Low Dose MT-1303 for Colitis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Bausch Site 018, Houston, TX
Colitis+3 More
Low Dose MT-1303 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug may help treat ulcerative colitis.

See full description

Eligible Conditions

  • Colitis
  • Ulcerative Colitis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Colitis

Study Objectives

This trial is evaluating whether Low Dose MT-1303 will improve 1 primary outcome and 3 secondary outcomes in patients with Colitis. Measurement will happen over the course of Baseline to Day 85.

Baseline to Day 85
Change from Baseline in the modified Mayo Score at Day 85
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 Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Colitis

Trial Design

3 Treatment Groups

High Dose
1 of 3
Low Dose
1 of 3
Placebo
1 of 3
Experimental Treatment
Non-Treatment Group

This trial requires 336 total participants across 3 different treatment groups

This trial involves 3 different treatments. Low Dose MT-1303 is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

High Dose
Drug
MT-1303 loading dose of 0.8 mg QD (Day 1-14) then maintenance dose of 0.4 mg QD (Day 15-85)
Low Dose
Drug
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)
Placebo
Drug
Matching placebo, QD (Day 1-85)

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to day 85
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to day 85 for reporting.

Closest Location

Bausch Site 018 - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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.

Patient Q&A Section

Is low dose mt-1303 typically used in combination with any other treatments?

"We found mt-1303 to be effective in this study and was typically considered safe and well tolerated as part of the induction, maintenance, and stabilization of disease." - Anonymous Online Contributor

Unverified Answer

How many people get colitis, ulcerative a year in the United States?

"Around 5.7 million people in the United States have at least one severe episode of UC or CD a year. UC was the more common of the two diseases." - Anonymous Online Contributor

Unverified Answer

What are common treatments for colitis, ulcerative?

"This is the largest study examining treatments of the inflammatory bowel disorders, and may have important implications for clinicians. For patients with Crohn's disease, common treatments include medical therapy with anti-TNF agents (mainly infliximab), and surgical procedures, whereas for UC patients, these options are common. The utility to physicians and patients of the use of alternative remedies is unknown." - Anonymous Online Contributor

Unverified Answer

Can colitis, ulcerative be cured?

"Colitis, ulcerative is a chronic immune-motile disease. This disease is not curable but this can usually be controlled by the patient's lifestyle changes and medications." - Anonymous Online Contributor

Unverified Answer

What are the signs of colitis, ulcerative?

"Colitis is characterized by symptoms such as bloody diarrhea, vomiting, abdominal pain, or weight loss. Most patients have signs of colitis such as diarrhea and abdominal pain that persist for less than two weeks and then disappear. Signs of celiac disease include skin flushing, weight loss, low-grade malabsorption, and diarrhea that lasts for more than a month. In celiac disease, if diarrhea persists, it is called IBS-D or irritable bowel syndrome with diarrhea. In ileal CD, there are signs and symptoms similar to colitis, such as diarrhea and abdominal pain. In children with CD, changes in growth, weight loss, and anemia can also imply a more severe form of CD." - Anonymous Online Contributor

Unverified Answer

What causes colitis, ulcerative?

"The same factors that increase the risk of IBD can cause colitis, and vice versa. This means that people with both ulcerative colitis and Crohn's disease have more than one factor causing inflammation." - Anonymous Online Contributor

Unverified Answer

What is colitis, ulcerative?

"Ulcerative colitis is a chronic inflammatory disease of the bowel that predominantly affects the colon. Symptoms vary depending on which part of the colon is affected. The disease is caused by an altered microbiota. Most cases are asymptomatic. It is strongly associated with inflammatory bowel disease (IBD) where many different autoimmune and infectious proteins are involved as cause or a synergistic effect. The disease is more common in females than males, and can also occur in adolescents." - Anonymous Online Contributor

Unverified Answer

What does low dose mt-1303 usually treat?

"Given the high cost and minimal safety of low dose mt-1303, it is surprising that only a small number of patients had the treatment extended to week 12. If low dose mt-1303 is ineffective in these patients, low dose mt-1303 should not be used for IBD." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of colitis, ulcerative?

"These are commonly seen primary causes of colitis secondary, which may involve any of the immunologic disorders. The most frequent cause of primary colonic disorders is a colonic neoplasm or fecal stricture(s. Most common sites of colorectal neoplasms include the right colon and sigmoid colon on an average. In primary colonic neoplasms, the most common sites of disease spread are to peritoneal or thoracic regions, followed by the ileocecal colon Region and then lymph node metastatic patterns. There also appears to be a high incidence of rectovulum neoplasm." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving low dose mt-1303?

"We found no evidence for mt-1303 as an effective anti-tumor drug. A thorough review of the available literature as well as additional validation of the findings in this report will be useful for the implementation of this novel compound in a clinical trial." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in low dose mt-1303 for therapeutic use?

"Currently available results suggest that low dose mt-1303 may have an antimetabolite or antimetabolite prodrug action to affect intestinal inflammatory and healing processes. The clinical use of mt-1303 remains in its infancy, but it is not without potential." - Anonymous Online Contributor

Unverified Answer

Has low dose mt-1303 proven to be more effective than a placebo?

"Findings from a recent study of this study demonstrated no significant difference in effectiveness of low dosage mt-1303 in comparison to placebo-controlled group. However, this did not necessarily mean that low dosage mt-1303 is less effective than the conventional dosage. To determine which dosage is more effective, larger studies are needed with adequate statistical power." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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