What side effects are associated with this type of intervention?

Common treatments for Inflammatory Bowel Disease (IBD) include integrin inhibitors like vedolizumab and AJM300, anti-TNF agents, and 5-aminosalicylic acids (5-ASA). Integrin inhibitors, such as vedolizumab, are generally well-tolerated but can cause headaches, joint pain, and increased risk of infections. Anti-TNF agents, like infliximab and adalimumab, may lead to infections, infusion reactions, and rare but serious risks like lymphoma. 5-ASA drugs, such as mesalamine, can cause nausea, headache, and rarely, kidney issues or pancreatitis. Each treatment has a unique side effect profile, and the choice of therapy should be tailored to the individual patient's condition and response to previous treatments.

What prior FDA approvals exist?

Integrin α4β7 inhibitors, such as vedolizumab, have been approved by the FDA for the treatment of Inflammatory Bowel Disease, including both Crohn's disease and ulcerative colitis. Vedolizumab specifically targets the α4β7 integrin, which plays a crucial role in the migration of immune cells to the gut, thereby reducing inflammation. Other FDA-approved treatments for IBD include anti-TNF agents like infliximab and adalimumab, which target tumor necrosis factor-alpha to control inflammation, and immunomodulators such as azathioprine and methotrexate. These treatments help manage symptoms and induce remission in patients with moderate to severe IBD.

What other types of research exist?

Promising novel alternatives to MORF-057 for IBD patients include AJM300 (carotegrast methyl), an oral α4-integrin antagonist, and Etrolizumab, an anti-integrin targeting β7 subunits. Both have shown efficacy and safety in clinical trials for ulcerative colitis.

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MORF-057 for Ulcerative Colitis (EMERALD-2 Trial)

Verified Trial

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

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

Summary

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Ulcerative Colitis.

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My symptoms are getting worse.

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

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I am taking medication for Ulcerative Colitis.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants in clinical remission at Week 12 as determined using the Modified Mayo Clinic Score (mMCS).

Secondary study objectives

Change from baseline to Week 12 in clinical response in the Modified Mayo Clinic Score (mMCS)

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

0 / 5Eligibility criteria met

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

Integrin inhibitors, such as MORF-057, work by blocking integrins that facilitate the adhesion and migration of leukocytes to inflamed gut tissues, thereby reducing inflammation and maintaining remission in IBD patients. Other common treatments include anti-TNF agents, which neutralize TNF-α to reduce systemic inflammation, and corticosteroids, which broadly suppress the immune response. Understanding these mechanisms helps in selecting the most appropriate therapy based on the specific inflammatory pathways involved in the patient's condition.

AJM300 (carotegrast methyl), an oral antagonist of α4-integrin, as induction therapy for patients with moderately active ulcerative colitis: a multicentre, randomised, double-blind, placebo-controlled, phase 3 study.Safety and Efficacy of AJM300, an Oral Antagonist of α4 Integrin, in Induction Therapy for Patients With Active Ulcerative Colitis.Leukocyte traffic control: a novel therapeutic strategy for inflammatory bowel disease--an update.