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A Phase 2a Open-Label Study to Evaluate the Efficacy and Safety of MORF-057 in Adults With UC

Primary Purpose

Inflammatory Bowel Diseases, Colitis, Ulcerative

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MORF-057
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, Moderately to severely active ulcerative colitis, Integrin

Eligibility Criteria

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

Inclusion Criteria:

  • Has signs/symptoms of moderately to severely active UC for at least 3 months prior to Screening
  • Has evidence of UC extending at least 15 cm from the anal verge
  • Is bio-naïve or had an inadequate response, loss of response, or intolerance to other UC drugs
  • 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
  • Primary non-responder to vedolizumab or other 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 Site
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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MORF-057

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline to Week 12 in the Robarts Histopathology Index (RHI) Score

Secondary Outcome Measures

Frequencies and proportions for treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and TEAEs leading to study drug discontinuation overtime
Change from baseline to Week 12 in the Modified Mayo Clinic Score
Maximum Plasma Concentration (Cmax) during single and multiple doses of MORF-057
Time to reach Cmax (Tmax) during single and multiple doses of MORF-057
Area under the curve (AUC) following single and multiple doses of MORF-057

Full Information

First Posted
March 10, 2022
Last Updated
August 3, 2023
Sponsor
Morphic Therapeutic, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05291689
Brief Title
A Phase 2a Open-Label Study to Evaluate the Efficacy and Safety of MORF-057 in Adults With UC
Official Title
A Phase 2a, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, and Tolerability of MORF-057 in Adults With Moderately to Severely Active Ulcerative Colitis (EMERALD-1)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 24, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
February 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 an open-label, single arm, multicenter, Phase 2a study evaluating the efficacy, safety, and tolerability of MORF-057 in adult patients with Moderately to Severely Active Ulcerative Colitis (UC)
Detailed Description
The main part of this Phase 2a study will consist of 3 study periods: a Screening Period, a Treatment Period and a Safety Follow-up Period. All participants who complete the open-label Treatment Period will have the opportunity to continue their treatment in an optional 26-week Long-term Extension study after completing the Week 52 assessments.

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, Moderately to severely active ulcerative colitis, Integrin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MORF-057
Arm Type
Experimental
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.
Primary Outcome Measure Information:
Title
Change from baseline to Week 12 in the Robarts Histopathology Index (RHI) Score
Time Frame
From baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Frequencies and proportions for treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and TEAEs leading to study drug discontinuation overtime
Time Frame
12 weeks
Title
Change from baseline to Week 12 in the Modified Mayo Clinic Score
Time Frame
From baseline to 12 weeks
Title
Maximum Plasma Concentration (Cmax) during single and multiple doses of MORF-057
Time Frame
12 weeks
Title
Time to reach Cmax (Tmax) during single and multiple doses of MORF-057
Time Frame
12 weeks
Title
Area under the curve (AUC) following single and multiple doses of MORF-057
Time Frame
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 moderately to severely active UC for at least 3 months prior to Screening Has evidence of UC extending at least 15 cm from the anal verge Is bio-naïve or had an inadequate response, loss of response, or intolerance to other UC drugs 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 Primary non-responder to vedolizumab or other 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
Facility Information:
Facility Name
Clinical Study Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Clinical Study Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Clinical Study Site
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
Clinical Study Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Clinical Study Site
City
Freehold
State/Province
New Jersey
ZIP/Postal Code
07728
Country
United States
Facility Name
Clinical Study Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Clinical Study Site
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Clinical Study Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Clinical Study Site
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Clinical Study Site
City
Bydgoszcz
ZIP/Postal Code
85-794
Country
Poland
Facility Name
Clinical Study Site
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Clinical Study Site
City
Katowice
ZIP/Postal Code
40-748
Country
Poland
Facility Name
Clinical Study Site
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Clinical Study Site
City
Lodz
ZIP/Postal Code
90-349
Country
Poland
Facility Name
Clinical Study Site
City
Oswiecim
ZIP/Postal Code
32-600
Country
Poland
Facility Name
Clinical Study Site
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Clinical Study Site
City
Sosnowiec
ZIP/Postal Code
41-209
Country
Poland
Facility Name
Clinical Study Site
City
Staszów
ZIP/Postal Code
28-200
Country
Poland
Facility Name
Clinical Study Site
City
Tychy
ZIP/Postal Code
43-100
Country
Poland
Facility Name
Clinical Study Site
City
Warsaw
ZIP/Postal Code
00-728
Country
Poland
Facility Name
Clinical Study Site
City
Warsaw
ZIP/Postal Code
02-665
Country
Poland
Facility Name
Clinical Study Site
City
Warsaw
ZIP/Postal Code
03-712
Country
Poland
Facility Name
Clinical Study Site
City
Łódź
ZIP/Postal Code
90-752
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

A Phase 2a Open-Label Study to Evaluate the Efficacy and Safety of MORF-057 in Adults With UC

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