282 Participants Needed

MORF-057 for Ulcerative Colitis

(EMERALD-2 Trial)

Recruiting at 106 trial locations
MT
Overseen ByMorphic Therapeutic, Inc
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Morphic Therapeutic, Inc
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 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-057.12345

Are You a Good Fit for This Trial?

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.
See 6 more

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.
See 11 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 3Experimental Treatment1 Intervention
MORF-057 Dosing Regimen Three for Induction and Maintenance Periods
Group II: Group 2Experimental Treatment1 Intervention
MORF-057 Dosing Regimen Two for Induction and Maintenance Periods
Group III: Group 1Experimental Treatment1 Intervention
MORF-057 Dosing Regimen One for Induction and Maintenance Periods
Group IV: Group 4Placebo Group2 Interventions
Matching Placebo Dosing Regimen for Induction and MORF-057 Dosing Regimen Four for Maintenance

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]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security