The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05291689
Recruitment Status : Active, not recruiting
First Posted : March 23, 2022
Last Update Posted : December 5, 2023
Sponsor:
Information provided by (Responsible Party):
Morphic Therapeutic, Inc

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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)

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Colitis, Ulcerative Drug: MORF-057 Phase 2

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : May 24, 2022
Actual Primary Completion Date : October 18, 2023
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: MORF-057 Drug: MORF-057
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change from baseline to Week 12 in the Robarts Histopathology Index (RHI) Score [ Time Frame: From baseline to 12 weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. Change from baseline to Week 12 in the Modified Mayo Clinic Score [ Time Frame: From baseline to 12 weeks ]
  3. Maximum Plasma Concentration (Cmax) during single and multiple doses of MORF-057 [ Time Frame: 12 weeks ]
  4. Time to reach Cmax (Tmax) during single and multiple doses of MORF-057 [ Time Frame: 12 weeks ]
  5. Area under the curve (AUC) following single and multiple doses of MORF-057 [ Time Frame: 12 weeks ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05291689


Locations
Layout table for location information
United States, Florida
Clinical Study Site
Tampa, Florida, United States, 33609
United States, Louisiana
Clinical Study Site
Lafayette, Louisiana, United States, 70503
United States, New Jersey
Clinical Study Site
Freehold, New Jersey, United States, 07728
United States, New York
Clinical Study Site
Brooklyn, New York, United States, 11235
Clinical Study Site
New York, New York, United States, 10075
Poland
Clinical Study Site
Bydgoszcz, Poland, 85-794
Clinical Study Site
Elblag, Poland, 82-300
Clinical Study Site
Katowice, Poland, 40-748
Clinical Study Site
Lodz, Poland, 90-349
Clinical Study Site
Oswiecim, Poland, 32-600
Clinical Study Site
Sopot, Poland, 81-756
Clinical Study Site
Sosnowiec, Poland, 41-209
Clinical Study Site
Staszów, Poland, 28-200
Clinical Study Site
Tychy, Poland, 43-100
Clinical Study Site
Warsaw, Poland, 00-728
Clinical Study Site
Warsaw, Poland, 02-665
Clinical Study Site
Łódź, Poland, 90-752
Sponsors and Collaborators
Morphic Therapeutic, Inc
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Morphic Therapeutic, Inc
ClinicalTrials.gov Identifier: NCT05291689    
Other Study ID Numbers: MORF-057-201
First Posted: March 23, 2022    Key Record Dates
Last Update Posted: December 5, 2023
Last Verified: December 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Morphic Therapeutic, Inc:
Ulcerative Colitis (UC)
Inflammatory Bowel Disease (IBD)
a4b7
Moderately to severely active ulcerative colitis
Integrin
Additional relevant MeSH terms:
Layout table for MeSH terms
Colitis
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Ulcer
 Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes