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

Primary Purpose

Ulcerative Colitis

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Low Dose MT-1303
High Dose MT-1303
Placebo
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bausch Site 025Recruiting
  • Bausch Site 023Recruiting
  • Salix Site 004Recruiting
  • Salix Site 003Recruiting
  • Salix Site 007Recruiting
  • Salix Site 006Recruiting
  • Bausch Site 013Recruiting
  • Bausch Site 024Recruiting
  • Salix Site 005Recruiting
  • Salix Site 010Recruiting
  • Bausch Site 011Recruiting
  • Bausch Site 020Recruiting
  • Bausch Site 008Recruiting
  • Bausch Site 022Recruiting
  • Salix Site 001Recruiting
  • Salix Site 002Recruiting
  • Bausch Site 017Recruiting
  • Bausch Site 021Recruiting
  • Bausch Site 014Recruiting
  • Bausch Site 018Recruiting
  • Bausch Site 019Recruiting
  • Bausch Site 012Recruiting
  • Salix Site 009

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Low Dose

High Dose

Placebo

Arm Description

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)

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

Matching placebo, QD (Day 1-85)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 19, 2021
Last Updated
July 25, 2023
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04857112
Brief Title
Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 29, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
336 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Dose
Arm Type
Experimental
Arm Description
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)
Arm Title
High Dose
Arm Type
Experimental
Arm Description
MT-1303 loading dose of 0.8 mg QD (Day 1-14) then maintenance dose of 0.4 mg QD (Day 15-85)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo, QD (Day 1-85)
Intervention Type
Drug
Intervention Name(s)
Low Dose MT-1303
Intervention Description
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
Intervention Name(s)
High Dose MT-1303
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Matching placebo, QD (Day 1-85)
Primary Outcome Measure Information:
Title
Change from Baseline in the modified Mayo Score at Day 85
Description
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.
Time Frame
Baseline to Day 85
Secondary Outcome Measure Information:
Title
The proportion of subjects with endoscopic improvement at Day 85
Description
The Mayo endoscopic subscore ranges from 0 to 3, with higher scores indicating worse severity. Endoscopic improvement is a Mayo endoscopic subscore of ≤1.
Time Frame
Baseline to Day 85
Title
The change from Baseline in the 2-component Mayo Score at Day 85.
Description
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.
Time Frame
Baseline to Day 85
Title
The proportion of subjects with clinical remission at Day 85 based on the modified Mayo Score
Description
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.
Time Frame
Baseline to Day 85

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alison Magnotti-Nagel
Phone
9085418664
Email
Alison.Magnotti-Nagel@bauschhealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Lahey
Organizational Affiliation
Bausch Health Americas, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Bausch Site 025
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 023
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Recruiting
Facility Name
Salix Site 004
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Name
Salix Site 003
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Individual Site Status
Recruiting
Facility Name
Salix Site 007
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Individual Site Status
Recruiting
Facility Name
Salix Site 006
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 013
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 024
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Individual Site Status
Recruiting
Facility Name
Salix Site 005
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Individual Site Status
Recruiting
Facility Name
Salix Site 010
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valeant S 44
Facility Name
Bausch Site 011
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 020
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 008
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 022
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Individual Site Status
Recruiting
Facility Name
Salix Site 001
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Individual Site Status
Recruiting
Facility Name
Salix Site 002
City
Freehold
State/Province
New Jersey
ZIP/Postal Code
07728
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 017
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 021
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73101
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 014
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 018
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 019
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 012
City
Suffolk
State/Province
Virginia
ZIP/Postal Code
23435
Country
United States
Individual Site Status
Recruiting
Facility Name
Salix Site 009
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Withdrawn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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