39 Participants Needed

MORF-057 for Ulcerative Colitis

Recruiting at 22 trial locations
MT
Overseen ByMorphic Therapeutic, Inc.
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Morphic Therapeutic, Inc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.12345

Are You a Good Fit for This Trial?

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.
See 2 more

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.
See 4 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: MORF-057Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Morphic Therapeutic, Inc

Lead Sponsor

Trials
4
Recruited
590+

Published Research Related to This Trial

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

Citations

Mycophenolate mofetil therapy for refractory inflammatory bowel disease. [2018]
Oral 5-aminosalicylic acid for inducing remission in ulcerative colitis. [2018]
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]
Use of mycophenolate mofetil in inflammatory bowel disease. [2021]
[A retrospective analysis of azathioprine in the treatment of 24 patients with refractory ulcerative colitis]. [2014]
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