A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC

Inflammatory Bowel Diseases Clinical Trial

— EMERALD-2  

Official title:

A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Active Dose Regimens of MORF-057 in Adults With Moderately to Severely Active Ulcerative Colitis (EMERALD-2)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05611671
• Other study ID #: MORF-057-202
• Status: Recruiting
• Phase: Phase 2
• Start date: October 31, 2022
• Est. completion date: July 2025

Study information

• Verified date: February 2024
• Source: Morphic Therapeutic, Inc
• Contact: Morphic Therapeutic, Inc
• Phone: 781-996-0955
• Email: clinicaltrials[@]morphictx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 2b randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of three active dose regimens of MORF-057 in adult patients with moderately to severely active Ulcerative Colitis (UC).

Description:

This is a Phase 2b randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of three active dose regimens of MORF-057 plus a placebo regimen in study participants with moderately to severely active UC. After completion of the 12-week Induction Period, participants may be switched to a different active MORF-057 regimen during the Maintenance Period. Those randomized into the placebo group in the Induction Period will be switched to receive an active MORF-057 regimen during the Maintenance Period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: July 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Has signs/symptoms of moderate to severe UC for at least 3 months prior to Screening
• Has evidence of UC extending at least 15 cm from the anal verge
• Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Oral aminosalicylates (e.g., mesalamine, sulfasalazine, olsalazine, or balsalazide), corticosteroids, immunosuppressants (e.g., azathioprine, 6-mercaptopurine, or methotrexate), advanced therapies for UC (e.g., biologic agents, Janus kinase [JAK] antagonists, or sphingosine-1-phosphate [S1P] receptor agonists)
• Subject has no prior exposure to approved or investigational anti-integrin therapies
• Agrees to abide by the study guidelines and requirements
• Capable of giving signed informed consent

Exclusion Criteria:

• Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or Crohn's disease or has clinical findings suggestive of Crohn's disease
• Has positive findings on a subjective neurological screening questionnaire
• Has a concurrent, clinically significant, serious, unstable comorbidity
• Previous treatment with vedolizumab or other licensed or investigational integrin inhibitors
• Participation in any other interventional study or received any investigational therapy within 30 days
• Previous exposure to MORF-057 and/or a known hypersensitivity to drugs with a similar mechanism to MORF-057
• Unable to attend study visits or comply with study procedures

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcer

Intervention

Drug:
• MORF-057
MORF-057 is a small molecule that is designed to selectively inhibit integrin a4ß7 and is administered orally.
• Placebo
Matching placebo (identical appearance to MORF-057) administered orally.

Locations

Country	Name	City	State
Australia	Clinical Study Site	Blacktown	New South Wales
Australia	Clinical Study Site	Brisbane	Queensland
Australia	Clinical Study Site	Brisbane	Queensland
Australia	Clinical Study Site	Concord	New South Wales
Australia	Clinical Study Site	Murdoch	Western Australia
Australia	Clinical Study Site	Parkville	Victoria
United States	Clinical Study Site	Austin	Texas
United States	Clinical Study Site	Boston	Massachusetts
United States	Clinical Study Site	Cedar Park	Texas
United States	Clinical Study Site	Chapel Hill	North Carolina
United States	Clinical Study Site	Freehold	New Jersey
United States	Clinical Study Site	Greenville	South Carolina
United States	Clinical Study Site	Houston	Texas
United States	Clinical Study Site	Kissimmee	Florida
United States	Clinical Study Site	Lancaster	California
United States	Clinical Study Site	Los Angeles	California
United States	Clinical Study Site	Mentor	Ohio
United States	Clinical Study Site	Miami	Florida
United States	Clinical Study Site	Miramar	Florida
United States	Clinical Study Site	New York	New York
United States	Clinical Study Site	Orlando	Florida
United States	Clinical Study Site	Sun City	Arizona
United States	Clinical Study Site	Wellington	Florida
United States	Clinical Study Site	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Morphic Therapeutic, Inc

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants in clinical remission at Week 12 as determined using the Modified Mayo Clinic Score (mMCS).	mMCS is a composite of the Mayo endoscopic and Mayo clinic scores, and stool frequency scores.	From baseline to 12 weeks
Secondary	Change from baseline to Week 12 in clinical response in the Modified Mayo Clinic Score (mMCS)	mMCS is a composite of the Mayo endoscopic and Mayo clinic scores, and stool frequency scores.	From baseline to 12 weeks