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

Last updated: July 29, 2025
Sponsor: Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)
Overall Status: Completed

Phase

2

Condition

Gastrointestinal Diseases And Disorders

Crohn's Disease

Inflammatory Bowel Disease

Treatment

MORF-057

Clinical Study ID

NCT05291689
27506
MORF-057-201
J6E-MC-KWAL
  • Ages 18-85
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has signs/symptoms of moderately to severely active UC for at least 3 months priorto 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 toother UC drugs

  • Agrees to abide by the study guidelines and requirements

  • Capable of giving signed informed consent

Exclusion

Exclusion Criteria:

  • Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis,radiation colitis, or Crohn's disease or has clinical findings suggestive of Crohn'sdisease

  • 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 investigationaltherapy within 30 days

  • Previous exposure to MORF-057 and/or a known hypersensitivity to drugs with asimilar mechanism to MORF-057

  • Unable to attend study visits or comply with study procedures

Study Design

Total Participants: 39
Treatment Group(s): 1
Primary Treatment: MORF-057
Phase: 2
Study Start date:
May 24, 2022
Estimated Completion Date:
February 19, 2025

Study 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.

Connect with a study center

  • Clinical Study Site

    Bydgoszcz, 85-794
    Poland

    Site Not Available

  • Clinical Study Site

    Elblag, 82-300
    Poland

    Site Not Available

  • Clinical Study Site

    Katowice, 40-748
    Poland

    Site Not Available

  • Clinical Study Site

    Krakow, 31-501
    Poland

    Site Not Available

  • Clinical Study Site

    Lodz, 90-349
    Poland

    Site Not Available

  • Clinical Study Site

    Oswiecim, 32-600
    Poland

    Site Not Available

  • Clinical Study Site

    Sopot, 81-756
    Poland

    Site Not Available

  • Clinical Study Site

    Sosnowiec, 41-209
    Poland

    Site Not Available

  • Clinical Study Site

    Staszów, 28-200
    Poland

    Site Not Available

  • Clinical Study Site

    Tychy, 43-100
    Poland

    Site Not Available

  • Clinical Study Site

    Warsaw, 02-665
    Poland

    Site Not Available

  • Clinical Study Site

    Łódź, 90-752
    Poland

    Site Not Available

  • Clinical Study Site

    Miami, Florida 33175
    United States

    Site Not Available

  • Clinical Study Site

    Tampa, Florida 33609
    United States

    Site Not Available

  • Clinical Study Site

    Lafayette, Louisiana 70503
    United States

    Site Not Available

  • Clinical Study Site

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Clinical Study Site

    Freehold, New Jersey 07728
    United States

    Site Not Available

  • Clinical Study Site

    Brooklyn, New York 11235
    United States

    Site Not Available

  • Clinical Study Site

    New York, New York 10075
    United States

    Site Not Available

  • Clinical Study Site

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • Clinical Study Site

    Austin, Texas 78748
    United States

    Site Not Available

  • Clinical Study Site

    Houston, Texas 77598
    United States

    Site Not Available

  • Clinical Study Site

    Southlake, Texas 76092
    United States

    Site Not Available

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