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A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC (EMERALD-2)

Primary Purpose

Inflammatory Bowel Diseases, Colitis, Ulcerative

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MORF-057
Placebo
Sponsored by
Morphic Therapeutic, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD), a4b7, Moderate-to-severe, Integrin, EMERALD

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Study SiteRecruiting
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  • Clinical Study Site
  • Clinical Study SiteRecruiting
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  • Clinical Study SiteRecruiting
  • Clinical Study SiteRecruiting
  • Clinical Study SiteRecruiting
  • Clinical Study SiteRecruiting
  • Clinical Study SiteRecruiting
  • Clinical Study SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

MORF-057 Dosing Regimen One for Induction and Maintenance Periods

MORF-057 Dosing Regimen Two for Induction and Maintenance Periods

MORF-057 Dosing Regimen Three for Induction and Maintenance Periods

Matching Placebo Dosing Regimen for Induction and MORF-057 Dosing Regimen Four for Maintenance

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 31, 2022
Last Updated
August 28, 2023
Sponsor
Morphic Therapeutic, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05611671
Brief Title
A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 31, 2022 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Morphic Therapeutic, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Colitis, Ulcerative
Keywords
Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD), a4b7, Moderate-to-severe, Integrin, EMERALD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
MORF-057 Dosing Regimen One for Induction and Maintenance Periods
Arm Title
Group 2
Arm Type
Experimental
Arm Description
MORF-057 Dosing Regimen Two for Induction and Maintenance Periods
Arm Title
Group 3
Arm Type
Experimental
Arm Description
MORF-057 Dosing Regimen Three for Induction and Maintenance Periods
Arm Title
Group 4
Arm Type
Placebo Comparator
Arm Description
Matching Placebo Dosing Regimen for Induction and MORF-057 Dosing Regimen Four for Maintenance
Intervention Type
Drug
Intervention Name(s)
MORF-057
Intervention Description
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo (identical appearance to MORF-057) administered orally.
Primary Outcome Measure Information:
Title
Proportion of participants in clinical remission at Week 12 as determined using the Modified Mayo Clinic Score (mMCS).
Description
mMCS is a composite of the Mayo endoscopic and Mayo clinic scores, and stool frequency scores.
Time Frame
From baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline to Week 12 in clinical response in the Modified Mayo Clinic Score (mMCS)
Description
mMCS is a composite of the Mayo endoscopic and Mayo clinic scores, and stool frequency scores.
Time Frame
From baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Morphic Therapeutic, Inc
Phone
781-996-0955
Email
clinicaltrials@morphictx.com
Facility Information:
Facility Name
Clinical Study Site
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Freehold
State/Province
New Jersey
ZIP/Postal Code
07728
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78748
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Study Site
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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