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Sphingosine-1-phosphate receptor modulator

Low Dose MT-1303 for Ulcerative Colitis

Phase 2
Recruiting
Research Sponsored by Bausch Health Americas, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Do you have the diagnosis of Ulcerative Colitis?
ANSWER YES if you are NOT taking other medications for Ulcerative Colitis in additional to Mesalamine, Sulfasalazine, Olsalazine, balzalazine or oral corticosteroids
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 85
Awards & highlights

Study Summary

This trial will study a new drug for ulcerative colitis, to see if it is better than placebo and can be used for long-term treatment.

Eligible Conditions
  • Ulcerative Colitis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 85
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 85 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in the modified Mayo Score at Day 85
Secondary outcome measures
The change from Baseline in the 2-component Mayo Score at Day 85.
The proportion of subjects with clinical remission at Day 85 based on the modified Mayo Score
The proportion of subjects with endoscopic improvement at Day 85

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low DoseExperimental Treatment1 Intervention
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)
Group II: High DoseExperimental Treatment1 Intervention
MT-1303 loading dose of 0.8 mg QD (Day 1-14) then maintenance dose of 0.4 mg QD (Day 15-85)
Group III: PlaceboPlacebo Group1 Intervention
Matching placebo, QD (Day 1-85)

Who is running the clinical trial?

Bausch Health Americas, Inc.Lead Sponsor
262 Previous Clinical Trials
81,692 Total Patients Enrolled
13 Trials studying Ulcerative Colitis
3,909 Patients Enrolled for Ulcerative Colitis
John LaheyStudy DirectorBausch Health Americas, Inc.
5 Previous Clinical Trials
1,142 Total Patients Enrolled

Media Library

Amiselimod (MT-1303) (Sphingosine-1-phosphate receptor modulator) Clinical Trial Eligibility Overview. Trial Name: NCT04857112 — Phase 2
Ulcerative Colitis Research Study Groups: Low Dose, High Dose, Placebo
Ulcerative Colitis Clinical Trial 2023: Amiselimod (MT-1303) Highlights & Side Effects. Trial Name: NCT04857112 — Phase 2
Amiselimod (MT-1303) (Sphingosine-1-phosphate receptor modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04857112 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there many research groups participating in this trial across America?

"To participate in this trial, it is ideal to choose the enrolling location nearest you as there are 30 different sites. Some of these include Fort Lauderdale, West Long Branch and San Bernardino. Keep in mind that travelling may be necessary depending on your proximity to these locations."

Answered by AI

If a patient is over 50, do they still qualify for the research?

"Eligibility requirements for this trial include being aged 18-75. There are 71 other trials available for patients that fall under the age of 18 and 363 studies for people over 65."

Answered by AI

Has MT-1303 been federally sanctioned for use at lower doses?

"Low Dose MT-1303 is currently in Phase 2 of clinical trials. Thus, while there is some evidence supporting its safety, none yet exists to suggest that it is an effective medication."

Answered by AI

How many people are currently being treated as part of this research?

"That is correct, the available information indicates that this study is open for enrollment. The listing was created on September 29th 2021 and updated most recently on June 7th 2022. There are 336 total patients needed to be enrolled at 30 different medical facilities."

Answered by AI

Are there specific inclusion criteria for this research project?

"Candidates for this clinical trial must have colitis and meet the age criteria of being between 18 to 75 years old. Currently, the study is looking to enroll 336 individuals."

Answered by AI

Are we still enrolling individuals for this clinical research?

"The trial is still open and actively recruiting patients, as shown by the clinicaltrials.gov date which was last updated on 6/7/2022. This study was first posted on 9/29/2021 and is looking for approximately 336 people across 30 different sites."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
Salix Site 006
Bausch Site 024
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Bausch Site 024: < 48 hours
Average response time
  • < 2 Days
~96 spots leftby Mar 2025