MORF-057 for Ulcerative Colitis

(EMERALD-2 Trial)

Recruiting at 106 trial locations

Overseen By Morphic Therapeutic, Inc

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Morphic Therapeutic, Inc

Must not be taking: Integrin inhibitors

Disqualifiers: Crohn's disease, Indeterminate colitis, others

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

Compensation: Varies

Number of Visits: Unknown

282 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called MORF-057 in adults with serious Ulcerative Colitis. The goal is to see if it can reduce inflammation in the gut and help the colon heal. Patients who don't respond well to current treatments might benefit from this new option.

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

The trial information does not specify if you need to stop your current medications. However, it mentions that participants should have had an inadequate response or intolerance to certain treatments, which might imply that you can continue some medications. It's best to discuss this with the trial coordinators.

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

Research shows that mycophenolate mofetil (MMF), a drug with similar immunomodulatory properties, has been effective in treating inflammatory bowel diseases like ulcerative colitis, suggesting potential effectiveness for MORF-057. ^{1 2 3 4 5}

Eligibility Criteria

Adults aged 18-85 with moderately to severely active Ulcerative Colitis (UC) who haven't responded well to certain UC treatments can join. They must not have used anti-integrin therapies before and should be able to follow study rules. People with a history of cancer in the last 5 years, unstable health conditions, or previous use of MORF-057 or similar drugs cannot participate.

Inclusion Criteria

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

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

I am able to understand and sign the consent form.

Exclusion Criteria

You cannot be participating in another study or have received any experimental treatment within the past 30 days.

I have not had colorectal or any cancer in the last 5 years.

I have been diagnosed with a specific type of colitis or have symptoms that may suggest Crohn's disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive one of three active dose regimens of MORF-057 or placebo for 12 weeks

12 weeks

Maintenance

Participants may switch to a different active MORF-057 regimen; placebo group switches to active regimen

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• MORF-057
• Placebo

Trial Overview The trial is testing three doses of MORF-057 against a placebo in adults with UC. It's randomized and double-blind, meaning neither the participants nor the researchers know who gets the real treatment versus the placebo until after results are collected.

Participant Groups

Group I: Group 3 Experimental Treatment 1 Intervention

MORF-057 Dosing Regimen Three for Induction and Maintenance Periods

Group II: Group 2 Experimental Treatment 1 Intervention

MORF-057 Dosing Regimen Two for Induction and Maintenance Periods

Group III: Group 1 Experimental Treatment 1 Intervention

MORF-057 Dosing Regimen One for Induction and Maintenance Periods

Group IV: Group 4 Placebo Group 2 Interventions

Matching Placebo Dosing Regimen for Induction and MORF-057 Dosing Regimen Four for Maintenance

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]