Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04857112




Registration number
NCT04857112
Ethics application status
Date submitted
19/04/2021
Date registered
23/04/2021
Date last updated
9/09/2025

Titles & IDs
Public title
Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis
Scientific title
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)
Secondary ID [1] 0 0
AMUC-2023
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Low Dose MT-1303
Treatment: Drugs - High Dose MT-1303
Treatment: Drugs - Placebo
Treatment: Drugs - MT-1303

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)

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)

Placebo comparator: Placebo - Matching placebo, QD (Day 1-85)

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


Treatment: Drugs: 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)

Treatment: Drugs: 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)

Treatment: Drugs: Placebo
Matching placebo, QD (Day 1-85)

Treatment: Drugs: 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 code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline in the modified Mayo Score at Day 85
Timepoint [1] 0 0
Baseline to Day 85
Secondary outcome [1] 0 0
The proportion of subjects with endoscopic improvement at Day 85
Timepoint [1] 0 0
Baseline to Day 85
Secondary outcome [2] 0 0
The change from Baseline in the 2-component Mayo Score at Day 85.
Timepoint [2] 0 0
Baseline to Day 85
Secondary outcome [3] 0 0
The proportion of subjects with clinical remission at Day 85 based on the modified Mayo Score
Timepoint [3] 0 0
Baseline to Day 85

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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, ß 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/11/2024
Sample size
Target
Accrual to date
Final
322
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Bausch site 1005 - Adelaide
Recruitment hospital [2] 0 0
Bausch site 1001 - Brisbane
Recruitment hospital [3] 0 0
Bausch site 1006 - Epping
Recruitment hospital [4] 0 0
Bausch site 1002 - South Brisbane
Recruitment hospital [5] 0 0
Bausch site 1007 - Woolloongabba
Recruitment postcode(s) [1] 0 0
5112 - Adelaide
Recruitment postcode(s) [2] 0 0
4010 - Brisbane
Recruitment postcode(s) [3] 0 0
3076 - Epping
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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California
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Florida
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Georgia
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Illinois
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Louisiana
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New Jersey
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Ohio
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Oklahoma
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Texas
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United States of America
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Virginia
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Belarus
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Homyel
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Belarus
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Minsk
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Belarus
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Mogilev
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Belarus
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Vitebsk
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Bulgaria
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Sofia
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Stara Zagora
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Varna
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Czechia
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Brno
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Czechia
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Hradec Králové
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Czechia
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Olomouc
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Pardubice
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Prague
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Slaný
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Pärnu
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Estonia
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Tallinn
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Georgia
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Tbilisi
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Germany
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Augsburg
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Berlin
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Brandenburg
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Cologne
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Dresden
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Frankfurt am Main
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Kiel
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Mainz
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Mannheim
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Remscheid
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Rostock
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Tübingen
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Wipperfürth
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Békéscsaba
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Kistarcsa
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Mohács
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Messina
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Milan
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Monza
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Padua
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Mie
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Miyagi
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Nagasaki
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Oita
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Saga
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Takayama
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Barnaul
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Orenburg
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Saint Petersburg
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Samara
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Tomsk
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Veliky Novgorod
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Russia
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Yekaterinburg
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Serbia
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Belgrade
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Serbia
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Kragujevac
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Serbia
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Pancevo
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Slovakia
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Banská Bystrica
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Bratislava
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Brezno
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Košice
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Prešov
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Slovakia
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Rimavská Sobota
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South Korea
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Busan
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South Korea
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Daegu
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South Korea
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Seoul
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South Korea
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Suwon
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South Korea
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Wonju
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Taiwan
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Kaohsiung City
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Taiwan
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Taichung
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Taiwan
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Tainan City
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kharkiv
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Ukraine
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Khmelnytskyi
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Kyiv
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Lutsk
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Ukraine
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Lviv
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Ukraine
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Odesa
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Ukraine
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Vinnytsia
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Ukraine
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Zaporizhia
Country [122] 0 0
Ukraine
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Zhytomyr

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bausch Health Americas, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John Lahey
Address 0 0
Bausch Health Americas, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04857112