day 15-85)

Also known as: Amiselimod

Low Dose

High Dose MT-1303 DRUG

MT-1303 loading dose of 0.8 mg QD (Day 1-14) then maintenance dose of 0.4 mg QD (Day 15-85)

Also known as: Amiselimod

High Dose

Placebo DRUG

Matching placebo, QD (Day 1-85)

Also known as: Amiselimod

Placebo

MT-1303 DRUG

0.4 mg MT-1303 QD for 36 weeks for those participants who continue on to the OLE period from the double-blind portion of the clinical study

Also known as: Amiselimod

Open Label Extension Period

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (185)

Bausch Site 025

Chandler, Arizona, 85225, United States

Location

Salix Site 004

Los Angeles, California, 90048, United States

Location

Salix Site 003

Rancho Cucamonga, California, 91730, United States

Location

Salix Site 007

Rialto, California, 92377, United States

Location

Salix Site 006

Ventura, California, 93003, United States

Location

Bausch Site 013

Maitland, Florida, 32751, United States

Location

Bausch Site 024

Miami, Florida, 33174, United States

Location

Salix Site 005

Miramar, Florida, 33027, United States

Location

Bausch site 026

Orlando, Florida, 32807, United States

Location

Salix Site 010

Snellville, Georgia, 30078, United States

Location

Bausch Site 011

Chicago, Illinois, 60637, United States

Location

Bausch Site 020

Glenview, Illinois, 60026, United States

Location

Bausch Site 008

Lafayette, Louisiana, 70503, United States

Location

Bausch Site 022

Metairie, Louisiana, 70006, United States

Location

Salix Site 001

Shreveport, Louisiana, 71103, United States

Location

Salix Site 002

Freehold, New Jersey, 07728, United States

Location

Bausch Site 017

Mentor, Ohio, 44060, United States

Location

Bausch Site 021

Oklahoma City, Oklahoma, 73101, United States

Location

Bausch Site 014

El Paso, Texas, 79905, United States

Location

Bausch Site 018

Houston, Texas, 77030, United States

Location

Bausch Site 019

Houston, Texas, 77030, United States

Location

Bausch Site 012

Suffolk, Virginia, 23435, United States

Location

Bausch site 1005

Adelaide, 5112, Australia

Location

Bausch site 1001

Brisbane, 4010, Australia

Location

Bausch site 1006

Epping, 3076, Australia

Location

Bausch site 1002

South Brisbane, 4101, Australia

Location

Bausch site 1007

Woolloongabba, 4102, Australia

Location

Bausch Site 1101

Homyel, 246029, Belarus

Location

Bausch Site 1104

Minsk, 220096, Belarus

Location

Bausch Site 1103

Mogilev, 212018, Belarus

Location

Bausch Site 1105

Vitebsk, 210002, Belarus

Location

Bausch Site 1301

Sofia, 1233, Bulgaria

Location

Bausch Site 1304

Sofia, 1407, Bulgaria

Location

Bausch Site 1302

Sofia, 1527, Bulgaria

Location

Bausch Site 1307

Sofia, 1680, Bulgaria

Location

Bausch Site 1303

Sofia, 1784, Bulgaria

Location

Bausch Site 1305

Stara Zagora, 6000, Bulgaria

Location

Bausch Site 1306

Varna, 9002, Bulgaria

Location

Bausch Health Site 1404

Brno, 615 00, Czechia

Location

Bausch Health Site 1405

Hradec Králové, 500 12, Czechia

Location

Bausch Health Site 1403

Olomouc, 779 00, Czechia

Location

Bausch Health Site 1406

Pardubice, 532 03, Czechia

Location

Bausch Health Site 1401

Prague, 130 00, Czechia

Location

Bausch Health Site 1402

Slaný, 274 01, Czechia

Location

Bausch Site 1503

Pärnu, 80010, Estonia

Location

Bausch Site 1501

Tallinn, 10138, Estonia

Location

Bausch Site 1502

Tallinn, 10617, Estonia

Location

Bausch Health Site 1602

Tbilisi, 0131, Georgia

Location

Bausch Health Site 1603

Tbilisi, 0160, Georgia

Location

Bausch Health Site 1604

Tbilisi, 0160, Georgia

Location

Bausch Health Site 1605

Tbilisi, 0160, Georgia

Location

Bausch Health Site 1606

Tbilisi, 0160, Georgia

Location

Bausch Health Site 1601

Tbilisi, 0172, Georgia

Location

Bausch Health Site 1718

Augsburg, 86156, Germany

Location

Bausch Health Site 1705

Berlin, 10117, Germany

Location

Bausch Health Site 1716

Berlin, 14050, Germany

Location

Bausch Health Site 1717

Brandenburg, 14770, Germany

Location

Bausch Health Site 1708

Cologne, 51103, Germany

Location

Bausch Health Site 1710

Dresden, 01307, Germany

Location

Bausch Health Site 1707

Frankfurt am Main, 60594, Germany

Location

Bausch Health Site 1706

Kiel, 24105, Germany

Location

Bausch Health Site 1712

Mainz, 55122, Germany

Location

Bausch Health Site 1713

Mannheim, 68167, Germany

Location

Bausch Health Site 1702

Nordhausen, 99734, Germany

Location

Bausch Health Site 1709

Remscheid, 42589, Germany

Location

Bausch Health Site 1714

Rostock, 18057, Germany

Location

Bausch Health Site 1701

Tübingen, 72076, Germany

Location

Bausch Health Site 1703

Wipperfürth, 51688, Germany

Location

Bausch Health Site 1805

Békéscsaba, H-5600, Hungary

Location

Bausch Health Site 1803

Kistarcsa, H-2143, Hungary

Location

Bausch Health Site 1801

Mohács, 7700, Hungary

Location

Bausch Health Site 1802

Székesfehérvár, H-8000, Hungary

Location

Bausch Health Site 1906

Florence, 50134, Italy

Location

Bausch Health Site 1904

Messina, 98125, Italy

Location

Bausch Health Site 1909

Milan, 20142, Italy

Location

Bausch Health Site 1901

Milan, 20157, Italy

Location

Bausch Health Site 1908

Monza, 20900, Italy

Location

Bausch Health Site 1907

Padua, 35128, Italy

Location

Bausch Health Site 1903

Turin, 10128, Italy

Location

Bausch Health Site 2004

Chiba, 260-8677, Japan

Location

Bausch Health Site 2014

Chiba, 285-8741, Japan

Location

Bausch Health Site 2011

Fukuoka, 814-0180, Japan

Location

Bausch Health Site 2005

Hiroshima, 734-8551, Japan

Location

Bausch Health Site 2009

Hokkaido, 004-0041, Japan

Location

Bausch Health Site 2019

Hokkaido, 060-8543, Japan

Location

Bausch Health Site 2016

Hyōgo, 663-8501, Japan

Location

Bausch Health Site 2013

Iwata, 020-8505, Japan

Location

Bausch Health Site 2020

Kagawa, 252-0375, Japan

Location

Bausch Health Site 2022

Kamakura, 247-0056, Japan

Location

Bausch Health Site 2017

Mie, 510-0016, Japan

Location

Bausch Health Site 2002

Miyagi, 983-8520, Japan

Location

Bausch Health Site 2008

Nagasaki, 852-8102, Japan

Location

Bausch Health Site 2006

Ōita, 870-0823, Japan

Location

Bausch Health Site 2007

Saga, 849-8501, Japan

Location

Bausch Health Site 2023

Takayama, 506-8550, Japan

Location

Bausch Health Site 2012

Tokyo, 108-8642, Japan

Location

Bausch Health Site 2018

Tokyo, 113-0034, Japan

Location

Bausch Health Site 2010

Tokyo, 169-0073, Japan

Location

Bausch Health Site 2021

Tokyo, 181-8611, Japan

Location

Bausch Health Site 2003

Tokyo, 192-0032, Japan

Location

Bausch Health Site 2202

Chisinau, 2005, Moldova

Location

Bausch Health Site 2205

Chisinau, MD-2068, Moldova

Location

Bausch Health Site 2201

Chisinau, MD2025, Moldova

Location

Bausch Health Site 2203

Chisinau, MD2025, Moldova

Location

Bausch Health Site 2204

Chisinau, MD2025, Moldova

Location

Bausch Health Site 2320

Bialystok, 15-322, Poland

Location

Bausch Health Site 2309

Bydgoszcz, 85-794, Poland

Location

Bausch Health Site 2323

Elblag, 82-300, Poland

Location

Bausch Health Site 2301

Krakow, 30-363, Poland

Location

Bausch Health Site 2306

Krakow, 31-156, Poland

Location

Bausch Health Site 2314

Lodz, 93-357, Poland

Location

Bausch Health Site 2318

Nowy Targ, 34-400, Poland

Location

Bausch Health Site 2305

Oświęcim, 32-600, Poland

Location

Bausch Health Site 2316

Rzeszów, 35-302, Poland

Location

Bausch Health Site 2304

Sopot, 81-756, Poland

Location

Bausch Health Site 2321

Staszów, 28-200, Poland

Location

Bausch Health Site 2302

Szczecin, 71-434, Poland

Location

Bausch Health Site 2315

Tychy, 43-100, Poland

Location

Bausch Health Site 2311

Warsaw, 00-635, Poland

Location

Bausch Health Site 2303

Warsaw, 00-728, Poland

Location

Bausch Health Site 2322

Warsaw, 02-665, Poland

Location

Bausch Health Site 2308

Warsaw, 03-580, Poland

Location

Bausch Health Site 2310

Wierzchosławice, 33-122, Poland

Location

Bausch Health Site 2313

Wroclaw, 50-414, Poland

Location

Bausch Health Site 2317

Wroclaw, 50-449, Poland

Location

Bausch Health Site 2307

Wroclaw, 51-162, Poland

Location

Bausch Health Site 2319

Wroclaw, 60-309, Poland

Location

Bausch Health Site 2403

Barnaul, 656015, Russia

Location

Bausch Health Site 2416

Chelyabinsk, 454076, Russia

Location

Bausch Health Site 2417

Chita, 672090, Russia

Location

Bausch Health Site 2419

Moscow, 115419, Russia

Location

Bausch Health Site 2406

Moscow, 115516, Russia

Location

Bausch Health Site 2405

Nizhny Novgorod, 603140, Russia

Location

Bausch Health Site 2411

Novosibirsk, 630005, Russia

Location

Bausch Health Site 2421

Orenburg, 460050, Russia

Location

Bausch Health Site 2413

Pyatigorsk, 357502, Russia

Location

Bausch Health Site 2408

Saint Petersburg, 191015, Russia

Location

Bausch Health Site 2409

Saint Petersburg, 191015, Russia

Location

Bausch Health Site 2415

Saint Petersburg, 195257, Russia

Location

Bausch Health Site 2402

Saint Petersburg, 197110, Russia

Location

Bausch Health Site 2422

Samara, 443041, Russia

Location

Bausch Health Site 2410

Tomsk, 634050, Russia

Location

Bausch Health Site 2401

Veliky Novgorod, 173008, Russia

Location

Bausch Health Site 2423

Yekaterinburg, 620109, Russia

Location

Bausch Health Site 2501

Belgrade, 11 000, Serbia

Location

Bausch Health Site 2502

Belgrade, 11 000, Serbia

Location

Bausch Health Site 2503

Belgrade, 11 000, Serbia

Location

Bausch Health Site 2505

Kragujevac, 34 000, Serbia

Location

Bausch Health Site 2504

Pančevo, 260 00, Serbia

Location

Bausch Health Site 2601

Banská Bystrica, 975 17, Slovakia

Location

Bausch Health Site 2604

Bratislava, 820 07, Slovakia

Location

Bausch Health Site 2605

Brezno, 97701, Slovakia

Location

Bausch Health Site 2603

Košice, 040 13, Slovakia

Location

Bausch Health Site 2602

Prešov, 080 01, Slovakia

Location

Bausch Health Site 2606

Rimavská Sobota, 979 01, Slovakia

Location

Bausch Health Site 2109

Busan, 48108, South Korea

Location

Bausch Health Site 2112

Daegu, 41404, South Korea

Location

Bausch Health Site 2105

Daegu, 41944, South Korea

Location

Bausch Health Site 2114

Daegu, 42601, South Korea

Location

Bausch Health Site 2107

Seoul, 03080, South Korea

Location

Bausch Health Site 2101

Seoul, 05278, South Korea

Location

Bausch Health Site 2110

Seoul, 06351, South Korea

Location

Bausch Health Site 2102

Seoul, 06591, South Korea

Location

Bausch Health Site 2103

Seoul, 06973, South Korea

Location

Bausch Health Site 2108

Seoul, South Korea

Location

Bausch Health Site 2113

Suwon, 442-723, South Korea

Location

Bausch Health Site 2106

Wŏnju, 26426, South Korea

Location

Bausch Health Site 2703

Kaohsiung City, 807377, Taiwan

Location

Bausch Health Site 2702

Taichung, 40201, Taiwan

Location

Bausch Health Site 2701

Taichung, 404327, Taiwan

Location

Bausch Health Site 2704

Tainan, 704302, Taiwan

Location

Bausch Health Site 2815

Ivano-Frankivsk, 76008, Ukraine

Location

Bausch Health Site 2803

Kharkiv, 61037, Ukraine

Location

Bausch Health Site 2801

Khmelnytskyi, 29000, Ukraine

Location

Bausch Health Site 2804

Kyiv, 01030, Ukraine

Location

Bausch Health Site 2807

Kyiv, 02091, Ukraine

Location

Bausch Health Site 2806

Kyiv, 04078, Ukraine

Location

Bausch Health Site 2814

Kyiv, Ukraine

Location

Bausch Health Site 2811

Lutsk, 43005, Ukraine

Location

Bausch Health Site 2810

Lviv, 79010, Ukraine

Location

Bausch Health Site 2805

Odesa, 65025, Ukraine

Location

Bausch Health Site 2816

Vinnytsia, 21028, Ukraine

Location

Bausch Health Site 2812

Zaporizhia, 69005, Ukraine

Location

Bausch Health Site 2808

Zaporizhia, 69065, Ukraine

Location

Bausch Health Site 2802

Zhytomyr, 10008, Ukraine

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

amiselimod

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• John Lahey

  Bausch Health Americas, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 23, 2021
• Study Start: September 29, 2021
• Primary Completion: September 3, 2024
• Study Completion: November 8, 2024
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

UA (14); TW (4); US (22); AU (5); PL (22); ES (3); BU (7); HU (4); DE (15); GE (6); SE (5); RU (17); MO (5); SL (6); IT (7); KR (12); BE (4); CZ (6); JP (21)