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MORF-057 for Ulcerative Colitis

Phase 2
Waitlist Available
Research Sponsored by Morphic Therapeutic, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Capable of giving signed informed consent
Has signs/symptoms of moderately to severely active UC for at least 3 months prior to Screening
Must not have
Unable to attend study visits or comply with study procedures
Has a concurrent, clinically significant, serious, unstable comorbidity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Summary

This trial will test if a new medication is effective and safe for people with moderate to severe ulcerative colitis.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects of MORF-057 aren't listed here, common ones associated with medications for UC might include headache, nausea, abdominal pain, fatigue and potential infusion-related reactions like fever or chills.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to understand and sign the consent form.
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I have had moderate to severe ulcerative colitis symptoms for at least 3 months.
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My ulcerative colitis extends 15 cm from the anal verge.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot attend the study visits or follow the study procedures.
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I have a serious health condition besides my cancer.
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My condition did not improve with vedolizumab or similar medications.
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I have had an allergic reaction to MORF-057 or similar drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline to Week 12 in the Robarts Histopathology Index (RHI) Score
Secondary outcome measures
Area under the curve (AUC) following single and multiple doses of MORF-057
Change from baseline to Week 12 in the Modified Mayo Clinic Score
Frequencies and proportions for treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and TEAEs leading to study drug discontinuation overtime
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: MORF-057Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MORF-057
2020
Completed Phase 1
~70

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Inflammatory Bowel Disease (IBD) include 5-aminosalicylates, glucocorticoids, immunomodulators, and biologic therapies. 5-aminosalicylates, such as mesalamine, reduce inflammation in the lining of the intestines. Glucocorticoids, like prednisone, suppress the overall immune response to decrease inflammation. Immunomodulators, such as azathioprine, alter the immune system to prevent ongoing inflammation. Biologic therapies, including infliximab and adalimumab, target specific components of the immune system, such as tumor necrosis factor (TNF), to block inflammatory pathways. These treatments are essential for IBD patients as they help manage symptoms, induce and maintain remission, and prevent complications. MORF-057, being studied for Ulcerative Colitis, likely works by modulating the immune response and reducing inflammation, similar to these established therapies, offering hope for improved disease management.
Emerging Therapies for Inflammatory Bowel Diseases.

Find a Location

Who is running the clinical trial?

Morphic Therapeutic, IncLead Sponsor
3 Previous Clinical Trials
557 Total Patients Enrolled

Media Library

MORF-057 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05291689 — Phase 2
Inflammatory Bowel Disease Research Study Groups: MORF-057
Inflammatory Bowel Disease Clinical Trial 2023: MORF-057 Highlights & Side Effects. Trial Name: NCT05291689 — Phase 2
MORF-057 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05291689 — Phase 2
~13 spots leftby Jul 2025