- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04857112
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)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Alison Magnotti-Nagel
- Phone Number: 9085418664
- Email: Alison.Magnotti-Nagel@bauschhealth.com
Study Locations
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Arizona
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Chandler, Arizona, United States, 85225
- Bausch Site 025
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Tucson, Arizona, United States, 85719
- Bausch Site 023
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California
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Los Angeles, California, United States, 90048
- Salix Site 004
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Rancho Cucamonga, California, United States, 91730
- Salix Site 003
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Rialto, California, United States, 92377
- Salix Site 007
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Ventura, California, United States, 93003
- Salix Site 006
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Florida
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Maitland, Florida, United States, 32751
- Bausch Site 013
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Miami, Florida, United States, 33174
- Bausch Site 024
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Miramar, Florida, United States, 33027
- Salix Site 005
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Georgia
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Snellville, Georgia, United States, 30078
- Salix Site 010
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Illinois
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Chicago, Illinois, United States, 60637
- Bausch Site 011
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Glenview, Illinois, United States, 60026
- Bausch Site 020
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Louisiana
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Lafayette, Louisiana, United States, 70503
- Bausch Site 008
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Metairie, Louisiana, United States, 70006
- Bausch Site 022
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Shreveport, Louisiana, United States, 71103
- Salix Site 001
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New Jersey
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Freehold, New Jersey, United States, 07728
- Salix Site 002
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Ohio
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Mentor, Ohio, United States, 44060
- Bausch Site 017
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73101
- Bausch Site 021
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Texas
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El Paso, Texas, United States, 79905
- Bausch Site 014
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Houston, Texas, United States, 77030
- Bausch Site 018
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Houston, Texas, United States, 77030
- Bausch Site 019
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Virginia
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Suffolk, Virginia, United States, 23435
- Bausch Site 012
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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)
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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)
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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)
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MT-1303 loading dose of 0.8 mg QD (Day 1-14) then maintenance dose of 0.4 mg QD (Day 15-85)
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Placebo Comparator: Placebo
Matching placebo, QD (Day 1-85)
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Matching placebo, QD (Day 1-85)
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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
Time Frame: Baseline to Day 85
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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.
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Baseline to Day 85
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of subjects with endoscopic improvement at Day 85
Time Frame: Baseline to Day 85
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The Mayo endoscopic subscore ranges from 0 to 3, with higher scores indicating worse severity.
Endoscopic improvement is a Mayo endoscopic subscore of ≤1.
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Baseline to Day 85
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The change from Baseline in the 2-component Mayo Score at Day 85.
Time Frame: Baseline to Day 85
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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.
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Baseline to Day 85
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The proportion of subjects with clinical remission at Day 85 based on the modified Mayo Score
Time Frame: Baseline to 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. Remission is defined as follows:
|
Baseline to Day 85
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: John Lahey, Bausch Health Americas, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AMUC-2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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