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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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline in the modified Mayo Score at Day 85
Secondary study objectives
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)

Find a Location

Who is running the clinical trial?

Bausch Health Americas, Inc.Lead Sponsor
262 Previous Clinical Trials
81,594 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
~82 spots leftby Nov 2025