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

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ClinicalTrials.gov Identifier: NCT05611671
Recruitment Status : Recruiting
First Posted : November 10, 2022
Last Update Posted : May 16, 2024
Sponsor:
Information provided by (Responsible Party):
Morphic Therapeutic, Inc

Study Description
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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).

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

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : October 31, 2022
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1
MORF-057 Dosing Regimen One for Induction and Maintenance Periods
 Drug: MORF-057
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Experimental: Group 2
MORF-057 Dosing Regimen Two for Induction and Maintenance Periods
 Drug: MORF-057
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Experimental: Group 3
MORF-057 Dosing Regimen Three for Induction and Maintenance Periods
 Drug: MORF-057
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Placebo Comparator: Group 4
Matching Placebo Dosing Regimen for Induction and MORF-057 Dosing Regimen Four for Maintenance
 Drug: MORF-057
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.

Drug: Placebo
Matching placebo (identical appearance to MORF-057) administered orally.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants in clinical remission at Week 12 as determined using the Modified Mayo Clinic Score (mMCS). [ Time Frame: From baseline to 12 weeks ]
    mMCS is a composite of the Mayo endoscopic and Mayo clinic scores, and stool frequency scores.


Secondary Outcome Measures :
  1. Change from baseline to Week 12 in clinical response in the Modified Mayo Clinic Score (mMCS) [ Time Frame: From baseline to 12 weeks ]
    mMCS is a composite of the Mayo endoscopic and Mayo clinic scores, and stool frequency scores.


Eligibility Criteria
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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
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
Contacts and Locations
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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): NCT05611671


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

Locations
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Sponsors and Collaborators
Morphic Therapeutic, Inc
More Information
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Responsible Party: Morphic Therapeutic, Inc
ClinicalTrials.gov Identifier: NCT05611671    
Other Study ID Numbers: MORF-057-202
First Posted: November 10, 2022    Key Record Dates
Last Update Posted: May 16, 2024
Last Verified: May 2024

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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)
a4b7
 Moderate-to-severe
Integrin
EMERALD
Additional relevant MeSH terms:
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Colitis
Intestinal Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Ulcer
 Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes