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

A Phase 2, Randomized, Double-Blinded, Placebo Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects With Mild to Moderate Ulcerative Colitis (UC)

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Low Dose MT-1303; Drug: High Dose MT-1303; Drug: Placebo; Drug: MT-1303

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.

• Study Type: Interventional
• Enrollment (Actual): 322
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia, 5112
    • Bausch site 1005
  • Brisbane, Australia, 4010
    • Bausch site 1001
  • Epping, Australia, 3076
    • Bausch site 1006
  • South Brisbane, Australia, 4101
    • Bausch site 1002
  • Woolloongabba, Australia, 4102
    • Bausch site 1007
• Belarus
  • Homyel, Belarus, 246029
    • Bausch Site 1101
  • Minsk, Belarus, 220096
    • Bausch Site 1104
  • Mogilev, Belarus, 212018
    • Bausch Site 1103
  • Vitebsk, Belarus, 210002
    • Bausch Site 1105
• Bulgaria
  • Sofia, Bulgaria, 1233
    • Bausch Site 1301
  • Sofia, Bulgaria, 1407
    • Bausch Site 1304
  • Sofia, Bulgaria, 1527
    • Bausch Site 1302
  • Sofia, Bulgaria, 1680
    • Bausch Site 1307
  • Sofia, Bulgaria, 1784
    • Bausch Site 1303
  • Stara Zagora, Bulgaria, 6000
    • Bausch Site 1305
  • Varna, Bulgaria, 9002
    • Bausch Site 1306
• Czechia
  • Brno, Czechia, 615 00
    • Bausch Health Site 1404
  • Hradec Králové, Czechia, 500 12
    • Bausch Health Site 1405
  • Olomouc, Czechia, 779 00
    • Bausch Health Site 1403
  • Pardubice, Czechia, 532 03
    • Bausch Health Site 1406
  • Prague, Czechia, 130 00
    • Bausch Health Site 1401
  • Slaný, Czechia, 274 01
    • Bausch Health Site 1402
• Estonia
  • Pärnu, Estonia, 80010
    • Bausch Site 1503
  • Tallinn, Estonia, 10138
    • Bausch Site 1501
  • Tallinn, Estonia, 10617
    • Bausch Site 1502
• Georgia
  • Tbilisi, Georgia, 0131
    • Bausch Health Site 1602
  • Tbilisi, Georgia, 0160
    • Bausch Health Site 1603
  • Tbilisi, Georgia, 0160
    • Bausch Health Site 1604
  • Tbilisi, Georgia, 0160
    • Bausch Health Site 1605
  • Tbilisi, Georgia, 0160
    • Bausch Health Site 1606
  • Tbilisi, Georgia, 0172
    • Bausch Health Site 1601
• Germany
  • Augsburg, Germany, 86156
    • Bausch Health Site 1718
  • Berlin, Germany, 10117
    • Bausch Health Site 1705
  • Berlin, Germany, 14050
    • Bausch Health Site 1716
  • Brandenburg, Germany, 14770
    • Bausch Health Site 1717
  • Cologne, Germany, 51103
    • Bausch Health Site 1708
  • Dresden, Germany, 01307
    • Bausch Health Site 1710
  • Frankfurt am Main, Germany, 60594
    • Bausch Health Site 1707
  • Kiel, Germany, 24105
    • Bausch Health Site 1706
  • Mainz, Germany, 55122
    • Bausch Health Site 1712
  • Mannheim, Germany, 68167
    • Bausch Health Site 1713
  • Nordhausen, Germany, 99734
    • Bausch Health Site 1702
  • Remscheid, Germany, 42589
    • Bausch Health Site 1709
  • Rostock, Germany, 18057
    • Bausch Health Site 1714
  • Tübingen, Germany, 72076
    • Bausch Health Site 1701
  • Wipperfürth, Germany, 51688
    • Bausch Health Site 1703
• Hungary
  • Békéscsaba, Hungary, H-5600
    • Bausch Health Site 1805
  • Kistarcsa, Hungary, H-2143
    • Bausch Health Site 1803
  • Mohács, Hungary, 7700
    • Bausch Health Site 1801
  • Székesfehérvár, Hungary, H-8000
    • Bausch Health Site 1802
• Italy
  • Florence, Italy, 50134
    • Bausch Health Site 1906
  • Messina, Italy, 98125
    • Bausch Health Site 1904
  • Milan, Italy, 20142
    • Bausch Health Site 1909
  • Milan, Italy, 20157
    • Bausch Health Site 1901
  • Monza, Italy, 20900
    • Bausch Health Site 1908
  • Padua, Italy, 35128
    • Bausch Health Site 1907
  • Turin, Italy, 10128
    • Bausch Health Site 1903
• Japan
  • Chiba, Japan, 260-8677
    • Bausch Health Site 2004
  • Chiba, Japan, 285-8741
    • Bausch Health Site 2014
  • Fukuoka, Japan, 814-0180
    • Bausch Health Site 2011
  • Hiroshima, Japan, 734-8551
    • Bausch Health Site 2005
  • Hokkaido, Japan, 004-0041
    • Bausch Health Site 2009
  • Hokkaido, Japan, 060-8543
    • Bausch Health Site 2019
  • Hyōgo, Japan, 663-8501
    • Bausch Health Site 2016
  • Iwata, Japan, 020-8505
    • Bausch Health Site 2013
  • Kagawa, Japan, 252-0375
    • Bausch Health Site 2020
  • Kamakura, Japan, 247-0056
    • Bausch Health Site 2022
  • Mie, Japan, 510-0016
    • Bausch Health Site 2017
  • Miyagi, Japan, 983-8520
    • Bausch Health Site 2002
  • Nagasaki, Japan, 852-8102
    • Bausch Health Site 2008
  • Saga, Japan, 849-8501
    • Bausch Health Site 2007
  • Takayama, Japan, 506-8550
    • Bausch Health Site 2023
  • Tokyo, Japan, 108-8642
    • Bausch Health Site 2012
  • Tokyo, Japan, 113-0034
    • Bausch Health Site 2018
  • Tokyo, Japan, 169-0073
    • Bausch Health Site 2010
  • Tokyo, Japan, 181-8611
    • Bausch Health Site 2021
  • Tokyo, Japan, 192-0032
    • Bausch Health Site 2003
  • Ōita, Japan, 870-0823
    • Bausch Health Site 2006
• Moldova
  • Chisinau, Moldova, 2005
    • Bausch Health Site 2202
  • Chisinau, Moldova, MD-2068
    • Bausch Health Site 2205
  • Chisinau, Moldova, MD2025
    • Bausch Health Site 2201
  • Chisinau, Moldova, MD2025
    • Bausch Health Site 2203
  • Chisinau, Moldova, MD2025
    • Bausch Health Site 2204
• Poland
  • Bialystok, Poland, 15-322
    • Bausch Health Site 2320
  • Bydgoszcz, Poland, 85-794
    • Bausch Health Site 2309
  • Elblag, Poland, 82-300
    • Bausch Health Site 2323
  • Krakow, Poland, 30-363
    • Bausch Health Site 2301
  • Krakow, Poland, 31-156
    • Bausch Health Site 2306
  • Lodz, Poland, 93-357
    • Bausch Health Site 2314
  • Nowy Targ, Poland, 34-400
    • Bausch Health Site 2318
  • Oświęcim, Poland, 32-600
    • Bausch Health Site 2305
  • Rzeszów, Poland, 35-302
    • Bausch Health Site 2316
  • Sopot, Poland, 81-756
    • Bausch Health Site 2304
  • Staszów, Poland, 28-200
    • Bausch Health Site 2321
  • Szczecin, Poland, 71-434
    • Bausch Health Site 2302
  • Tychy, Poland, 43-100
    • Bausch Health Site 2315
  • Warsaw, Poland, 00-635
    • Bausch Health Site 2311
  • Warsaw, Poland, 00-728
    • Bausch Health Site 2303
  • Warsaw, Poland, 02-665
    • Bausch Health Site 2322
  • Warsaw, Poland, 03-580
    • Bausch Health Site 2308
  • Wierzchosławice, Poland, 33-122
    • Bausch Health Site 2310
  • Wroclaw, Poland, 50-414
    • Bausch Health Site 2313
  • Wroclaw, Poland, 50-449
    • Bausch Health Site 2317
  • Wroclaw, Poland, 51-162
    • Bausch Health Site 2307
  • Wroclaw, Poland, 60-309
    • Bausch Health Site 2319
• Russia
  • Barnaul, Russia, 656015
    • Bausch Health Site 2403
  • Chelyabinsk, Russia, 454076
    • Bausch Health Site 2416
  • Chita, Russia, 672090
    • Bausch Health Site 2417
  • Moscow, Russia, 115419
    • Bausch Health Site 2419
  • Moscow, Russia, 115516
    • Bausch Health Site 2406
  • Nizhny Novgorod, Russia, 603140
    • Bausch Health Site 2405
  • Novosibirsk, Russia, 630005
    • Bausch Health Site 2411
  • Orenburg, Russia, 460050
    • Bausch Health Site 2421
  • Pyatigorsk, Russia, 357502
    • Bausch Health Site 2413
  • Saint Petersburg, Russia, 191015
    • Bausch Health Site 2408
  • Saint Petersburg, Russia, 191015
    • Bausch Health Site 2409
  • Saint Petersburg, Russia, 195257
    • Bausch Health Site 2415
  • Saint Petersburg, Russia, 197110
    • Bausch Health Site 2402
  • Samara, Russia, 443041
    • Bausch Health Site 2422
  • Tomsk, Russia, 634050
    • Bausch Health Site 2410
  • Veliky Novgorod, Russia, 173008
    • Bausch Health Site 2401
  • Yekaterinburg, Russia, 620109
    • Bausch Health Site 2423
• Serbia
  • Belgrade, Serbia, 11 000
    • Bausch Health Site 2501
  • Belgrade, Serbia, 11 000
    • Bausch Health Site 2502
  • Belgrade, Serbia, 11 000
    • Bausch Health Site 2503
  • Kragujevac, Serbia, 34 000
    • Bausch Health Site 2505
  • Pančevo, Serbia, 260 00
    • Bausch Health Site 2504
• Slovakia
  • Banská Bystrica, Slovakia, 975 17
    • Bausch Health Site 2601
  • Bratislava, Slovakia, 820 07
    • Bausch Health Site 2604
  • Brezno, Slovakia, 97701
    • Bausch Health Site 2605
  • Košice, Slovakia, 040 13
    • Bausch Health Site 2603
  • Prešov, Slovakia, 080 01
    • Bausch Health Site 2602
  • Rimavská Sobota, Slovakia, 979 01
    • Bausch Health Site 2606
• South Korea
  • Busan, South Korea, 48108
    • Bausch Health Site 2109
  • Daegu, South Korea, 41404
    • Bausch Health Site 2112
  • Daegu, South Korea, 41944
    • Bausch Health Site 2105
  • Daegu, South Korea, 42601
    • Bausch Health Site 2114
  • Seoul, South Korea, 03080
    • Bausch Health Site 2107
  • Seoul, South Korea, 05278
    • Bausch Health Site 2101
  • Seoul, South Korea, 06351
    • Bausch Health Site 2110
  • Seoul, South Korea, 06591
    • Bausch Health Site 2102
  • Seoul, South Korea, 06973
    • Bausch Health Site 2103
  • Seoul, South Korea
    • Bausch Health Site 2108
  • Suwon, South Korea, 442-723
    • Bausch Health Site 2113
  • Wŏnju, South Korea, 26426
    • Bausch Health Site 2106
• Taiwan
  • Kaohsiung City, Taiwan, 807377
    • Bausch Health Site 2703
  • Taichung, Taiwan, 40201
    • Bausch Health Site 2702
  • Taichung, Taiwan, 404327
    • Bausch Health Site 2701
  • Tainan City, Taiwan, 704302
    • Bausch Health Site 2704
• Ukraine
  • Ivano-Frankivsk, Ukraine, 76008
    • Bausch Health Site 2815
  • Kharkiv, Ukraine, 61037
    • Bausch Health Site 2803
  • Khmelnytskyi, Ukraine, 29000
    • Bausch Health Site 2801
  • Kyiv, Ukraine, 01030
    • Bausch Health Site 2804
  • Kyiv, Ukraine, 02091
    • Bausch Health Site 2807
  • Kyiv, Ukraine, 04078
    • Bausch Health Site 2806
  • Kyiv, Ukraine
    • Bausch Health Site 2814
  • Lutsk, Ukraine, 43005
    • Bausch Health Site 2811
  • Lviv, Ukraine, 79010
    • Bausch Health Site 2810
  • Odesa, Ukraine, 65025
    • Bausch Health Site 2805
  • Vinnytsia, Ukraine, 21028
    • Bausch Health Site 2816
  • Zaporizhia, Ukraine, 69005
    • Bausch Health Site 2812
  • Zaporizhia, Ukraine, 69065
    • Bausch Health Site 2808
  • Zhytomyr, Ukraine, 10008
    • Bausch Health Site 2802
• United States
  • Arizona
    • Chandler, Arizona, United States, 85225
      • Bausch Site 025
  • California
    • Los Angeles, California, United States, 90048
      • Salix Site 004
    • Rancho Cucamonga, California, United States, 91730
      • Salix Site 003
    • Rialto, California, United States, 92377
      • Salix Site 007
    • Ventura, California, United States, 93003
      • Salix Site 006
  • Florida
    • Maitland, Florida, United States, 32751
      • Bausch Site 013
    • Miami, Florida, United States, 33174
      • Bausch Site 024
    • Miramar, Florida, United States, 33027
      • Salix Site 005
    • Orlando, Florida, United States, 32807
      • Bausch site 026
  • Georgia
    • Snellville, Georgia, United States, 30078
      • Salix Site 010
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Bausch Site 011
    • Glenview, Illinois, United States, 60026
      • Bausch Site 020
  • Louisiana
    • Lafayette, Louisiana, United States, 70503
      • Bausch Site 008
    • Metairie, Louisiana, United States, 70006
      • Bausch Site 022
    • Shreveport, Louisiana, United States, 71103
      • Salix Site 001
  • New Jersey
    • Freehold, New Jersey, United States, 07728
      • Salix Site 002
  • Ohio
    • Mentor, Ohio, United States, 44060
      • Bausch Site 017
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73101
      • Bausch Site 021
  • Texas
    • El Paso, Texas, United States, 79905
      • Bausch Site 014
    • Houston, Texas, United States, 77030
      • Bausch Site 018
    • Houston, Texas, United States, 77030
      • Bausch Site 019
  • Virginia
    • Suffolk, Virginia, United States, 23435
      • Bausch Site 012

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	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); Other Names: Amiselimod
Experimental: 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)	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); Other Names: Amiselimod
Placebo Comparator: Placebo; Matching placebo, QD (Day 1-85)	Drug: Placebo; Matching placebo, QD (Day 1-85); Other Names: Amiselimod
Other: 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	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; Other Names: Amiselimod

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of subjects with endoscopic improvement at Day 85	The Mayo endoscopic subscore ranges from 0 to 3, with higher scores indicating worse severity. Endoscopic improvement is a Mayo endoscopic subscore of ≤1.	Baseline to Day 85
The change from Baseline in the 2-component Mayo Score at Day 85.	2-component Mayo scoring is accomplished by summation of subscores for endoscopic findings and rectal bleeding, with higher scores indicating worse severity. Each subscore ranges from 0 to 3. The 2-component Mayo Score is the sum of the rectal bleeding plus endoscopic subscores, with a range from 0 to 6.	Baseline to Day 85
The proportion of subjects with clinical remission at Day 85 based on the modified Mayo Score	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. Remission is defined as follows: Endoscopy subscore of ≤1 (excludes friability); and; Rectal bleeding subscore of 0; and; At least one-point decrease in stool frequency subscore from Baseline to achieve a stool frequency subscore of ≤1.	Baseline to Day 85

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.
• Investigators: Study Director: John Lahey, Bausch Health Americas, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2021
• Primary Completion (Actual): September 3, 2024
• Study Completion (Actual): November 8, 2024

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (Actual): April 23, 2021

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs; amiselimod
• Other Study ID Numbers: AMUC-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No