MORF-057 for Ulcerative Colitis

Recruiting at 22 trial locations

Overseen By Morphic Therapeutic, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Morphic Therapeutic, Inc

Disqualifiers: Crohn's disease, Serious comorbidity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

35 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medicine called MORF-057 to see if it can help adults with serious bowel disease (Ulcerative Colitis) by reducing gut inflammation and improving symptoms.

Do I need to stop my current medications for the MORF-057 trial?

The trial information does not specify if you need to stop your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the drug MORF-057 for ulcerative colitis?

Research on similar drugs like mycophenolate mofetil (MMF) shows it can be effective for treating ulcerative colitis, suggesting that MORF-057 might also help. Additionally, treatments like 5-aminosalicylic acid and budesonide have been effective for ulcerative colitis, indicating that drugs targeting similar pathways could be beneficial. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults with moderately to severely active Ulcerative Colitis (UC) that's been present for at least 3 months. Participants must have UC extending 15 cm from the anal verge and may be new to treatment or unresponsive/intolerant to other UC drugs. They should not have Crohn's disease, certain colitis types, neurological issues on screening, previous MORF-057 exposure or hypersensitivity, serious health problems, or recent participation in another study.

Inclusion Criteria

I am able to understand and sign the consent form.

I have had moderate to severe ulcerative colitis symptoms for at least 3 months.

I have not tried or did not respond well to other ulcerative colitis drugs.

Exclusion Criteria

I cannot attend the study visits or follow the study procedures.

I have a serious health condition besides my cancer.

My condition did not improve with vedolizumab or similar medications.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MORF-057 for 12 weeks to evaluate efficacy, safety, and tolerability

12 weeks

Multiple visits for blood sampling and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term Extension

Participants may opt into continuation of treatment for an additional 26 weeks

26 weeks

Treatment Details

Interventions

• MORF-057

Trial Overview The trial is testing MORF-057's effectiveness and safety in treating Ulcerative Colitis. It’s an open-label Phase 2a study where all participants receive the drug; there are no comparison groups. The goal is to see how well it works and what side effects occur when given to people with moderate-to-severe UC.

Participant Groups

Group I: MORF-057 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Morphic Therapeutic, Inc

Lead Sponsor

Trials

4

Recruited

590+

Findings from Research

The newer formulations of 5-aminosalicylic acid (5-ASA) were found to be significantly more effective than placebo in inducing remission in active ulcerative colitis, with a pooled odds ratio of 0.51, indicating a lower failure rate in achieving clinical improvement.

While 5-ASA showed a trend towards better outcomes compared to sulfasalazine (SASP), the difference was not statistically significant, and 5-ASA was better tolerated, suggesting it may be a preferable option despite potential cost considerations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral 5-aminosalicylic acid for inducing remission in ulcerative colitis. Sutherland, L., Roth, D., Beck, P., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Mycophenolate mofetil therapy for refractory inflammatory bowel disease. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Oral 5-aminosalicylic acid for inducing remission in ulcerative colitis. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of budesonide MMX (Cortiment) for the treatment of mild-to-moderate active ulcerative colitis: study protocol for a prospective multicentre observational cohort study. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Use of mycophenolate mofetil in inflammatory bowel disease. [2021]

5. China pubmed.ncbi.nlm.nih.gov

[A retrospective analysis of azathioprine in the treatment of 24 patients with refractory ulcerative colitis]. [2014]