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

PHASE2CompletedINTERVENTIONAL
Enrollment

322

Participants

Timeline

Start Date

September 29, 2021

Primary Completion Date

September 3, 2024

Study Completion Date

November 8, 2024

Conditions
Ulcerative Colitis
Interventions
DRUG

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)

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)

DRUG

Placebo

Matching placebo, QD (Day 1-85)

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

Trial Locations (185)

1233

Bausch Site 1301, Sofia

1407

Bausch Site 1304, Sofia

1527

Bausch Site 1302, Sofia

1680

Bausch Site 1307, Sofia

1784

Bausch Site 1303, Sofia

2005

Bausch Health Site 2202, Chisinau

3076

Bausch site 1006, Epping

4010

Bausch site 1001, Brisbane

4101

Bausch site 1002, South Brisbane

4102

Bausch site 1007, Woolloongabba

5112

Bausch site 1005, Adelaide

6000

Bausch Site 1305, Stara Zagora

7700

Bausch Health Site 1801, Mohács

9002

Bausch Site 1306, Varna

10008

Bausch Health Site 2802, Zhytomyr

10117

Bausch Health Site 1705, Berlin

10128

Bausch Health Site 1903, Turin

10138

Bausch Site 1501, Tallinn

10617

Bausch Site 1502, Tallinn

14050

Bausch Health Site 1716, Berlin

14770

Bausch Health Site 1717, Brandenburg

18057

Bausch Health Site 1714, Rostock

20142

Bausch Health Site 1909, Milan

20157

Bausch Health Site 1901, Milan

20900

Bausch Health Site 1908, Monza

21028

Bausch Health Site 2816, Vinnytsia

23435

Bausch Site 012, Suffolk

24105

Bausch Health Site 1706, Kiel

26426

Bausch Health Site 2106, Wŏnju

29000

Bausch Health Site 2801, Khmelnytskyi

30078

Salix Site 010, Snellville

32751

Bausch Site 013, Maitland

32807

Bausch site 026, Orlando

33027

Salix Site 005, Miramar

33174

Bausch Site 024, Miami

35128

Bausch Health Site 1907, Padua

40201

Bausch Health Site 2702, Taichung

41404

Bausch Health Site 2112, Daegu

41944

Bausch Health Site 2105, Daegu

42589

Bausch Health Site 1709, Remscheid

42601

Bausch Health Site 2114, Daegu

43005

Bausch Health Site 2811, Lutsk

44060

Bausch Site 017, Mentor

48108

Bausch Health Site 2109, Busan

50134

Bausch Health Site 1906, Florence

51103

Bausch Health Site 1708, Cologne

51688

Bausch Health Site 1703, Wipperfürth

55122

Bausch Health Site 1712, Mainz

60026

Bausch Site 020, Glenview

60594

Bausch Health Site 1707, Frankfurt am Main

60637

Bausch Site 011, Chicago

61037

Bausch Health Site 2803, Kharkiv

65025

Bausch Health Site 2805, Odesa

68167

Bausch Health Site 1713, Mannheim

69005

Bausch Health Site 2812, Zaporizhia

69065

Bausch Health Site 2808, Zaporizhia

70006

Bausch Site 022, Metairie

70503

Bausch Site 008, Lafayette

71103

Salix Site 001, Shreveport

72076

Bausch Health Site 1701, Tübingen

73101

Bausch Site 021, Oklahoma City

76008

Bausch Health Site 2815, Ivano-Frankivsk

77030

Bausch Site 018, Houston

Bausch Site 019, Houston

79010

Bausch Health Site 2810, Lviv

79905

Bausch Site 014, El Paso

80010

Bausch Site 1503, Pärnu

85225

Bausch Site 025, Chandler

86156

Bausch Health Site 1718, Augsburg

90048

Salix Site 004, Los Angeles

91730

Salix Site 003, Rancho Cucamonga

92377

Salix Site 007, Rialto

93003

Salix Site 006, Ventura

97701

Bausch Health Site 2605, Brezno

98125

Bausch Health Site 1904, Messina

99734

Bausch Health Site 1702, Nordhausen

115419

Bausch Health Site 2419, Moscow

115516

Bausch Health Site 2406, Moscow

173008

Bausch Health Site 2401, Veliky Novgorod

191015

Bausch Health Site 2408, Saint Petersburg

Bausch Health Site 2409, Saint Petersburg

195257

Bausch Health Site 2415, Saint Petersburg

197110

Bausch Health Site 2402, Saint Petersburg

210002

Bausch Site 1105, Vitebsk

212018

Bausch Site 1103, Mogilev

220096

Bausch Site 1104, Minsk

246029

Bausch Site 1101, Homyel

357502

Bausch Health Site 2413, Pyatigorsk

404327

Bausch Health Site 2701, Taichung

443041

Bausch Health Site 2422, Samara

454076

Bausch Health Site 2416, Chelyabinsk

460050

Bausch Health Site 2421, Orenburg

603140

Bausch Health Site 2405, Nizhny Novgorod

620109

Bausch Health Site 2423, Yekaterinburg

630005

Bausch Health Site 2411, Novosibirsk

634050

Bausch Health Site 2410, Tomsk

656015

Bausch Health Site 2403, Barnaul

672090

Bausch Health Site 2417, Chita

704302

Bausch Health Site 2704, Tainan City

807377

Bausch Health Site 2703, Kaohsiung City

07728

Salix Site 002, Freehold

615 00

Bausch Health Site 1404, Brno

500 12

Bausch Health Site 1405, Hradec Králové

779 00

Bausch Health Site 1403, Olomouc

532 03

Bausch Health Site 1406, Pardubice

130 00

Bausch Health Site 1401, Prague

274 01

Bausch Health Site 1402, Slaný

0131

Bausch Health Site 1602, Tbilisi

0160

Bausch Health Site 1603, Tbilisi

Bausch Health Site 1604, Tbilisi

Bausch Health Site 1605, Tbilisi

Bausch Health Site 1606, Tbilisi

0172

Bausch Health Site 1601, Tbilisi

01307

Bausch Health Site 1710, Dresden

H-5600

Bausch Health Site 1805, Békéscsaba

H-2143

Bausch Health Site 1803, Kistarcsa

H-8000

Bausch Health Site 1802, Székesfehérvár

260-8677

Bausch Health Site 2004, Chiba

285-8741

Bausch Health Site 2014, Chiba

814-0180

Bausch Health Site 2011, Fukuoka

734-8551

Bausch Health Site 2005, Hiroshima

004-0041

Bausch Health Site 2009, Hokkaido

060-8543

Bausch Health Site 2019, Hokkaido

663-8501

Bausch Health Site 2016, Hyōgo

020-8505

Bausch Health Site 2013, Iwata

252-0375

Bausch Health Site 2020, Kagawa

247-0056

Bausch Health Site 2022, Kamakura

510-0016

Bausch Health Site 2017, Mie

983-8520

Bausch Health Site 2002, Miyagi

852-8102

Bausch Health Site 2008, Nagasaki

870-0823

Bausch Health Site 2006, Ōita

849-8501

Bausch Health Site 2007, Saga

506-8550

Bausch Health Site 2023, Takayama

108-8642

Bausch Health Site 2012, Tokyo

113-0034

Bausch Health Site 2018, Tokyo

169-0073

Bausch Health Site 2010, Tokyo

181-8611

Bausch Health Site 2021, Tokyo

192-0032

Bausch Health Site 2003, Tokyo

MD-2068

Bausch Health Site 2205, Chisinau

MD2025

Bausch Health Site 2201, Chisinau

Bausch Health Site 2203, Chisinau

Bausch Health Site 2204, Chisinau

15-322

Bausch Health Site 2320, Bialystok

85-794

Bausch Health Site 2309, Bydgoszcz

82-300

Bausch Health Site 2323, Elblag

30-363

Bausch Health Site 2301, Krakow

31-156

Bausch Health Site 2306, Krakow

93-357

Bausch Health Site 2314, Lodz

34-400

Bausch Health Site 2318, Nowy Targ

32-600

Bausch Health Site 2305, Oświęcim

35-302

Bausch Health Site 2316, Rzeszów

81-756

Bausch Health Site 2304, Sopot

28-200

Bausch Health Site 2321, Staszów

71-434

Bausch Health Site 2302, Szczecin

43-100

Bausch Health Site 2315, Tychy

00-635

Bausch Health Site 2311, Warsaw

00-728

Bausch Health Site 2303, Warsaw

02-665

Bausch Health Site 2322, Warsaw

03-580

Bausch Health Site 2308, Warsaw

33-122

Bausch Health Site 2310, Wierzchosławice

50-414

Bausch Health Site 2313, Wroclaw

50-449

Bausch Health Site 2317, Wroclaw

51-162

Bausch Health Site 2307, Wroclaw

60-309

Bausch Health Site 2319, Wroclaw

11 000

Bausch Health Site 2501, Belgrade

Bausch Health Site 2502, Belgrade

Bausch Health Site 2503, Belgrade

34 000

Bausch Health Site 2505, Kragujevac

260 00

Bausch Health Site 2504, Pančevo

975 17

Bausch Health Site 2601, Banská Bystrica

820 07

Bausch Health Site 2604, Bratislava

040 13

Bausch Health Site 2603, Košice

080 01

Bausch Health Site 2602, Prešov

979 01

Bausch Health Site 2606, Rimavská Sobota

03080

Bausch Health Site 2107, Seoul

05278

Bausch Health Site 2101, Seoul

06351

Bausch Health Site 2110, Seoul

06591

Bausch Health Site 2102, Seoul

06973

Bausch Health Site 2103, Seoul

Unknown

Bausch Health Site 2108, Seoul

Bausch Health Site 2814, Kyiv

442-723

Bausch Health Site 2113, Suwon

01030

Bausch Health Site 2804, Kyiv

02091

Bausch Health Site 2807, Kyiv

04078

Bausch Health Site 2806, Kyiv

All Listed Sponsors
lead

Bausch Health Americas, Inc.

INDUSTRY

NCT04857112 - Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis | Biotech Hunter | Biotech Hunter