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MORF-057 for Ulcerative Colitis (EMERALD-2 Trial)
Verified Trial
Phase 2
Recruiting
Research Sponsored by Morphic Therapeutic, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Answer YES if you do NOT you have any unstable medical conditions rigth now.
Have you been diagnozed with Ulcerative Colitis?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 12 weeks
Awards & highlights
EMERALD-2 Trial Summary
This trial tests a new drug to help people with Ulcerative Colitis. It looks for safety & effectiveness in a controlled study.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects for MORF-057 aren't listed here, common ones for UC medications may include headache, nausea, abdominal pain, fatigue, and potential allergic reactions.
EMERALD-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Ulcerative Colitis.
Select...
My symptoms are getting worse.
Select...
I have not had colorectal or any cancer in the last 5 years.
Select...
I am taking medication for Ulcerative Colitis.
EMERALD-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants in clinical remission at Week 12 as determined using the Modified Mayo Clinic Score (mMCS).
Secondary outcome measures
Change from baseline to Week 12 in clinical response in the Modified Mayo Clinic Score (mMCS)
EMERALD-2 Trial Design
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
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
317 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had moderate to severe ulcerative colitis symptoms for at least 3 months.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.I am taking medication for Ulcerative Colitis.I have had moderate to severe ulcerative colitis symptoms for at least 3 months.I am able to understand and sign the consent form.I have never received treatments targeting integrins.I have been treated with MORF-057 or am allergic to similar drugs.My ulcerative colitis extends 15 cm from the anal verge.I have a serious health condition besides my cancer.My ulcerative colitis extends 15 cm from the anal verge.I have been treated with vedolizumab or similar drugs before.I have tried at least one UC treatment without success or could not tolerate it.I have not had colorectal or any other cancer in the past 5 years.I have been diagnosed with Ulcerative Colitis.My symptoms are getting worse.I have been diagnosed with Ulcerative Colitis.I am between 18 and 85 years old.You have reported neurological symptoms on a questionnaire.I have never received anti-integrin therapies.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2
- Group 2: Group 3
- Group 3: Group 4
- Group 4: Group 1
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants aged 20 and older eligible for inclusion in this experiment?
"The research team is only considering volunteers aged between 18 and 85 years."
Answered by AI
How many individuals have joined this research initiative?
"Affirmative. According to the data posted on clinicaltrials.gov, this trial was first advertised on October 31st 2022 and is currently seeking participants. The study requires 280 volunteers from 2 medical centres."
Answered by AI
Is it possible for me to become a participant in this experiment?
"This trial is accepting 280 colitis ulcerative sufferers, aged between 18 and 85. To be eligible applicants must have exhibited inadequate response to oral aminosalicylates (mesalamine, sulfasalazine etc), corticosteroids, immunosuppressants or advanced UC therapies. Patients should also agree to the study guidelines; provide informed consent; exhibit moderate-severe symptoms for 3 months prior to screening with evidence of UC extending 15cm from anal verge and not have been exposed previously to anti-integrin treatments."
Answered by AI
Has Group 3 fulfilled all the regulatory requirements of the FDA?
"Although there is some evidence of safety, the lack of efficacy data suggests that Group 3 should receive a rating of 2."
Answered by AI
Is it possible to join this medical study at the present moment?
"As confirmed on clinicaltrials.gov, this medical trial is presently recruiting patients. It was first advertised on October 31st 2022 and the information was refreshed November 9th 2022."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
Florida
How old are they?
18 - 65
What site did they apply to?
Other
Clinical Study Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
3+
0
Why did patients apply to this trial?
I'm hoping this trial will help with my medical issue.
PatientReceived 1 prior treatment
How responsive is this trial?
Most responsive sites:
- Clinical Study Site: < 24 hours
Typically responds via
Email
Phone Call
Average response time
- < 2 Days
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