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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study 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.

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

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 Jun 2025
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