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Trial record 2 of 3 for:    MORF-057

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

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ClinicalTrials.gov Identifier: NCT05291689
Recruitment Status : Recruiting
First Posted : March 23, 2022
Last Update Posted : November 2, 2022
Information provided by (Responsible Party):
Morphic Therapeutic, Inc

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 Moderate to Severe Ulcerative Colitis (UC)

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 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 Moderate to Severe Ulcerative Colitis (EMERALD-1)
Actual Study Start Date : May 24, 2022
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

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.

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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • 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

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

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Contact: Morphic Therapeutic, Inc. 781-996-0955 clinicaltrials@morphictx.com

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United States, Florida
Clinical Study Site Recruiting
Miami, Florida, United States, 33175
Clinical Study Site Recruiting
Tampa, Florida, United States, 33609
United States, Louisiana
Clinical Study Site Recruiting
Lafayette, Louisiana, United States, 70503
United States, Massachusetts
Clinical Study Site Recruiting
Boston, Massachusetts, United States, 02215
United States, New Jersey
Clinical Study Site Recruiting
Freehold, New Jersey, United States, 07728
United States, New York
Clinical Study Site Recruiting
Brooklyn, New York, United States, 11235
Clinical Study Site Recruiting
New York, New York, United States, 10075
United States, South Carolina
Clinical Study Site Recruiting
Greenville, South Carolina, United States, 29605
United States, Texas
Clinical Study Site Recruiting
Austin, Texas, United States, 78748
Clinical Study Site Recruiting
Houston, Texas, United States, 77598
Clinical Study Site Recruiting
Southlake, Texas, United States, 76092
Clinical Study Site Recruiting
Bydgoszcz, Poland, 85-794
Clinical Study Site Recruiting
Elblag, Poland, 82-300
Clinical Study Site Recruiting
Katowice, Poland, 40-748
Clinical Study Site Recruiting
Krakow, Poland, 31-501
Clinical Study Site Recruiting
Lodz, Poland, 90-349
Clinical Study Site Recruiting
Oswiecim, Poland, 32-600
Clinical Study Site Recruiting
Sosnowiec, Poland, 41-209
Clinical Study Site Recruiting
Staszów, Poland, 28-200
Clinical Study Site Recruiting
Tychy, Poland, 43-100
Clinical Study Site Recruiting
Warsaw, Poland, 00-728
Clinical Study Site Recruiting
Warsaw, Poland, 02-665
Clinical Study Site Recruiting
Warsaw, Poland, 03-712
Clinical Study Site Recruiting
Łódź, Poland, 90-752
Sponsors and Collaborators
Morphic Therapeutic, Inc
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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: November 2, 2022
Last Verified: September 2022

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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)
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes