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

NCT ID: NCT04857112

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 322 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-29
• Study Completion Date: 2024-11-08

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.

Detailed Description

This is a Phase 2, randomized, double-blinded, placebo-controlled 3-arm, multi-center, parallel-group study with an open-label extension (OLE) period. The study includes a Screening Period (of up to 28 days) and a 12-week Double-Blind Period (Day 1 through Day 85) for all subjects. Subjects completing the Double-Blind Period through Day 85 will be provided the opportunity to continue in the OLE Period of the study to receive treatment through approximately one year. Subjects who do not participate in the OLE Period will be followed for 84 days in a Safety Follow-up Period.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Low Dose

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)

Group Type: EXPERIMENTAL

Low Dose MT-1303

Intervention Type: 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)

High Dose

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

Group Type: EXPERIMENTAL

High Dose MT-1303

Intervention Type: DRUG

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

Placebo

Matching placebo, QD (Day 1-85)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo, QD (Day 1-85)

Open Label Extension Period

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

Group Type: OTHER

MT-1303

Intervention Type: 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

Interventions

Low Dose MT-1303

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)

Intervention Type: DRUG

High Dose MT-1303

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

Intervention Type: DRUG

Placebo

Matching placebo, QD (Day 1-85)

Intervention Type: DRUG

MT-1303

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

Intervention Type: DRUG

Other Intervention Names

Amiselimod; Amiselimod; Amiselimod; Amiselimod

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Lahey

Role: STUDY_DIRECTOR

Bausch Health Americas, Inc.

Locations

Bausch Site 025

Chandler, Arizona, United States

Salix Site 004

Los Angeles, California, United States

Salix Site 003

Rancho Cucamonga, California, United States

Salix Site 007

Rialto, California, United States

Salix Site 006

Ventura, California, United States

Bausch Site 013

Maitland, Florida, United States

Bausch Site 024

Miami, Florida, United States

Salix Site 005

Miramar, Florida, United States

Bausch site 026

Orlando, Florida, United States

Salix Site 010

Snellville, Georgia, United States

Bausch Site 011

Chicago, Illinois, United States

Bausch Site 020

Glenview, Illinois, United States

Bausch Site 008

Lafayette, Louisiana, United States

Bausch Site 022

Metairie, Louisiana, United States

Salix Site 001

Shreveport, Louisiana, United States

Salix Site 002

Freehold, New Jersey, United States

Bausch Site 017

Mentor, Ohio, United States

Bausch Site 021

Oklahoma City, Oklahoma, United States

Bausch Site 014

El Paso, Texas, United States

Bausch Site 018

Houston, Texas, United States

Bausch Site 019

Houston, Texas, United States

Bausch Site 012

Suffolk, Virginia, United States

Bausch site 1005

Adelaide, , Australia

Bausch site 1001

Brisbane, , Australia

Bausch site 1006

Epping, , Australia

Bausch site 1002

South Brisbane, , Australia

Bausch site 1007

Woolloongabba, , Australia

Bausch Site 1101

Homyel, , Belarus

Bausch Site 1104

Minsk, , Belarus

Bausch Site 1103

Mogilev, , Belarus

Bausch Site 1105

Vitebsk, , Belarus

Bausch Site 1301

Sofia, , Bulgaria

Bausch Site 1304

Sofia, , Bulgaria

Bausch Site 1302

Sofia, , Bulgaria

Bausch Site 1307

Sofia, , Bulgaria

Bausch Site 1303

Sofia, , Bulgaria

Bausch Site 1305

Stara Zagora, , Bulgaria

Bausch Site 1306

Varna, , Bulgaria

Bausch Health Site 1404

Brno, , Czechia

Bausch Health Site 1405

Hradec Králové, , Czechia

Bausch Health Site 1403

Olomouc, , Czechia

Bausch Health Site 1406

Pardubice, , Czechia

Bausch Health Site 1401

Prague, , Czechia

Bausch Health Site 1402

Slaný, , Czechia

Bausch Site 1503

Pärnu, , Estonia

Bausch Site 1501

Tallinn, , Estonia

Bausch Site 1502

Tallinn, , Estonia

Bausch Health Site 1602

Tbilisi, , Georgia

Bausch Health Site 1603

Tbilisi, , Georgia

Bausch Health Site 1604

Tbilisi, , Georgia

Bausch Health Site 1605

Tbilisi, , Georgia

Bausch Health Site 1606

Tbilisi, , Georgia

Bausch Health Site 1601

Tbilisi, , Georgia

Bausch Health Site 1718

Augsburg, , Germany

Bausch Health Site 1705

Berlin, , Germany

Bausch Health Site 1716

Berlin, , Germany

Bausch Health Site 1717

Brandenburg, , Germany

Bausch Health Site 1708

Cologne, , Germany

Bausch Health Site 1710

Dresden, , Germany

Bausch Health Site 1707

Frankfurt am Main, , Germany

Bausch Health Site 1706

Kiel, , Germany

Bausch Health Site 1712

Mainz, , Germany

Bausch Health Site 1713

Mannheim, , Germany

Bausch Health Site 1702

Nordhausen, , Germany

Bausch Health Site 1709

Remscheid, , Germany

Bausch Health Site 1714

Rostock, , Germany

Bausch Health Site 1701

Tübingen, , Germany

Bausch Health Site 1703

Wipperfürth, , Germany

Bausch Health Site 1805

Békéscsaba, , Hungary

Bausch Health Site 1803

Kistarcsa, , Hungary

Bausch Health Site 1801

Mohács, , Hungary

Bausch Health Site 1802

Székesfehérvár, , Hungary

Bausch Health Site 1906

Florence, , Italy

Bausch Health Site 1904

Messina, , Italy

Bausch Health Site 1909

Milan, , Italy

Bausch Health Site 1901

Milan, , Italy

Bausch Health Site 1908

Monza, , Italy

Bausch Health Site 1907

Padua, , Italy

Bausch Health Site 1903

Turin, , Italy

Bausch Health Site 2004

Chiba, , Japan

Bausch Health Site 2014

Chiba, , Japan

Bausch Health Site 2011

Fukuoka, , Japan

Bausch Health Site 2005

Hiroshima, , Japan

Bausch Health Site 2009

Hokkaido, , Japan

Bausch Health Site 2019

Hokkaido, , Japan

Bausch Health Site 2016

Hyōgo, , Japan

Bausch Health Site 2013

Iwata, , Japan

Bausch Health Site 2020

Kagawa, , Japan

Bausch Health Site 2022

Kamakura, , Japan

Bausch Health Site 2017

Mie, , Japan

Bausch Health Site 2002

Miyagi, , Japan

Bausch Health Site 2008

Nagasaki, , Japan

Bausch Health Site 2006

Ōita, , Japan

Bausch Health Site 2007

Saga, , Japan

Bausch Health Site 2023

Takayama, , Japan

Bausch Health Site 2012

Tokyo, , Japan

Bausch Health Site 2018

Tokyo, , Japan

Bausch Health Site 2010

Tokyo, , Japan

Bausch Health Site 2021

Tokyo, , Japan

Bausch Health Site 2003

Tokyo, , Japan

Bausch Health Site 2202

Chisinau, , Moldova

Bausch Health Site 2205

Chisinau, , Moldova

Bausch Health Site 2201

Chisinau, , Moldova

Bausch Health Site 2203

Chisinau, , Moldova

Bausch Health Site 2204

Chisinau, , Moldova

Bausch Health Site 2320

Bialystok, , Poland

Bausch Health Site 2309

Bydgoszcz, , Poland

Bausch Health Site 2323

Elblag, , Poland

Bausch Health Site 2301

Krakow, , Poland

Bausch Health Site 2306

Krakow, , Poland

Bausch Health Site 2314

Lodz, , Poland

Bausch Health Site 2318

Nowy Targ, , Poland

Bausch Health Site 2305

Oświęcim, , Poland

Bausch Health Site 2316

Rzeszów, , Poland

Bausch Health Site 2304

Sopot, , Poland

Bausch Health Site 2321

Staszów, , Poland

Bausch Health Site 2302

Szczecin, , Poland

Bausch Health Site 2315

Tychy, , Poland

Bausch Health Site 2311

Warsaw, , Poland

Bausch Health Site 2303

Warsaw, , Poland

Bausch Health Site 2322

Warsaw, , Poland

Bausch Health Site 2308

Warsaw, , Poland

Bausch Health Site 2310

Wierzchosławice, , Poland

Bausch Health Site 2313

Wroclaw, , Poland

Bausch Health Site 2317

Wroclaw, , Poland

Bausch Health Site 2307

Wroclaw, , Poland

Bausch Health Site 2319

Wroclaw, , Poland

Bausch Health Site 2403

Barnaul, , Russia

Bausch Health Site 2416

Chelyabinsk, , Russia

Bausch Health Site 2417

Chita, , Russia

Bausch Health Site 2419

Moscow, , Russia

Bausch Health Site 2406

Moscow, , Russia

Bausch Health Site 2405

Nizhny Novgorod, , Russia

Bausch Health Site 2411

Novosibirsk, , Russia

Bausch Health Site 2421

Orenburg, , Russia

Bausch Health Site 2413

Pyatigorsk, , Russia

Bausch Health Site 2408

Saint Petersburg, , Russia

Bausch Health Site 2409

Saint Petersburg, , Russia

Bausch Health Site 2415

Saint Petersburg, , Russia

Bausch Health Site 2402

Saint Petersburg, , Russia

Bausch Health Site 2422

Samara, , Russia

Bausch Health Site 2410

Tomsk, , Russia

Bausch Health Site 2401

Veliky Novgorod, , Russia

Bausch Health Site 2423

Yekaterinburg, , Russia

Bausch Health Site 2501

Belgrade, , Serbia

Bausch Health Site 2502

Belgrade, , Serbia

Bausch Health Site 2503

Belgrade, , Serbia

Bausch Health Site 2505

Kragujevac, , Serbia

Bausch Health Site 2504

Pančevo, , Serbia

Bausch Health Site 2601

Banská Bystrica, , Slovakia

Bausch Health Site 2604

Bratislava, , Slovakia

Bausch Health Site 2605

Brezno, , Slovakia

Bausch Health Site 2603

Košice, , Slovakia

Bausch Health Site 2602

Prešov, , Slovakia

Bausch Health Site 2606

Rimavská Sobota, , Slovakia

Bausch Health Site 2109

Busan, , South Korea

Bausch Health Site 2112

Daegu, , South Korea

Bausch Health Site 2105

Daegu, , South Korea

Bausch Health Site 2114

Daegu, , South Korea

Bausch Health Site 2107

Seoul, , South Korea

Bausch Health Site 2101

Seoul, , South Korea

Bausch Health Site 2110

Seoul, , South Korea

Bausch Health Site 2102

Seoul, , South Korea

Bausch Health Site 2103

Seoul, , South Korea

Bausch Health Site 2108

Seoul, , South Korea

Bausch Health Site 2113

Suwon, , South Korea

Bausch Health Site 2106

Wŏnju, , South Korea

Bausch Health Site 2703

Kaohsiung City, , Taiwan

Bausch Health Site 2702

Taichung, , Taiwan

Bausch Health Site 2701

Taichung, , Taiwan

Bausch Health Site 2704

Tainan City, , Taiwan

Bausch Health Site 2815

Ivano-Frankivsk, , Ukraine

Bausch Health Site 2803

Kharkiv, , Ukraine

Bausch Health Site 2801

Khmelnytskyi, , Ukraine

Bausch Health Site 2804

Kyiv, , Ukraine

Bausch Health Site 2807

Kyiv, , Ukraine

Bausch Health Site 2806

Kyiv, , Ukraine

Bausch Health Site 2814

Kyiv, , Ukraine

Bausch Health Site 2811

Lutsk, , Ukraine

Bausch Health Site 2810

Lviv, , Ukraine

Bausch Health Site 2805

Odesa, , Ukraine

Bausch Health Site 2816

Vinnytsia, , Ukraine

Bausch Health Site 2812

Zaporizhia, , Ukraine

Bausch Health Site 2808

Zaporizhia, , Ukraine

Bausch Health Site 2802

Zhytomyr, , Ukraine

Countries

United States; Australia; Belarus; Bulgaria; Czechia; Estonia; Georgia; Germany; Hungary; Italy; Japan; Moldova; Poland; Russia; Serbia; Slovakia; South Korea; Taiwan; Ukraine

Other Identifiers

AMUC-2023

Identifier Type: -

Identifier Source: org_study_id